TIONAL

GUIDELNS FOR
COMPREHNSIV
HIV PREVNTIO,
CARE AND
TMEN RA

February 2022
Table of Contents
Forward i
Acknowledgement ii
Acronyms and Abbreviations iii
Summary of the changes made in these guidelines v
CHAPTER ONE - INTRODUCTION 1
1.1. Background and Context 1
1.2. Rationale 2
1.3. Objectives of the Guidelines 2
1.4.Target Audience 3
1.5.Guiding Principles 3
CHAPTER TWO: HIV PREVENTION 4
2.1 HIV Combination Prevention 4
2.2. Condom programing for KPP and general populations 8
2.3. Pre Exposure Prophylaxis 8
2.4. Prevention and management of Gender Based Violence (GBV) 11
2.5. Post Exposure Management including Prophylaxis 12
2.5.1. Management of Occupational Exposure to HIV 12
2.5.2. Prevention of HIV Transmission after Sexual Assault 16
2.6. Undetectable=Un-transmittable (U=U) (የ=የ) 17
2.7. Screening and treatment of Sexually Transmitted Infections 18
2.8. Voluntary Medical Male Circumcision (VMMC) 18
2.9.Care of HIV Exposed Infants (HEI) 18
CHAPTER THREE: HIV CASE FINDING 23
3.1. HIV Testing Services 23
3.1.1. Core Principles 23
3.1.2. Guiding Principles for HIV counseling and testing 24
3.2. Demand creation for HTS 25
3.3. HIV Testing Service Provision Settings 26
3.3.1. Facility Setting 26
3.3.2. Community Setting 26
3.4. Approaches of HTS 27
3.4.1. Voluntary Counseling and Testing (VCT) 27
3.4.2. Provider Initiated Testing and Counseling (PITC) 27
3.4.2.1. Use of HIV Risk Screening Tool (HRST) to Enhance PITC 29
3.4.2.2. Eligible clients for HIV Testing and counseling while providing PITC
29
includes:
3.4.3. Index Case Testing 29
3.4.4. Social Network Strategy (SNS) 33
3.4.5. HIV Self Testing 34
3.4.6. Recency Testing 36
3.5. Procedures of HTS delivery 37
3.6. HIV Testing in infants and children 43
3.7. Retesting 44
3.8. Quality assurance and Quality Improvement for HTS 46
3.9. Linking People Diagnosed with HIV Infection 48
3.10. Ethical and Legal Recommendations for HIV Testing Service 50
CHAPTER FOUR: CARE AND TREATMENT OF PEOPLE LIVING WITH HIV
52
INFECTION
4.1. General Care Packages for PLHIV 52
4.2. Advanced HIV Disease 53
4.3. Preparing People Living with HIV for ART 55
4.4. When to Start ART 56
4.4.1. When to Start ART in Adults and Adolescents 56
4.4.2. When to Start ART in Pregnant and Breast-feeding Women 56
4.4.3. When to Start ART in Children 57
4.4.4. When to start ART in adults, adolescents, and children with TB 57
4.4.5. When to start ART in adults, adolescents, and children with drug resistant TB 57
4.4.6. When to start ART in HIV/HBV co-infected patients 57
4.4.7. When to start ART in HIV/Cryptococcal meningitis co-infected patients 57
4.5. What ART regimen to start with (first-line ART) 58
4.5.1. First-line regimen for adults and adolescents 59
4.5.2. First line ART for children 59
4.5.3. Consideration for first line ART regimen for PLHIV on TB treatment 59
4.5.4. Consideration for alternative and special circumstance first line ART
59
regimens
4.6. Monitoring response to ART 59
4.6.1. What to expect in the first months of ART and how to manage them 59
4.6.2. Clinical and laboratory monitoring 61
4.6.3. Monitoring drug toxicities and substitution of ARV 67
4.6.4. Drug interactions 71
4.7. Re-engaging with care after ART interruption 75
4.8. Diagnosis and management of antiretroviral treatment failure 75
4.9. Management of treatment failure 80
4.9.1. Management of first-line treatment failure (switching to second-line ART) 80
4.9.2. Management of second-line treatment failure (switching to third line ART) 81
4.9.3. Second line ART service in health centers 84
CHAPTER FIVE: PREVENTION, SCREENING, AND MANAGEMENT OF COMMON
85
CO-INFECTIONS AND COMORBIDITIES
5.1. Co-trimoxazole preventive therapy (CPT) 86
5.2.Tuberculosis 88
5.3. Pneumonia 108
5.3.1.Bacterial Pneumonia 108
5.3.2.Pneumocystis pneumonia 110
5.3.3.Lymphoid Interstitial Pneumonitis 111
5.4. Hepatitis B and C 111
5.4.1.HBV/HIV co-infection management 112
5.4.2.HCV HIV co-infection management 113
5.5. Sexual Transmitted Infection and Cervical Cancer 114
5.6. Non-Communicable Disease (NCD) 117
5.7. HIV and Mental Health Disorders 117
5.8.HIV related skin and oral conditions 121
5.8.1. Etiological classification of skin disorders in HIV disease 121
5.8.2. Pruritic Papular Eruption (PPE) 124
5.8.3. Dysphagia and odynophagia 124
5.9.HIV related Neurological conditions 125
5.9.1.Toxoplasma gondii encephalitis 126
5.9.2.Cryptococcal infection 127
5.9.3. Peripheral neuropathies 131
5.10. Visceral leishmaniasis 131
CHAPTER SIX: SERVICE DELIVERY 133
6.1. Differentiated HIV service delivery 134
6.1.1 Less intensive DSD models 137
6.1.1.1 Appointment Spacing Model (ASM/6MMD) 137
6.1.1.2 Three Months ARV Dispensing (3MMD) 137
6.1.1.3. Fast Track ARV Drugs Refill Model 137
6.1.1.4. Health Extension Professional Managed Community ART refill group
138
(HEP_CAG)
6.1.1.5. Peer lead community based ART distribution/Group (PCAD/G) 138
6.1.2 More intensive DSD models 138
6.1.2.1. Health care worker managed DSD Model for adolescent living with HIV
138
(DSD for ALHIV)
6.1.2.2 DSD for key population (for FSWs) 139
6.1.2.3 DSD for Advanced HIV Disease and PLHIV at high risk Disease
139
Progression
6.1.2.4 MCH _DSD 140
6.2. Recommendations to strengthen the continuum of treatment and care 140
6.2.1 Disclosure 140
6.2.1.1 Disclosure in Children 141
6.2.1.1 Planning for disclosure 143
6.2.1.2 Stages of disclosure 143
6.2.1.3 Post –disclosure assessments and follow-up 144
6.2.1.3 Disclosure in adults 144
 6.2.2. Retention 146
6.2.2.1 Good practices to optimize retention 146
6.2.2.2 Specific population considerations 147
6.2.3. Adherence to ART 150
6.2.3.1. Barriers to adherence 150
6.2.3.2. Supportive interventions 151
6.2.3.3 Monitoring adherence to ART in routine program and care settings 152
6.2.4. Task shifting for HIV treatment and care 153
6.2.5 Decentralizing HIV treatment and care 154
6.2.6 Integrating and linking services 154
6.2.7. Adolescent-friendly health services 155
6.2.8. Improving the quality of HIV care services 156
6.3. Pharmaceuticals Supply Management System 157
6.3.1. Supply Chain Management 157
6.3.2. ART Pharmacy Services 159
6.4. Laboratory and diagnostic services 162
CHAPTER SEVEN - GUIDANCE FOR PROGRAM MANAGERS AND LEADERS 167
7.1 Guiding principles 167
7.2. Overview of the HIV/AIDS National Strategic Plan 2021-2025 168
7.4. HIV response in the context of COVID 19 170
7.5. Key parameters for decision-making 171
7.6. Roles and responsibility 172
7.7. Coordination mechanisms 174
CHAPTER EIGHT - MONITORING AND EVALUATION 175
8.1. Introduction to HIV/AIDS Program Monitoring & Evaluation (M&E) 175
8.2. Key Indicators 176
8.3. Data reporting, data flow and quality assurance 197
8.3.1. Data quality assurance 197
8.4. HIV/AIDS Program Monitoring 198
8.4.1. Supportive supervision
8.4.2. program Performance Review 198
8.5. Other Monitoring Considerations 198
8.6. Recording and reporting Tools in HIV/ AIDS Program 199
CHAPTER NINE - ANNEXES 200
Annex 1: KP Minimum Service Package 200
Annex 2: Immunization schedule for HIV exposed infants 204
Annex 3: Growth curves 205
Annex 4. Instruction for MUAC measurement 211
Annex 5a. HIV Risk assessment tool for children <15 years of age 212
Annex 5b. HIV Risk assessment tool for adults and adolescents > 15 years of age 214
Annex 6a. Clinical Conditions that make eligible for HIV Testing Service in adults and
215
adolescents
Annex 6b. Clinical Conditions that make eligible for HIV Testing Service in children 216
Annex 6b. Clinical Conditions that make eligible for HIV Testing Service in children 217
Annex 7: Dosage of antiretroviral drugs for adults and adolescents 218
Annex 8: Dosage of antiretroviral drugs in children 219
Annex 9: Pediatric ARV drug formulations, side effects and special considerations in
221
children
Annex 10: Grading of toxicity in adults and adolescents 226
Annex 11: Grading of adverse events in children 227
Annex 12. Laboratory grading of adverse events in adults and adolescents (ACTG) 229
Annex 13: Grading toxicities in children by selected laboratory findings 230
Annex 14: Pediatric TB screening tool 231
Annex 15: Adult TB screening tool 233
Annex 16: Follow-up form for Clients Whose Viral Load Result >50 copies/ml 235
Annex 17: Cohort register for clients with unsuppressed viral load(>50copies/ml) 238
Annex 18: Screening with VIA testing using see and treat approach 239
Annex 19: Screening with HPV testing followed by VIA triage algorithm 240
Annex 20: Brief mental health disorders symptom screening tool and referral tool for
241
PLHIV
Annex 21: DSD model of HIV care client classification tool/Assessment form 243
Forward

Antiretroviral treatment (ART) began in 2003 and free ART was launched in Ethiopia in 2005. According
to the 2020 spectrum estimate, 622,326 Ethiopians are living with human immunodeficiency virus
(HIV) and all of them require ART. However, only 80.5 % of adults and 40% of children and adolescents
are currently taking antiretroviral (ARV) drugs.

Recognizing the need for antiretroviral treatment, the Government of Ethiopia (GOE) issued the first
ARV guidelines in 2003, which were revised in 2005, 2008, 2014 and 2018 for provision of quality
prevention, care and treatment services at all levels. With continued evidence based updates, the
Ministry of Health has revised the national guideline to scale up and improve the quality of service
at all levels.

Expansion and strengthening HIV prevention, care and treatment activities at regional, zonal, woreda
and community levels through targeted social mobilization emphasizing Key and Priority Populations
and active community participation are expected to enhance the HIV epidemic control.

These consolidated guidelines on preventing and treating HIV infection bring together a series of
recommendations to promote the highest quality, person-centered delivery of care for people living
with and affected by HIV. Amid COVID 19 pandemic, program adaptations are required to ensure
continuity of the services including service delivery approaches put forward with the aim to promote
self-management.

The Ministry of Health believes that these guidelines, along with other national guidelines and training
manuals, provide the much needed framework and impetus to move towards universal access for
HIV services and the agenda for ending AIDS by 2030 as a key national health strategic objective.

Dereje Duguma, MD, MIH

State Minister of Health,
Federal Democratic Republic of Ethiopia

i
Acknowledgement

The Ministry of Health expresses its appreciation for the institutions participated in the revision of
these consolidated HIV prevention care and treatment guidelines and partners, which supported
the revision workshops expense. Special thanks goes to UNICEF for supporting the design and
printing of the document. The ministry also recognizes the following experts for their contribution
in the revision of the guidelines.

Name Organization Name Organization

Mrs. Mirtie Getachew MOH Dr. Ambachew Tefera Project Hope
Sr Seble Mamo MOH Dr. Miftah Kemal ICAP
Mrs. Alemtsehay Abebe MOH Dr. Mesfin Girma ICAP
Mr.Dejene Mulatu MOH Dr. Seblewongel Abate WHO
Dr. Zerihun Hika MOH/ICAP Dr. Yayeh Negash UNICEF
Mrs.Genet Getachew MOH Dr. Fana Tefera CDC
Dr. Getnet Bantayehu MOH/ICAP Dr. Solomon Ahmed CDC
Mr. Mulu Legesse MOH/GHSC-PSM Mr Asmamaw Silesh CHAI
Mr.Teklu Lemessa MOH Dr. Minesh Shah CDC
Mr. Mesfin Bekele MOH Mr Yalemsew Derib PSM
Mrs. Aregash Mola MOH Dr. Fahmi Ahmed WHO
Dr. Zebyideru Zewdie MOH/ICAP Dr. Chanie Temesgen CDC
Mr. Kifle Mitiku FHAPCO Mr. Tamene Tadesse Project Hope
Mr. Netsanet Haniko FHAPCO
Mr Getnet Hailu EPHI
Mrs. Kidist Zealias EPHI
Mrs. Tigist Kassahun EPSA
Dr. Mesfin Shimelis CDC
Dr. Ghion Tirsite WHO

ii
Acronyms and Abbreviations

3TC Lamivudine
ABC Abacavir
AFB Acid fast bacilli
AIDS Acquired Immune Deficiency Syndrome
ANC Antenatal Care
ARV Antiretroviral
ART Antiretroviral Therapy
AZT/ZDV Zidovudine
CBC Complete Blood Count
CD4 cells Type of T-lymphocyte, white blood cells
CMV Cytomegalovirus
CPT Cotrimoxazole Preventive Therapy
CrAg Cryptococcal antigen
DBS Dried Blood Spot
DTG Dolutegravir
DRV Darunavir
DHS Demographic and Health Survey
DNA Deoxyribonucleic acid
DPV-VR Dapivirine vaginal ring
DOTS Directly Observed Therapy Short Course
EFV Efavirenz, also abbreviated as EFZ
FBO Faith-based organization
FDC Fixed dose combination
FHAPCO Federal HIV/AIDS Prevention and Control Office
MOH Ministry of Health
HAART Highly active antiretroviral therapy
HBV Hepatitis B Virus
HCV Hepatitis C Virus
HIV Human Immunodeficiency Virus
HTS HIV Testing Services
IP Infection Prevention
IPT INH Preventive Therapy
IPLS Integrated Pharmaceuticals Logistics System
IRIS or IRS Immune Reconstitution Inflammatory Syndrome also called Immune
Reconstitution Syndrome (IRS)

iii
 INSTI Integrase strand transfer inhibitor (also known as integrase inhibitor)
LFT Liver Function Test
LPV Lopinavir
MTCT Mother-To-Child Transmission (of HIV)
MD Medical Doctor
NFV Nelfinavir
NGO Non-governmental Organization
NNRTI Non-nucleoside reverse transcriptase inhibitor
NRTI Nucleoside Analogue Reverse Transcriptase Inhibitor
NVP Nevirapine
OIs Opportunistic Infections
PCR Polymerase chain reaction
PEP Post-exposure prophylaxis
PI Protease Inhibitor
PITC Provider Initiative Testing and Counselling
PLHIV People living with HIV
PMTCT Prevention of mother-to-child transmission (of HIV)
PrEP Pre-exposure prophylaxis using ARVs before HIV exposure
RMU Rational medicine use
RNA Ribonucleic acid
RTV, r Ritonavir
PI/r Ritonavir boosted Protease Inhibitor
RAL Raltegravir
RFT Renal function test
RT Reverse transcriptase
STI Sexually Transmitted Illnesses
TB Tuberculosis
TDF Tenofovir
U/A Urine analysis
UNAIDS The Joint United Nations Program on HIV/AIDS
UP Universal Precautions
WHO World Health Organization
ZDV Zidovudine (also abbreviated as AZT)

iv
Summary of the
changes made in
these guidelines

The following list of recommendations consists ■ All HIV Exposed Infants will undergo
of either introducing new initiatives or/and through DNA-PCR antigen test at 4-6 weeks
modifications of previous recommendations, as and repeat DNA-PCR test at 9 months for
adopted from the updated WHO 2021 guidelines, those who tested negative.
and other relevant working documents.
HIV Case Finding
HIV Prevention
■ HIV Risk Screening Tool (HRST) should be
■ For adults and adolescents TDF + 3TC are implemented for all individuals (children,
recommended as the preferred backbone adolescents and adults) at service delivery
regimen for HIV PEP and Dolutegravir (DTG) units to improve HIV case detection and
is recommended as the preferred third drug yield of provider initiated testing.
for HIV PEP and when available, ATV/r,
DRV/r and LPV/r may be considered as an ■ Universal HIV testing will be implemented
alternative third drug options for PEP. for all pregnant women at the first ANC
visit, however retesting will be done based
■ In ten years and younger, AZT + 3TC is on their risk.
recommended as the preferred backbone
regimen for HIV PEP and ABC + 3TC or ■ Retesting for unknown or HIV-negative
TDF + 3TC can be considered as alternative post-partum women, can be considered
regimens and DTG is recommended as for key populations or for those who have
the preferred third drug for HIV PEP with virally unsuppressed HIV positive partners.
approved DTG dosing and when available.
■ The age limit of biological children of PLHIV
■ Undetectable=Untransmittable (U=U) is for ICT service increased from 15 to 19.
contextualized in Ethiopia setting by naming
“የማይታይ መጠን = የተገታ መተላለፍ (የ=የ) ■ The window period has been changed from
(“Yemaytay Meten = Yetegeta Metelalef”) 12 weeks to 6 weeks since third generation
focusing on demand creation for viral load kit can detect infection of 4 to 6 weeks.
testing, improving adherence to ART that
result in durable undetectable viral load ■ Recency testing is implemented to detect
resulted preventing sexual transmission of recent HIV infection less than one year.
HIV.

v
■ Provider Initiated Testing and Counseling ■ DTG containing regimens is the preferred first
workflow has been modified to follow those line regimens for all children age >4weeks
who decline testing and/or weight ≥ 3kg and the preferred first-
line regimen for all adults and adolescents
■ The HIV testing algorithm is revised and children >30kg is TDF+3TC+DTG as a
considering the current implementation once-daily dose. Accordingly the optimized
challenges and the available treatment regimen sequencing is modified.
recommendations.
■ Diagnosis of advanced HIV disease is done
HIV care and treatment through CD4 testing of clients at base
line (re-engaging with care after a period
■ ART should be initiated for all individuals of interruption for >28 days) and targeting
(children, adolescents, and adults) living with those who have interrupted ART treatment
HIV rapidly, preferably same day, (within an and with persistently high Viral load (>1000
hour for laboring mother) after confirming copies per ml).
HIV diagnosis, regardless of WHO clinical
stage and CD4 cell count except for TB and Revised treatment monitoring with viral
cryptococcal meningitis. load testing

■ Start ART in all TB patients living with HIV as 1. Viral suppression: is a viral load that is
soon as possible within 2 weeks following undetectable, equal to or less than 50 copies/
initiation of anti-TB treatment regardless of ml.
their CD4 count except when there is TB
meningitis. If a patient has TB meningitis, 2. Low-level viraemia: is one or more viral load
delay ART for at least 4 weeks and initiate results that are detectable (more than 50 copies/
within 8weeks after treatment of TB ml) but equal to or less than 1000 copies/ml.
meningitis is initiated.
3. Virological failure Viral load above 1000
■ ART should be delayed by 4-6 weeks of copies/ml based on two consecutive viral
ART following initiation of treatment for load measurements in 3 months, apart with
cryptococcal meningitis. Earlier ART is enhanced adherence support following the first
associated with more severe adverse event viral load test.
and increased mortality with cryptococcal
meningitis

vi
■ Treatment failure threshold should remain at a Unsuppressed viral load results should be
1000 copies/ml. The treatment monitoring immediately communicated
algorithm is revised based on these new
recommendations. b Conduct same-day testing using point-of-
care viral load testing for a repeat viral load
■ Whenever possible, use same-day point- test, where available, to expedite the return of
of-care testing (POC) for viral load testing results. If not available, viral load specimens
of pregnant and breastfeeding women to and results for a repeat viral load should be
expedite the return of results and clinical given priority across the laboratory referral
decision-making. If this is not available, viral process (including specimen collection, testing
load specimens and results for pregnant and return of results).
and breastfeeding women should be
given priority across the laboratory referral
process.

■ The viral load testing schedule is revised for

pregnant and breast feeding women.

vii
TB/HIV Service Delivery

■ LF-LAM is included for active TB diagnosis ■ Differentiated service delivery for HIV
in PLHIV with TB symptoms, serious illness treatment is based on four building blocks.
and/or Advanced HIV Disease In any given differentiated service delivery
model for HIV treatment, the building blocks
■ TB Preventive Therapy (TPT) is the use of need to be defined separately for clinical
Isoniazid, rifapentine or other medications consultations, ART refills and psychosocial
to sterilize latent TB infection. The preferred support.
regimen for adult PLHIV is a combination of
INH and refapentine to be taken once per ■ The diversity of models and eligibility
week for three months (3HP). criteria are modified based on the new
recommendations. Eligibility criteria to be
Cervical cancer Screening considered as established on ART (Stable)
are those clients which are above 5 years
■ Cervical cancer screening is an important old of age, on ART for >6 month, evidence
test in women living with HIV to prevent of treatment of success, adherence of
significant morbidity and mortality the client should be >95% and no current
associated with HPV. Cervical cancer is illness.
a preventable disease and is curable if
diagnosed and treated early. Women living
with HIV have a higher risk of pre-cancer
and invasive cervical cancer.

viii
CHAPTER ONE:
INTRODUCTION
1.1. Background and Context the performance of the HIV case identification
in Ethiopia for closing the gaps to treatment and
HIV infection is one of the global public health achieve epidemic control, the remaining 21% of
issues. In 2020, more than 37.7 million [30.2 PLHIV need to be reached. (EDHS 2016)
million–45.1 million] people were living with
HIV, and 1.5 million [1.0 million–2.0 million] Free ART service was launched in January 2005
people acquired HIV. Nearly 45% of the people and public hospitals start providing free ART in
newly infected with HIV live in sub-Saharan March 2005. Currently ART service is being
Africa (UNAIDS; 2021). available in more than 1,500 health facilities.
According to the program data in 2020, around
The first evidence of HIV epidemic in Ethiopia 465,457 adults and 17,670 children under the age
was detected in 1984. Since then, HIV/AIDS of 15 are taking ARV, with ART need of 578,188
has claimed the lives of millions and has left for adults and 42,971 for children under 15 years
behind hundreds of thousands of orphans. of age. Based on the new spectrum estimate
The government of Ethiopia took several steps for 2020, ART coverage for adults (age >15) has
in preventing further disease spread, and in reached 80.5 % but the coverage remains low
increasing accessibility to HIV care, treatment (40.03%) for children (age <15) living with HIV.
and support for persons living with HIV. According to EPHI 2020/21 report, the national
viral load testing coverage was 74.5%, with a
The HIV epidemic in Ethiopia is characterized suppression rate of 95%.
as mixed, with wide regional variations and
concentrations in urban areas, including some The National Guidelines for Comprehensive HIV
distinct hotspot areas driven by key and priority Prevention, Care and Treatment was last revised
populations. According to the EDHS done in in 2018. Since then, new information as well
2016, the national adult (15-49) HIV prevalence as evidence-based best practices has become
is 0.96 %; the urban prevalence was 2.9%, available to make HIV prevention, testing and
which is seven times higher than that of the treatment more effective and accessible,
rural (0.4%). National HIV Related Estimates ensuring the continuity of HIV prevention,
and Projections (2020), also shows that the HIV treatment and care specially focusing on KPPs
prevalence varies from region to region ranging amid COVID-19 pandemic which created the
from less than 0.15% in Ethiopia Somali to need to revise the existing guidelines. Hence,
4.13% in Gambella. this guideline is revised taking into consideration
of the current recommendations released by
The progress towards achieving the first 95 WHO in 2021.
target has been far behind the track; only 79%
of PLHIV know their HIV status. To accelerate

1
1.2. Rationale

■ Guidance on the implementation of ■ These guidelines enable key clinical,

national epidemic control roadmap through operational, and programmatic implications
geographic and population prioritization, of new science and emerging practice in HIV
targeted interventions focusing on cost programs to be comprehensively reviewed
effective and high impact prevention, care periodically across populations, age groups
and treatment services. and settings.

■ Guidance on using combination HIV 1.3. Objectives of the Guidelines

prevention services like targeted SBCC and
demand creation focusing on KPPs, condom ■ To provide evidence based update on
promotion and distribution, PEP, PrEP, STI, combination prevention interventions
VMMC and prevention and management of targeting KPP and general populations.
GBV.
■ To provide update on new initiatives of HIV
■ Guidance on using innovative HIV testing case identification and Care and treatment
approaches like targeted HIV testing by implementation strategies and standardize
HIV risk screening tools (HRST) for all age service delivery models in the context of the
groups, Index Case Testing (ICT), social continuum of HIV care in the comprehensive
network strategy (SNS) among FSWs and HIV/AIDS service delivery setting.
their sexual network members, HIV self-
■ To provide guidance on key operational
testing and recency testing.
and service delivery issues that need to
■ Guidance on using optimized ARV drugs be addressed to increase access to HIV
presented within the context of the services, to improve quality, strengthen the
continuum of HIV-related prevention, continuum of HIV care and further integrate
treatment, and care. These guidelines the provision of HIV prevention, care and
address updates on the newly recommended treatment into health systems; and
ARV regimen in all population groups since
■ To serve as a reference material for health
the introduction of DTG.
service providers and program managers.

■ Guidance on the consistency of approaches

and linkage across the various settings in
which HIV Prevention, Case identification,
Care and Treatment related services
provided.

2
1.4.Target Audience

The guideline is intended to be used by: ■ Public Health Approach: the guidelines are
based on a public health approach to scale
■ Health care providers at health facilities up the use of HIV Testing, and ARV drugs
and communities such as medical and along the continuum of HIV prevention,
public health specialists, physicians, health treatment, and care.
officers, nurses, pharmacy personnel,
laboratory technologist and case managers ■ Participatory: Adapting and implementing
providing care to people infected and the guidelines should realize the rights and
affected with HIV and others. responsibilities, Greater and meaningful
involvement of people living with HIV
■ HIV/AIDS program managers, health principles.
experts, health care program planners and
researchers ■ Accessibility: The recommendations in
the guideline should be implemented at
■ Organizations involved in HIV related all levels to strengthening broader health
commodities procurement, supply systems for ensuring the provision of
management, and service delivery. universal health care.

■ Public and private health sector, Civic ■ Human Right: Implementation of the
Society Organizations including PLHIV guidelines needs to be accompanied by
associations, community-based and faith- efforts to promote and protect the human
based organizations, universities, health rights of people who need HIV services,
science colleges and other key stakeholders including ensuring informed consent,
working on HIV/AIDS programs. preventing stigma and discrimination in the
provision of services, and promoting gender
1.5.Guiding Principles equity.

■ Effectiveness: the guidelines should ■ Evidence-Based: Implementation of the

facilitate effectiveness of the national recommendations in these guidelines should
program by contributing and expediting the be informed by local context, including HIV
achievement of key global targets and the epidemiology, availability of resources and
goals for the National HIV/AIDS Strategic comorbidities, the organization and capacity
Plan for 2021-2025 and Health Sector of the health system and anticipated cost–
Transformation Plan 2020/21- 2024/25(HSTP effectiveness.
II) to realize the Sustainable Development
Goals.

3
CHAPTER TWO:
HIV PREVENTION
2.1 HIV Combination Prevention

HIV prevention approach based solely on one mass media, community level, small group
element does not work and can hinder the level and inter personal) to disseminate
HIV response. There is no single magic bullet behavioral messages designed to encourage
for HIV prevention. Hence, use of a growing people to reduce behaviors that increase risk of
number of combination interventions have transmission. Condom promotion is an essential
shown promise in effectively protecting against component for the behavioral intervention.
HIV transmission and acquisition. These
include behavioral risk reduction, knowledge 2.Biomedical interventions are those that
of Sero-status, Pre-Exposure Prophylaxis directly influence the biological system through
(PrEP), condoms, medical male circumcision, which the virus infects a new host, such as
screening, and management of sexually condom use, PrEP, PEP, voluntary medical male
transmitted infections, and use of antiretroviral circumcision, Screening and management
medications. Therefore, it is recommended of STIs, HTS and ART. Condoms effectively
to use a mix of behavioral, biomedical, and reduce sexual transmission of HIV, if used
structural HIV prevention actions and tactics consistently and correctly. Voluntary medical
which suit with the country’s epidemic. male circumcision reduces acquisition of
infection for men by up to 60% as compared to
HIV Combination prevention is likely to be uncircumcised men.
most effective when implemented at different
points in the “transmission cycle”, when the 3.Structural interventions address the critical
transmission rate is impeded, and structural social, legal, political, and environmental
barriers are addressed. enablers that contribute to the national HIV
response and measures to reduce stigma
Core programmatic components and discrimination, the promotion of gender
equality and prevention of gender-based
HIV Combination prevention approach includes violence, economic empowerment, and access
three types of mutually reinforcing interventions: to education.

1.Behavioral interventions include a range of A package of combination HIV prevention

social behavior change communication and intervention is recommended for KP to
demand creation programs that use various standardize the services (Refer Annex 1)
communication channels and platforms (e.g.

4
Recommended HIV Combination ■ Strengthen workplace HIV prevention
Prevention Interventions/Activities interventions through mainstreaming.

Behavioral interventions/Activities ■ Strengthen intra- and extracurricular school

HIV education programs.
■ SBCC intervention: Peer education sessions
(small group and one to one), risk reduction ■ Conduct peer education programs in
counseling and preparation and Distribution schools, higher education institutes
of SBCC materials and Technical, Vocational Education and
Training (TVET).
■ Scale-up comprehensive prevention
interventions addressing key and priority ■ Conduct life-skill education in schools,
populations. higher education institutes and TVET.

■ Targeted outreach activities (like targeted ■ Integrate HIV/AIDS into school curriculum.
mobilization and demand creation)
■ Train teachers on management of school
■ Condom promotion: demand creation and HIV/AIDS programs.
skill building among KPPs and general
populations. ■ Develop and disseminate targeted SBCC
message in schools, higher education
■ Harm reduction for people who inject drugs institutes and TVET.
(PWID): needle and syringe programs
through social marketing and CSO channels ■ Strengthen youth leadership development
and opioid substitution therapy. programs.

■ Promotion of health care seeking behaviors ■ Develop an HIV intervention strategy for
through existing services like health school and higher education.
education.
■ Strengthen anti-AIDS clubs in schools,
■ Strengthen community-based HIV higher education institutes and TVETs.
prevention interventions to address the
■ Strengthen out-of-school youth HIV
general population through: -
prevention programs.
■ Enhancement of adaptive community
■ Life skill education, Peer Education,
conversation (CC) and dialogue and
and youth dialogue to address children,
integrate with existing community
adolescent, and youth
structures.

■ Strengthen Youth Center to provide

■ Develop and disseminate HIV prevention
comprehensive HIV SRH services
messages using print, social and electronic
media.

5
 ■ Integration of HIV Prevention with ■ Develop and disseminate SBCC materials
Voluntarism for people with disability.

■ Targeted outreach mobilization for Biomedical interventions/Activities

prevention, testing, and linkage services
■ Ensure availability, acceptability and
■ Intensify HIV prevention in development affordability of quality condoms using the
schemes including new development total marketing approach (free condoms,
corroders. social marketing, and private sector)

■ Map development corridors, mega project ■ Identify universal need of condom and
areas like industrial park, construction forecasting condom quantity.
sites, military, refuges campus and private
development schemes. ■ Ensure quality condom procurement,
storage, and distribution.
■ Integrate HIV prevention in the project
proposals of development schemes. ■ Monitor appropriate storage, availability
and accessibility of condoms.
■ Develop and disseminate targeted HIV/
AIDS messages. ■ Promote use of condom and build skill on
correct and consistence use of condom.
■ Conduct peer education, life skill education
and canteen-based education targeting ■ Conduct targeted condom distribution,
workers (permanent and seasonal). particularly for key and priority populations.

■ Provide VCT, STI and ART/PMTCT services ■ Ensure access and enhance uptake of
at worksite clinics or through outreach or targeted HIV testing and counseling
referral and linkages with nearby health services to eligible clients and address the
facilities. special need of people with disability.

■ Ensure the provision of HIV prevention ■ Strengthen Pre Exposure prophylaxis (PrEP)
services to the surrounding communities service for eligible population groups
of development corroders.
■ Ensure the provision of PEP service for the
■ Scale-up HIV prevention among population eligible population groups.
groups with special needs.
■ Increase availability and utilization of STI
■ Integrate SBCC interventions for people prevention, screening and treatment
with disability in their service provision services
centers.

6
 ■ Create strong leadership for STI programs. ■ Strengthen community mobilization
platforms including health extension
■ Intensify health education to improve program, family health team (FHT), CSOs,
treatment seeking behavior and utilization CBOs and FBOs.
of STI services.
■ Improve access to health services through.
■ Promote and implement active STI
partner notification system to identify and ■ Decentralization of service provision
link those in the sexual network to STI
management and HTS. ■ Provision of differentiated service delivery

■ Ensure availability of STIs kits/drugs in all ■ Ensure affordability and acceptability of

health facilities. health care services

■ Train heath care workers on syndromic ■ Ensure provision of user friendly services
approaches STI case diagnosis and
management with consideration of people ■ Address socio-cultural factors like address
with disability. harmful traditional practices that fuel HIV/
AIDS
■ Accelerate voluntary medical male
circumcision in areas where needed. ■ Address stigma and discrimination through:

■ Ensure access and enhance uptake of ■ Education, advocacy, and communication

PMTCT services. of the public through religious and
community leaders.
■ Treatment with ART and having undetectable
viral load. ■ Empowerment and engagement of PLHIV
and their associations in advocacy and
Structural interventions/Activities communication.

■ Strengthen Legal and policy environment ■ Empowerment of HIV Positive adolescents

(legal support system). and youths using adolescent psychosocial
support programs.
■ Revise the national HIV policy
■ Engagement of media in communication
■ Develop capacity for legal support system and advocacy.
at different levels
■ Monitoring and enforcement of anti-
■ Strengthen partnership with concerned discriminatory laws and regulations.
sectors and organization

7
■ Reduce economic vulnerability: ■ Increase demand and enhance correct and
consistent use of condoms for different
■ Strengthen the provision of income segments of population; and
generating activity (IGA) support to
vulnerable women and high risk adolescent ■ Generate strategic information and ensure
girls and young women. an integrated, effective monitoring and
evaluation system for condom programming.
■ Care and support program for OVCs and
PLHIVs (for those who are less empowered 2.3. Pre Exposure Prophylaxis
in economy, psychosocial, education etc.)
Pre-exposure prophylaxis (PrEP) of HIV is the
■ Promote gender equality and prevention use of ARV drugs by individuals who are not
and management of gender-based violence. infected with HIV but at a substantial risk to block
the acquisition of HIV. Substantial risk of HIV
■ Supportive interventions designed to infection is provisionally defined as an incidence
enhance referrals, adherence, retention, of HIV higher than 3 per 100 person-years in
and community mobilization. the absence of pre-exposure prophylaxis (PrEP)
and risk behavior like inconsistence condom
■ Mainstream HIV/AIDS prevention activities
use. PrEP should be offered as an additional
into sectors and workplaces.
prevention choice for people at substantial risk
of HIV infection.
2.2. Condom programing for KPP
and general populations The target beneficiaries for PrEP service in
Ethiopia are HIV Negative FSWs and HIV
For the achievement of HIV prevention and negative partners of Sero- discordant couples.
family planning services, condom programming The nationally recommended PrEP drug is a
has been playing a pivotal role. To address gaps fixed dose combination that contains Tenofovir
in areas of program coordination, supply chain 300mg and Lamivudine 300mg once daily for
management and access to quality condoms, the identified target groups with substantial
four major strategic objectives have been risk for HIV infection. In the context of
identified and should be implemented: COVID 19 pandemic, a three Multi Month
Dispensing (3MMD) PrEP drugs for all clients is
■ Enhance supportive environment and recommended. While taking PrEP, clients should
leadership for the implementation of have follow up facility visit for prescription refills,
coordinated and sustainable condom counseling on risk reduction, counseling on
programming. correct and consistent use of condoms; routine
screening of STIs, family planning service HIV
■ Ensure the availability and accessibility of
testing, and assessments of adherence and
quality condoms in sustainable manner.
retention as part of combination HIV prevention
package.

8
Nationally developed oral PrEP demand creation The following are the criteria used to identify
materials using flip chart, poster and brochures participants eligible for PrEP service among
should be utilized both at facility and community target populations
levels through active engagements of PrEP
service providers and peer service providers Table 2.1: Eligibility Criteria for PrEP
for improving PrEP service uptake and PrEP-
retention.

WHO also recommended that the Dapivirine

vaginal ring (DPV-VR) for women every 28
days and injectable PrEP every two months
for all eligible clients at substantial risk of HIV
infection, as part of combination prevention
approaches.

HIV Negative FSWs HIV Negative Partners in Sero-Discordant Couples

■ HIV negative using a rapid antibody ■ HIV negative using a rapid antibody test as per the
test as per the National HIV testing National HIV testing algorithm on the day of PrEP
algorithm on the day of PrEP initiation. initiation.

■ No clinical suspicion of acute HIV ■ No clinical suspicion of acute HIV infection.

infection.
■ Substantial risk of HIV infection (any ONE of the
■ Self- identifying FSWs. following in the past six months):

■ No contraindications to PrEP medicines ■ Has a known HIV positive sexual partner(s) who
(TDF/3TC) is not on ART or

■ On ART less than six months, or not yet

achieved undetectable viral load < 50 ml/copies
or

■ No contraindications to PrEP medicines (TDF/3TC)

9
Exclusion criteria and contraindications for PrEP

■ Finding of HIV infection (existing HIV infection should be ruled out by testing using
the national algorithm on the same day of PrEP initiation).

■ Finding of Signs/symptoms of acute HIV infection, with probable recent exposure

to HIV.

■ Estimated creatinine clearance of less than 60 ml/min (if known).

■ Client reported allergy or there is contraindication to any medicine in the PrEP

regimen.

■ Known Hepatitis B infection.

■ Unwillingness or not being ready to use PrEP as prescribed and/or give detail
information required for monitoring.

When do we stop PrEP? ■ Clients with poor adherence for two

consecutive months (Missing five and
Starting PrEP does not mean staying on PrEP above pills per month) to the prescribed
for life. At every follow up visit, review patient dosing regimen despite efforts to improve
reported risk behavior and evaluate the need daily adherence.
to continue PrEP as a component of HIV
prevention. The following criteria are reasons to ■ Clients on PrEP whose HIV positive partner
stop PrEP: achieved undetectable viral load while on
ART.
■ HIV Sero-conversion while on PrEP
■ No longer at substantial risk (e.g., no longer
■ Sustained elevation of creatinine clearance engaged in sex work)
(eCRCL) < 60ml/min.
How to safely discontinue PrEP
■ Clients who have side effects from the
medicine that interfere with quality of life. Clients should be informed how to safely
discontinue and restart PrEP. This includes
■ Finding of Hepatitis B infection (clients with the need to contact health care provider and
HBsAg Positive test result) to continue PrEP for 28 days post-high risk

10
behavior. Before discontinuing PrEP, the health 2.4. Prevention and management
care providers should conduct the following of Gender Based Violence (GBV)
activities.
Gender inequalities and gender based violence
■ Perform HIV test to confirm whether HIV place girls and women particularly at increased
infection has occurred. risk of HIV infection. Young women with
disabilities face even higher risks. The span
■ If HIV positive, establish linkage to HIV care
and scope of addressing gender inequalities
& treatment.
and gender-based violence is broader than
just within the health sector. It requires multi-
■ If negative, appoint the client after 12 weeks
sectoral responses and investments and should
for HIV testing and ensure that the client
include gender responsive programing and
continues to take PrEP for 28 days after the
budgeting in the HIV response.
high-risk event.
The following interventions will be addressed
■ In addition, discuss with the clients on
to prevent and manage GBV:
alternative methods to reduce the risk of
acquiring HIV such as correct and consistent
■ Build capacity of health facilities to provide
use of condoms, desired behavioral change
comprehensive GBV services including
to avoid risk.
training of health workers, availing provider
tools (Job aids, SOPs, etc.) and reporting
How to safely restart PrEP
tools at site level

Any person who wishes to resume taking

■ Provide comprehensive services in
PrEP medications after having stopped should
health facilities for survivors of GBV that
undergo all the same pre-prescription evaluation
includes screening and management of
as a person being newly prescribed PrEP,
intimate partner violence, medico legal
including an HIV test to establish that they are
examination, HIV testing, STIs screening
still without HIV infection. In addition, an open
and management and pregnancy testing,
discussion with clients is important to clarify
PEP, emergency contraception, counseling,
the changed circumstances since discontinuing
referral for social and legal services.
medication that indicate the need to resume
medication, and the commitment to take it.
■ Strengthen schoolgirls clubs, make youth
centers and health clinics gender sensitive
and girls’ friendly. Provide integrated
services including psychosocial support,
HIV, SRH and GBV related services.

11
■ Undertake community dialogue on ■ Antiretroviral treatment immediately after
promotion of gender equality and prevention exposure to HIV can reduce risk of infection
of GBV by integrating into the health by about 80%.
extension program.
Support for post exposure management in
■ Ensure referral system is in place to medico health facilities
legal services for survivors
■ Regular prevention education for employees
■ Strengthen youth friendly clinics at facility (health workers, cleaners, and other staff)
levels to provide comprehensive GBV involved in institutional care for PLHIV.
services.
■ Ensure availability of control mechanisms
2.5. Post Exposure Management for effective observation of standard
including Prophylaxis precaution.

2.5.1. Management of Occupational ■ Establish system for post exposure

Exposure to HIV management to ensure urgent attention
for victims who have sustained accidental
■ Health care workers and supporting staff blood exposure.
have a low but measurable risk of HIV
infection after accidental exposure to Minimum package for PEP sites/facilities
infected blood or body fluid.
1. Assign one trained physician / Health Officer /
■ Compliance with infection prevention nurse as PEP focal person for the facility.
recommendations is the backbone in
prevention of occupational HIV infection. 2. The contact address of the facility PEP focal
The priorities therefore must be to train person and the facility ART nurse or any other
health personnel in infection prevention and second person assigned to coordinate PEP
provide them with necessary materials and activities in the facility should be posted in all
protective equipment. outpatient and inpatient departments within
the heath facility.
■ Risk of HIV infection after a needle stick
or cut exposure to HIV-infected blood is 3. PEP ARV drugs should be made available in
estimated to be 0.3% (3 in 1000). The risk designated sites inside the heath facility which
of HIV infection after exposure of mucous may be accessible to all staff, 24 hours, and 7
membranes to HIV-infected blood is days a week.
estimated to be 0.1% (1 in 1000). However,
risk could vary depending on severity of 4. Provider support tools like algorithm for
injury and viral load in the source patient. determination of the severity of exposure
(Exposure Code) and PEP register should be
available in the facility.

12
Steps to manage potential HIV exposed d) If the HCW is warranted to take PEP: Choose
person appropriate PEP regimen, counsel about the
ARVs and prescribe according to PEP algorithm.
1. Treat the exposure site /immediate
measures. e) Document properly on the PEP follow-up
register.
■ Percutaneous injury or injury to non-intact
skin: f) Appoint the exposed person and follow.

■ Wash the exposed site with soap and water g) Conduct follow up HIV testing at 6 weeks.
as soon as possible, without scrubbing.
Assessment of exposure risk:
■ Avoid using antiseptics.
Low-risk exposure:
■ Allow free bleeding but do not squeeze the
wound. ■ Exposure to small volume of blood or blood
contaminated fluids
■ Exposed mucous membranes:
■ Following injury with a solid needle
■ Irrigate copiously with clean water or saline.
■ Asymptomatic source patient
2. Report the exposure:
High-risk exposure:
■ To the PEP focal person or the ART physician
or nurse in the facility immediately. ■ Exposure to a large volume of blood or
potentially infectious fluids.
3. The PEP focal person who needs to do:
■ Exposure to blood or potentially infectious
a) Clinical evaluation, counseling and testing of fluids from a patient with clinical AIDS or
the exposed person and complete the exposure acute HIV infection or known positive with
reporting form. high viral load.

b) Do risk assessment and determine the ■ Injury with a hollow needle.

exposure code (EC) and source HIV status code
(HIV SC) using the PEP algorithm. ■ Needle used in source patient’s artery or
vein.
c) Using the EC and HIVSC determine whether
PEP is warranted for the exposed HCW. ■ Visible blood on device.

■ Deep and extensive injury.

13
Table 2.2: Interpretation of exposure code (severity of exposure).

Exposure Code Type of exposure

Is a minor muco-cutaneous exposure to small volume of blood for

1 EC 1
short period (few seconds to minutes)

Is a major muco-cutaneous exposure to large volume of blood for

2 EC 2 longer duration (several minutes), or mild percutaneous exposure
(with solid needle or superficial scratch or injury).

Severe percutaneous exposure (large bore hollow needle, deep

3 EC 3
puncture, visible blood on devise, needle used in patient artery/vein).

Table 2.3: Interpretation of the HIV status of the source patient.

HIV Source Code (SC) The HIV status and severity of the illness in the source patients

The source patient is HIV positive but is asymptomatic and has

1 HIV SC 1
reasonably good immune status.

The source patient is HIV positive and is symptomatic, may have

2 HIV SC 2 AIDS or has other evidence of advanced illness (low CD4 or high
viral load).
The HIV status of the source patients is unknown (either the patient
has refused HIV testing or died or discharged before HIV testing)
3 HIV SC unknown
or the source patient is unknown (e.g., unlabeled blood sample in
a laboratory).

Table 2.4: Recommended PEP based on risk assessment.

Exposure code
Status code
EC 1 EC 2 EC 3

SC 1 Basic 2 drug PEP Basic 2 drug PEP Expanded 3 drug PEP

SC 2 Basic 2 drug PEP Expanded 3 drug PEP Expanded 3 drug PEP

SC unknown Consider basic 2-drugs PEP.

HIV negative No PEP warranted No PEP warranted No PEP warranted

14
Table 2.5: Recommended ARVs for PEP and administration guide

Category Regimen ARV drug regimen Dose Frequency Duration

Adults and Two drug 2-Drug Regimen: Tenofovir TDF 300mg Once daily
adolescents regimen (TDF) + Lamivudine(3TC)
3TC 300mg
Three drug 3-Drug Regimen: Triple FDC (TDF Once daily
regimen Triple FDC 300mg,3TC

Tenofovir (TDF) + 300mg,DTG 50mg)

Lamivudine (3TC) + (TDF300mg,

Dolutegravir (DTG) 3TC300mg, EFV

600mg)
Or

Tenofovir(TDF) + 28 days
Lamivudine (3TC) +
Efavirenz (EFV)

OR

Lopinavir/ritonavir (LPV/r)

Or
LPV/r400mg /100mg Twice daily
Atazanavir/ritonavir (ATV/r)
ATV/r300mg/100mg Once daily

children Two drugs Zidovudine (AZT) +3TC Based on weight Twice daily
(refer dosing chart)
Three drugs AZT +3TC +DTG or EFV or Based on weight AZT+ 3TC and
LPV/r Or ATV/r (refer dosing chart) LPV/r Twice
daily and For
28 days
DTG /EFV/
ATV/r Once
daily

Timing of initiation of prophylaxis: Testing and monitoring after occupational

exposure:
To be effective, PEP should be initiated as soon
as possible (within 1-2 hours). The maximum ■ Testing source: rapid HIV test is done after
delay for initiation of treatment which would counseling and consent has been secured.
prevent infection is not known in humans. If the source patient is negative, there is no
Do not consider PEP beyond 72 hours post need of further assessment of the exposed
exposure. Prophylaxis is to be given for 28 days. health care worker. If the result is positive
the health care worker needs to be tested.

15
■ Testing of health care worker: HIV testing 2.5.2. Prevention of HIV Transmission
should be performed immediately after after Sexual Assault
exposure. If result is positive there is no
need for PEP, but if negative you should 1. Any person presenting to a health facility after
administer PEP as soon as possible as potential exposure to HIV during sexual assault
outlined above and then repeat HIV testing should be strictly counseled and examined by
at 6 weeks. trained health care worker about the potential
risk of HIV infection and ensure there is no
■ Remember to initiate PEP immediately after misuse of PEP.
exposure until test result confirms the HIV
status of the victim. Stop PEP if the health 2.Parents/guardian of traumatized children
worker is positive for HIV antibodies. should be counseled and informed on the risk
of HIV infection after sexual assault.
■ Following HIV exposure there is a need for
psychosocial support. 3. The following points should be covered in the
counselling:
■ Any health care workers presenting to a
health facility with potential exposure to HIV a) The exact risk of transmission is not known,
should be strictly counseled and examined but it exists.
by trained health care worker about the
b) It is important to know the victim’s HIV
potential risk of HIV infection and ensure
status prior to any antiretroviral treatment.
there is no misuse of PEP.

Recommended regimen for PEP

Dolutegravir (DTG) 50 mg daily in combination with tenofovir disoproxil Lamivudine (3TC)

300 mg daily as the preferred regimen in healthy adults and adolescents for 28 days

Alternatively, AZT or TDF+3TC+EFV for 28 days or

Boosted Lopinavir OR boosted Atazanavir can substitute EFV.

DTG is approved for all children older than 4 weeks weighing more than 3kg and available
with dispersible tablets that can be easily administered for all children weighting less than
20kg. For children weighting more than 20 kg, 50 mg adult film-coated tablets can be use.

16
 PEP is not recommended.
a) If victim presents more than 72 hours after exposure.
b) Following condom leak or tear.

c) It is the patient’s choice to have immediate 2.6. Undetectable=Un-

HIV testing or, if s/he prefers, this can be transmittable (U=U) (የ=የ)
delayed until 72 hours post examination visit.
When HIV positive person taking ART achieves
d) PEP is not recommended after 72 hours undetectable viral load levels (<50 copies/ml)
following sexual assault. Patients should be and maintained at least for 6 months, the risk
counseled about risk of infection and the of transmitting HIV through sex is significantly
possibility of transmitting infection during minimized. Globally, this concept is called
sero-conversion. They should be instructed Undetectable = Untransmittable (U=U) and
to return at 6 weeks post sexual assault for Ethiopia has contextualized its naming in to
voluntary counseling and HIV testing. “የማይታይ መጠን = የተገታ መተላለፍ (የ=የ).

4. It is strongly recommended that the Creating dialogue for U=U/“የ=የ”/ in clinical

implementation of post-rape prophylaxis should settings is vital because clients perceive their
be carefully monitored and evaluated for: healthcare providers as a trusted source, and
providers can improve client’s understanding of
■ Pregnancy test
this information.

■ Emergency contraceptives
Promoting U=U in clinical settings also gives
healthcare providers an opportunity to reinforce
■ Psychosocial Support
and support adherence to antiretroviral
medicines, ensure continuity of treatment and
■ Legal support
regular clinical monitoring, encourage viral load
■ Screening for conventional STIs and follow- testing, and provide complimentary services
up management such as sexual and reproductive health.

■ Drug side effects At a population level, U=U messages have the

power to reduce HIV stigma and discrimination
■ Sero-conversion by sharing the robust scientific evidence that
PLHIV with durably undetectable viral load
prevents sexual transmission HIV. Therefore,
appropriate U=U/“የ=የ” messages should
be campaigned and communicated to the
communities using various media outlets and
community platforms.

17
2.7. Screening and treatment of The national VMMC strategic document 2020-
Sexually Transmitted Infections 2022 has been developed with the aim of
attaining this goal; MOH has identified the
Active screening and treatment of STIs using following four major strategic objectives:
syndrome approach will be provided to KPPs and
their partners integrated through community ■ Improve communities’ understanding on the
and health facility level service delivery outlets. benefits and risks of MC and build positive
Currently, a syndromic approach is being used attitudes towards utilizing VMMC services.
to screen and treat STIs although consideration
for rapid and laboratory STI testing and same ■ Expand the service delivery at all healthcare
day/early treatment for individuals presenting facilities to keep pace with the created
with STIs may be considered in the future. demand of VMMC in specific population
There is a need to build the capacity of HCPs groups.
on syndromic management. The STIs program
■ Promote Early Infant Male Circumcision into
ownership, management and monitoring and
health service delivery system.
evaluation need to be strengthened.

■ Strengthen program sustainability and

2.8. Voluntary Medical Male
ownership (develop sustainability strategy).
Circumcision (VMMC)
Moreover, roles and responsibilities have been
Voluntary Medical Male Circumcision (VMMC) assigned for key stakeholders and monitoring
services should be offered as part of a and evaluation system for VMMC has been
combination HIV prevention effort to reduce incorporated.
the incidence of HIV in high HIV and low
Male Circumcision (MC) prevalence settings. 2.9.Care of HIV Exposed Infants
MOH in collaboration with partners started
(HEI)
implementing the VMMC service since 2009 in
the Gambella host population, with the objective
Infants born to HIV positive pregnant women by
of reaching 90% among uncircumcised males
definition are HIV exposed and these infants can
aged between 10-49 years with a special focus
be infected with HIV during pregnancy, labor or
on 15-29 years by 2022.
after birth through breast feeding. All HEI will
undergo through DNA-PCR antigen test at six
A minimum package of services, including
weeks and repeat DNA-PCR test at 9 months
targeted information and education on safer
for those who tested negative. While the child
sex, condom promotion and distribution,
with HIV infection can often be identified during
offering HIV testing service and management
the two months of life, HIV infection often
of sexually transmitted infections, must be
cannot be excluded until after 18 months of age
delivered along with the male circumcision
particularly in breast feeding babies.
procedure. However, the current national
strategic plan includes some woredas of SNNP
region at target areas for VMMC.

18
Pediatric HIV disease can progress very rapidly ■ Introduce appropriate complementary food
and may require treatment before a positive after six months and continue breastfeeding
diagnosis can be confirmed. HIV infected as the general population.
infants are susceptible to many opportunistic
infections including pneumocystis pneumonia 6.Immunization: All HEI should be immunized
(PCP), TB and other bacterial infections that are according to expanded program on immunization
associated with high rates of mortality. (EPI) recommendations. (Refer annex 2)

Components of clinical care for the HEI 7. ARV prophylaxis for HIV exposed infants

1.History Considering all HIV Exposed Infants (HEIs) as

high-risk infants, enhanced postnatal prophylaxis
2.Physical examination (ePNP) is recommended for all of them. ePNP is
providing NVP and AZT prophylaxis for the first
3.Growth assessment 6weeks and continuing only NVP prophylaxis
for an additional 6 weeks. Infant prophylaxis
■ Growth is the most sensitive clinical should begin within one hour at birth or as soon
indicator of HIV infection in infants and as HIV exposure is recognized postpartum.
young children.
■ NVP and AZT Prophylaxis syrups shall be
■ Children with HIV infection are at high risk started within 1 hour of birth to the HEI up
for poor growth. to 72hrs.

■ Growth should be monitored closely for all ■ For HIV exposed infants identified after birth
HIV exposed and infected infants. (through infant or maternal HIV antibody
testing)
4.Developmental assessment: Use
developmental check list to assess growth and ■ Infants on breastfeeding: ‐ Initiate ART for
development. the mother ‐ Provide NVP and AZT for 6
weeks and continue only NVP for additional
5.Infant feeding: Nutrition and feeding history 6 weeks. ‐ Collect specimen for DNA PCR
should be assessed regularly. Ongoing testing at 6 weeks of age and repeat DNA
counseling on infant feeding practice PCR at 9 months of age for those who
should be done, according to the national tested negative at 6 weeks of age.
recommendation.

■ Safer infant feeding practices, either

exclusive breastfeeding for the first 6
months or exclusive replacement feeding
for the first six months. Avoid mixed feeding.

19
 ■ If the infant is brought within 72 hours of For babies delivered at home:
birth provide AZT and NVP prophylaxis for
6 weeks. ■ If a mother is known to be HIV-positive, ARV
prophylaxis should be administered to the
■ Infant identified as HIV exposed after newborn even if the mother did not receive
72 hours after birth (through infant or ARVs during pregnancy or labor.
maternal HIV antibody testing) and is NOT
Breastfeeding , ■ If the mother’s HIV status is unknown,
offer HIV testing and counseling and, if the
■ Initiate maternal ART
mother tests positive, give the baby NVP
■ No prophylaxis needed once daily and AZT twice daily; assess the
■ Do DNA PCR testing accordance with mother, initiate ART and provide appropriate
national recommendations on early care.
infant diagnosis
■ Initiate treatment if the infant is infected

Table 2.6: Dosage of AZT and NVP syrup for infant prophylaxis for different age groups

Infant age NVP daily dosing (10mg/ml) AZT daily dose (10mg/ml)
Dose in mg Dose in ml Dose in mg Dose in ml
Birth to 6 weeks:
Birth weight 2mg/kg, once 0.2ml/kg, once 4mg/kg per dose, 0.4 ml/kg per does,
<2000g daily daily twice daily twice daily

Birth weight 10mg, once 1 ml, once

10mg, twice daily 1ml, twice daily
2000-2499 g daily daily

Birth weight 15mg, once 1.5 ml, once

15 mg twice daily 1.5ml twice daily
>2500 g daily daily
> 6 weeks to 12 weeks

2 ml, once
20mg, once daily or half a No dose established for prophylaxis for this age
daily 50 mg tablet, group
once daily

20
Note: ■ NVP and AZT Infant doses: The oral syringe
should not be placed directly into the bottle.
■ AZT and NVP concentration are 50mg/5ml. Infant dose should be measured by pouring
a small amount of syrup into a cup, and
■ AZT and NVP syrups should be started at then draw the actual dose with oral syringe.
birth and provide for all HEI Discard the leftover suspension in the cup.

■ AZT and NVP syrups should be started at 8.Co-trimoxazole preventive therapy (CPT)
birth and provided for six weeks Using pediatric co-trimoxazole in all HIV
exposed infants significantly reduces the rate
■ NVP alone should be continued for additional of PCP and other bacterial infections and in turn
6 weeks reduces infant morbidity and mortality rates.
Start co-trimoxazole to all HEI from 6 weeks of
■ Follow the manufacturer’s instruction for
age and continue until the child is confirmed not
the duration of use following opening. The
to have HIV infection using antibody test after
bottle should be labeled with the date on
18 months of age.
which it was 1stopened.

Table 2.7: Dose of CTX for prevention of PCP in infants and children

Single Strength Double Strength

Suspension Per Pediatric tablet
Age adult tablet adult tablet
5ml (200/40mg) (100/20mg)
(400/80mg) (800/160mg)
< 6mo 2.5ml 1 tablet 1/4 tablet --
6 mo- 5yrs 5 ml 2 tablets 1/2 tablet --
6-14 yrs 10 ml 4 tablets 1 tablet 1/2tablet
>14 yrs -- -- 2 tablets 1 tablet

9. TB risk assessment 10. Determination and evaluation of infection

status
At each visit the infant should be evaluated for
Tuberculosis. We need to ask for household One of the goals of follow-up of HEI is to identify
exposure with an adult who has tuberculosis and treat the HIV infected ones early. All HEI
and symptoms suggestive of the disease and should have DNA-PCR testing at 6 weeks of
chest radiography if clinically indicated. age and repeat DNA-PCR test at 9 months.

21
11. Current assessment and plan Follow-up visits and schedule

At each visit based on the findings on history, Follow-up schedule: At birth, 6 weeks, then
physical examination (that includes growth and monthly for 6 months, then every 3 months until
development assessment) and/or laboratory HIV infection is excluded. But also advise the
investigations, we need to have the assessment mother to bring the infant at any time, if there
of the infant and we should plan our next steps are new signs and symptoms. HIV-exposed
in their management and follow-up. infants with health problems may need more
frequent follow-up visits than other infants.

Table 2.9.3. Follow-up visit schedule for HIV exposed infants.

at
Age in weeks/months 6 wk 10 wk 14 wk 5m 6m 9m 12 m 15 m 18 m
birth
History x X x x X x X x X x
Physical exam x X x x X x X x X x
Growth Assessment x X x x X x X x X x
Developmental
x X x x X x X x X x
assessment
Infant feeding
x X x x X x X x X x
Counseling
Do DNA PCR if the test is not done at 6
weeks**
*Repeat DNA PCR at 9 months for all Perform rapid antibody
Determination of HIV *DNA HEI DNA PCR negative at 6 weeks of test at least 6 weeks
status PCR age and Do DNA PCR test at any time after cessation of
if the child is sick (sign and symptoms breastfeeding.
suggestive of HIV infection) with
negative test result at 6 weeks

AZT + NVP for the

X
first 6 weeks

NVP alone for

X X
additional 6 weeks
Continue until HIV is excluded, and infant is no longer at risk from
CPT X
breastfeeding.
TB Risk Assessment At each visit
Immunizations x x x x x x x
Adherence counseling x x x x x x x x x x
Vitamin A x x x
Note: This is the minimum; children should be seen more frequently if clinically indicated.

22
CHAPTER THREE:
HIV CASE FINDING
3.1. HIV Testing Services ■ Support the scale-up of high-impact
interventions to reduce HIV transmission
HIV testing services refer to the full range and HIV related morbidity and mortality.
of services that should be provided with
HIV testing, including counselling (pre-test HTS service quality should not be compromised,
information and post-test counselling); linkage hence standard operating procedures (SoPs),
to appropriate HIV prevention, treatment, care protocols, and other necessary job aides must
and other clinical services and the delivery of be followed and regularly monitored.
accurate results.
Targeted HIV Testing Service
HIV testing services (HTS) should be provided
to eligible clients who are at high risk of HIV Targeted HTS is a process whereby individuals
infection. HTS need to focus on high-risk who are at risk of acquiring of HIV infection are
individuals who remain undiagnosed need to tested for HIV if found eligible based on HIV risk
be tested and linking them to treatment and screening tool. The focus of targeted testing is
care services as early as possible. People who towards identifying of new HIV positive cases
are HIV-negative but with an ongoing risk also and proper utilization of HRST is important to
need to be re-tested and provided appropriate implement targeted testing and achieve the
prevention package of services. first 95 of the UNAIDS goals.

3.1.1. Core Principles

As we move closer to epidemic control, case
finding will become more and more difficult
Effective and efficient HTS service delivery
hence HIV testing services should utilize HIV
models and approaches should focus on:
risk screening tools for both adults and children,
enhanced index case testing response for 1. Reaching the largest number of individuals
recent infections, etc. with HIV who remain undiagnosed with higher
HIV risk
Goals of HIV testing services
2. Increasing acceptability, equity and demand
■ Identify people living with HIV by providing
to reach those left behind, including key
high-quality testing services for individuals,
populations.
couples and families,
3. Prioritizing approaches that are most cost
■ Effectively link individuals and their families
effective and efficient
to HIV treatment, care and support and to
HIV prevention services, based on their
status,

23
4. Achieving national program targets (95-95-95) ■ Confidentiality: HTS are confidential,
meaning that what the HIV counseling and
5. Ensure linkage to treatment for individuals testing provider and the person discuss will
who are diagnosed HIV positive and providing not be disclosed to anyone else without
appropriately tailored prevention for those who the expressed consent of the person being
test HIV negative tested. Counselors should raise, among
other issues, whom else the person may
3.1.2. Guiding Principles for HIV
wish to inform and how they would like
counseling and testing
this to be done. Shared confidentiality with
HTS should always be voluntary. Protecting partner or family members and trusted
and maintaining client confidentiality is others and with health care providers is
important, especially when offering ICT. An often highly beneficial.
enabling environment that removes barriers
■ Counseling: HIV counseling and testing
such as stigma, discrimination, IPV is important
services must be accompanied by
for increasing access to and uptake of HTS.
appropriate and standardized pre-test
Therefore, the WHO guiding principles (also
information and post-test counseling.
called 5Cs) should be applied in all HTS sites.

■ Correct: HIV counseling and testing providers

Consent: People receiving HIV counseling and
should strive to provide standardized testing
testing must give informed verbal consent to
services to reach to correct diagnosis.
be tested and counseled. Written consent
is not required. They should be informed of
■ Connection: Connections to prevention, care
the process for HIV counseling and testing
and treatment services should include the
and their right to decline testing. In Ethiopia,
provision of effective referral to appropriate
for pediatric age group (less than 15 years of
follow-up services as indicated, including
age), the parents or guardian need to consent
long-term prevention care and treatment
verbally. Mature minors (13-15 years old who
services.
are married, pregnant, commercial sex workers,
street children, heads of families, or who are
sexually active) can give verbal consent by
themselves.

Unconscious or patient who is not in status of

providing self-consent, should not be tested
for HIV unless the clinician determines it is
necessary to establish diagnosis and make
treatment decisions. Consent of kin should be
obtained during counseling.

24
Client’s Rights for HTS

Clients’ rights during testing and counseling. Clients have the right to:

■ Confidentiality

■ Privacy

■ Refuse testing

■ Be treated with respect and

■ Asking information or question.

3.2. Demand creation for HTS Many demand creation strategies have been
assessed for how they affect HIV testing uptake
Demand creation and mobilization strategies and the proportion of people living with HIV
include activities intended to directly improve an diagnosed, including the following:
individual’s knowledge, attitudes, motivations,
and intentions to test and to inform the decision 1. Evidence-informed platforms for
to obtain HIV testing services. delivering demand creation include:

Good practice approaches for demand ■ Peer-led demand creation interventions for
creation KPPs

Demand creation to increase HIV testing service ■ Digital platforms, such as short-prerecorded
uptake and engage those in greatest need of videos encouraging testing at health facility
services is a valuable tool for mitigating stigma, waiting areas
discrimination and IPV. Priorities may need to
be set among demand creation approaches, 2. Approaches that have showed evidence of
depending on the setting, target population, increasing demand for HTS include:
available resources, and geographic area with
• Advertising specific attributes of HIV testing
high burden of HIV as part of a strategy to reach
services: on Radio, TV, social media, print and
PLHIV who do not know their status and have
electronic media.
high risk to HIV infection.

• Brief key messages and counselling by

providers

25
• Messages during couples counselling that organ/tissue is required prior to all procedures
encourage testing, involving transfer of body fluids or body parts,
such as artificial insemination, corneal grafts, and
• Messages related to risk reduction, to organ transplant. Donors should be specifically
encourage testing among high-risk individuals, informed about HIV testing of donated blood,
organ or tissue and link those with HIV positive
• Motivational messages: through PLHIVs, test results to posttest counselling, care, and
religious leaders, (it could be speech at treatment services.
gatherings, written, picture or graphic message),

3.3. HIV Testing Service Provision

Mandatory HIV testing is required:
Settings
■ HIV testing that will be done by the
HIV testing and counseling services can be
court order
provided in two major settings:

3.3.1. Facility Setting ■ Testing of blood after donation, and

Currently, the HIV testing and counseling ■ Testing of organs before organ
services in health facilities are: transplant

1. Client initiated HIV counseling and testing

(VCT)
3.3.2. Community Setting
2. Provider initiated HIV testing and counseling
(PITC), which is provided by opt-out approach Refers to HTS offered in the community,
using HIV risk screening tool at all clinical outside of a health facility. It can be delivered
service delivery points except during first ANC in many ways and in different settings and
testing. venues. These include HTS at fixed locations
in the community, mobile outreach in hotspots
3. Mandatory HIV testing and community sites such as bars, youth
centers, workplaces, and home based. It can
Mandatory HIV testing can only be performed also be delivered either alone or in combination
for specific reasons with individuals or groups with testing and screening for other infectious
when requested by the court. HIV is a blood- diseases such as TB, hepatitis and STIs.
borne pathogen readily spread by blood
transfusion or tissue/organ transplantation: As for any HTS, linkage to appropriate services
therefore, it is mandatory to test blood or tissue after community-based testing is critical. While
for HIV before transfusion, transplantation or providing HTS services in the community,
grafting. Mandatory screening of donated blood/ providers should use nationally approved
protocols as appropriate.

26
Workplace HTS: ■ Client Initiated: Voluntary Counseling and
Testing (VCT)
HTS in the workplace is an effective strategy
for reaching high risk individuals such as ■ Provider Initiated Testing and Counseling
mining, the transport and logistics sector, mega (PITC)
projects, large farming areas, the military and
other uniformed services. ■ Index Case Testing

Targeted mobile outreach ■ Social Network based HIV testing (SNS)

Targeted mobile outreach focuses on high-risk ■ HIV self-testing (HIVST)

populations to avail HTS as mobile outreach in
areas of low coverage and poor accessibility. The implementation of the VCT, PITC approaches
HTS services can also be provided to high- will use the respective protocols. However, if
risk populations such as widows, divorced and couples would like to get HTS together, couple
homebased female sex workers. counseling and testing (CHCT) protocol will be
used. Each protocol has different components
Home-based HTS: having tasks and scripts.

HTS using ICT approach can be offered in the 3.4.1. Voluntary Counseling and Testing
(VCT)
home has the potential to reach undiagnosed
partners of index cases and eligible biological
VCT is initiated by clients seeking to know
children. It can effectively reach undiagnosed
their HIV status. VCT is the oldest approach
individuals if offered at timings outside of work
of testing that gives client an opportunity to
hours.
confidentially explore his/her HIV risks to learn
his/her HIV test result. The VCT intervention is
3.4. Approaches of HTS “client-focused” to the extent that you focus on
the client’s unique issues and circumstances
A strategic mix of different HIV testing
related to HIV risk. The intervention is based on
approaches are needed for an effective and
a risk reduction model designed to reduce, not
efficient national HTS program depending on
necessarily eliminate risk.
the epidemiology and resources available.
Differentiated HIV testing service delivery 3.4.2. Provider Initiated Testing and
approaches are recommended to address Counseling (PITC)
the needs of a variety of population groups,
contexts, and epidemic settings. This refers to HIV testing, and counselling
recommended by a provider during a visit to
The following HTS approaches are recommended a health care facility. The health care provider
to reach the 2030 global target to end HIV/AIDS should use HIV risk screening tool to determine
epidemic control: whether the client is eligible for the HIV testing

27
or not. A brief counselling or pretest information PITC is an “Opt-out” approach. With the “opt-
should always accompany testing even for out” approach, individuals may specifically
diagnostic purposes and patients should never decline the HIV test having received pre-test
be forced to undergo testing against their will. information, without affecting their care. If a
Clients presenting with symptoms or signs client declines HIV testing service, a provider
of illness possibly attributable to HIV; it is a should try to understand the reasons for the
basic responsibility of health care providers to refusal. If a client is convinced, HTS can be
recommend HIV testing and counselling as part provided. But if not, the client will be advised to
of routine clinical management. reconsider his decision and return to get HTS at
another time.

Figure 3.1. PITC Flow Chart

28
3.4.2.1. Use of HIV Risk Screening Tool 3.4.2.2. Eligible clients for HIV Testing
(HRST) to Enhance PITC and counseling while providing PITC
includes:
HIV risk screening tool enables service providers
to identify high risk clients. It gives opportunity ■ All pregnant at first ANC visit, laboring, and
for targeted HIV testing. HIV risk screening postpartum women with unknown HIV
tool is a tool, having a set of questions, used status.
to identify clients with specific risks for HIV.
HRST helps to determine a client’s HIV risk and ■ Partners of HIV positive pregnant/
whether the client is eligible for HIV testing or postpartum women
not based on the below category:
■ Sexual partners of index cases and all under
■ Client’s HIV status (is the client a known 19 children of PLHIV; biological siblings and
HIV positive case or not?) biological parents.

■ HIV risk behavior (practicing unprotected ■ Female sex workers with unknown HIV
sex, having concurrent multiple sexual status.
partners, etc.)
■ All TB patients and presumptive TB cases
■ Clinical symptoms or signs of HIV with unknown HIV status

■ Occupational risk ■ All patients with Sexually transmitted

infections (STIs) and their partners
Benefits of Using HIV Risk Screening Tool
■ Children orphaned by AIDS.
HRST reduces over testing, improves case
finding and subsequently increase yield. Risk ■ Patients with clinical signs or symptoms of
screening tools have been utilized in different HIV/AIDS visiting health facilities (Annex 6a,
countries to identify clients who need to be 6b and 6c).
tested and maximize HIV case detection and
increase efficient utilization of limited resources
3.4.3. Index Case Testing
including RTKs. In our setup, risk screening tool
An index case is defined as an individual who
can be applied at all service delivery points
is HIV positive. When counsellors identify
with the exception for the first ANC/labor/post-
index cases whose sexual partners or eligible
partum visit. (Refer annexed 3a and b)
biological children are not tested for HIV, they
should immediately provide partner services
including notification and contact tracing.

To improve case-finding, countries need to use

29
a mix of innovative testing strategies to identify Principles of ICT
positive individuals. Index case testing is one of
the most important case finding approaches to ■ Client centered and focused
identify HIV positive individuals.
■ Confidential
ICT is a high yield, targeted testing approach
for identifying and linking new HIV infected ■ Voluntary and non-coercive
individuals to treatment services. This approach
needs to be optimally utilized for case detection ■ Non-judgmental
and to break HIV transmission cycle.
■ Culturally, linguistically, appropriate
Some of the PLHIV might have not yet disclosed
■ Accessible and available to all
their HIV status to their partners while others
have partners with ongoing risk. Clients’
■ Comprehensive and integrative
concerns should be addressed to improve
disclosure and testing service uptake among Approaches of ICT Services
index partners and HIV exposed biological
children. If there is/are children who are not 1. Client Referral - Index clients tell partners
biological children of the index case but is/are about infection and encourage him or her to
exposed to HIV, HTS will be provided though come to testing center for testing. A trained
this approach is not part of ICT. health care provider encourages the index
clients to disclose his /her status to his/her
A critical function of ICT is partner elicitation, partners. In this approach, the index client takes
a process through which index patients are responsibility for encouraging partner(s) to seek
interviewed to elicit information about their HTS. This is often notified verbally by the index
sexual partners, counseled and assisted on client.
disclosure and continuously supported to bring
their partner for HIV testing. Partner services 2. Contract referral: The index client enters
are voluntary, based on the decision of the a “contract” with the health care provider
index patient, and are provided confidentially whereby he or she agrees to disclose their HIV
in a patient-centered framework. The role status to all partner(s) and or to refer them for
of the service providers will be providing HTS within two weeks.
counseling about the risk of HIV transmission
and importance of disclosure, assisting on If partner(s) do not access HTS within this period,
disclosure, educating on the benefits of early health care providers contact the partner(s)
treatment and better outcome. directly to notify them that they may have
been exposed to HIV without any disclosure of
the index client after getting permission from
the index client. Health care providers offer

30
voluntary HTS to partner(s) and other family ■ Has [partner’s name] ever hit, kicked,
members as appropriate while maintaining the slapped, or otherwise physically hurt you?
confidentiality of the index client.
■ Has [partner’s name] ever threatened to
3. Dual Referral - Index clients and service hurt you?
provider will notify his/her partner together.
The provider offers voluntary HIV testing to ■ Has [partner’s name] ever forced you to
the index client and partner(s) for the potential do something sexually that made you feel
exposure to HIV and encourage them to seek uncomfortable?
HIV testing together without any disclosure of
the index client HIV status. Step 6: Determine the preferred method of
partner notification or child testing for each
4. Provider Referral (Optional) - Health care named partner/child. Offer HIVST if a client
provider will call or send text message to his/ prefers HIVST and provide necessary support
her partner of potential exposure of HIV without including provision of HIVST kit.
disclosing the index client name and HIV status
to visit HIV testing sites without telling them the Step 7: Contact all named partners in addition
client’s name (this will be done anonymously). biological children less than 19 years old
In this approach, the index client has no role biological children and provide conventional HIV
and involvement in the process. testing at the health facility and community
level.
Steps of Index Case Testing
Step 8: Record outcomes of ICT
Step 1: Introduce the concept of index testing
during pretest session or PMTCT/ART visit Step 9: Provide appropriate services for children
and partner(s) based on HIV status.
Step 2: Offer index testing as a voluntary service
to all clients testing HIV-positive Step 10: Follow-up with client to assess for any
adverse events associated with index testing
Step 3: If client accepts participation, obtain
consent to inquire about their partner(s) and N.B: IPV screening MUST be administered to
biologic child (ren) all sexual contact of the index client. From the
three asked questions, if the answer is “yes” to
Step 4: Obtain a list of partners in last 12 months one of the questions, ICT service should not be
and biological children < 19 with unknown HIV initiated to avoid adverse outcomes.
status.

Step 5: Conduct an intimate partner violence

(IPV) risk assessment for each named partner.

31
Adverse Event Monitoring and Reporting and trust building between the client and
System the provider. To this effect, ongoing in person
counseling has been the main stay used by ICT
Adverse Event is defined in the context of ICT, counselors. However, due to changes in service
as an incident that results in harm to the client delivery following the COVID-19, providing in
as a result of their participation in index testing person counseling has been challenged and
services. several clients are being put on multi month
dispensing (MMD). Virtual Phone counseling
Site level adverse event monitoring, response is counseling strategy to use in the context of
and reporting system forms need to be COVID-19 where clients prefer to stay away
available at the facility or community testing from sites. Phone counseling integrated to ICT
sites for service providers to document and helps to reach and counsel index cases who
monitor consent, IPV, and frequency of adverse are on MMD but have contacts not yet tested/
events. Actively monitor reasons for refusing not elicited, newly diagnosed but have not yet
index testing services, prevalence of IPV and disclosed and required follow up counseling. It
other adverse events (e.g., confidentiality is a tool to support sites to provide phone-based
breaches, stigmatization, coercive tactics, etc.) counseling to elicit contacts of index clients
for improvement. ensuring communication privacy, support
indexes virtually to select contact referral
Service providers should routinely ask index approaches, and provide exposure notification
clients if they experienced any adverse events mechanisms for partners with testing options
following participation in index testing services. including the HIV self-test.

NB: Unintended negative outcome as result Index Case Testing (ICT) minimum standards
of HIV status disclosure could still occur in
the future and, as such, follow up should Index testing should be client-centered and
occur while all contacts are being traced. All focused on the needs and safety of the index
reports of adverse events should be properly client and his or her partner(s) and children.
documented. They should also be informed of Further, sites offering index testing services
their ability to make a complaint if these rights must ensure appropriate systems are in place
are violated. This can be done through posters in for testing service providers to identify and
waiting/examination rooms, patient handouts, respond to clients who disclose their fear or
and other educational materials. Index clients experience with Intimate Partner Violence (IPV)
should be provided multiple pathways for from partner(s).
issuing concerns or complaints regarding index
testing services. These include suggestion The minimum standards for a site to provide
boxes within health facilities and community safe and ethical ICT services are:
testing sites.
■ Providers trained on HTS including index
Phone Counseling for Index Case Testing testing procedures, IPV screening, adverse
Index case testing is not a onetime activity. event monitoring, 5Cs, and ethics.
It requires follow up counseling, relationship

32
■ Adherence to 5C’s (consent, confidentiality, The underlying assumption of SNS is that people
counseling, correct test results, and in the same social network share similar risk
connection to prevention/treatment) behaviors that predispose them for HIV. This
is not limited to current behaviors but includes
■ IPV risk assessment and provision of first past behaviors. The overall approach is to enlist
line response, including safety check and HIV-positive and high-risk HIV-negative persons
referrals to clinical and non-clinical services to recruit individuals from their social, sexual,
(if not provided on site) and drug injecting networks for HIV testing
services. Once recruited and tested, network
■ Secure environment to store patient members become recruiters and refer members
information, and of their networks for testing. This process
continues, creating chains of recruitment that
■ A site level adverse event monitoring and can penetrate hidden networks.
reporting system.
This strategy uses inclusion and exclusion
3.4.4. Social Network Strategy (SNS)
criteria to identify the appropriate target/
recruitment process and enhances success of
Social network strategy (SNS) is a case-finding
the SNS.
strategy that uses social network connections to
locate individuals engaging sexual partner/s and
Inclusion criteria for recruiters/seeds include:
it can also be applied for FSWs, drug injecting
partners and social contacts of key population
■ HIV positive and/or high-risk negative
members with HIV and of those who are HIV-
negative and at ongoing risk. ■ Willing to refer network members to HTS

SNS has been used to find new HIV cases ■ Comfortable talking about HIV
among key populations who have difficulty in
accessing HIV testing services. It has also been ■ Knowledgeable about HTS and testing
used to find previously diagnosed individuals locations
who were out of care, and who may then be
linked to ART for the first time or re-engaged in Exclusion criteria for recruits include:
ART services. SNS is a peer-driven HIV testing
approach by addressing people’s confidentiality • Persons who might pose a risk for
concerns and broadening the reach to social violence,
contacts, social network-based HIV testing
approaches can improve the acceptability of • Persons with significant mental
partner services among key populations and so illness who might interfere with appropriate
reach more people who may not otherwise test participation,
for HIV.
• Known HIV positive cases,

33
There are four major phases to a social networks As with all approaches to HIV testing, HIVST
program. These phases are should always be voluntary, not coercive, or
mandatory.
1. Recruiter Enlistment: In this phase, HIV-
positive or HIV-negative high-risk persons who Delivery of HIV Self Testing
are willing to recruit individuals at risk for HIV
infection from their social, sexual, or drug- HIVST can be delivered in two ways depending
using networks are enlisted into the program. on the level and type of support provided.
To identify recruiters, approach HIV positive
clients and identify additional people through Directly assisted HIVST refers to trained/
the existing HTS or ART/PMTCT services. oriented providers, or peers giving individuals
an in-person demonstration before or during
2. Engagement (Orientation, Interview, and HIVST on how to perform the test and interpret
Coaching): After recruiters are enlisted into the the test result.
program, they are provided with an orientation
session that explains the nature of the program Unassisted HIVST refers to when individuals
and the social network techniques that might be self-test for HIV and only use an HIVST kit with
used to approach their associates and discuss manufacturer-provided instructions for use.
HIV testing with them.
HIV Self -Testing, as a key strategy in the context
3. Recruitment of Network Associates: Next, of COVID-19, should be utilized optimally as
recruiters will refer individuals for testing who additional testing strategy to reach clients
they have identified as being at risk for HIV undiagnosed otherwise and those who could
infection. All individuals should be approached not be reached timely because of MMD and
by the recruiter alone, without the provider). COVID-19 situation.

4. HTS: The next phase involves providing HTS Both directly assisted and unassisted HIVST
to the network associates identified through may include additional support:
the social network strategy.
■ Manufacturer’s instructions and brochures.
3.4.5. HIV Self Testing
■ Brief in-person demonstration (one-on one)
HIV self-testing (HIVST) refers to a process in before testing.
which a person collects his or her own specimen
(oral fluid or blood) and then performs an HIV ■ In-person assistance during procedure.
test and interprets the result, often in a private
setting, either alone or with someone he or she ■ Hotline contacts for HIVST information.
trusts. HIV self-testing should be offered as an
■ Virtual support via telephone and text to
additional approach to HIV testing services.
track based on clients preference

34
Demand creation strategy of HIVST ■ Community-based organizations

To create awareness and increase uptake of NB: Providers and users should be aware that
HIVST, advocacy and communication strategies HIVST is not recommended for people with
should aim to emphasize: a known HIV status, as this may lead to an
incorrect self-test result.
■ Correct use of the self-test kits, and ensure
correct interpretation of results and linkage Standards and procedure
for confirmatory testing,
Directly Assisted HIVST: HIVST must be
■ Demand creation should be tailored to conducted using the nationally approved HIV
high-risk target populations. It will be rapid self-test kit(s). The kit(s) will include
most successful when developed with instructions in English and local language
communities in local setting. as well as pictorial diagrams to aid ease of
use and correct interpretation of results. All
■ Demand creation will be conducted at service delivery points distributing HIV self-
health facility and community platforms. test kits should display instructions on HIVST
Clients should get adequate information procedures. In addition, all outlets should show
to increase their knowledge and decision- those who will assist clients how to perform
making ability to test themselves the test. The assistant will provide pretest
information, demonstration, and interpretation
Methods of demand creation of the result.

Clear messages are needed to ensure that If the HIVST result is reactive, the assistant
users understand what to do after a reactive should link the self-tester to conventional HIV
self-test result, including where to go to testing for confirmation, where the approved
access conventional HTS for confirmation of national HIV testing algorithm is utilized. And
results, treatment, care, and other support. The the assistant will also follow whether the
messages can be delivered through: confirmation test performed and whether the
client is enrolled to ART if test result turns out
■ One to one (health care providers, health to be positive.
extension professionals, peer educators,
volunteers). For individuals with non-reactive self-test
results, the assistant should advise the self-
■ Print media (banners, poster, fliers) tester to retest in 3-6 months if the client has
an ongoing risk to HIV infection.
■ Audio visual

■ Networks of people living with HIV

35
Unassisted HIVST ■ The safety, quality, and performance of
HIVST should be further verified upon
Refers to when individuals self-test for HIV delivery and before distribution to the
using a self-test kit using an instruction provided clients.
with the kit. Service providers/ trained peers
who distribute HIVST kits should demonstrate ■ Adequate orientation and demonstration
the instructions on HIVST procedures. Users should be given to the clients to verify the
should be informed about links or contact presence of control line irrespective the
details to access additional support, such as result.
telephone hotlines or instructional videos.
3.4.6. Recency Testing
The kit will include instructions in local languages
and pictorial diagrams to aid simplicity of use Recent HIV infection is referred to as HIV
and correct interpretation of result. infection acquired in the past 12 months.
Recency testing distinguishes between recent
Quality assurance of HIVST (HIV infection acquired in the past 12 months) and
long-term HIV infection. Recent HIV infections
Guidance on ensuring the quality of HIV self- are presented with the following manifestations
testing test kits and testing processes include: as high viral load, immature and weak immune
response, continued high risk behavior, High
■ Monitor the quality of HIVST through probability of ongoing transmission (40%-60%
integrating with the existing HTS QA of transmissions). Recency testing provides
program opportunity for interruption of transmission
by contact tracing and it increase yield of HIV
■ Include HIVST in mentoring and supportive testing.
supervision activities
Probable recent infection case is a confirmed
■ Ensure provision of HIVST instructions with newly diagnosed HIV positive individual who
pictorial illustrations in local language on tested positive for recent infection.
how to conduct self-testing and obtain the
correct results. Confirmed recent infection is a confirmed
newly diagnosed HIV positive individual who
■ All clients should be informed to follow tested positive for recent infection and has high
manufactures instructions in the test kits viral load.
insert.
Purposes of Recency Testing
■ All clients must also be aware of correct
practices to minimize biosafety risks the The identification of newly infected individuals
need to confirm any reactive test results as and the presence of recent infection will
per the national HIV testing algorithm. support the national HIV program to rapidly

36
respond to sub-populations and sites where is guided by the magnitude and the spread of
high levels of HIV transmissions are detected. transmission. Some clusters may require routine
Following identification of cases, responding public health actions such as ICT Services and
to individuals with probable recent infection linkage to care and treatment services, while
or groups of HIV-infected persons with sexual other clusters may require enhanced response
partners and social networks is a critical step activities (e.g. targeted demand creation and
toward bringing the nation closer to the goal of testing as well as strengthening partnership of
no new infections. relevant stakeholders).

Case reporting and HIV recency data should 3.5. Procedures of HTS delivery
be used to guide an enhanced response at the
health facility/site level and at the cluster/above During provision of testing service, providers
site level. As the country is getting closer to should follow specific procedures as outlined
epidemic control, it is recommend conducting below. While following the procedures,
recency testing for all newly diagnosed HIV providers need to utilize the national guideline,
cases. protocol, cue-card, and job-aids.

A. Site Level Response a. Client registration

Healthcare providers are required to document At service delivery points, clients will be
all probable recent infections and risk factor registered using code numbers, names, MRN
information about the newly identified HIV (Medical record number). Conduct HIV risk
positive cases to provide enhanced response screening: If eligible based on the HRST, provide
and timely monitoring. pre-test information

Site level response includes: b. Pre-test information

■ All newly diagnosed HIV positive individuals Pre-test information should be provided by
should be linked and start ART within the health care providers or counselors. Couples
same day. should be encouraged to receive results
together. Pre-test information for PITC can
■ ICT services should be provided for sexual be provided in the form of individual or group
partners and eligible biological children information sessions. The relevant information
that should be provided includes but not limited
B. Above-Site level response to:

Above site response is primarily based on the • Exposure to HIV infection and
identification and analysis of clusters based on implications of undiagnosed HIV infection.
the CBS data. The type and level of public health
response needed for each identified cluster • The clinical and prevention benefits of

37
HIV testing individuals, sexual partners, and c. Offer HIV Testing:
eligible biological children (less than 19 years).
■ If a client accepts HIV testing when offered,
■ Benefits of early ART and the fact that proceed to HIV testing.
people with HIV who achieve and maintain
an undetectable viral load cannot transmit ■ If a client decline HIV testing, identify the
HIV sexually to their partners. problem and proceed to HIV testing if
successful.
■ The meaning of an HIV-positive diagnosis
and of an HIV-negative diagnosis. ■ If a client declines and the counseling is not
successful, plan return for testing
■ The importance of disclosing known HIV
status to the provider to minimize repeat d. Conduct HIV Testing
testing of a known case. There is a possibility
for false negative result if a person who is Ethiopia is implementing the low prevalence
already on ART is tested for HIV using an (<5%) testing strategy. Currently we are using
antibody test. serial algorithm (three test algorithms instead
of tiebreaker). In a serial testing algorithm, the
■ Verbal consent should be obtained before samples are tested by a first test. The results
conducting HIV testing from: of the first test determine whether additional
testing is required. To improve the acceptability,
■ Adult client including mature minors, uptake and quality of service delivery for HTS
in all settings, rapid diagnostic tests (RDTs)
■ Guardian or next of kin if a client has an should be used. These testing strategies have
altered consciousness or a child under 15 been developed assuming that all HIV assays
years of age used have a sensitivity of at least 99% and
a specificity of at least 98%, resulting in an
■ The confidentiality of the test result and any overall positive predictive value of 99%. The HIV
information shared by the client testing must be done using nationally accepted
RDTs following national HIV testing strategy as
■ Discuss any concern or questions through shown below. Same day results should always
availing more time for the client be respected irrespective of the type of delivery
approach.
■ The client’s right to refuse testing and that
declining testing will not affect the client’s
access to HIV-related services or general
medical care.

38
Figure 3.2: Recommended HIV testing strategy for Ethiopia.

A1+

A1-

■ All individuals are tested on Assay 1 (A1). should be asked to return in 14 days for
Anyone with a non-reactive test result (A1-) additional testing.
is reported HIV negative.
■ Individuals who are reactive on Assay 1 but
■ Individuals who are reactive on Assay 1 non-reactive on Assay 2 (A1+; A2-) should
(A1+) should then be tested on a separate be repeated on Assay 1
and distinct Assay 2 (A2).
■ If repeat Assay 1 is non-reactive (A1+; A2-;
■ Individuals who are reactive on both Assay repeat A1–), the status should be reported
1 and Assay 2 (A1+; A2+) should then be as HIV negative;
tested on a separate and distinct Assay 3
(A3). ■ If repeat Assay 1 is reactive (A1+; A2–;
repeat A1+), the status should be reported
■ Report HIV-positive if Assay 3 is reactive as HIV-inconclusive, and the individual asked
(A1+; A2+; A3+) to return in 14 days for additional testing.

■ Report HIV-inconclusive if Assay 3 is non-

reactive (A1+; A2+; A3-). The individual

39
e. Providing HIV test results ■ Conduct risk reduction plan: Clients who
do have sex with a person with unknown
Test results should be declared in person status can protect themselves by using
maintaining privacy (not by telephone, email, condoms correctly and consistently every
or letter). Sites should not provide written HIV time they have sex.
negative test results to clients to avoid misuse
of results. Clients with HIV positive results ■ Identify support for risk reduction plan:
requesting or requiring referral to other facility Identify a person to whom the client fills
should be referred to the appropriate institution comfortable to disclose the risk reduction
with pertinent information. plan.

f. Provide Post-test counseling ■ Provide information on HIV prevention

interventions and how to access them:
All clients undergoing HIV testing should be Condoms, PrEP methods, and harm-
provided with post-test counseling in person reduction services for people who inject
as individual or couple. The messages and drugs
information included in post-test counselling
and their intensity need to be tailored according ■ Address disclosure and partner referral:
to the test result. For those with negative This HIV test result only shows your current
results, this will further depend on whether HIV status, and it cannot tell us about your
they face ongoing HIV risk. Messages should sexual partner’s HIV status
always be clear and concise and client-centered,
acceptable to the client and delivered in a safe, Posttest counseling services: HIV positive
confidential, and non-judgmental manner. Post- result
test counseling should be provided by health
care providers or counselors. Using counseling support tools provide posttest
counseling for HIV positive clients as below:
Post-test counseling service: HIV negative
result ■ Provide the HIV test result clearly and simply
explain the meaning of test result in person.
Using cue card, provide posttest counseling for Focus on the client’s level of understanding
HIV negative client as below: and acknowledge that the test result may be
difficult to hear, however a provider needs
■ Provide HIV test result in person: Inform to explain to the client and have confidence
the meaning of HIV negative test result. in client’s ability to adjust and cope.
Explain window period in case of recent
exposure or ongoing risk and recommend ■ Discuss immediate concerns and
repeat testing based on the client’s level of help the client to identify who could
recent exposure and/or ongoing risk. provide immediate support (individual or
organizations in the community).

40
■ Assess current health conditions and link ■ Provide disclosure support and do partner
to services as appropriate, e.g., TB, OI, STI, elicitation. Assisted partner notification and
etc. referral services are voluntary at the choice
of the client and are provided confidentially
■ Assess the risk of intimate partner violence in a client-centered framework
(IPV) and discuss possible steps to ensure
safety of clients, particularly women, who ■ Stress the importance of same day/early
are diagnosed HIV-positive. ART initiation including prophylaxis for OI if
required. If a client is a pregnant woman,
■ Assess the risk of suicide, depression, and advise about the need for PMTCT service.
other mental health issues and discuss
positive living. ■ Discuss if there are barriers to same day
initiation, arrange a follow-up visit for clients
■ Reassure the client about maintaining who are unable to start ART.
confidentiality of the test result. Clients
might be concerned about others knowing ■ Retesting is required before ART initiation
their HIV status, and they will need time to using the existing testing algorithm by the
figure out who to disclose to and how to ART or PMTCT provider.
manage their situation. Also explain about
the importance of shared confidentiality. ■ Assess the need for any additional health
care services including family planning and
■ Advise to use condom consistently and provide the service or refer.
correctly all the time. Assess clients’
knowledge on proper use of condoms and ■ Encourage and provide time for the client to
conduct condom demonstration. Inform ask additional questions.
clients about the importance of preventing
transmission of HIV or other STI to their ■ Link clients from SDPs to ART clinic through
partners /or re-infection with different accompanied referral for further counseling,
strains of HIV. The client may inform you confirmatory testing and subsequent
that his/her partner(s) has already been services.
tested. If the partner tested positive, note
that protection from other strains of HIV and
STI is important for both individuals. If the
partner tested negative, provide counseling
to the client to protect the negative partner.

41
 Disclosure Support

All clients, positive or negative, should be empowered to inform their sexual partner/s of
their test result. When HIV-positive clients are reluctant or fearful to disclose their results,
the counselor should provide additional counseling to help the client to disclose the test
result and bring the partner for testing.

■ Counselor should discuss the benefits and risks of disclosing HIV-positive status to
partner(s) and support individuals and couples with disclosure.

■ For couples, mutual disclosure has many benefits. People with HIV who can share
their results with a trusted partner will often find it easier to cope with their diagnosis
and to adhere to ART.

■ If a client fails to disclose after two documented counseling sessions and the counselor
feels that the partner is at risk of infection, he/she should consult the supervisor or
health facility head for further action including revealing the result. This will help to
share responsibility of handling a difficult case with the health care provider and will
protect safety of providers.

■ Disclosure and risk of intimate partner violence. Planning for disclosure should include
steps to maximize client’s safety. Counselling for index client who are considering
voluntary or mutual disclosure of HIV-positive status should include discussion about
the challenges of their situation, the potential risk of violence and ways to disclose
more safely. Options when a client fear of violence or are experiencing violence
include mediated, delayed disclosure. If there is risk of severe violence, advice not
to disclose.

■ Disclosing HIV status to children is a process. Counselors should be encouraged to

answer children’s questions truthfully from early age. Information should be given in a
way a child can understand at a pace she/he can cope with according to their cognitive
and emotional maturity. For details refer chapter six

42
3.6. HIV Testing in infants and Recommendations
children
■ HIV testing and counseling should be offered
Mortality is very high among untreated infants to under five children visiting health facilities
infected with HIV in the first year of life, making if eligible based on HIV risk screening tool.
early HIV testing, prompt return of results
■ All HIV-exposed infants must have HIV
and rapid initiation of treatment is essential.
virological testing at six weeks of age or
Definitive diagnosis at the end of the risk
at the earliest opportunity thereafter using
period of mother-to-child transmission (breast
conventional PCR testing.
feeding period) should be ensured. For children
18 months of age and older (who are not being
■ For infants with an initial positive virological
breastfed or who stopped breastfeeding for at
test result, on the same day ART should be
least six weeks), standard HIV serological tests
started and a second specimen needs to
such as rapid diagnostic tests can be used to
be collected to confirm the initial positive
reliably determine HIV infection status.
virological test result.

■ Children 18 months of age or older with

suspected HIV infection or HIV exposure
should have HIV serological testing using a
standard HIV testing algorithm.

43
Note:

■
a
Point-of-care DNA PCR can be used to after cessation of breastfeeding (to allow for
diagnose HIV infection as well as to confirm development of HIV antibodies). For infants
positive results. younger than 18 months of age DNA PCR
should be performed to confirm infection. If
■
b
Start ART without delay. At the same the infant is older than 18 months, negative
time, retest to confirm infection. As antibody testing confirms that the infant
maternal treatment is scaled up and is uninfected; positive antibody testing
MTCT transmission rates decrease, false- confirms infant is infected.
positive results are expected to increase:
retesting after a first positive DNA PCR ■ If a child tested negative for DNA PCR
is hence important to avoid unnecessary becomes symptomatic suggestive of HIV
treatment, particularly in settings with infection, do PCR test.
lower transmission rates. If the second
test is negative, a third DNA PCR should be 3.7. Retesting
performed before interrupting ART.
Retesting refers to a situation where additional
■
c
For children who were never breastfed, testing is performed for an individual after a
additional testing following a negative defined period for explicit reasons. Retesting
DNA PCR at 4-6 weeks is included in this is always performed on a new specimen and
algorithm to account for potential false- may or may not use the same assays (tests)
negative DNA PCR results. as the one at the initial test visit. There is a
need to reduce unnecessary retesting among
■
d
The risk of HIV transmission remains as long persons who have previously been tested and
as breastfeeding continues. If the 9-month learnt their results. Most people do not require
test is conducted earlier than 3 months retesting to validate an HIV-negative result.
after cessation of breastfeeding, infection However, it is important to accurately identify
acquired in the last days of breastfeeding persons who do require retesting. Such persons
may be missed. Retesting at 18 months or include those whose initial test results were
3 months after cessation of breastfeeding indeterminate, those who tested negative but
(whichever is later) should be carried out for are at ongoing risk for acquiring HIV (e.g., due
final assessment of HIV status. to high-risk behaviors) and those who may be
in the early stages of infection and have not yet
■
e
If breastfeeding extends beyond 18 developed a sufficient level of antibodies that
months, the final diagnosis of HIV status can be detected by rapid antibody (‘window
can only be assessed at the end of period’).
breastfeeding. If breastfeeding ends before
18 months, the final diagnosis of HIV Retesting will be conducted for:
status with antibody testing can only be A. Individuals with ongoing risk
assessed at 18 months. Antibody testing
should be undertaken at least 3 months B. Before ART initiation

44
A. Retesting for individuals with ongoing B. Retesting before initiation of ART
risk
It is required that all HIV positive clients linked
Retesting is recommended for persons who to care and treatment services need to be
tested negative but have an ongoing risk: retested before treatment is initiated. Retesting
aims to rule out possible technical or secretarial
1. Occupational exposure or sexually assaulted errors, including specimen mix-up through
client who started post exposure prophylaxis mislabeling and transcription errors, as well as
(PEP): retest at 6 weeks, 3 months, and 6 random error either due to the provider or the
months. test device.

2. A pregnant during the third trimester, Retesting a person diagnosed to be HIV positive
laboring, or postpartum period will be eligible to verify the diagnosis should include:
for re-testing if:
■ Taking a new specimen for each newly and
■ She has unknown or HIV-negative status previously diagnosed individual, preferably
and in sero-discordant relationships, conducted by a different provider using the
current testing algorithm, prior to initiation
■ Pregnant women whose partner has an of ART.
updated but unsuppressed viral load result,
■ Retesting is preferably conducted at a
■ She has ongoing HIV risk in late pregnancy different site/unit, ideally the site where the
(unprotected sex, STI, etc.). decision about ART/PMTCT initiation will
be made or another unit designated and
3. People with STI, viral hepatitis, monitored by the ART/PMTCT clinic.
presumptive TB, clinical manifestations of HIV:
retest at 6 weeks. ■ If the retesting result is negative (the
previous test result is positive and the
4. Female sex workers and PWID consider current test result is negative), different
retesting every six months. provider should repeat the test either using
the same kit or different batch of test kit if
5. Have specific incidents of known HIV
available.
exposure at 6weeks.
Retesting people on ART is not recommended.
6. Discordant couple: retest after
The effect of ART in suppressing viral replication
6-12month or even earlier based on risk of
may extend to suppression of the immune
infection to a discordant partner such as HVL.
response and therefore reduction of antibody
production. Once a person is started on ART,
7. Individuals receiving PrEP every quarter
low antibody titers make it challenging to
discern whether an individual is indeed HIV
positive, and this will lead to potential risks of
incorrect diagnosis (false negative result).

45
C. Retesting 14 days later after an HIV- ■ Conduct regular mentoring and periodic
inconclusive status: Perform retest using supervision sessions to provide technical
the same assay and different/new sample assistance to improve quality of HTS.

Repeat testing ■ Introduce HTS quality assurance system to

monitor performance of service providers
When the same specimen is tested again on a regular basis.
on the same assay when the initial result is
reactive, or test results are discordant. The ■ Conduct proficiency testing every four
assay is repeated to rule out biological false months.
reactivity. For assays that utilize capillary whole
blood, another prick may be needed to collect Quality assurance
adequate specimen volume, but it must be in
the same testing event. Quality assurance (QA) for HIV counseling and
testing refers to periodic assessments of factors
3.8. Quality assurance and Quality that affect the quality of HIV testing. Issues that
need to be addressed while conducting QA:
Improvement for HTS
■ Have the counselors/service provider
Quality can be defined as accessible services
received basic training packages approved
that meet the need of clients and providers,
by MOH?
in an equitable and acceptable manner, within
the available resources and in line with national
■ Is there enough physical space to provide
guidelines. While providing the HTS, quality of
that ensures privacy of the clients and point
the service should address the major parameters
of care testing?
of quality: safety, efficiency, effective (correct
result) and provided with reasonable time. It
■ Are basic supplies and provider support
should be easily accessible services that meet
tools available to provide HTS?
the need of clients and providers, should be
conducted in line with national guidelines. To ■ Is the service accessible and affordable to
ensure the quality of HTS, all service providing the clients?
sites should:
■ Are clients satisfied with the services?
■ Provide standardized conventional HTS
procedures at all time ■ Are counseling and testing sessions
conducted according to nationally approved
■ Ensure all service providers undergo on the protocols?
standardized HTS training.

■ Conduct RTKs quality control for all newly

received kits.

46
■ The QA Should be conducted by well-trained Quality control (QC) is a procedure or set of
program supervisors on regular basis to procedures intended to ensure that a performed
ensure HIV testing service qualities. The service adheres to a defined set of quality criteria
roles and responsibilities of the supervisors or meets the requirements of the client. It is an
are: important means of verifying for the test kit and
the procedures used are performing according
■ To determine if counselors/service providers
to the manufacturer’s intended specifications.
received standard trainings and refresher
courses.
Quality control of HIV testing
■ To monitor how well counselors/service
providers follow the counseling and testing Only test kits validated by the Ethiopian Public
protocol. Health Institute should be used by counseling
and testing sites. Training and supervision of
■ To monitor whether clients feel that their laboratory staff, accurate testing materials that
confidentiality is protected and satisfied are well stored and have not expired, and good
with the services they are provided. maintenance of laboratory records are essential
to ensure the quality HIV testing.
■ To make sure that HIV test results are given
in person during the post-test counseling
External quality assessment (EQA)
session.

Supervision for quality assurance of HIV For EQA, proficiency testing samples (dried
testing: tube specimen), which was prepared by the
higher laboratory tier, i.e., national reference
The supervisory visits for HIV testing standards laboratory (NRL), regional reference laboratory
and biosafety should assure that: (RRL) or EQA centers must be done. This
method evaluates individual’s performance in
■ The national testing protocol is consistently
testing procedure, results reporting, capabilities
being followed.
of laboratories and testing points on performing
■ The laboratory operating procedures are HIV rapid testing. Sites failing the proficiency
being observed. tests need to receive additional technical
supervision and support. In addition, onsite
■ Infection prevention practice is in place.
evaluation must be done at least twice a year.
■ Proficiency testing is in place including
quality control testing in central laboratory. Internal quality control (IQC)

■ A standardized laboratory logbook is For IQC, trained laboratory technicians in the

available and being used. facility should regularly perform the IQC to
verify the quality before the test kits are being
■ Technical support for QA is in place.
used by the testing units.

47
3.9. Linking People Diagnosed Post-test counselling messages remain key.
with HIV Infection They should be concise, addressing the needs
of the client and focusing on supporting linkage
Linkage is defined as a process of actions and to care. Post-test counselling messages need
activities that support people testing for HIV to be tailored to specific populations and their
and people diagnosed with HIV to engage situations and whether their test results are
with prevention, treatment, and care services HIV-positive, negative, inconclusive or they
as appropriate for their HIV status. For people already know their status and need to engage,
with HIV, it refers to the period beginning with re-engage in care. Messages need to provide
HIV diagnosis and ending with enrolment in clients with the latest information, including:
care or treatment. It is critical for people living
with HIV to enroll in care as early as possible. ■ The personal health benefits of early ART
This enables timely initiation of ART as well as initiation
access to interventions to prevent the further
■ People living with HIV receiving ART
transmission of HIV, prevent other infections
who achieve and maintain Undetectable
and co-morbidities and thereby to minimize loss
Viral Load result has minimum risk of
to follow-up.
transmission to their partners
Linkage to HIV treatment, prevention, care,
■ The benefits of voluntary provider-assisted
support, and other relevant services is the
referral for people living with HIV.
primary responsibility of HIV testing services
and the testers and providers delivering
All people with HIV-positive diagnoses should
HIV testing services Multiple factors may
be offered a package of support interventions
hinder successful linkage to care, including
that ensure timely linkage to care including
distance from services, transport costs, long
ART initiation with in/outside the health facility,
waiting times at the facility and, for those
friendly and flexible services designed to suit
testing positive, stigma and disclosure-related
specific population groups and digital platform.
concerns.
Providers should note that people who are HIV-
negative but at ongoing risk also need to be
Linkage to HIV care should be improved
linked to effective prevention services.
through interventions that support people in
the initial steps in the continuum of care. Such
The following interventions have demonstrated
interventions may vary based on the local
benefit in improving timely linkage of PLHIV
context, including: the health-care delivery
after an HIV diagnosis:
systems, geography, and target population.
A combination of interventions is needed
1. Efficient interventions to reduce time
to improve linkage to prevention, care, and
between diagnosis and engagement in care,
treatment for specific groups at risk.
including support for HIV disclosure, tracing
and training staff.

48
2. Peer support and navigation approaches for ■ Ensure that a referring and accepting health
linkage care facilities or sites are accountable
for assurance of the client’s referral is
3. Quality improvement approaches using data successful.
to improve linkage.
■ Strengthen Post-test counseling in such a
Good practices of linkage to care at site level way that the client understands the benefits
of ART; develop trust and confidence on the
The recommended good practices to improve provider and reaches to informed decision
linkage of HIV positive person to care and on linkage.
treatment services after the person is found
positive should be implemented at all sites. ■ Promote health seeking behavior for service
utilization
A. Implement standardized service delivery
system that will improve referral and linkage ■ Educate clients on benefits of early ART
between HIV chronic care through: initiation and related care.

■ Prepare standard operating procedure ■ Call or text to the client and remind him/her
(SOP) for inter- and intra- facility service for linkage service.
outlets referral linkage system
B. Standardized documentation, reporting
■ Strengthen referral system between health system and feedback practice through:
facility and community by using SOP.
■ Ensure the availability and sustainability of
■ Establish site level support groups to recording and reporting formats.
improve escorting/accompanied referral and
feedback practices for intra-facility referral. ■ Ensure a referral and linkage feedback
mechanism in health facility.
■ Establish facility and catchments area level
regular referral linkage auditing system to ■ Ensure standardization of guidelines and
ensure that all new HIV infected clients are training materials on referral and linkages
linked to ART. issues.

■ Map and establish network between C. Improve the engagement of Health Extension
available, chronic care, and other support Workers (HEW), PLHIV in awareness creation
services in the area (linkage service activities:
directory).
■ Support HEWs in their day-to-day
■ Preparing, avail and utilize service directory information education and communication
which can be availed in soft copy or other (IEC) / behavioral change communication
forms. (BCC) activities in relation to HIV.

49
■ Establish and strengthen PLHIV associations ■ HTS shall be strengthened through effective
and support groups to be involved in the networking, consultation, and collaboration
facilitation of referral and linkage through among stakeholders.
escorting and other mechanisms.
■ HTS shall be standardized nationwide
D. Reduce stigma and discrimination through: and shall be supervised, supported, and
regulated by appropriate government health
■ Community involvement authorities.

■ Identification and analysis of the root cause ■ Informed consent for testing shall be
of stigma and discrimination. obtained in all cases unless it is a mandatory
testing.
■ Development of IEC/BCC material and
utilize media focusing on stigma and ■ Mandatory HTS should be permissible for
discrimination. the following conditions:

■ Advocacy of gender inequality that 1. Screening purposes of blood and blood

predisposes to stigma and discrimination. components for transfusion,

■ Leadership role in community activities to 2. In cases of organ or tissue transplantation,

address stigma and discrimination through and
contextual available values and norms of the
community. 3. Order of court.

■ Involvement of PLHIV to reduce stigma and ■ Adequate pre-test information needs to be

discrimination and to be part of prevention given for ANC clients, TB and STI patients.
and care services.
■ All clients who are eligible for HTS based on
3.10. Ethical and Legal HIV risk screening tool shall be offered pre-
Recommendations for HIV Testing test information and post-test counseling.

Service
■ Test results, positive or negative, shall be
declared to clients in person and must be
■ Knowingly transmitting HIV shall impose
provided with post-test counseling.
punitive legal measures.

■ HIV test results will not be provided in

■ HTS shall be integrated into existing health
certificate form; however, referral will be
and social welfare services and be available
offered to access prevention, care, and
in all settings for KPP: government, non-
treatment services.
governmental, private sector, workplace,
and faith-based organizations.

50
■ Clients’ confidentiality will always be ■ Youth-friendly counseling and testing
maintained, however: services shall be made widely available
for youth population based on HIV risk
■ Results can be shared with other health screening tool.
care providers with those involved in clinical
management of clients as part of shared ■ People with physical disabilities and mental
confidentiality. impairment require special care when
providing counselling and testing services,
■ Clients can be referred for HIV services or particularly regarding communication
other services while stating his/her HIV shall accommodate the special needs of
status if required or upon request. people with visual and hearing impairments
by adopting appropriate medium of
■ Cases of altered state of consciousness communication.
and his/her partner or care giver are at risk
of infection, based on the circumstances ■ Individuals under the immediate influence
the endangered partner or care giver shall of alcohol or addictive drugs (substance
have the right to access the information use) shall not be offered HIV testing due
regarding the sero-status of the index case. to a mental inability to provide informed
consent.
■ Couples shall be encouraged to be
counseled, tested, and receive results ■ For a mentally impaired individual requires
together. the knowledge and consent of his/her
guardian and should be for the benefit of
■ Partner notification shall be encouraged the mentally impaired individual or patient.
in cases where one partner receives the
results alone. Ethics in counseling

■ In some special cases, such as child ■ All service providers shall abide by the
adoption, a counselor may refuse a testing rules, regulations and protocols contained
request when this is not in the best interest in this document and other related national
of the child. guidelines

■ Children who have been sexually abused ■ All service providers shall observe the ethical
and put at risk of HIV infection shall receive requirements of confidentiality, informed
counseling, be encouraged to test for HIV consent, proper counseling, anonymity and
and helped to access appropriate services. privacy.

■ The result of HIV testing is the property of ■ Shared confidentiality shall be promoted.
the child tested and shall not be disclosed
to third parties unless clearly in the best
interest of the child

51
CHAPTER FOUR:
CARE AND TREATMENT OF PEOPLE LIVING
WITH HIV INFECTION

4.1. General Care Packages for

PLHIV

It is critical for people living with HIV to initiate ■ Ensure that barriers to adherence and
ART as early as possible. This enables to treatment continuity are assessed and
shorten the time between HIV diagnosis and addressed accordingly.
ART initiation hence significantly reducing
HIV related morbidities and mortality, and ■ Ensure client is fully aware and makes
transmission of HIV. informed decision for early initiation and
continuation of treatment
As all PLHIV are eligible for ART, enrolment in
care provides an opportunity for close clinical Key elements of chronic HIV care include:
and laboratory monitoring, early assessment
and timely prevention and management of ■ Retesting for verification
opportunistic infections and other comorbidities.
Many interventions are relevant across the ■ Complete clinical assessment (history
full continuum of care, including care for HIV- taking, complete physical examination and
exposed individuals and PLHIV before initiation relevant lab tests)
of treatment. The following critical interventions
■ WHO clinical staging
need to be addressed at initial encounter with
the client:
■ Prevention, screening and management of
opportunistic infections and co-morbidities
■ Confirm HIV status by retesting and enrolling
(see chapter 5)
into HIV care (including recording into HIV
positive tracking and pre-ART registers).
■ Rapid ART initiation
■ Ensure any OI and other clinical problems
■ Patient monitoring and follow up
that may delay ART initiation are ruled out
or addressed.
■ Support for disclosure and assisted partner
notification
■ Ensure initiation of ART within two weeks
after TB treatment is started except when
■ Risk reduction counseling and combination
signs and symptoms of meningitis (both TB
HIV prevention approaches
and/or cryptococcal meningitis) are present.

52
■ Screening for and managing mental health Diagnosis of Advanced HIV Disease:
problems and substance use
Diagnosis of advanced HIV disease is done
■ Adherence and psychosocial counseling through CD4 testing of clients at base line for
and support those initiating treatment,(re-engaging with
care after a period of interruption for >28 days)
■ Nutritional assessment and counseling and targeting those who have interrupted ART
treatment and with persistently unsuppressed
■ Screening for other STIs VL (>1000 copies per ml). In addition to CD4
testing and when CD4 testing is unavailable, a
■ Prevention screening and treatment of clinical diagnosis of WHO stage 3 or 4 can also
cervical cancer. be used to diagnose advanced HIV disease.

■ Management of pain and symptoms. Package of care for PLHIV with advanced
disease
■ Pregnancy status, family planning and
contraception. In Ethiopia among adults (ages 15-64 years)
living with HIV, 35.8% (45.6% of men and
■ Document all relevant client information
31.1% of women) had immunosuppression
with CD4 count less than 350 cells per microliter
4.2. Advanced HIV Disease
(μL). Whereas among adults who reported that
they were unaware of their HIV-positive status,
Definition of advanced HIV disease
22.0% had severe immunosuppression which
is a CD4 count less than 200 cells/μL (16.9% of
For adults and adolescents, and children
men and 26.5% of women), (EPHIA 2017/2018).
older than five years, advanced HIV
People with advanced HIV disease are at high
disease is defined as CD4 cell count
risk of death, even after starting ART, the risk
<200cells/mm3 or WHO stage 3 or 4
will increase with declining CD4 cell count. The
event.
most common causes of death are TB, severe
bacterial infections and cryptococcal meningitis.
All children younger than five years
old with HIV are considered as having
A package of interventions including screening,
advanced HIV disease.
treatment and/or prophylaxis for major
opportunistic infections, rapid ART initiation and
intensified adherence support interventions
should be offered to everyone presenting
with advanced HIV disease including those

53
who are re-engaging with care after a period advanced HIV disease and who should be
of interruption for >28 days. Baseline CD4 cell offered the package of care as presented in
count testing for all PLHIV remains clinically table 4.1.
important in order to identify those who have

Table 4.1: WHO recommendations for components of packages of care for people with advanced
HIV disease.

Areas for Adults &

Intervention CD4 cell count Children
the package Adolescents

Sputum Xpert ® MTB/ RIF as Any Yes Yes

the first test for TB diagnosis
among symptomatic PLHIV

LF-LAM for TB diagnosis among ≤200 cells/mm3 (inpatient) Yes Yes

Diagnosis people with symptoms and ≤100cells/mm3
signs of TB (outpatient) Or any CD4
count with TB symptoms
or if seriously ill.

Cryptococcal antigen screening <100 cells/mm3 Yes No

Prophylaxis Co-trimoxazole prophylaxis ≤350 cells/ mm3 or clinical Yes Yesz

& preventive stage 3 or 4
treatment
TB preventive treatment a Any Yes Yesa

Fluconazole pre-emptive <100 cells/ mm3 Yes NA

therapy for cryptococcal
antigen– positive people
without evidence of meningitis b

ART Rapid ART initiation as Any Yes Yes

initiation mentioned abovec

Defer initiation if clinical Any Yes Yes

symptoms suggest TB or
cryptococcal meningitis

Adapted Tailored counselling to <200 cells/mm3 Yes Yes

adherence ensure optimal adherence
support to the advanced disease
package, including home
visits if feasible

a. TB preventive treatment should be provided in accordance with current guidance.

b. When cryptococcal antigen screening is not available, fluconazole primary prophylaxis should be
given to adults and adolescents living with HIV who have a CD4 cell count of < 100 cells/mm3.
c. People receiving a positive WHO four-symptom screen should initiate ART while being evaluated
for TB if clinical signs and symptoms of meningitis are absent.

54
4.3. Preparing People Living with ■ Reiterate the benefits of ART for the
HIV for ART client’s own health and for reduced risk of
transmission to partners
Before initiating people on ART, assess client’s
willingness and their readiness to initiate ■ Consequences of delaying initiation.
ART, discuss in detail about the ARV regimen,
■ Encourage disclosure to partners/family.
dosage, the likely benefits and possible adverse
effects, and agree on the required follow-up
■ Encourage engagement in peer and
and monitoring visits. For children with HIV, this
community support.
conversation should directly involve the parent/
legal guardian and include discussion about
NB: Clients who declined initiation need to
disclosing their HIV status. Initiation of ART
be seen repeatedly on a weekly bases for
in children should consider nutritional status,
continued counseling and support to initiate
any co-morbidities and potentially interacting
ART.
medications for possible contraindications or
dose adjustment. If there is mental health problem, substance
use or psychosocial problems that are major
After going through detailed discussion, quickly
barriers to initiation, appropriate support
assess the readiness and offer rapid ART
should be provided, and readiness to initiate
initiation. Check the following issues to assess
ART should be reassessed at regular intervals.
readiness of the clients:
Utilize a range of patient information materials
as well as community and peer support to help
■ Patient understands the benefits of
the person’s readiness and decision to start
ART, adherence and need for lifelong
therapy.
commitment and appointment schedules.

People starting treatment and care givers

■ Patient understands possible side effects of
should understand that the first ART regimen
ARVs.
offers the best opportunity for effective
virological suppression and immune recovery,
■ Patient understands the importance of
and that successful ART requires them to
disclosure and family support.
take the medications exactly as prescribed.
If clients or caregiver declines initiating ART as They should be advised that many adverse
early as possible, address the following issues effects are temporary or may be treated, or
in the subsequent visits with the aim of initiating that substitutions can often be made when
ART as soon as possible: necessary. People receiving ART and care
givers should also be asked regularly about
■ Identify and address barriers for starting any other medications that are taken, including
ART. herbal remedies and nutritional supplements.

55
People receiving ART should understand that; confirmed HIV diagnosis, clinical assessment,
they should continue practicing safer sex and assessment of client readiness except in
(including condom use) and avoidance of other the case of TB meningitis and cryptococcal
high-risk activities, such as sharing of injecting meningitis. ART initiation should be offered
equipment, to prevent transmitting HIV to other on the same day (initiating ART on the date
people. of HIV diagnosis), for people who are ready to
start. Rapid ART initiation, including same-day
In conclusion the following principles should be increases the number of people starting ART,
considered: reduces mortality, and may further reduce both
mother-to-child transmission and transmission
■ ART should be started rapidly based on a to HIV-negative partners. This recommendation
client’s informed decision. applies to all PLHIV at all age groups and is
particularly important in people with very low
■ Interventions should be implemented to CD4 cell counts who have an increased risk of
address barriers to ART. death.

■ HIV programs should promote treatment 4.4.1. When to Start ART in Adults and
literacy among all PLHIV, including Adolescents
providing information on the benefits of
early treatment, the lifelong commitment Rapid treatment initiation is associated with
required, the risks of delaying treatment clinical and HIV prevention benefits, improving
and available adherence support. survival, and reducing the incidence of HIV
infection at the family and community level.
■ Care providers should support shared Start ART rapidly, preferably same day, to all
decision-making. adults and adolescents with a confirmed HIV
diagnosis who are ready and willing regardless
4.4. When to Start ART of their WHO clinical stages and CD4 counts.
Prenatally infected adolescents need special
All HIV positive individuals are eligible for ART. consideration and support as they may have
The ideal time for ART initiation is at time readiness issues to accept HIV status and
of HIV diagnosis. Understanding of clients decision to start ART.
about HIV and the importance of life long
treatment adherence need to be emphasized. 4.4.2. When to Start ART in Pregnant
and Breast-feeding Women
All adherence barriers should be exhaustively
assessed and addressed while ART is initiated.
Start ART rapidly, preferably same day, to all
pregnant and breastfeeding women living with
Rapid ART initiation is defined as initiation of
HIV regardless of their WHO clinical stages and
ART within seven days of HIV diagnosis, if there
CD4 counts. For women identified at labor and
are no contraindications. Rapid ART initiation
delivery, provide ART within the same hour of
should be offered to all PLHIV following a

56
HIV diagnosis with brief counseling and provide least 4 weeks and initiate within 8weeks after
detailed counseling on ARV and adherence treatment of TB meningitis is initiated.
after delivery. Make sure to provide enhanced
ARV prophylaxis for the infant immediately after 4.4.5. When to start ART in adults,
adolescents, and children with drug
birth. resistant TB
4.4.3. When to Start ART in Children
Antiretroviral therapy is recommended for all
patients with HIV and drug- resistant TB (both
Start ART rapidly, preferably same day, to all
MDR/XDR-TB) requiring second-line anti-
children living with HIV regardless of their WHO
tuberculosis treatment, irrespective of CD4 cell
clinical stages and CD4 counts/percentage.
count, as early as possible (within the first two
Infants and young children infected with
weeks) following initiation of anti-tuberculosis
HIV have exceptionally higher morbidity and
treatment.
mortality. Up to 52% and 75% of children die
before the age of two and five years respectively 4.4.6. When to start ART in HIV/HBV co-
in the absence of any intervention. infected patients

For HIV infected infants diagnosed with the Start ART rapidly for all HIV/HBV co-infected
first DNA PCR result, initiate ART and take DBS patients regardless of their CD4 count.
specimen for confirmatory DNA PCR. Continue
ART if the second DNA PCR confirms positive 4.4.7. When to start ART in HIV/
results; whereas if the second DNA PCR turns
Cryptococcal meningitis co-infected
patients
negative, without holding the ART, make the 3rd
DNA PCR test. (Refer the algorithm, Figure 3.3) ART should be delayed by 4-6 weeks following
initiation of treatment for cryptococcal
For HIV infected infants and younger children
meningitis. Earlier ART is associated with more
who need particular care and support, ensure
severe adverse event and increased mortality
the readiness and understanding of their parents
with cryptococcal meningitis.
and care givers. Counseling on dosage and
administration should be provided for parents/
care givers in case of HIV infected infants.
ART should be initiated for all
4.4.4. When to start ART in adults,
adolescents, and children with TB individuals (children, adolescents,
and adults) living with HIV rapidly,
Start ART in all TB patients living with HIV as preferably same day, (within an hour for
soon as possible within 2 weeks following laboring mother) after confirming HIV
initiation of anti-TB treatment regardless of their diagnosis, regardless of WHO clinical
CD4 count except when there is TB meningitis. stage and CD4 cell count except for TB
If a patient has TB meningitis, delay ART for at and cryptococcal meningitis.

57
4.5. What ART regimen to start
with (first-line ART)

Using simplified, less toxic, more effective, and

convenient regimens as fixed-dose combination
is recommended for first-line ART.

Table 4.2. Summary table for what ART regimen to start with (first-line ART)

Preferred first-line Alternative first-line

Population Special circumstances a
regimens regimens
Adolescents(10 to 19
years OR weight ≥30
kg), adults, pregnant, TDF + 3TC + EFV AZT+ 3TC + ATV/r
childbearing and TDF+3TC+DTG (FDC)
b
AZT + 3TC + DTG TDF+ 3TC+ ATV/r
breast feeding women AZT + 3TC + EFV ABCc+3TC+DTG
including those with TB/
HIV- co infection

Children > 4weeks and ABC+3TC+EFV d

ABC+ 3TC+LPV/r
≥3kg but less than 10 ABC + 3TC + DTGb* AZT+3TC+EFV
AZT+3TC+DTG
years AZT+3TC+LPV/ra

a
ABC or boosted PIs (ATV/r, LPV/r) can be In case of TB-HIV co-infection, the dose of
b*

used in special circumstances for those clients DTG should be doubled depending on body
who could take neither DTG nor EFV due to weight of the child.
contraindication and/or side effects.
c
For PLHIV with renal insufficiency and anemia
b
In case of TB-HIV co-infection, the dose of
DTG should be 50mg BID. d
EFV is for children 3 years and older.

58
4.5.1. First-line regimen for adults and Special circumstances may include situations
adolescents where preferred or alternative regimens may
not available or suitable because of significant
The preferred first-line regimen for adults and toxicities, anticipated drug-drug interactions.
adolescents (>10 years of age or >30 kg body
weight) including pregnant and breast feeding 4.6. Monitoring response to ART
women is TDF+ 3TC+DTG as a once-daily dose.
Monitoring of patients on ART should start
4.5.2. First line ART for children
from the day of initiation. Although taking ART
is a lifelong commitment, the first six months of
The preferred first-line regimen for children
therapy are especially important.
> 4weeks and ≥3kg but less than 10 years is
ABC+3TC+DTG. Availability of a new generic 4.6.1. What to expect in the first months
formulation of 10mg DTG in 2021 has created of ART and how to manage them
the opportunity to use DTG based regimen for
children living with HIV (CLHIV) who are at least Clinical and immunological improvement and
4weeks of age and weight 3kg or more. virological suppression are expected when
individuals adhere to ART, but care providers
4.5.3. Consideration for first line ART need to be alert as opportunistic infections and/or
regimen for PLHIV on TB treatment
immune reconstitution inflammatory syndrome
(IRIS) may develop, as well as early adverse
In case of TB-HIV coinfections in adults and
drug events, such as drug hypersensitivity, in
adolescents, including pregnant/breast feeding
the first three months of ART.
women and children >20kg body weight, the
dose of DTG should be 50mg BID. For children
ART significantly decreases mortality and HIV
less than <20kg, the dose of DTG depends on
related illnesses; however, mortality can be
the exact body weight of the child.
higher in the first three to six months of ART
(Refer Annex 8)
initiation among people who started ART
4.5.4. Consideration for alternative with advanced HIV disease with existing co-
and special circumstance first line ART infections and/or co-morbidities, severely low
regimens hemoglobin, low body mass index (severe
malnutrition) and/or very low CD4 counts.
If the preferred regimen is contraindicated or
not available, alternative regimen is used. These In most adults and children, when ART is
regimens are effective and tolerable but have initiated, immune recovery starts and CD4 cell
potential disadvantages when compared with counts rise. Generally, this increase occurs
the preferred regimens. An alternative regimen during the first year of treatment, and then
may be a preferred regimen for some clients. continues to rise further during the second
year. However, severe immune-suppression
may persist in some individuals who do not

59
experience a significant rise in CD4 cell count Timing of ART in people with opportunistic
with treatment, especially those with a very infections requires balancing a greater risk of
low CD4 cell count at the time of ART initiation. IRIS after early initiation against continuing high
Consideration should be given to continue mortality if ART is delayed.
prophylaxis for OI such as CPT till patients
recover immunologically. Health care providers need to give due
consideration for patients with signs and
Immune Reconstitution Inflammatory symptoms of TB meningitis and cryptococcus
Syndrome (IRIS) infection before initiating ART. Providers
should give close attention to patients with
Immune Reconstitution Inflammatory risk factors for IRIS, including those presented
Syndrome (IRIS) is a spectrum of clinical signs with CD4 count <50 cells/mm3, disseminated
and symptoms thought to be associated with opportunistic infections or tumors.
immune recovery brought about by a response
to ART. In patients with advanced HIV disease
the risk of IRIS is high, it even goes higher when The most important steps to reduce the
CD4 count gets below 50 cells/mm3. IRIS may development of IRIS include:
present in two different ways: paradoxical
IRIS, when an opportunistic infection or tumor ■ Earlier HIV diagnosis and rapid
diagnosed before ART initially responds to initiation of ART
treatment but then deteriorates after ART
starts; or unmasking IRIS, in which initiating ART ■ Improved screening and
triggers disease that is not clinically apparent management of TB and Cryptococcus
before ART. It should be considered only when before ART
the presentation cannot be explained by a new
infection, expected course of a known infection ■ Optimal management of
or drug toxicity. opportunistic infections

The clinical spectrum is diverse, and IRIS has

been reported for many different infections, The diagnosis of IRIS can be challenging, and
tumors and non-infectious conditions. The typically has the following criteria:
most serious and life-threatening forms of
paradoxical IRIS are due to TB, Cryptococcus, ■ A low pretreatment CD4 count (often less
Kaposi’s sarcoma and hepatitis. BCG vaccine– than 100 cells/mm3) except in tuberculosis.
associated IRIS (localized and systemic) may IRIS secondary to preexisting M. tuberculosis
occur in some HIV infected infants. IRIS is infection may occur in individuals with CD4
generally self-limiting, and interruption of ART counts >200 cells/mm3
is rarely indicated, but people may need to be
reassured in the face of protracted symptoms
to prevent discontinuation of or poor adherence
to ART.

60
■ The absence of evidence of alternate IRIS is not indicative of treatment failure or drug
diagnoses, including drug-resistant side effect. It is a transient phenomenon and is
infection, bacterial super infection, drug not a reason to stop ART or change regimen.
allergy or other adverse drug reactions, and The OI should be treated using standard
reduced drug levels due to non-adherence guidelines and in critically sick patients short
drug-drug interactions or mal-absorption. ; course of corticosteroid might be indicated to
control severe symptoms.
■ The presence of clinical manifestations
consistent with an inflammatory condition; 4.6.2. Clinical and laboratory monitoring
and
Standardized clinical assessment of patients
■ A temporal association between and, when available baseline CD4 count,
antiretroviral therapy (ART) initiation and the are important to determine the severity of
onset of clinical features of illness- usually immunosuppression and decide on initiation
within the first 3 months. of prophylactic therapies. Patients shall be
thoroughly evaluated at baseline and at periodic
Management of IRIS follow up visits to monitor for response to
treatment, IRIS, adverse effects, and treatment
■ Patients should generally be treated for the intolerance or non-adherence. Patient readiness
underlying OI as soon as possible. before ART initiation and treatment adherence
at subsequent visits should always be assessed,
■ Continuation of ART when IRIS occurs. and necessary support should be provided when
barriers are identified. Opportunistic infections
Role of anti-inflammatory agents: including TB, cryptococcal infection, and other
co-morbidities including non-communicable
Anti-inflammatory agents may be particularly
diseases (NCDs) should be regularly assessed
helpful in the setting of obstructive mass
and managed.
lesions (e.g. expanding cervical lymph node).
Use of anti-inflammatory agents, particularly
corticosteroids, must be weighed against
potential risks and side effects. When a decision
is reached to treat with corticosteroids, initiate
therapy with prednisone at a dose of 1 mg/kg/
day (maximal dose 60 to 80 mg) followed by a
rapid taper over a 10 to 14-day period. IRIS in
closed spaces (e.g. CNS OI) should be managed
promptly or referred to appropriate center to
avert significant morbidity and mortality.

61
Table 4.3. Baseline and follow-up assessment

Baseline assessment, week 0 (First encounter)

Objective: to conduct initial assessment.

Assess Act

■ Check/Assess if retesting for verification ■ Do retesting for verification if not done

is done and documented. Determine treatment readiness.
■ Assess: socio-economic status, any HIV ■ Start CPT and TPT if clinically indicated
related illnesses in the past, advanced Consider provision of prophylaxis for
HIV disease, symptom screen for TB, other OIs (e.g. Fluconazole)
other OI, co-morbidities, pregnancy, past
■ Treat OIs.
and current medication.
■ Manage co-morbidities
■ Determine WHO staging.
■ Start ART for those who are ready and
■ Clinical records: fill intake form, follow up
have no adherence barriers; and give
form and registers (positive tracking, pre
appointment to return after two weeks.
ART or ART registers).
If not, give appointment to return within
■ Counselling and education: adherence, one week. For those who still defer ART
treatment readiness, disclosure, and continue to counsel on benefit of rapid
address adherence barriers. ART initiation and start them on ART as
■ BP and BMI early as possible. (N.B. Continue follow
up counselling sessions until the patient
is initiated on ART).
■ Patients who are not initiated on ART
due to meningitis (TB/cryptococcus),
(Refer section 4.4.7.)
■ Continue ART for transfer-ins.
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49
■ Refer if necessary.

2nd visit: 2 weeks after initiation

Objective: To determine toxicity/intolerance, adherence, and IRIS

■ Clinical assessment for: IRIS, toxicity

etc.
■ Manage toxicity as indicated.
■ Assess and support adherence,
addressing adherence barriers. ■ Treat OI if diagnosed.
■ Provide counseling and education ■ Gtive appointment to return in 2 weeks.
including prevention of HIV transmission. ■ Screen for cervical cancer for women
■ Lab tests if necessary. between 15-49 if not done
■ Support disclosure if not done. ■ Screen for STI
■ BP and BMI ■ Refer if necessary.

62
3rd visit: 4 weeks after initiation
Objective: Same as second visit

■ Same as 3rd visit. ■ Refill ART and other medicines as

■ Hgb if patient is on AZT. necessary for one month.
■ BP and BMI ■ Treatment of OI and comorbidities if
identified.
■ Manage drug toxicity and intolerance.
■ Assess and provide adherence support
and patient education including HIV
prevention.
■ Do other lab tests as indicated
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49 if not done
■ Refer if necessary.
■ Appointment to return after 4 weeks.

4th visit: 8 weeks after initiation

Objective: same as 3rd visit

■ Same as 4th visit. ■ Refill ART and other drugs as necessary

■ BMI and BP for 1 month.
■ Treatment of OI and co-morbidities.
■ Manage toxicity and intolerance.
■ Provide adherence support and patient
education including HIV prevention.
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49 if not done
■ Refer if necessary.
■ Appointment to return after 4 weeks.

5th visit: 12 weeks after initiation

Objective: Same as 4th visit.

■ Same as 5th visit. ■ Refill ART and other drugs as necessary

■ BP and BMI for 1 month.
■ Treatment of OI and other co-
morbidities.
■ Manage toxicity and intolerance.
■ Assess and provide adherence support
and patient education including HIV
prevention.
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49 if not done
■ Refer if necessary.
■ Appointment to return after 4 weeks

63
 6th visit: 16weeks after initiation
Objective: Same as 5th visit

■ Same as 6thvisit. ■ Refill ART and other drugs as necessary

■ BP and BMI for 1 month.
■ Treatment of OI and other co-
morbidities.
■ Manage toxicity and intolerance.
■ Assess and provide adherence support
and patient education including HIV
prevention.
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49 if not done
■ Refer if necessary.
■ Appointment to return after 4 weeks.

7th visit: 20 weeks after initiation

Objective: Same as 6th visit

■ Same as 6th visit. ■ Refill ART and other drugs as necessary

■ BP and BMI for 1 month.
■ Assess and provide adherence support
and patient education including HIV
prevention.
■ Treat OI and other co-morbidities.
■ Manage toxicity and intolerance.
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49 if not done
■ Refer if necessary.
■ Appointment to return after 4 weeks.

8th visit: 24 weeks after initiation

Objective: Same as 7th visit

■ Same as 6th visit. ■ Assess and provide adherence support

■ BP and BMI and patient education including HIV
prevention.
■ Determine viral load.
■ Refill ART and other drugs as necessary
for 3 months.
■ Treat OI and other co-morbidities.
■ Manage toxicity and intolerance.
■ Screen for STI
■ Screen for cervical cancer for women
between 15-49 if not done
■ Refer if necessary.
■ Appointment to return after 3months.

64
Note:

■ Newly started patients will be appointed every two weeks during the first month of treatment
and every 4weeks (every month) then after until 24 weeks of treatment. After the 24th week of
initiation of antiretroviral therapy patients will be scheduled to return every twelve weeks.
■ OIs prophylaxis, treatment for co-morbidities and SRH services should be provided in the context
of/integrated with ART multi month dispensing.
■ Patients should be encouraged to come at any time if they have concerns and can be seen out
of the above schedule whenever necessary.
■ For follow up schedule during COVID19 pandemic, refer service delivery section (Chapter 6).

Table 4.4. Recommended tests for HIV treatment monitoring and approaches to screening for co-
infections and non-communicable diseases.

Management Recommended Desirable (if feasible)

Baseline/ART ■ CBC including hemoglobind ■ HBV (HBsAg)a serology.

initiation ■ HCV serology.
■ CD4 cell count.
■ Pregnancy test.
■ Cryptococcus antigen if CD4 cell count <100 ■ HPV-DNA if available
cells/mm3.
■ Lab investigations
■ FBS for major non
communicable
■ Gene Xpert, LF -LAM if eligible chronic diseases and
comorbiditiesb
■ Pregnancy test
■ Serum creatinine and
estimated glomerular
filtration rate (eGFR) for
starting TDFe

65
 Management Recommended Desirable (if feasible)

Receiving ART ■ HIV viral load at 6 and 12 months after initiating ■ Serum creatinine and
ART and every 12 months thereafter eGFR for TDFc

■ Viral load testing for pregnant mothers: ■ Pregnancy test,

especially for women
■ Newly diagnosed mothers: Conduct a viral load of childbearing age
by three months after ART initiation to ensure not receiving family
planning.
that there has been rapid viral suppression. If
viral load testing is expected to be undertaken ■ CD4 cell count if
near the planned viral load at 34–36 weeks of indicated
gestation, the first viral load test can be delayed
■ HPV-DNA if available
until weeks 34–36 of gestation.

■ For women already on ART, conduct VL testing

at the first contact at ANC (VL result conducted
in the last 3 months before the first contact can
also be used), at 34-36 weeks of gestational
age or delivery at the latest, followed by three
months after delivery and then every 6months.

■ For those who are already on ART with previous

VL test conducted more than three months
back repeat VL test at first ANC contact /
PMTCT visit, at 34-36 weeks of gestational age
(or at the latest at delivery) and 3 months after
delivery and every six months thereafter until
MTCT risk ends.

■ For all pregnant women, regardless of ART

initiation timing: conduct viral load testing at
34–36 weeks of gestation (or at the latest at
delivery) to identify women who may be at risk
of treatment failure and/or may deliver infants at
higher risk of perinatal transmission

■ For all breastfeeding women, regardless of

when ART was initiated: conduct a viral load
test three months after delivery and every six
months thereafter to detect viremic episodes
during the postnatal period

■ FBS at 6 months after ART and every 12

months annually.

66
a
If feasible, HBsAg testing should be performed 4.6.3. Monitoring drug toxicities and
at baseline to identify people with HIV and HBV substitution of ARV
coinfection and who should therefore initiate
TDF-containing ART. Guiding principles

b
Consider assessing for the presence of chronic ■ Establish whether the clinical condition is
conditions that can influence ART management, due to ARV toxicities, other drugs, or other
such as hypertension, other cardiovascular illness including new OIs.
diseases, diabetes and TB according to the
WHO Package of Essential NCD interventions ■ Try to identify the responsible ARV drug.
(PEN), mental health Gap Action Program
(mhGAP) or national standard protocols ■ Assess the severity using toxicity grading
matrix (Annex 10 and 11)
C
Monitoring may include a range of tests,
including serum creatinine and estimated Major types of ARV toxicities
glomerular filtration rate (eGFR), serum
phosphate and urine dipsticks for proteinuria The major causes of drug discontinuation in the
and glycosuria. eGFR = 140– age (years) × body first 3-6 months after initiating ART are due to
weight (kg)/(72 × serum Cr in mg/dL) for male drug toxicities; and hence, they must be closely
and eGFR = 140– age (years) × body weight monitored.
(kg) × 0.85/(72 × serum Cr in mg/dL) for female.
They typically occur from few weeks to
d
Among children and adults with a high risk of months after ART initiation or change. The most
adverse events associated with AZT (low CD4 common side effects related to the ARV drugs
or low BMI). recommended in these national guidelines are
provided in the table below.
e
Among people with a high risk of adverse
events associated with TDF: underlying renal
disease, older age group, low body mass index
(BMI), diabetes, hypertension and concomitant
use of a boosted PI or potential nephrotoxic
drugs.

N.B. If the recommended baseline tests are not

available, it should not delay ART initiation

67
Table 4.5. Types of toxicities associated with first, second and third-line ARV drugs

Major types of
ARV Drug Risk factors Suggested management Remark
toxicity
Hypersensitivity Substitute with TDF or
ABC
reaction AZT
ATV/r Electrocardiographic Pre-existing conduction Use with caution in
Abnormalities (PR system disease. concomitant people with preexisting
and QRS interval use of other drugs that may conduction disease or
prolongation) prolong the PR interval who are on concomitant
drugs they may prolong
the PR or QRS interval

Indirect Underlying hepatic disease, This phenomenon Strongly

hyperbilirubinemia HBV and HCV co-infection is clinically benign; advice the
(clinical jaundice) Concomitant use of however, can be client not
hepatotoxic drugs associated with to seek
social and personal traditional
discomfort and in some healers
circumstances with and herbal
stigma. Substitute with medications
LPV/r only if adherence
compromised

Renal stone History of renal stone. Substitute with LPV/r

Anemia, neutropenia Baseline anemia or Avoid use of AZT for
neutropenia CD4 count ≤200 people with HIV and
cells/mm3. severe anemia at
baseline (hemoglobin
AZT <7.0 g/dl) as first-line
therapy.

Substitute with TDF or

ABC
Hepatotoxicity Underlying hepatic disease; Substitute with ATV/r or
Coinfection with HBV or LPV/r. When it is used
HCV; Concomitant use of in third-line ART, limited
hepatotoxic drugs. options are available.
DRV/r
Severe skin and Sulfonamide allergy. For hypersensitivity
hypersensitivity reactions, substitute
reactions. with another therapeutic
class
Hepatotoxicity Coinfection with Hepatitis B Substitute another
DTG* Hypersensitivity or C, Liver disease. therapeutic class: EFV or
reactions boosted PIs

68
 Major types of
ARV Drug Risk factors Suggested management Remark
toxicity
Insomnia Body Older than 60 years Low Consider morning
weight gain or CD4 or high viral load Female dose or substitute EFV,
obesity African ethnicity boosted PI Monitor body
weight and promote anti-
obesity measures (Such
as diet and physical
exercise). If significant
increase despite
measures, consider
substituting EFV or
boosted PI
Electrocardiographic People with pre-existing Use with caution in
abnormalities (PR conduction system disease; people with pre-existing
and QT interval concomitant use of other conduction disease or
prolongation, drugs that may prolong the those on concomitant
torsade’s de PR interval, Congenital long drugs that may prolong
pointes). QT syndrome, Hypokalemia the PR or QRS intervals
Concomitant use of drugs
that may prolong the QT
interval
Hepatotoxicity Underlying hepatic disease If LPV/r is used in
HBV and HCV co-infection children, substitute with
Concomitant use of DTG or EFV according
hepatotoxic drug to age. ATV can be
used for children older
than 6 years. If LPV/r
LPV/r is used in second-line
ART for adults, use
ATV/r. If boosted PIs are
contraindicated and the
person has failed an
NNRTI based first line
ART use DTG or consult
specialist
Pancreatitis Advanced HIV disease, Substitute another
Alcohol class (INSTIs) therapeutic class
(INSTIs)
Dyslipidemia Cardiovascular risk factors Substitute another
such as obesity and diabetes therapeutic class
(INSTIs)
Diarrhea Risk factor unknown Substitute with ATV/r or
DTG

69
 Major types of
ARV Drug Risk factors Suggested management Remark
toxicity
There are rare Use AZT only
NVP (For HEIs reports of
prophylaxis) Hypersensitivity and
hepatotoxicity
Persistent central Depression or other mental
nervous system disorder (previous or at
toxicity (such as baseline) Daytime dosing
abnormal dreams,
depression or
mentalconfusion)** DTG or boosted PI
Hepatotoxicity Underlying hepatic disease
EFV – HBV and HCV co-infection
Concomitant use of
hepatotoxic drug
Convulsions History of seizure
Severe skin Risk factors unknown.
Hypersensitivity Use DTG or boosted PI
reaction.
Gynecomastia Risk factor unknown. Use DTG or boosted PI
Chronic kidney Underlying renal disease; Substitute with AZT or
disease, acute older age; BMI <18.5 ABC.
renal injury, Fanconi (or body weight <50 kg);
syndrome. untreated diabetes mellitus; Do not initiate TDF
untreated hypertension; at eGFR <50 mL/
Concomitant use of min, uncontrolled
nephrotoxic drugs or boosted hypertension, untreated
PI. diabetes, or presence
TDF
Decreases in bone History of osteomalacia and of renal failure. It is
mineral Density. pathological fracture; risk recommended to
factors for osteoporosis or monitor growth in
bone loss. children taking TDF
Lactic acidosis Prolonged exposure to containing regimen.
or severe nucleoside analogues;
hepatomegaly with Obesity.
steatosis.

70
*Hyperglycemia has been reported from Strategies for managing adverse drug
different sites in Ethiopia and small-scale reactions:
studies from other countries.
Step 1: Establish whether the problem is due
**Most CNS side effects will improve within to antiretroviral drugs, other medications, OIs,
2-4 weeks after initiation non HIV related problems or clinical condition.

NB: Step 2: Try to identify the responsible ARV drug.

■ For those patients with HBV and HIV co- Step 3: Assess the degree/severity of the
infection suffering from TDF toxicity, consult Adverse Event using the ACTG/PACTG adverse
or refer national viral hepatitis guideline. events grading system.

■ The clinical manifestations due to Step 4: Manage the adverse event according
hypersensitivity reactions for some ARVs to severity and decide whether to substitute
may be confused with IRIS or discontinue ARV drug based on common
adverse events clinical grading system. Annexes
Drug substitutions for ARV drug toxicity 10 and 11.

Drug regimen or single agent substitutions may Step 5: Report Adverse event through
be required for drug toxicity and to avoid drug appropriate tools and channels (Refer chapter 6)
interactions.
4.6.4. Drug interactions
Clinical considerations
Providers should be aware of all drugs that
■ Delaying substitutions or switches when people with HIV are taking when ART is initiated
there are severe adverse drug effects may and new drugs that are added during treatment
cause harm and may affect adherence, maintenance.
leading to drug resistance and treatment
failure.

■ When drug interruptions are required, it is

important to consider the various half-lives
of ARV drugs. For example, when a NNRTI
needs to be discontinued, a staggered
approach should be used by prolonging the
use of the NRTI backbone for two weeks
except life threatening conditions (grade 4
conditions) where you have to discontinue
all ARV drugs (see annexes 10 and 11 for
details).

71
Table 4.6. Key ARV drug interactions and suggested management

ARV
Key interactions Effect Suggested management
drugs
Ribavirin and
AZT pegylated Substitute with TDF
interferonalpha-2a
Bedaquiline Avoid the combination

Amodiaquine, DHA/ Use an alternative antimalarial agent or

piperaquine substitute EFV for DTG

Artemisinin or Use an alternative antimalarial agent or

lumefantrine substitute EFV for DTG
Risk of QT prolongation with ATV/r and
LPV/r
Adjust the methadone dose as
EFV Methadone
appropriate
Hormonal Use alternative or additional
contraceptives contraceptive methods
Adjust the amlodipine dose as
Amlodipine
appropriate
Simvastatin and
Adjust the statin dose as appropriate
atorvastatin
Low-dose
dexamethasone Double dose of dexamethasone
(COVID-19)
Adjust the PI dose or substitute with
Rifampicin
DTG
Lovastatin and Increase Use an alternative dyslipidemia agent
simvastatin concentration (for example pravastatin)
Halofantrine and
Boosted Use an alternative antimalarial agent
lumefantrine
PI Estrogen-
Use alternative or additional
(ATV/r, based hormonal
contraceptive methods
DRV/r, contraception
LPV/r) Methadone and Adjust methadone and buprenorphine
Buprenorphine doses as appropriate
Astemizole and
Use alternative antihistamine agent
terfenadine
Reduce serum Do not provide 3HP with protease
Rifapentine
level inhibitors and consider 6H in this case
nephrotoxic drugs
[e.g. aminoglycosides,
amphotericin
Exacerbate
TDF B, ganciclovir, Avoid concurrent use
nephrotoxicity
pentamidine,
vancomycin or
interleukin-2]

72
ARV
Key interactions Effect Suggested management
drugs
ritonavir boosted PIs Closely monitor renal function

Monitor for TDF-associated adverse

Ledipasvir- or
effects, including renal dysfunction,
velpatasvir-containing
particularly when TDF is coprescribed
Regimens
with boosted HIV PIs
Lithium TDF: monitor renal function closely
Use alternative anticonvulsant
Carbamazepine, agent,(such as valproic acid or
Phenobarbital, and gabapentin) or if not possible substitute
phenytoin DTG with EFV and for children below 3
years substitute with boosted PIs

Use DTG at least 2 hours before or

at least 6 hours after supplements
containing polyvalent cations, including
Polyvalent Cation Absorption of
but not limited to – Fe-, Ca-, Mg-, or
products containing DTG is affected/
Zn-multivitamin supplements; mineral
Mg, Al, Fe, Ca, and Zn reduced
supplements, cation containing
laxatives and Al-, Ca- or Mg- containing
antacids. Monitor for virological efficacy.

Increases
DTG 50mg BID. For pediatrics DTG BID
metabolism
by weight band. Continue with twice
of DTG, and
Rifampicin, daily dosing of DTG in children for 2
hence reduces
weeks after use of rifampicin has ended
DTG concentration of
based on their weight band
DTG in the blood.

No evidence that changes of dose of

Rifapentine rifapentine or DTG is needed to achieve
adequate exposures of DTG

Start metformin at lowest dose and

titrate based on glycemic control.
Monitor for adverse events of
metformin Or adjust metformin dosing
DTG increases if already on metformin
metformin levels,
Metformin
which may lead to When starting or stopping DTG in
hypoglycemia. patients on metformin dose adjustment
of metformin may be necessary to
maintain optimal glycemic control
and/or minimize adverse events of
metformin.

73
Table 4.7: Drug-drug interactions (ARVs and anti-TB drugs for treatment of DR-TB).

Responsible Responsible
Clinical Condition Recommendations
ARV drug/s anti TB drug/s

Monitor blood counts regularly. Replace

AZT if bone marrow suppression
Bone marrow
AZT Lzd, R, H occurs. Consider suspension of Lzd.
suppression
Also consider cotrimoxazole, if patient is
taking.
When severe, stop both the ART
and TB medications, and restart
EFV protease H, R, E, Z, Bdq,
the TB medications first. Consider
Hepatotoxicity inhibitors, PAS, Eto/ Pto,
cotrimoxazole, if patient is taking. Also
NRTIs FQ
rule out viral hepatitis (Hepatitis A, B, C &
Cytomegalovirus(CMV)).
TDF may cause renal injury. If possible,
avoid TDF in patients receiving
aminoglycosides or amikacin. If TDF is
absolutely indicated, serum creatinine
and electrolytes should be monitored (at
Amino-
least every two weeks). Even without
Renal toxicity TDF glycosides,
the concurrent use of TDF, PLHIV have
amikacin
increased risk of renal toxicity secondary
to aminoglycosides and amikacin. In the
presence of renal insufficiency, ARV and
anti-TB medications need to have their
doses adjusted.
EFV has a high rate of CNS side effects
in the first 2–3 weeks of use, but
typically self-limited and resolves. At
present, there are limited data on the
Central nervous
Cs, H, Eto/Pto, use of EFV with Cs; concurrent use is
system (CNS) EFV
FQ the accepted practice with frequent
toxicity
monitoring for central nervous system
toxicity. Psychosis can occur with Cs,
but is rare with EFV alone; other causes
should always be ruled out.
PIs may result QTc prolongation. The
Protease Bdq, Dlm, Mfx, additive effects of combining ART with
QTc Prolongation inhibitors Gfx, Cfz, Lfx, known second-line anti-TB drugs on
(PIs) LPV/r Ofx QTc prolongation is not known. Close
monitoring is indicated.

74
 Protease inhibitors tend to cause insulin
resistance and hyperglycemia. Eto/
Dysglycaemia Protease
Pto tends to make insulin control in
(disturbed blood inhibitors Gfx, Eto/Pto
diabetics more difficult, and can result
sugar regulation) (PIs)
in hypoglycemia and poor glucose
regulation.
For patients who are co-infected with HIV and MDR/XDR-TB, there is limited information on
interactions of ARV drugs with new drugs such as bedaquiline and delamanid. Concomitant
use of EFV and PIs with bedaquiline may interfere with drug concentrations and require close
clinical monitoring; alternative ARV options should be considered, if possible.
N.B. For details of ARVs and anti-TB drugs for treatment of DR-TB interactions, please refer the
latest TB guideline

4.7. Re-engaging with care after ■ Monitor the viral load closely and determine
ART interruption the VL at 3 and 6 months after resuming
ART. If the viral load is >1000copies/ml in
Interruption in treatment is defined as client the two consecutive measurements, switch
has missed appointment for greater than 28 to second or third line regimen and continue
days from the last appointment date. People adherence support
who interrupted their treatment need to be re-
■ Those with low level viraemia, (50 –1000
evaluated for possible adherence barriers and
copies/ml) need to be provided with
advanced clinical conditions.
enhanced adherence counselling and viral
For reengaged clients after missing appointment load testing after 3 months to promote
for greater than 28 days (interrupted treatment), more viral suppression.(see figure 4.1)
the following essential elements should be part
*For clients who missed their appointments
of the care.
less than 28 days, assess for the cause and
■ Exhaust all possible adherence barriers and strengthen adherence support. In addition,
provide an ongoing Enhanced Adherence ensure the clients are on optimized regimen
Support (EAS). (DTG based treatment for those who are on
first line).
■ Resume the same (previous) ART regimen
they used before interruption. 4.8. Diagnosis and management
■ People interrupting treatment on NNRTI
of antiretroviral treatment failure
–containing regimen are at higher risk of
Monitoring individuals receiving ART is
drug resistance and should restart ART
important to ensure successful treatment,
using a DTG-containing regimen if not
identify adherence problems and determine
contraindicated to DTG.
whether and which ART regimens should be
■ Maintain close or frequent follow-up switched in case of treatment failure. Routine
schedule. viral load testing is a more sensitive and

75
 earlier indicator of treatment failure. Routine proactively. Aside from the routine viral load
viral load testing should be done at 6 and 12 testing schedule, viral load testing should be
months of initiating ART and then every 12 used whenever there is clinical or immunologic
months thereafter to detect treatment failure suspicion of treatment failure.

Table 4.8: Definitions of clinical, immunological and virological failure for the decision to switch ART
regimens

Failure Definition Remark

Adults and adolescents

New or recurrent clinical event indicating
severe immunodeficiency (WHO clinical stage
4 condition and certain WHO clinical stage 3
conditions (pulmonary TB and severe bacterial
infections) may also indicate treatment failure) The condition must be
after 6 months of optimal adherence to differentiated from immune
Clinical
appropriate ART regimen. reconstitution inflammatory
failure
syndrome occurring after
Children initiating ART.
New or recurrent clinical event indicating
advanced or severe immune deficiency (WHO
clinical stage 3 and 4 clinical condition with
exception of TB) after 6 months of effective
treatment.

Adults and adolescents

■ CD4 count at or below 250 cells/mm3 Without concomitant or recent
following clinical failure or infection to cause a transient
■ Persistent CD4 levels below 100 cells/mm3. decline in the CD4 cell count.
Persistent is to mean at least
2 CD4 measurements below
Immunologic the threshold.
failure Children
Current WHO clinical and
Younger than 5 years immunological criteria have
Persistent CD4 level below 200 cells/mm3or low sensitivity and positive
<10% predictive value for identifying
Older than 5 years Persistent CD4 levels below individuals with virological
100 cells/mm3. failure.

An individual must be taking

ART for at least 6 months
Viral load above 1000 copies/ml based on two before it can be determined
Virologic consecutive viral load measurements 3 months that a regimen has failed.
failure apart with enhanced adherence support following VL testing should not be
the first viral load test done when there is an
acute infection/fever. (Refer
algorithm on Figure 4.1.)

76
NB: repeat viral load result >1000 copies/ml after
three months of EAS following the first viral
1. Viral suppression: is a viral load that is
load. Those with low-level viraemia at the first
undetectable, equal to or less than 50 copies/
viral load test (50–1000 copies/ml) need to be
ml.
provided with enhanced adherence support
2. Low-level viraemia: is any viral load results (EAS) and repeat viral load test after 3 months
that are detectable (more than 50 copies/ml) to promote viral suppression. If viral load is still
but equal to or less than 1000 copies/ml. 50-1000 copies/ml, maintain ARV drug regimen
and continue viral load test every six months. In
3. Virological failure Viral load above 1000
addition, continue the routine follow up support
copies/ml based on two consecutive viral
and link to community-based adherence
load measurements in 3 months, apart with
support services.
enhanced adherence support following the first
viral load test. Enhanced Adherence Support (EAS)

Treatment failure threshold should remain at 1000 Enhanced adherence support is important for
copies/ml. Viral suppression or undetectability, patients that have unsuppressed VL, persisted
however, are defined as viral load equal to or or new immunosuppression, developing new
less than 50 copies/ml. PLHIVs should be OI or have multiple adherence barriers. It
supported with adherence counselling to shall be systematic and with documenting the
achieve viral suppression .However, treatment interventions provided during the EAS period.
failure should be considered for those with a Table 4.9: Summary of components of EAS.

Enhanced adherence support sessions overview

First Session ■ Review cognitive, behavioral, emotional, and socio-economic barriers to

(When the adherence:
viral load ■ Treatment literacy
result >50
is received; ■ Medications: dosage, timing, storage
Day 0) ■ Side effects
■ Motivation
■ Mental health screening (screen for depression and other common
mental problems using national Mental Health Assessment tool (Annex
20)
Action:
■ Discuss risk reduction (e.g. for substance abuse)
■ Discuss patient’s support systems
■ Assist patient to develop adherence plan to address the identified
issues.
■ Referrals and networking when necessary

77
 Second ■ Review adherence plan from the first session and discuss any challenge.
Session ■ Identify other possible gaps and emerging issues.
(30days after
the first Action
session) ■ Assist patient to modify the adherence plan to address the identified issues
■ Referrals and networking when necessary.

Third Session ■ Review adherence plan from the first and second session and discuss any
(60 days challenges.
after the first ■ Identify other possible gaps and emerging issues.
session)
Action

■ Assist patient to modify the adherence plan to address the identified issues.

■ Decision on repeat VL based on current adherence:

■ If the adherence is good, plan repeat VL testing after a month and explain
possible ways forward, emphasizing the role of the patient and the health
facility in terms of strengthening adherence.

■ If adherence challenges persist, link to appropriate client centered care.

Fourth
■ Take the second VL sample.
Session (90
days from ■ All efforts should be employed to get the VL result as soon as possible.
the first ■ As soon as the VL result is received, discuss the result with the client.
session)
Action

1.If VL is < 50 copies/ml, maintain the current regimen and encourage

adherence

2.If VL is 50-1000 copies/ml, continue the current regimen and the monthly
EAS for the next 3months then repeat the viral load testing. If the low-
level viremia (50–1000 copies/ml) persists, maintain ARV drug regimen and
continue viral load test every six months.

In addition, continue the routine follow up support and link to community-

based adherence support services. If VL is > 1000 copies/ml, switch to
appropriate regiment (second or third line).

78
Figure 4.1. Treatment monitoring algorithm

a. Unsuppressed viral load results should be Implementation considerations for

immediately communicated treatment monitoring of pregnant and
breastfeeding women
b Conduct same-day testing using point-of-
care viral load testing for a repeat viral load Whenever possible, use same-day point-of-care
test, where available, to expedite the return of testing for viral load testing of pregnant and
results. If not available, viral load specimens breastfeeding women to expedite the return
and results for a repeat viral load should be of results and clinical decision-making. If this is
given priority across the laboratory referral not available, viral load specimens and results
process (including specimen collection, testing for pregnant and breastfeeding women should
and return of results). be given priority across the laboratory referral
process (including specimen collection, testing
and return of results).

79
For all pregnant women, regardless of ART For all breastfeeding women, regardless of
initiation timing: when ART was initiated:

Conduct viral load testing at 34–36 weeks of Conduct viral load test three months after
gestation (or at the latest at delivery) to identify delivery and every six months thereafter to
women who may be at risk of treatment failure detect viremic episodes during the postnatal
and/or may deliver infants at higher risk of period.
perinatal transmission.
4.9. Management of treatment
In addition: failure
a) For pregnant women receiving ART before
4.9.1. Management of first-line
conception: treatment failure (switching to second-
line ART)
Conduct a viral load test at the first antenatal
care visit (or when first presenting) to identify
Using a boosted PI + two NRTI combinations
women at increased risk of in utero transmission.
is recommended as the preferred strategy
■ For women already on ART, conduct VL for second-line ART for adults, adolescents,
testing at the first contact at ANC (VL result and children. Two NRTI + DTG can be used as
conducted in the last 3 months before second line regimen if it is not used in the first
the first contact can also be used), at 34- line.
36 weeks of gestational age or delivery at
Guidance for changing ARV regimens for
the latest, followed by three months after
treatment failure
delivery and then every 6months.
■ Ensure diagnosis of treatment failure to
■ For those who are already on ART with avoid premature switching.
previous VL test conducted more than three
months back repeat VL test at first ANC ■ Assess adherence and address barriers.
contact /PMTCT visit, at 34-36 weeks of
■ Assess for and address drug interaction
gestational age (or at the latest at delivery)
issues.
and 3 months after delivery and every six
months thereafter until MTCT risk ends.
■ Do not add one drug to a failing regimen.
b) For pregnant women starting ART during
■ Consider resistance and cross resistance
pregnancy:
patterns.
Conduct a viral load by three months after
ART initiation to ensure that there has been ■ Get advice from experienced clinicians.
rapid viral suppression. If viral load testing is
expected to be undertaken near the planned ■ At least two new drugs.
viral load at 34–36 weeks of gestation, the first
■ Preferably one new drug class.
viral load test can be delayed until weeks 34–36
of gestation

80
Once it is decided and patients are switched to Before switching to third line regimen, health
second-line regimen, strong adherence support care providers should ensure the following.
should be continued and viral load monitoring
■ Two consecutive viral load measurements
should be started after 6 months of second-line
> 1000 copies/ml at least 3 months apart.
treatment and then every 12 month.

4.9.2. Management of second-line ■ First viral load measurement done at least

6 months after switching to second-line
treatment failure (switching to
regimen.
third line ART)
■ The repeat VL test should be done after 3
Patients who are on second-line regimen and
months of enhanced adherence support.
have high viral load level (>1000copies/ml) after
6 months of treatment need to go through the
The approach in switching to third line should
algorithm as described for first line treatment
follow the guiding principles listed out for
failure with enhanced adherence support
switching to second line drugs.
and repeat test after three months to decide
second line treatment failure. Once patients
are confirmed to have second line failure, they
should be referred to hospitals selected for
third line ART service.

Treatment failure is indicated by virological

non-suppression with or without immunologic
and/or clinical deterioration. Before switching
to third-line regimen, the issue should be
discussed with experienced physician in HIV
care and treatment. Treatment failure while on
a second line PI regimen is often due to non-
adherence.

Doctors and nurses should participate directly

in the adherence assessments, and do not
delegate the assessment to the adherence
counselor alone (see enhanced adherence
counseling section for detailed steps of
adherence counseling for patients with
adherence problems).

81
 Table 4.10: Summary of sequencing options for first line, second line and third line ART regimens for adults, adolescents, and children

82
Population 1st line regimens 2nd line regimens 3rd line regimens a,b
DRV/rC+TDF+3TC+EFV
Preferred TDF + 3TC + DTG AZT+3TC+ATV/r or LPV/r
DRV/r+TDF+3TC+DTGe
AZT+3TC+DTG or ATV/r
TDF+3TC+EFV DRV/r+TDF+3TC +DTGf
or LPV/r
Alternative TDF+3TC+DTG or ATV/r or
Adults and AZT+3TC+ EFV DRV/r+AZT+3TC+DTG
LPV/r
adolescents 10
years & older AZT+3TC+DTG TDF+3TC+ ATV/r or LPV/r DRV/r+AZT+3TC +EFV
AZT+3TC+ DTG or ATV/r
ABC+3TC+EFV DRV/r+TDF+3TC +DTG
or LPV/r
Special ABC+3TC+DTG AZT+3TC+ATV/r or LPV/r DRV/r+TDF+3TC +EFV
Circumstances
TDF+3TC+ATVr or LPV/r AZT+3TC+DTG DRV/r+TDF+3TC +EFV
AZT+3TC+ATVr or LPV/r TDF+3TC+DTG DRV/r+AZT+3TC +EFV
For those <3 years, maintain second line
Children 4weeks regimens till they become 3years.
to 10 years and Preferred ABC+3TC+DTG AZT+3TC+LPV/r
>3kg For children 3-10 Years, switch to DRV/
rd+DTGg+ABC+3TC
For those <3 years, maintain second line
regimens till they become 3years.
Alternative ABC+3TC+LPV/r AZT+3TC +DTG
For children 3-10 Years, switch to DRV/r
+ABC+3TC+ EFV

For those <3 years, maintain second line

regimens till they become 3years.
AZT+3TC+DTG ABC+3TC+LPV/r For children 3-10 Years, switch
to DRV/r +AZT+3TC+EFV or DRV/
r+DTG+AZT+3TC
 For those <3 years, maintain second line
Special regimens till they become 3years.
ABC+3TC+EFV AZT+3TC+DTG
circumstances For children 3-10 Years, switch to DRV/r
+ABC+3TC+EFV

For those <3 years, maintain second line

regimens till they become 3years.
AZT+3TC+EFV ABC+3TC+DTG or LPV/r For children 3-10 Years, switch
to DRV/r +AZT+3TC+EFV or DRV/
r+DTG+AZT+3TC

For those <3 years, maintain second line

regimens till they become 3years.
AZT+3TC+LPV/r ABC+3TC+DTG or EFV For children 3-10 Years, switch
to DRV/r+AZT+3TC+EFV or DRV/
r+DTG+AZT+3TC

a. Consider genotyping before constructing a third line regimen whenever accessible, however switching to third line should not be delayed
while waiting for the result, if the TAT is prolonged.
b. When constructing third line regimens for special circumstances in the absence of genotyping please consult senior experts on HIV
c. In PI-experienced patients, the recommended DRV/r dose should be 600mg/100 mg twice daily; refer the weight band for pediatrics
d. DRV/r should not be used in children younger than three years of age.
e. DTG based 3rd line following use of INSTI must be administered with DTG BD.

83
4.9.3. Second line ART service in health Eligible patients for second line ART service
centers at health centers

Patients who have treatment failure on first line The following criteria should be used to sort out
ARV regimens in health centers can be switched treatment failure patients who will be switched
to second line ART in the same facility based on to second line ART or will have follow up at the
the below mentioned criteria; also patients who health centers:
were switched to second line ART in hospitals
can be transferred to selected health centers a. Patients who fulfill the criteria of treatment
for follow-up. failure and with no signs of clinical failure

Eligible health centers to provide second b. Patients who are initiated on second line ART
line ART service at hospital and became stable with no signs of
OI or drug toxicity and transferred out to health
Second line ART service is available at health centers having second line ART.
centers that have a patient load of 200 or more.
That is a reasonably adequate patient load which
could give rise to viable number of prospective
clients who might need to be switched to a
second line ART.

84
CHAPTER FIVE:
PREVENTION, SCREENING, AND MANAGEMENT OF
COMMON CO-INFECTIONS AND COMORBIDITIES
ART has reduced mortality and morbidity Recommended general care for PLHIV
associated with HIV and transformed HIV
into a chronic disease requiring lifetime care. The following package of care and prevention
Coinfections and comorbidities, including intervention are nationally recommended for
physical and mental health conditions are adults, adolescents and children living with HIV:
common among people living with HIV. ■ Psychosocial counselling and support
Comprehensive HIV care includes combination
■ Disclosure and partner notification
HIV prevention, the promotion of general health
and well-being, maintaining quality of life, ART, ■ Co-trimoxazole prophylaxis
the prevention and management of coinfections ■ TB counselling, screening and preventive
and comorbidities. therapy
■ Preventing common fungal infections
Opportunistic infections are the predominant
causes of morbidity and mortality among ■ Preventing sexually transmitted infections
and supporting reproductive health needs,
HIV-infected patients. The level of immunity
including preventing and screening for
determines the occurrence and type of OIs. In
cervical cancer
general, milder infections such as herpes zoster
and other skin infections occur early whereas ■ Prevention of malaria
serious life-threatening infections such as CNS ■ Nutrition
toxoplasmosis and Cryptococcal meningitis
■ Family planning
occur later with severe immune-suppression.
Some life-threatening infections, such as ■ Prevention of mother-to-child HIV
transmission;
pneumonia and TB, may occur early as well as
later. When TB occurs later it is atypical, more ■ Water sanitation and hygiene
disseminated and more extra pulmonary. This ■ Orphans and vulnerable children (OVC)
chapter provides a brief overview of common
and important concomitant conditions among General strategies to prevent opportunistic
people living with HIV. This includes information infections are:
on co-trimoxazole prophylaxis, the diagnosis,
■ Reduction of exposure
prevention and treatment of TB, pneumonia,
viral hepatitis, sexually transmitted infections, ■ Chemoprophylaxis (primary/secondary)
cervical cancer prevention and mental health. ■ Immunization and
■ Rapid ART initiation

85
5.1. Co-trimoxazole preventive among adults, adolescents, pregnant women,
therapy (CPT) and children for prevention of pneumocystis
pneumonia, toxoplasmosis, bacterial infections
Co-trimoxazole preventive therapy (CPT) should and diarrhea caused by Isospora belli or
be implemented as an integral component of Cyclospora species, as well as benefits for
a package of HIV-related services. Existing malaria prophylaxis.
recommendations cover initiation of CPT Table 5.1 CPT indication for primary prophylaxis

Criteria for Criteria for Monitoring

Age
initiation discontinuation* approach

In all, starting at Until the risk of HIV According to the

HIV exposed infants 4–6 weeks after transmission ends or HIV national HEI follow
birth infection is excluded up schedule

Discontinue when they

become older than 5years
of age who are clinically
<5 years In all stable, with evidence of Clinical at 3-month
immune recovery and/
or viral suppression on
ART**

Discontinue in those who

are clinically stable (those
individuals on ART for at
least one year without any
new WHO clinical stage 2,
3 or 4 events) with;
Any WHO stage
and CD4 count ≤ ■ Evidence of immune
350 cells/mm3
Intervals ≥5 years, recovery and/or viral
including adults suppression (CD4
Or WHO stage 3 or
4, irrespective of count >350 cells/
CD4 level mm3, with viral load
suppression) or

■ Two consecutive CD4

count > 350 cells/mm3
if no VL result

86
Contraindications to co-trimoxazole preventive ■ Severe renal disease and
therapy:
■ Glucose-6-phosphate dehydrogenase
■ Severe allergy to sulfa drugs (G6PD) deficiency

■ Severe liver disease Table 5.2: Dosage of co-trimoxazole for adults,

adolescents, children and infants.

Suspension Single strength Double strength

Age(weight ) (240 mg/5ml co- tab (480 mg of Co- tab (960 mg of co-
trimoxazole) trimoxazole) trimoxazole)
Up to 6month (5kg) 2.5ml/day ¼ tab/day -
6 months to 5 yr
5 ml/day 1/2 tab/day -
(5-15 kg)
6-14 yr (15-30 kg) 10ml/day 1 tab/day ½ tab/day
>14 yrs (>30 kg) 2 tab/day 1 tab/day

Table 5.3: Adverse effects of CPT and management.

Toxicity Clinical description Recommendation

Prescribe antihistamine and continue

Grade 1 Erythema, pruritis
CPT and close follow-up.

Diffuse maculopapular rash, dry Prescribe antihistamine and continue

Grade 2
desquamation CPT and close follow-up.

STOP CPT, manage and re-introduce

Vesiculation, minor mucosal
Grade 3 after 2 weeks with observation
ulceration
(desensitize).

Exfoliative dermatitis
STOP CPT NEVER RESTART CO-
Grade 4 Steven-Johnson syndrome or
TRIMOXAZOLE
erythema multiforme, moist
desquamation

87
5.2.Tuberculosis ■ Strengthen the coordination mechanism for
integrated TB/HIV services at all levels;
TB is the most frequent life-threatening OI and
■ Conduct surveillance to determine HIV
a leading cause of death among HIV infected
burden among TB patients and TB burden
people. TB remains the leading cause of
among HIV patients;
mortality among people living with HIV, despite
substantial scale-up of ART, accounting for 30% ■ Carry out joint TB/HIV planning for integrated
of the AIDS-related deaths reported in 2019. TB TB and HIV services delivery; and
increases HIV replication through the process
■ Conduct monitoring and evaluation of
of immune activation leading to increased
collaborative TB/HIV activities.
viral load and this results in a more rapid
progression of HIV disease. On the other hand, B. Reduce the burden of TB in HIV infected
HIV increases susceptibility to be infected with people and initiate early antiretroviral therapy
M. Tuberculosis, the risk of progression to TB (the three I’s i.e., Intensive case finding, TB
disease and the incidence and prevalence of preventive therapy and Infection control)
TB. The lifetime risk of HIV positive individuals
■ Intensify TB case finding and ensure quality
to develop TB is 50%, the annual risk is 10%.
TB treatment;
The WHO recent estimation indicates the risk
of developing active TB disease is 18 times ■ Initiate TB prevention with earlier initiation
higher in PLHIV. In Ethiopia, WHO estimation of ART and TB Preventive therapy (TPT); and
indicated that 5.3% of TB cases notified in
■ Ensure tuberculosis infection control in
PLHIV in 2019. Moreover, a national level data
healthcare and congregate settings.
report indicated that the prevalence of TB in
PLHIV is 7.3%. Thus, it is essential for both TB C. Reduce the burden of HIV in patients with
and HIV control programs to synergize their presumptive and diagnosed TB.
joint efforts and intensify the implementation
■ Provide HIV testing and counseling to
of TB/HIV collaborative activities to mitigate
presumptive and confirmed TB patients.
the dual burden of TB/HIV in populations at
risk or affected by both diseases. The rationale ■ Provide HIV prevention services for
for the integration is that tuberculosis and HIV presumptive and confirmed TB patients;
prevention and control programs share mutual
■ Provide co-trimoxazole preventive therapy
challenges of high impact of TB on HIV and
for HIV positive TB patients.
vice versa. Therefore, the two programs must
collaborate to provide better service for the co- ■ Ensure HIV/AIDS prevention, treatment,
infected patients. and care for HIV positive TB patients; and

Nationally recommended TB/HIV ■ Provide ART for HIV positive TB patients.

collaborative activities
A. Strengthen the mechanisms for integrated
TB and HIV services delivery

88
Table 5.4 Timing of ART for adults and children with TB

New HIV positive

Patients with signs and HIV positive patients
Patients with tuberculosis found to be HIV
symptoms suggesting taking ART diagnosed
positive
(presumptive with TB
tuberculosis cases)

■ Rapid ART initiation ■ ART should be started in all TB patients, ■ Start anti-TB
should be offered including those with drug-resistant TB,
to all people living irrespective of the CD4 count. ■ Modify ART regimen
to avoid drug-drug
with HIV following
interaction
a confirmed HIV ■ ART should be started as soon as
diagnosis and possible within two weeks of initiating
■ Evaluate for
clinical assessment TB treatment, regardless of CD4 count, treatment failure
and to people living among all people living with HIV. (Adult,
with HIV with signs adolescent and children), except when
and symptoms signs and symptoms of meningitis are
suggesting present.
TB. Except for
central nervous ■ ART should be delayed at least four
system disease weeks (and initiated within eight weeks)
(meningitis), initiate after treatment for TB meningitis is
ART while rapidly initiated. Corticosteroids should be
investigating for TB, considered adjuvant treatment for TB
with close follow- meningitis. (Note. For people living
up within seven with HIV with TB meningitis, immediate
days to initiate TB ART is associated with more severe
treatment if TB is adverse events compared with initiating
confirmed. ART two months after the start of TB
treatment)

■ DTG should be used as the preferred

drug in patients starting ART while on
Anti-tuberculosis treatment but dose of
DTG should be doubled (50 mg BID).

■ When second line is initiated LPV/r is

preferable. Note that the dose of the
ritonavir should be doubled to counter
the effect of Rifampicin on the Protease
inhibitors.

89
The 3Is intervention Children less than 10 years:

■ Current cough,
I.Intensify TB case finding and ensure quality
TB treatment
■ Fever,
Tuberculosis case finding should be intensified
■ Poor weight gain
in all HIV testing and counseling services for
HIV positive clients by using a set of simple
■ Close contact with a person with TB disease
questions for early identification of presumptive
TB cases. HIV positive clients coming through Clients with any one of the above symptoms
HIV testing services should be informed should be investigated for active TB
about the advantages of being screened for
TB. Once informed about the risk of developing Diagnosis of TB in HIV infected people
active TB, they should undergo screening for it.
Adults and adolescents living with HIV should Although there have been significant
undergo intensified tuberculosis case finding improvements in the diagnosis and treatment
using symptom-based TB screening questions of TB, there are still limitations in early detection
should be instituted at chronic HIV care and and treatment of all forms of TB cases among
treatment clinics for all people living with HIV. PLHIV. A systematic review study that
Any HIV positive patient with TB screen positive estimated the prevalence of TB in PLHIV studies
result should undergo appropriate evaluation reported on postmortem testing showed 46%
and investigation for TB. In addition to symptom of TB cases remain undiagnosed, which made
based screening, to consider sensitive TB the most prominent opportunistic infection
screening test like CXR for routine screening of among PLHIV. Moreover, of the total 815,000
TB in PLHIV with no sign and symptoms of TB. estimated HIV-associated TB cases worldwide
in 2019, only 56% were notified. This indicates
Symptom based TB screening for all PLHIV that TB diagnosis is still a challenge in PLHIV,
and it is rarely bacteriologically confirmed.
All clients living with HIV infection should be
The conventional sputum microscopy is the
screened for active TB with any one of the
cheapest and fastest method that is used
following symptoms:
to diagnose TB since 1882. However, the
Adult and adolescents: sensitivity of sputum smear microscopy for
the diagnosis of TB is low in PLHIV due to poor
■ Current cough
quality sputum production and low bacillary
concentration.
■ Fever
Particularly in severely immunocompromised
■ Weight loss or poor weight gain patients, the sensitivity of sputum smear
microscopy is significantly reduced. Other
■ Night sweats challenges that make TB diagnosis difficult

90
include non-specific clinical presentation of TB high TB/HIV burden settings. It is recommended
that is attributable to high prevalence of extra- for use as a simple point-of-care test to assist
pulmonary and disseminated forms of TB in TB diagnosis in HIV positive adult patients with
individuals with advanced HIV disease. signs and symptoms of TB and with low CD4
cell counts. Based on the generalization of
Currently, rapid, and more accurate molecular
the data from adults, this recommendation is
technologies have been developed and
also used in children living with HIV who have
available to diagnose TB in PLHIV. Polymerase
signs and symptoms of TB. However, there is
chain reaction (PCR), real-time PCR, and loop-
limited evidence on the specificity of LAM test
mediated isothermal amplification (LAMP) are
in children.
the molecular techniques that are commercially
available for the diagnosis of TB. However, the LAM test could decrease mortality through
diagnostic performance of these technologies quicker diagnosis and early treatment
has not been fully evaluated for the diagnosis commencement among PLHIV and severely
of TB in PLHIV. sick.

Although rapid and accurate molecular Eligible PLHIV for LF-LAM Test
assays have significantly reduced the gap
in TB case detection among PLHIV, their WHO 2019 policy update on LF- LAM
accessibility continued to be a challenge, due recommends the currently available urinary
to the infrastructure required and the cost of LAM assays have suboptimal sensitivity and
procurement and maintenance. Thus, access to are therefore not suitable as general diagnostic
rapid and accurate diagnostic tests at the point tests for TB. However, unlike traditional
of care is significantly restricted in resource diagnostic methods, they demonstrate
limited settings where the burden of TB/HIV improved sensitivity for the diagnosis of TB
co-infection is high. Moreover, interruption among individuals coinfected with HIV. The
of electricity and inadequate laboratory estimated sensitivity is even greater in patients
infrastructure and inefficient sample referral with low CD4 cell counts.
mechanisms are the challenges that limit the
Therefore, HIV-positive adults, adolescents and
accessibility of rapid and accurate molecular
children with the following criteria are eligible
diagnostic tests.
for Urine LF - LAM test to assist in the diagnosis
To minimize the challenges that are associated of active TB:
to sputum based diagnostic tests, urine based
For inpatient settings
rapid TB diagnostic tests are recommended to
detect TB in PLHIV with Advanced HIV Disease. ■ With signs and symptoms of TB (pulmonary
Alere lipoarabinomannan (LAM) assay is one and/or extra pulmonary)
of the urine based rapid diagnostic tests for
TB detection in PLHIV. Evidence suggests the ■ With advanced HIV disease or who are
importance of LAM in the detection of TB at seriously ill

91
■ Irrespective of signs and symptoms of TB, aged under 5 years should be considered as
with a CD4 cell count of less than 200 cells/ having advanced disease.
mm3
Figure 5.1. Algorithm for LF - LAM testing to aid in the
Seriously ill is defined based on four danger diagnosis of TB among PLHIV in inpatient settings
signs: respiratory rate of more than 30/minute,
temperature of more than 39 °c heart rate of For outpatient settings
more than 120/minute and unable to walk
unaided. ■ With signs and symptoms of TB (pulmonary
and/or extra pulmonary) or seriously ill
Advanced HIV disease: is defined as a CD4
cell count of less than 200 cells/mm3 or a WHO ■ Irrespective of signs and symptoms of TB
clinical stage 3 or 4 event at presentation for and with a CD4 cell count of less than 100
care for adults, adolescents and children greater cells/mm3
than five years. All children with HIV who are

92
In outpatient settings, WHO recommends ART. Hence setting other criteria may limit the
against using LF-LAM to assist in the diagnosis Urine LF -LAM utilization. Therefore LF-LAM
of active TB in HIV-positive adults, adolescents, test should be conducted for all HIV infected
and children: children under 5 years at least once as per
below criteria:
■ Without assessing TB symptoms
To offer LF-LAM for all HIV infected <5 years
■ Without TB symptoms and unknown CD4 children backlog/currently on treatment once
cell count or without TB symptoms and irrespective of clinical stage or CD count/CD 4
CD4 cell count greater than or equal to 200 percentage
cells/mm3
All newly enrolled under 5 HIV infected children
■ Without TB symptoms and with a CD4 cell (at Enrollment) irrespective of clinical stage or
count of 100–200 cells/mm3 CD4 count/CD4 percentage

Remarks Once cleared the backlog, offer LF- LAM at

any time when children presented with TB
a.All patients with signs and symptoms of symptoms, or serious illness or advanced HIV
pulmonary TB who can produce sputum should stage or CD4 percentage less than 15%.
have as their initial diagnostic test at least one
sputum specimen submitted for Xpert® MTB/
RIF (Ultra) assay. This also includes children and
adolescents living with HIV who can provide a
sputum sample.

b.LF-LAM should be used as an-add on to

clinical judgement in combination with other
tests. It should not be used as a replacement or
triage test. More details are given in Algorithms
for LF-LAM use.

Note for using LF-LAM test for children less

than 5 years:

Latest WHO guideline consider all HIV

infected children age <5 years old to follow as
advanced HIV disease , besides nationally we
have a limited number of under 5 children on

93
Figure 5.2. National TB Diagnostic algorithm for PLHIV incorporating Urine LF-LAM testing in outpatient settings

Diagnosis of extra-pulmonary tuberculosis in PLHIV

Extra-pulmonary tuberculosis is more HIV- diagnostic capacity. Therefore, it is important

related than pulmonary tuberculosis. The for healthcare workers to have a high-index of
accurate diagnosis of extra-pulmonary suspicion and critically evaluate through clinical
tuberculosis is complex and difficult, particularly algorithms. It is also recommended to do organ
in peripheral health facilities with limited specific investigations.

94
Note: Antibiotic trial: Antibiotic trial has a role to treat
concomitant bacterial infection for PLHIV with
■ Xpert MTB/RIF test is recommended as cough or serious illness. However, antibiotic trial
diagnostic test for CSF in patients presumed is not helpful in the diagnosis of TB in PLHIV.
to have TB meningitis.
Table 5.5: Extra pulmonary TB diagnostic
■ One sputum sample for the facility which approaches in PLHIV.
have Xpert test and two sample for sample
referring facilities.

Investigations and
Type of TB Evidence Strongly Suggestive of EPTB
recommendations
2cm or more in size, Asymmetrical/localized; LN Aspirate for AFB has
Painless swelling; Firm/fluctuated; Cervical 85% yield, if not possible
Lymph Node TB
location; patient with weight loss, night to do FNAC of LN, start
sweats, fever anti-TB.
Unilateral effusion: Aspirate of fluid is clear
and straw colored and clots on standing in
a tube without anti-coagulants or pleural Start anti-TB as soon as
Pleural effusion
fluid analysis shows protein >30g/L &>50% possible.
lymphocytes; Patients with weight loss, night
sweats, fever, or evidence of TB elsewhere
Admit patient, start anti-TB
Patients with weight loss, night sweats, fever;
with steroids as soon as
cerebrospinal fluid clear with high protein,
Tuberculosis possible. Start treatment
low glucose, and lymphocytes; Cryptococcal
Meningitis for cryptococcal meningitis
antigen (or Indian Ink and fungal culture)
based on clinical or lab
negative in CSF, evidence of TB elsewhere
evidence.
Hemodynamically significant pericardial
effusion, often with pleural effusions, CXR, Echocardiograph
Lung fields clear and intra-thoracic or chest ultrasound;
lymphadenopathy. pericardiocentesis, and
Pericardial pericardial biopsy; routine
Usually patients with weight loss, night
Effusion TB Workup.
sweats, fever.
N.B. 90% of pericardial effusions in HIV Start anti-TB as soon as
positive patients in high-TB burden areas is possible
due to TB.
Patients with weight loss, night sweats, fever,
Start anti-TB treatment (add
Disseminated TB and cough; Abnormal CXR (which can include
antibiotics if critically ill)
miliary pattern); Large spleen/liver, Anemia

Pain over localized area, children/adolescents Spinal imaging (e.g. X-Ray,

–often thoracic vertebrae. MRI); FNA of vertebral
TB of the Spine
lesions and /or Para spinous
Adults: frequently lumbar vertebrae. abscesses when feasible.

95
II.TB Prevention Therapy (TPT)

Latent tuberculosis infection (LTBI) is the state The selection of treatment options for LTBI by
of persistent immune response to stimulation programs and clinicians should consider the
of mycobacterium tuberculosis antigens characteristics of the clients who are to receive
without evidence of clinically apparent active treatment and acceptability of treatment for
tuberculosis (TB). Estimates show a quarter of the higher completion rate. The benefits of all
global population is infected with tuberculosis, the treatment options outweigh the potential
where most cases are asymptomatic and non- harm. Shorter TPT regimens have been shown
infectious. Studies show that, on average, to be as effective and better tolerated than
5-10% of these latently infected persons have longer regimens, and thus may be preferable
lifetime risk of progressing to develop active for individuals receiving treatment, clinicians
TB, usually within the first five years of initial providing treatment, and program managers.
infection. However, risk of progression is
dependent on immunological status. For adults and adolescents living with HIV, TPT
should be provided to those who are unlikely
Treatment of LTBI to prevent progression to to have active TB based on appropriate clinical
active disease is one of the global key strategies algorithm, irrespective of CD4 count, ART
to ending the TB epidemic. Increasingly, eligible status, pregnancy status or history of treatment
targets and treatment options are expanding, for prior episode of TB before THREE years.
with significant implications in the programmatic Children and infants less than 1 year of age
management of LTBI. TPT is the use of Isoniazid, should be provided preventive therapy only if
rifapentine or other medications to sterilize they have a history of household contacts with
latent TB infection. Screening for exclusion of pulmonary TB and active TB in the child has
active TB in HIV infected persons is the single been excluded in investigation.
most important step that should precede the
decision to initiate TPT. Concerns regarding the Clinicians should follow the algorithms for
development of INH resistance should not be a initiation and selection of regimen for the
barrier to providing TPT. specific population groups eligible for TPT as
indicated in section below.

96
Figure 5.3. Algorithm for initiating TPT in adults and adolescents ≥15 years living with HIV

97
Figure 5.4. Children <15 years living with HIV and without household TB exposure

98
Figure 5.5. HIV-exposed Children and HIV negative children and adolescents
<15 years of age with household exposure to PTB case

99
Regimen and dosage for treatment of LTBI

Table 5.6. Regimen for treatment of latent TB infection.

Population Age group and ART

Selection of TPT regimen
group regimen
Preferred regimen Alternative regimen
Adults, adolescents,
Daily isoniazid
children, and infants of all
preventive treatment
ages taking a PI-based
for 6 months (6H)
ART regimen
Children and adolescents
Daily isoniazid
aged <15 years taking
preventive treatment
a DTG-based ART
for 6 months (6H)
regimen
■ Daily isoniazid
Persons living
with HIV preventive
Children and adolescents Weekly isoniazid treatment for 6
aged <15 years taking Plus rifapentine for 3 months (6H)
EFV-based ART regimen months (3HP*). ■ Daily rifampicin
Plus isoniazid for 3
months (3RH).

Adolescents and adults ■ Daily isoniazid

Weekly isoniazid
living with HIV (≥ 15 years preventive
Plus rifapentine for 3
of age) taking non-PI treatment for 6
months (3HP).
based ART regimen months (6H)
Daily rifampicin Plus -Daily isoniazid
Infants and children <2
isoniazid for 3 months preventive treatment
years of age)
(3RH). for 6 months (6H)
HIV-negative Eligible adolescents and -Daily isoniazid
persons children aged between Weekly isoniazid preventive treatment
≥2 -14 years (refer to Plus rifapentine for 3 for 6 months (6H)
eligibility criteria specified months (3HP). -3RH will be used as
above) alternative to 3HP
*3HP: should be taken with food to prevent GI upset; if patients are unable to swallow tablets
(due to age or illness), the tablets can be crushed and added to a small amount of semi-solid
food

100
Drug-drug interactions with antiretroviral if safe to do so. Overall, 3HP is a safe and
medicines effective treatment for latent TB infection.
Clinically significant drug reactions are rarely
Drug-drug interactions should be cautiously experienced by patients receiving 3HP, and
considered in using rifampicin and rifapentine even less commonly require discontinuation
in persons who are receiving antiretroviral of treatment. Severe reactions are particularly
treatment (ART). Both rifampicin and rifapentine rare. Nonetheless, healthcare workers should
should not be administered in persons who be familiar with the important drug reactions so
are receiving nevirapine or Protease Inhibitor that they can recognize rare occurrences and
(PI) based regimen. A three-month weekly manage them appropriately.
rifapentine plus isoniazid can safely be used in
patients receiving efavirenz-based antiretroviral Therefore, in general: If an AE occurs while a
regimen without the need for dose adjustment. patient is receiving 3HP, they should be advised
Studies show that co-administration of not to take any further doses and contact the
rifapentine with raltegravir and dolutegravir ART providers and TB focal persons of the
based regimen is both safe and well tolerated health facilities as appropriate.
in HIV infected adults and adolescents aged ≥
15 and do not need any dose adjustment. Minor adverse events are likely to occur in a
small proportion of individuals/patients. Rarely
Monitoring adverse events serious adverse events may occur, and hence
both the health care provider and patient should
Routine clinical monitoring of persons receiving be vigilant and manage such events rapidly. This
TPT is necessary to ensure adherence and can be achieved by careful assessment of the
continuity of care. Adverse effects, including patient prior to commencing 3HP, and routine
those considered as medically “minor”, may monitoring during treatment as indicated below:
be a barrier for adherence in a person who is
otherwise well. TPT related adverse events
(AEs), identified during treatment should be
properly monitored, managed and reported per
national recommendation, using health facilities
reporting systems.

Management of adverse events (AEs)

Individuals receiving TPT do not have active

disease and therefore their risk for adverse
events during treatment must be minimized.
Moreover, the regimen can be withheld while
an AEs is assessed, and there is time for the
regimen to be recommenced and completed

101
Table 5.7. Baseline assessment and monitoring during TPT

The most common drug reactions with 3HP are:

■ Liver toxicity (less common than for 6H)
■ Flu-like reactions (more common than for 6H)
Drug
interactions Drug reactions are usually mild and self-limiting, but occasionally they can be
severe.
Children usually tolerate 3HP very well and have much lower rates of drug
reactions.

Active TB must be ruled out before commencing TPT. 3HP is currently not
recommended in:
■ Pregnancy
■ Age <2years
■ Information on baseline liver function is important in the following:
■ HIV+ (done as part of ART assessment but not mandatory)
Baseline
assessment ■ Daily alcohol consumption
■ Liver disorders including viral hepatitis
■ Postpartum period (≤3 months after delivery)
■ Concomitant use of other hepatotoxic substances
Individuals at higher risk of peripheral neuropathy should be offered vitamin
B6 (pyridoxine) supplementation with 3HP; if B6 is not available, this should
not delay starting a course of 3HP

Red/orange discoloration of urine and other body fluids while receiving 3HP
is normal and completely harmless.
If patients experience any symptoms concerning for an AE:
■ Do not take any further doses of3HP
■ Contact a healthcare provider for advice
■ Only continue receiving 3HP if advised to do so by a healthcare provider
Counselling
Individuals should be alert to the following symptoms:
for AEs
■ Weakness, fatigue, loss of appetite, persistent nausea (early symptoms
of
■ hepatotoxicity)
■ Flu-like, or other acute symptoms appearing shortly after receiving a dose
of 3HP
■ Symptoms of active TB (appendix1)

102
Adherence support and monitoring Contraindications for TPT

Clients receiving TPT should be supported at Individuals with any one or more of the following
home level, either by adherence case managers, conditions should not receive TPT:
HEWs or family supporter. They should have
monthly scheduled follow up that is coordinated ■ Symptoms compatible with tuberculosis
with other services, such as HIV care, child and even if the diagnosis is not yet confirmed;
maternal health services, as necessary. At each
follow-up visit, the healthcare provider should: ■ Active hepatitis (chronic or acute);

■ Educate clients and their families about ■ Regular and heavy alcohol consumption;
the benefit of TPT, potential side effects,
and importance of returning back to a ■ Prior allergy or intolerance to medicine(s) in
health facility for new symptom/sign or any the regimen; and
concern.
■ Symptoms of peripheral neuropathy
■ Evaluate and counsel clients on importance
In addition, rifapentine is not currently indicated
of treatment adherence and completion.
for children below 2 years, PLHIV receiving PI
Case managers, adherence supporters, and
or NVP based ART regimens, and pregnant and
HIV care and child health service providers
breastfeeding women.
should support treatment adherence and
monitoring, as part of comprehensive HIV
Patient management after treatment
care and child health services.
interruption:

■ Evaluate and routinely monitor drug side

TPT is said to be completed when a person
effects, including hepatitis, peripheral
completed a full course of treatment within the
neuropathy or rash. Stop TPT if serious
specified period. Completion of ITP is defined
adverse effect is identified and manage the
as “completed” if a patient completed the full
patient.
course of therapy within nine months period
(i.e. the six months of doses should be finished
■ Evaluate for signs and symptoms of active
in nine months). If a patient has interrupted TPT
TB, other opportunistic infections (OIs) or
without medical personnel advice, the client
diseases.
should be traced by health extension workers
■ Stop TPT, if active TB is diagnosed, which (HEW) or through the index person or other
requires immediate start of anti-TB family member who is already enrolled in care,
treatment and treatment must be resumed. It is important
to identify barriers and support treatment
adherence. However, concerns about adherence
should not be a barrier to the use of TPT. If the

103
client discontinues isoniazid-based TPT for a MMD will be aligned with ART MMD to reduce
period of less than three months: Resume the unnecessary facility visits. Facility level follow
same course by adding for the missed doses up visit & adherence monitoring will be aligned
at the end. If the client discontinues treatment with TPT dispensation at initiation and month
for a period of more than three months, then three. Documentation of TPT completion will
re-initiate new course of treatment. be aligned to clinical visit following expected
TPT completion at month six (for 6H) and at
Completion for 3HP is defined when the patient month three (for 3HP).
took at least 11 doses of treatment in 16 weeks.
III. TB Infection, prevention, and control
TB preventive treatment in Newborns
PLHIV are at increased risk of acquiring
Once a pregnant woman with TB has been TB in health care facilities and congregate
on treatment for TB for several weeks before settings. Each health care facility should have
delivery, it is less likely that the baby will a TB infection control plan for the facility that
become infected. The risk is highest if a mother includes administrative, environmental, and
is diagnosed at the time of delivery or shortly personal protection measures to reduce the
thereafter. If a pregnant woman is found to transmission of TB in health care and congregate
have pulmonary TB shortly before delivery, then settings and to provide surveillance of TB
the baby, and if possible, the placenta, should disease among workers. Health care workers
be investigated for evidence of congenital TB with HIV should be provided with ART and TPT
infection. If the result is positive, the newborn if they are eligible. TB can affect everyone, but
should be treated accordingly. If asymptomatic, specific population groups, including PLHIV
the newborn should receive TB preventive and healthcare workers, have a higher risk
treatment followed by BCG immunization. of acquiring TB infection and progressing to
Breastfeeding can be safely continued during disease once infected.
this period.
Summary of recommendations for key
TPT service provision amid COVID19: actions for infection control

At TPT initiation, all PLHIV will receive Administrative (facility-level infection control
standardized comprehensive education and committee and protocols):
counseling on benefits of TPT, importance
of adherence, TPT-related AEs, with clear A set of administrative controls is the first and
instructions to present for evaluation at onset most important component of any IPC strategy.
of any sign or symptoms indicative of TPT- These key measures comprise specific
related AEs. All patients will be placed on three interventions aimed at reducing exposure
months TPT MMD (both for clients on daily and therefore reducing transmission of M.
isoniazid for 6 months [6H] and rifapentine tuberculosis. These include:
and isoniazid weekly for 3 months [3HP]). TPT

104
■ Triage and patient separation systems (i.e. Respiratory protection
management of patient flows to promptly
identify and separate presumptive TB Respiratory protection controls are designed
cases); to further reduce the risk of exposure to M.
tuberculosis (and other airborne pathogens)
■ Prompt initiation of effective treatment; and for health workers in special areas and
circumstances. The recommendations given
■ Respiratory hygiene including cough here are aimed at strengthening these controls,
etiquette. and preventing the inadequate implementation
of respiratory protection programs that may
Health workers and care providers lead to a false sense of security and therefore
increase the risk to health care staff.
■ Surveillance and information
■ Ensure presumptive and TB patients do
■ Package of care for HIV-positive workers not walk along rooms in which susceptible
(ART and TB preventive therapy) individuals are evaluated (Eg. ART clinic)

■ Protective equipment (particulate respirator ■ Enforcing cough etiquette; health education

masks that meet or exceed N95 standards) is given to cover mouth and nose with
soft paper, cloth or using one’s arm while
■ Relocation for health care workers living
coughing or sneezing.
with HIV to a lower-risk area
■ Properly implementing cough etiquette
Environmental
to contain the dispersal of respiratory
secretions and practicing respiratory
To reduce the risk of transmission of M.
hygiene maneuvers to properly dispose
tuberculosis, air can be made less infectious
used tissues and masks are important
through the use of three principles: dilution,
preventive measures hence;
filtration and disinfection. Environmental
controls are aimed at reducing the concentration
■ HCWs should give health education on the
of infectious droplet nuclei in the air. This is
prevention and control of TB.
achieved by using special ventilation systems
to maximize airflow rates or filtration, or by ■ Posting of pictures showing precautions at
using germicidal ultraviolet (GUV) systems to waiting area is essential.
disinfect the air. Ventilation systems can also be
used to control the direction of airflow to reduce ■ Issuing face masks for MDR-TB patients
the spread of infection; for example, through and providing health education to overcome
the use of exhaust fans to generate negative MDR TB- associated stigma is also
pressure gradients. Environmental controls are important.
used in combination with other IPC measures
to help prevent the spread of M. tuberculosis

105
To reduce exposure in households: Presumptive treatment of TB for people
living with HIV
■ Houses should be adequately ventilated,
particularly rooms where people with The rationale for presumptive TB treatment
infectious TB spend considerable time is to prevent the death of people with HIV in
(natural ventilation may be sufficient to situations where expedited diagnosis of TB
provide adequate ventilation); is not possible or feasible due to the clinical
condition of the patient or limited access to
■ Anyone who coughs should be educated on TB diagnostic services. While there is no case
cough etiquette and respiratory hygiene so definition of presumptive TB, WHO algorithms
as to behave accordingly at all times; while include initiation of TB treatment for people with
infectious TB patients should: HIV in peripheral facilities based exclusively on
clinical suspicion (without TB investigations) for
■ Spend as much time as possible seriously sick patients (with respiratory distress)
outdoors; based on the judgement of the clinician.

■ Sleep in an adequately ventilated room; This approach is based on expert opinion and
emphasizes that every effort should be made
■ Minimize contact with children(< 5yrs) to confirm the diagnosis of TB after initiation
and immune-suppressed individuals; of presumptive treatment and that treatment
and should be stopped only if there is bacteriological,
histological or strong clinical evidence of an
■ Spend as little time as possible in
alternative diagnosis.
congregate and public transport market.
Introduce HIV prevention interventions for
■ Reduce the burden of HIV in patients with
presumptive and confirmed TB patients
presumptive and confirmed TB
All clients attending TB clinics should be
■ Provide HIV testing and counseling to
screened for STI using a set of simple questions.
presumptive and confirmed TB patients
Those with symptoms of STI should be treated
or referred to the treatment providers. (Refer
HIV testing is an entry point for HIV care and
to the National Guideline for the Treatment of
treatment services including ART. This equally
STI using the Syndromic Approach.) Condoms
applies to TB patients. Significant proportions of
should be made available in TB clinics.
TB patients are co-infected with HIV. Among TB
patients who are also HIV-infected, other OIs
are significant causes of morbidity and mortality
even with a successful treatment of TB. Hence,
HIV testing and counseling should be routinely
offered to all TB patients.

106
Provide co-trimoxazole preventive therapy Management consideration for TB/HIV Co-
for HIV positive TB patients infections

Co-trimoxazole is a safe and broad-spectrum In the management of TB/HIV confection,

antibiotic with activity against a broad range of treatment of tuberculosis is always given
bacterial, fungal and protozoal infections that priority over ART. As soon as HIV is identified
are common cause for morbidity and mortality in a TB patient, the patient should be enrolled
in HIV infected populations. Therefore, CPT is to HIV chronic care. Ideally, the HIV care can be
recommended to all TB/HIV co-infected patients delivered at the TB clinic for the duration of TB
regardless of their CD4 Count. All PLHIV with treatment.
TB and receiving CPT should be registered on
the unit TB register, as well as the Pre ART/ In settings where this is not possible, there
ART Register. They should also be monitored should be a strong referral system in place to link
monthly. the TB/HIV co-infected patient to the HIV clinic
promptly. Appropriate clinical, psychosocial and
Ensure HIV prevention, treatment, and care laboratory evaluations (including complete blood
for HIV positive TB patients count, chemistry tests and CD4 count tests) as
per the national guidelines for ART should be
Referral linkages between TB and HIV services performed as soon as possible. Patients should
must be strengthened to provide comprehensive be initiated on CPT and ART regardless of CD4
HIV prevention services for TB patients and count or WHO clinical stage and ART regardless
their families. Tuberculosis control program of CD4 count or WHO clinical stage. ART is
should implement procedures for prevention of recommended for all HIV infected TB patients
occupational and nosocomial exposure to HIV regardless of CD4 count or WHO clinical stage.
infection in their services. Health units should CD4 cells count shall preferably be determined
be equipped with protective materials and for all HIV infected TB patients. The preferred
routinely follow standard precautions to prevent regimen for TB/HIV co-infected adult patients is
HIV transmission in the healthcare settings. TDF+3TC+DTG (adjust dose of dose of DTG to
Linkage should be ensured for pregnant and 50mg BID, for children use appropriate weight
non-pregnant HIV positive clients to access band), regardless of pregnancy status.
services for prevention of mother to child
transmission. TB clinics should establish linkage Multidrug-resistant TB and HIV
with HIV services to provide the continuum of
care and support for HIV positives during and Multidrug-resistant TB (MDR-TB) is defined
after completion of anti-TB treatment. as TB that is resistant to at least isoniazid and
rifampicin. Patients with both HIV and MDR-
TB face complicated clinical management,
fewer treatment options and poor treatment
outcomes.

107
Outbreaks of MDR-TB among people with HIV Clinical manifestation
have been documented in hospital and other
settings, especially in Eastern Europe and in Typically, the patient presents with sudden
Southern African countries with a high HIV onset of cough, sputum production, chest pain,
prevalence. People with HIV with suspected fever and/or shortness of breath.
drug-resistant TB should be tested using Xpert
MTB/RIF where possible, since this test is more Diagnosis
sensitive for detecting TB among people with
HIV and rapidly detects rifampicin resistance, The clinical suspicion is based on a history
thus greatly shortening the time to diagnose of acute symptoms presented over days to a
and treat MDR-TB. few weeks and/or abnormal physical signs of
systemic infection and consolidation in the
The burden of MDR-TB can be reduced by affected lung/s. Radiologic imaging can assist
strengthening HIV prevention, improving in confirming the diagnosis of pneumonia.
infection control and improving collaboration
between HIV and TB control activities, with Treatment
special attention to the groups at the highest
For adults
risk of MDR-TB and HIV infection, such as
people who inject drugs and those exposed in
For less sever pneumonia,
congregate settings.
■ Amoxicillin 500mg TID OR erythromycin
5.3. Pneumonia 500 mg QID OR doxycycline 100 mg BID for
seven days (Avoid doxycycline in pregnancy).
5.3.1.Bacterial Pneumonia
■ Alternative, azithromycin 500 mg per day
This can occur in immune-competent individuals
for three days OR clarithromycin 500 mg
but in HIV-infected patients, particularly those
twice daily for seven days.
infected with S. pneumoniae; incidence of
bacteremia accompanying pneumonia is
■ If not improving after three days with good
increased compared with individuals who are
adherence to the antibiotics, review and
not HIV infected. Bacterial pneumonia occurs
consider switching to IV regimen:
during the whole spectrum of HIV disease but
tends to be more severe and recurrent as the
■ Ceftriaxone 1-2gm IV once per day plus
CD4 counts drops significantly. In addition,
erythromycin 500 mg oral (if not taken
pneumonia can concomitantly present with
earlier) or IV four time a day for 7 days.
sinusitis and/or bacteremia. If not treated
promptly, extra pulmonary complications like
empyema, meningitis, pericarditis, hepatitis and
arthritis can follow. Streptococcus pneumonia
and Hemophilus influenzae are the most
common etiologies of community acquired
pneumonia.

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For pediatric age groups: give erythromycin adult dose. If not improving
after three days and if patient is adherent to the
For less sever pneumonia Amoxicillin 40mg/ antibiotic, review and consider switching to IV
kg divided in to three doses per day for seven ceftriaxone 75-100gm per kg IV/IM once a day
days. In children and infants allergic to penicillin, or equally divided dosed twice a day for 7 to 10
use erythromycin; for infants aged one month days. Maximum dose 2-4gm per day for seven
up to two years, erythromycin 125 mg four days.
times daily for seven days; for age groups2-8
years, erythromycin 250 mg four time per day Table 5. 8. Management of less severe
for seven days; for age groups above 8 years pneumonia in PLHIV

Management of less severe pneumonia

If allergic to If not improving after 3 days and

Age First line treatment
penicillin good adherence

Ceftriaxone IV/IM: 75 mg/kg,

Amoxicillin 40mg/
once a day or in two divided
All ages kg in three divided -
doses for 7-10 days (Max dose:
doses for 7 days
2-4 gm/day)

Erythromycin: 125
1month-2 years -
mg, QID, 7 days

Erythromycin: 250
2-8 years -
mg, QID, 7 days

Erythromycin: 500
Above 8 years -
mg, QID, 7 days

When the patient has presented with clinical Adults:

evidence of severe pneumonia, admit for
■ Tachypnea, old age (>65 years), cyanosis,
parenteral antibiotic treatment and supportive
hypotension, systolic blood pressure
therapy or refer the patient if admission is
<80mm Hg, multi-lobar involvement and
impossible. Signs of severe pneumonia include:
altered mental status,
Children:
The respiratory rate in tachypnea is summarized
■ Chest in-drawing, grunting and presence of as below:
danger signs in children

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 S. No. Age-group Respiratory Rate (RR)

1 Birth to 2 months >60/minute

2 2 months to 1 year >50/minute

3 1 year to 5 years >40/ minute

4 5 years and above >30/minute

5.3.2.Pneumocystis pneumonia an induced sputum sample using special stains

like Giemsa or methylamine silver stains, but
Pneumocystis pneumonia is caused by these tests are not routinely done in Ethiopia.
Pneumocystis jiroveci, formerly known as
pneumocystis carini pneumonia, a ubiquitous Treatment
organism that is classified as a fungus but also
shares biologic characteristics with protozoa. It ■ Use Trimethoprim 15-25 mg/kg, three or
commonly occurs when patients have significant four times daily for 21 days.
immune suppression (adults: CD4<200cells/
mm3 or children: CD4 percentage < 14%). ■ Close monitoring is necessary during the
initial five days of treatment and if patient
Clinical manifestation grows sicker, administration of oxygen is
useful.
Typical clinical presentations are characterized
by insidious onset of low grade fever, dry
■ In severely ill patients with marked
cough, and dyspnea exacerbated by exertion.
respiratory distress and extensive chest
Physical examination reveals fever, tachypnea,
X-ray findings:
tachycardia and scattered rales in the lungs,
but examination of the lungs can appear ■ Children: add prednisolone - 2mg/kg per
normal in some patients. In children highest day for the first 7 - 10 days followed by
incidence is seen between 2-6 months of age a tapering regimen for the next 10 - 14
and is characterized by abrupt onset of fever, days.
tachypnea, dyspnea and cyanosis.
■ Adults: add prednisolone - 80mg for the
Diagnosis
first five days, 40 mg until 11 days and
20 mg until completion of intensive co-
Presumptive diagnosis of PCP is based on
trimoxazole therapy.
clinical judgement and typical chest X-ray
findings revealing a perihilar interstitial
■ Toxicity of co-trimoxazole, like skin rash,
infiltration with tendency to spread outwards.
bone marrow suppression, hepatitis and
Note that the chest X-ray can be normal in
renal failure can be troublesome in some
20% of patients. Definitive diagnosis of PCP is
patients with advanced HIV disease and
based on demonstration of the organism from
requires close monitoring.

110
Secondary prophylaxis after completion of the Diagnosis
course of treatment with co-trimoxazole should
be continued. (Refer Table 4.1). It is usually based on findings of clinical
examination. Diffuse bilateral reticulonodular
The alternative regimens for mild to moderate infiltrate on X-ray with mediastinal
cases of PCP include: lymphadenopathy. It is important to exclude
tuberculosis and other infectious etiology.
■ Clindamycin 600 mg qid plus primaquine 15
mg bid; or Treatment

■ Clindamycin 600 mg qid plus dapsone 100 Provide symptomatic treatment (hydration,
mg daily. oxygen). Use antibiotics if there is
a superimposed bacterial infection.
Consider spontaneous pneumothorax in Bronchodilators may be helpful in mild to
patients with sudden deterioration in clinical moderate disease. Corticosteroids are usually
condition. reserved for children with significant hypoxemia
and symptoms of pulmonary insufficiency. Give
5.3.3.Lymphoid Interstitial Pneumonitis
prednisolone 1 – 2 mg/kg/24 hrs for 6 – 8 weeks
and then taper as tolerated.
Lymphoid interstitial pneumonitis (LIP) is one
of the most common chronic lower respiratory
5.4. Hepatitis B and C
conditions occurring in up to 25% of children
with HIV/AIDS.
Introduction

Clinical manifestations
Chronic Hepatitis B and C Virus infection are
major global public health problems. WHO
It ranges from asymptomatic disease with
estimates that, in 2019, 71 million people had
isolated radiographic findings to bullous
chronic HCV infection and 257 million people
lung disease with pulmonary insufficiency.
chronic HBV worldwide, and 820 000 people
Symptomatic children present with insidious
died from HBV and 290 000 from HCV, mainly
onset of tachypnea, cough, and mild to moderate
from cirrhosis or hepatocellular carcinoma. In
hypoxemia with normal auscultatory findings
2019, there were 1.5 million new chronic HCV
or minimal rales or wheezing. Progressive
infections. In Ethiopia, over 30 studies have been
disease is accompanied by digital clubbing and
conducted since 1980’s, to determine a sero-
symptomatic hypoxemia. Associated physical
prevalence of various hepatitis viruses in the
findings include generalized lymphadenopathy,
country. It is reported that 12% of the hospital
hepatosplenomegaly and parotid enlargement.
admissions and 31% of mortality in medical
wards were due to all causes of chronic liver

111
disease. The National sero-survey conducted by ■ Inmates of correctional facilities
MoH and EPHI in 2017 shows the prevalence
of HBsAg was estimated to be 9.4 among the ■ Household and sexual contacts of HBsAg
general population aged 15 years and above positive people
with regional variations; the highest being in
the Afar region (28.8%). The pooled prevalence ■ Female Sex workers
of anti-hepatitis C virus antibody (anti HCV) was
3.1%. Unlike HBV, anti HCV virus prevalence in ■ History of multiple sexual partners or STIs
HIV infected individuals were higher, 5.5%.
■ Patients undergoing renal dialysis
Early identification of people with chronic HBV
■ People needing immunosuppressive
or HCV infection enables them to receive the
therapy
necessary care and treatment to prevent or
delay the progression of liver disease. Testing
Chronic HBV is defined as persistence of
also provides an opportunity to link people to
HBsAg for more than six months and chronic
interventions to reduce transmission, through
HCV infection is HCV antibody positive with
counselling on risk behavior and provision of
viremic HCV infection.
prevention commodities and HBV vaccination.
5.4.1.HBV/HIV co-infection management
In our set up systematic screening for viral
hepatitis B and C is prioritized for the following HIV co-infection has been shown to have
population groups: a profound impact on almost every aspect
of the natural course of HBV infection and
■ People who have received medical or dental includes more rapid progression to cirrhosis
interventions in settings where infection and hepatocellular carcinoma (HCC), higher
control practices are substandard liver-related mortality, and decreased treatment
response compared with persons without HIV
■ Pregnant women
coinfection.

■ Children born to HBV or HCV positive

HIV/HBV co-infected persons also demonstrate
mothers
more rapid HIV disease progression compared
to those who are HIV-infected alone, and have an
■ People with injecting drugs
impaired recovery of CD4 cells. HIV clients are
among the high risk groups for HBV and should
■ People living with HIV
be given priority for screening. i.e all HIV clients
■ Health care workers exposed to biological should get screened for HBV and evaluated
fluids for chronic infection as per the national viral
hepatitis prevention and control guideline. After
■ People who ever received blood or blood test result, vaccination or treatment and care
products for reactive patients are recommended when
resources permit.

112
Treatment options for patients with HIV/ 5.4.2.HCV HIV co-infection management
HBV co-infection:
HIV patients are among high risk groups for
■ ART should be started rapidly. HCV and should be given priority for screening.
Therefore, all HIV patients should be screened
■ If treatment is indicated for HBV, TDF+3TC and confirmation VL test should be done for
+ DTG as a preferred regimen. HCV screened positives.

■ The use of lamivudine as mono-therapy in Anti-HCV rapid diagnostic test (RDT) or

any of these diseases is contraindicated immunoassay (IA) can be used for screening
due to high YMDD resistance. and HCV RNA viral load test using either
quantitative or qualitative PCR should be used
■ When switching treatment in patients with to confirm chronic HCV infection.
HIV on ART failure, the second line regimen
should contain TDF + 3TC to continue the Persons with HIV/HCV coinfection generally
treatment against HBV. have more rapid disease progression than
mono-infected persons. Even among persons
■ If tenofovir-associated renal toxicity occurs, in whom ART leads to successful control of
the dose of tenofovir should be adjusted HIV infection (i.e. undetectable HIV viral load),
according to the renal clearance. the risk of hepatic decompensation among
coinfected persons is higher than among
■ Note: treatment of HIV without the use of
persons with HCV mono-infection.
TDF in the regimen may lead to flares of
hepatitis B due to ART-associated immune All chronic HCV infected individuals should be
reconstitution. treated to eradicate the virus and achieve cure
so that complications can be avoided. Follow up
■ Similarly, treatment discontinuation,
quantitative or qualitative HCV RNA viral load is
especially of 3TC, has been associated with
required to confirm if the patient has achieved
HBV reactivation, ALT flares and, in rare
Sustained Virologic Response (SVR).
cases, hepatic decompensation.
HCV treatment outcomes with DAAs are
NB: For further reference please consult the
comparable in persons with HIV/HCV
national Viral Hepatitis prevention and control
coinfection to those with HCV mono-infection.
guidelines.
Because DAAs are safe and effective for people
with HIV/HCV, there is no longer any need to
consider them as a special or difficult-to-treat
population. However, there are important
drug-drug interactions and shared side effects
like headache, fatigue and anemia with pan-
genotypic HCV regimens and ART. Therefore,

113
checking for drug-drug interactions and side 5.5. Sexual Transmitted Infection
effects between HIV and HCV medications and Cervical Cancer
needs to be given appropriate attention. The
HCV treatment for children is differed until 12 The epidemiological synergy between HIV
year of age and treatment with interferon-based and sexually transmitted infections is well
regimens should no longer be used. established, and they frequently coexist.
Most of these infections are asymptomatic,
For adolescents (12–17 years), the treatment at especially among women. However, even
this time still requires genotyping to identify the asymptomatic STIs can cause complications,
appropriate regimen. This include: be transmitted to sexual partners and enhance
HIV transmission. STI services should be an
■ Sofosbuvir/ledipasvir 12 weeks in genotypes
integral part of comprehensive HIV care among
1, 4, 5 and 6
adults and adolescents. Refer the revised STI
guideline for syndromic management of STIs.
■ Sofosbuvir/ribavirin 12 weeks in genotype 2
Prevention of cervical cancer:
■ Sofosbuvir/ribavirin 24 weeks in genotype 3
Cancer of the cervix is the second most
For adults without cirrhosis, the following pan-
common cancer, among women in Ethiopia
genotypic regimens is recommended for use in
with over 6,200 new cases every year and with
adults 18 years of age or older can be used:
a mortality close to 5,000 (Globocan 2018).
According to Addis Ababa Population Based
■ Sofosbuvir/velpatasvir for 12 weeks
Cancer Registry (2012-2015), the leading cause
■ Sofosbuvir/daclatasvir for 12 weeks cancer type among women is breast cancer
(32.3%) followed by cervical cancer (14.5%).
■ Glecaprevir/pibrentasvir 8 weeks3
Cervical cancer is a preventable disease
For adults with compensated cirrhosis, the and is curable if diagnosed and treated early.
following pan-genotypic regimens can be used: 99% of cervical cancer is caused by high risk
human papilloma viruses (HPV) types. Types
■ Sofosbuvir/velpatasvir for 12 weeks 16 and 18 cause 70 percent of cervical cancer.
Women living with HIV (WLHIV) are about six
■ Glecaprevir/pibrentasvir for 12 weeks times more at risk of developing pre-cancerous
lesions and invasive cervical cancer. The risk
■ Sofosbuvir/daclatasvir for 24 weeks and persistence of HPV infection increases
with low CD4 count and high HIV viral load.
Refer the national viral hepatitis prevention and
control guideline for further information

114
Target Population: Treatment of Precancerous Lesions:

Women Living with HIV (WLHIV) are at a a.Cryotherapy

much greater risk for developing cervical
cancer and require a more frequent screening. Cryotherapy is the treatment of choice for
Start screening at the time of HIV diagnosis, precancerous lesions that meet eligibility
regardless of age, once sexually exposed (15- criteria. Treatment is to be offered without
49 is recommended). requiring biopsy diagnosis (screen and treat)
in a single visit approach whenever feasible.
Screening Frequency: Only providers who have demonstrated clinical
competencies in cryotherapy are permitted to
WLHIV should be screened every two years perform the procedure. Treat using a double-
as part of routine care for HIV-positive women, freeze (three minutes freeze, five minutes
regardless of whether they are on antiretroviral. defrost, three minutes freeze) technique to
Following abnormal results and/or treatment, achieve a 3-5 mm ice ball around the cryo-tip.
repeat screening at 6months. If follow-up Follow-up screening with VIA for those VIA
screening is normal, return to screening every positive is in one year.
two years.
NB: Do not treat with cryotherapy during
Screening methods: pregnancy. Reschedule the woman when she
is more than 12 weeks postpartum.
Depending on the availability of resources, this
guideline recommends the following types of b.Thermal ablation
screening methods (refer annex 19 and 20 for
the algorithm). Thermal ablation is another novel ablative
treatment of option for precancerous lesions,
1.Visual inspection: with acetic acid (VIA) or and is sometimes called “cold coagulation” or
Lugol’s iodine (VILI) “thermocoagulation”. The equipment is fairly
simple, and treatment is based on a 20–30
2.HPV DNA test second application of a reusable metallic probe
that is electrically heated to approximately 100
3.Cytology: °C, leading to epithelial and stromal destruction
of the lesion. The treatment time is shorter with
■ conventional (Pap smear)
thermal ablation and also the use of thermal
ablation overcomes one major disadvantage of
■ liquid-based cytology(LBC)
cryotherapy which is the need for a refrigerant
gas (N2O or CO2). The gas containers are
bulky and heavy to transport and some areas
of LMIC may have supply issues. In addition,
frequent refilling of freezing gas can be costly.
The use of thermocoagulation for the treatment

115
of CIN is as effective as other methods, such and unclear type of cervical abnormality to
as cryotherapy and LEEP, with the advantage rule out invasive cervical cancer. It involves
of being rapid and is also associated with low the removal of a cone-shaped area from the
occurrence of side effects cervix, including portions of the outer cervix
(ecto-cervix) and inner cervix (endo-cervix)
c. Loop Electrosurgical Excision Procedure and is usually done in the operating room
(LEEP) under general or regional (spinal or epidural)
LEEP is reserved for precancerous lesions anesthesia.
that are not eligible for cryotherapy or thermal
Linkage and Integration of services:
ablation. It should be done by providers who
have demonstrated clinical competence in the
ART clinics should be closely linked with
procedure. LEEP requires anesthesia and is to
VIA clinics or sites providing cervical cancer
be performed only in settings that can handle
prevention services, or ideally, provide the
potential urgent complications related to the
services at the unit.
procedure (e.g., heavy bleeding).Follow-up
screening with VIA in one year.
Table 5.9. Healthcare delivery level by type of
d. Conization (Cone Biopsy) service and type of health care workers

Conization is recommended for the treatment of

lesions that cannot be treated with cryotherapy

Healthcare
Service provided Type of health care workers
delivery level
VIA/cryotherapy/thermal ablation,
Nurse, midwives, health officer,
PAP smear, colposcopy, LEEP biopsy,
Tertiary hospital MD residents and specialists
histopathology radiotherapy, radical
(gyn/obn, gyn-oncologists)
surgery chemotherapy and palliative care

VIA/cryotherapy/thermal ablation,
Nurse, midwives, health officer,
Regional/general PAP smear, colposcopy LEEP biopsy
MD residents and specialists
hospitals histopathology, radical surgery and
(gyn/obs, gyn-oncologists)
palliative care

District hospitals / VIA/cryotherapy/ thermal ablation, biopsy, Nurse, midwives, health officer,
primary hospitals palliative care MD

VIA/cryotherapy/ thermal ablation,

Health centers Nurse, midwives, health officer
palliative care

For details on prevention, screening and treatment, refer to guideline for cervical cancer prevention
and control in Ethiopia, 2021.

116
5.6. Non-Communicable Disease 5.7. HIV and Mental Health
(NCD) Disorders

According to WHO estimates, non- Globally, Mental Health Disorders (MHD) are
communicable diseases, including more common among PLHIV than among the
hypertension, cardiovascular disease, renal general population. Depression, Anxiety, PTSD,
disease, cancer, chronic respiratory disease, and Cognitive impairment are common types
diabetes and mental health disorders, account of MHD in patients following HIV diagnosis or
for 63% of global deaths. Low- and middle- during its progression to AIDS. The magnitude
income countries bear 86% of the burden of of common MHDs among PLHIV in Ethiopia
non-communicable diseases. has been studied and the following results
show that the prevalence is significantly high.
Compared with the general population, PLHIV A meta-analysis has shown that prevalence
have increased risk of developing a range of of depression among PLHIV in Ethiopia was
chronic non-communicable diseases, including 36.65%, and the prevalence for common mental
cardiovascular disease, hypertension, diabetes, disorders among PLHIV have been found to be
chronic obstructive pulmonary disease, kidney 33% in Hawasa and 24% in Debre Markos.
disease and cancer.
One of the reasons why mental health problem
Cardiovascular disease is now one of the are more common among PLHIV is that having
leading causes of non-AIDS-related morbidity MHD is one of the risk factor for becoming
and mortality among PLHIV. Both HIV and non- infected with HIV. People with MHDs are more
communicable diseases require health systems likely to be exploited by others and less able
that can deliver effective acute and chronic care to negotiate safe sexual relationships including
and support adherence to treatment. Chronic use of condoms with partners. They may be
HIV care provides the opportunity for assessing, less likely to stay in the kind of steady, long-
monitoring and managing non-communicable term relationships in which partners can protect
diseases, especially through primary care. each other from getting HIV.

Integrating interventions such as nutrition Furthermore, mental, neurological and substance

assessment, dietary counselling and support, use disorders (MNS) are important in HIV care
smoking cessation, exercise promotion, because of issues related to adherence, risk of
blood pressure monitoring and when available HIV transmission, and overall outcome of HIV
cholesterol management as part of HIV care can care. Evidence also suggests that treatment of
help to reduce the risks of non-communicable co-morbid psychiatric conditions may improve
diseases among PLHIV and improve HIV adherence to ART, underlining the importance
treatment outcomes. Therefore, screening of of recognition and treatment of psychiatric
PLHIV for these comorbidities during every visit conditions. Evidence further pointed out that
is a critical component of care and treatment there is continued under-recognition and under
package. treatment of these conditions among PLHIV.
Factors contributing to the under-recognition of

117
MNS symptoms related to: and Tigray regions showed that, of the total
PLHIV screened by case managers, clinicians
■ The overlap between the symptoms of confirmed that about 8% of them had some
depression and symptoms of HIV disease. form of MHD. In this study, the concordance
between the case managers’ screening results
■ Related to recognition of certain psychiatric and the clinicians’ diagnoses was about 68%
disorders, specifically depression and over the 15-month pilot implementation period
anxiety, there is a mistaken belief that these Therefore, the proactive screening of PLHIV
symptoms are expected in those diagnosed for MHD helps to early identification and
with HIV disease. Depression or anxiety management PLHIV with co-morbidities. Ten
symptoms that are more severe or that percent or more of people will experience one
persist beyond the period of initial discovery of the common mental disorders in the course
of HIV infection should prompt evaluation of their life. It includes problems with low mood,
and treatment. excessive worry, or difficult behaviors that do
get in the way of daily function.
■ The neuropsychiatric side effects associated
with some ARVs like Zidovudine, abacavir, The rest are categorized as severe mental
and efavirenz have been associated with disorders which are much less common, but
neuropsychiatric symptoms. much more serious. They include problems
with thinking that severely limit function and
The other issue worth mentioning with regard may make the person a danger to themselves
to comorbid HIV and MNS problems is drug- or others.
drug interactions (DDIs) between the ARV drugs
and psychotropic drugs. DDIs are important to Below are the common MNS problems
consider in the co-treatment of the two health integrated into HIV clinic. Please refer to
conditions because they make either group of annex 20 for the brief mental health disorders
drugs less effective or toxic. symptom screening and referral tool.

Therefore, integration of MNS symptom Priority mental health disorders (WHO)

screening into HIV services is important to
improve treatment outcome of PLHIV. This has 1.Psychosis: this is the collective name for a
been implemented in Ethiopia using a task- group of serious disorders characterized by
sharing approach among lay healthcare works changes in behavior (for example poor self-care,
(case managers) and clinicians. In this model, restlessness), strange thoughts or beliefs (for
trained lay case managers proactively screened example believing that others wish to do the
patients using a mental health screening tool individual harm) and related dispositions.
and subsequently linked potential clients with
trained clinicians working at HIV clinics for 2.Mania: a form of severe mental illness in
further diagnosis and treatment. A pilot project which a person is excessively happy or irritable
study conducted in selected sites in Amhara (experiences extreme mood swings), appears

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over-active and sleeps poorly. People with mania ■ Patients with problem of ART adherence
have poor reasoning skills (they have difficulty
understanding what is good and what is bad), ■ Patients who refused to start ART
and display excessive self-confidence.
■ Patients who are on ART preparation for >2
weeks
3.Depression: this is the most common priority
disorder and is characterized by excessive ■ Patients with advanced HIV disease
sadness, loss of interest, lack of energy and
related symptoms. ■ Patients with other health problems

4.Suicide: refers to the intentional ending of Mental health aspects of living with HIV
one’s own life.
Reaction to the diagnosis
5.Abuse of alcohol and other substances:
this is the excessive use of these substances People have many different reactions to learning
to the detriment of one’s health. that they have HIV infection. They may react
initially with anger, shock, or denial and these
6.Childhood mental disorders: these are reactions can change or recur over time.
different types of mental disorders related to
childhood developments. If people feel guilty for something that they
feel led to their acquisition of HIV:
7.Dementia: is characterized by memory
problems and broader problems with thinking ■ Reassure that no one can foresee all the
and understanding. consequences of what they do

■ Reassure that life offers many opportunities

8.Epilepsy: this is a chronic or longstanding
to do good and they will have many chances
condition caused by abnormal electrical
in the future feel better about themselves.
conductions in the brain. In its most obvious
form, it is characterized by episodic loss of For feelings of loneliness and isolation
consciousness and repetitive jerky movements
of the body. ■ Note that there are millions of people living
well with HIV, both in Ethiopia and other
On the other hand, ACMs/HCWs should countries
prioritize the below PLHIV groups for MHD
screening at ART and PMTCT clinic. ■ Note that they are right to be cautious about
who they tell, but that over time they will
■ Newly initiated on ART find many accepting people and develop
many close relationships
■ Patients with high viral load
■ Remind them that the ART site and its many
■ Patients re-engaged into care after services will always be a place that they can
treatment interruption turn to for support and care

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For feelings of grief and loss not common or severe. Some medications to
think about in particular are:
■ Acknowledge that this is a big change, that
life looks very different ■ Efavirenz can cause mental health-related
side effects in as many as half of patients
■ Be optimistic that the loss will heal with taking it. Symptoms can begin on the first
time day of treatment but are likely to resolve after
2-4 weeks. Some can be very troubling, and
■ Express your willingness to be of support include confusion, trouble concentrating,
and vivid, odd dreams. Hallucinations and
■ Suggest self-care mood changes have also been seen, and
depression has been reported. There is
■ Remind them that this is a treatable
concern that these side effects can be made
problem, and that you and the ART staff will
worse by alcohol or other substances. INH
be here to evaluate their concerns.
(used in the treatment of TB) can cause
hallucinations, paranoia, and low mood.
Mental health side effects of ARV drug

Table 5.10. ART-psychotropic/antiepileptic drug

Many of the medications used to treat HIV and
interactions
related infections have mental health-related
side effects. For most medications, these are

Psychotropic
Interactions
drugs
Decrease PI and NNRTI levels; use other anticonvulsant. Carbamazepine
Carbamazepine
toxicity possible if combined with RTV.
All PI’s can increase levels of diazepam and bromazepam, as can Efavirenz
Diazepam,
and nevirapine can decrease diazepam levels. Lorazepam, oxazepam, and
bromazepam
temazepam are unaffected by ARVs.
No specific problems for PIs or NNRTIs. Can be some variation in the level
Fluoxetine
of fluoxetine or the ARVs. But does interact with many other medications.

Haloperidol PIs can increase haloperidol level; NNRTIs can decrease haloperidol levels.

Can decrease PI and NNRTI levels but is ok to use with NRTIs. Not
Phenobarbital
recommended with LPV/r.
Can decrease PI and NNRTI levels but is ok to use with NRTIs. Not
Phenytoin recommended with LPV/r. If must use with LPV, may need higher doses of
both medications.

Risperidone Some PIs may increase risperidone levels. Avoid use with RTV.

Tricyclic OK with NNRTIs and NRTIs. OK with PI’s except LPV/r, RTV, – those
antidepressants medications can raise the TCA level to toxic levels (use fluoxetine instead).

Valproic acid No significant interactions

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5.8.HIV related skin and oral 1.Excessive dryness of the skin (Xerosis cutis)
conditions
2.Eczemas like seborrheic dermatitis or contact
HIV infection increases the prevalence and dermatitis
severity of skin and oral diseases, especially
3.Folliculitis that may include infections by
when the person’s CD4 cell count declines
Staphylococcus aureus or hypersensitivity to
below 200 cells/mm3. As a result, skin and
insects
oral conditions affect up to 90% of adults and
children with HIV in resource-limited settings.
4.Drug eruptions
Adverse drug reactions of the skin are also 100
times more common among people living with
5.Scabies
HIV than among the general population, and
their prevalence increases as immunodeficiency 6.Intertrigo (Candida, tinea, herpes simplex)
worsens. Immune reconstitution inflammatory
syndrome occurs in 10–25% of people living In most patients, diagnosis can be established
with HIV starting ART. by examining the lesions. However, as immune
deficiency advances it may be useful to use
Different kinds of OI, such as herpes zoster, and investigations such as biopsy to diagnose
other viral, fungal and bacterial infections occur specific dermatosis or use staining and culture
in the skin. Manifestations of adverse drug to diagnose specific infections.
reactions and non-infectious conditions also
occur in the skin. In most instances diagnoses 5.8.1. Etiological classification of
of skin disorders with HIV disease are made
skin disorders in HIV disease
on clinical grounds. Most skin disorders in HIV
disease can be cured or ameliorated, but a few Skin disorders in HIV infected patients can
fail to improve even with good general clinical occur due to infections, neoplasm, and
and immunological responses to ART. hypersensitivity to foreign agents including
drugs, or to unknown causes. Nevertheless,
Pruritus is the most common dermatologic
infections are commonly seen in clinical
symptom in HIV infected patients. It can be
practice; refer to the following table:
localized indicating primary skin lesion, or
generalized that may or may not indicate primary
skin lesions. In many patients, pruritus may be
severe and may not be amenable to available
therapy. The most common skin conditions
associated with pruritus in patients with HIV
include the following:

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Table 5.11: Common skin infections in HIV disease.

Clinical
Infections Disease Treatment Remark
Presentations

Adult: Amoxicillin
500 mg TID for
5-14 days based on Mostly
Poorly defined
clinical response or encountered
erythema. Pus
erythromycin 500 lower
Cellulitis and crust at the
mg QID if allergic to extremities
site plus signs of
penicillin. and often
inflammation.
unilateral.
Children: 20-40mg/kg
per day on TID basis

Use topical antibiotics:

Bacterial Erythematous small
use Amoxicillin for
papules usually Usually a
extensive disease for
Impetigo limited to few superficial
5-14 days (see dose
lesions coalescing in lesion.
above for adults and
to crusted plaques.
children) for 7 days

Nodular lesion
with extensions Adults: Cloxacillin 500
mg QID for ten days. Involves the
to the deeper
Carbuncle trunk as well
structure. Signs Children: 50-100 mg/ as extremities.
of inflammation kg/day on QID basis
present.

Painful vesicular
lesion around
mouth or genitalia. Adults: Acyclovir 400
Recurrent and mg TID for ten days.
Herpes simplex
extensive, difficult Children 20 mg/kg/
to eradicate during dose 4X/d
advanced immune
deficiency.
Viral When it
Adults: Acyclovir 800 involves the
Painful and mg 5X per day for eyes, it is
vesicular eruptions seven days. a medical
with dermatomal
Herpes zoster Monitor renal function. emergency.
distribution.
Children: 20–40 mg/kg Do not give
When healed, scar
per dose four times a Acyclovir* if
will remain.
day. duration is >72
hours.

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 Clinical
Infections Disease Treatment Remark
Presentations

Painless flat to
raised warts over
Podophyllin, Premalignant
fingers or genitalia
Imiquimod, and risk
Warts / verrucae in advanced immune
Cryotherapy, Consult for cervical
deficiency, they tend
experts cancer.
to be multiple and
Viral exophytic.

Umbilicated and
raised facial lesions
Molluscum that tend to be May not require
Contagious
Contagiosum very big during therapy;
immunodeficiency
state.

Pruritic lesions
ranging from
pinpointed
BBL, lindane or Burrows are
erythematous
permethrin to be visible in mild
papules involving
applied to whole body. infestations
inter digital, axillae
Parasitic but in crust
Scabies and groin areas to Ivermectin 200
infestation scabies may
varying degrees microgram/kg stat
not be evident
of hyperkeratotic orally.
leading to
plaques associated
misdiagnosis.
with significant
skin thickening and
crusting.

Topical antifungal for

Superficial causing limited skin affected.
Fungus Dermatophytosis ringworm or Fluconazole for
athlete’s foot extensive lesion 100mg
daily for ten days.

White plaques on
the buccal mucosa Miconazole gel 2%
including the tongue apply BID
that can be scraped
Thrush off leaving red base Fluconazole 100 mg
(bleeding). Can be daily for ten days
associated with for recurrent or
candida paronychia oropharyngeal thrush.
or intertrigo.

Disseminated
Cryptococcus
Presentation varies
can be confused
from fungating
for Molluscum
Deep Fungal nodules and tumors
contagiosum. Treat
Infection to ulcers and diffuse
with amphotericin
papulo nodular
induction and/
disease
or fluconazole
maintenance.

*If patient has ophthalmic involvement refer to ophthalmic specialist.

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5.8.2. Pruritic Papular Eruption (PPE) Oral candidiasis presents with oral sores,
change in the sense of taste, and when it
Pruritic papular eruption is common among HIV involves the throat and oesophagus, pain on
infected patients causing substantial morbidity swallowing; however it can be asymptomatic
in sub-Saharan Africa. Its prevalence ranges in some patients. Diagnosis is established
from12-46% and it is uncommon in HIV negative clinically when a curd-like membrane is visible
patients (PPV of 82-87% and may play role in on the surface of the tongue and buccal
diagnosing HIV). The pathogenesis is unknown mucosa. Typically the base of the membrane
but it may be related to hypersensitivity to bleeds upon scraping it.
arthropod bites. In extreme form, eosinophilia
and eosinophilic infiltrates of the skin are Diagnosis
present. Severity of rash often correlates
with CD4 count. The clinical manifestation is Diagnosis of oral candidiasis is established
intensely pruritic, discrete, firm papules with clinically when a curd-like membrane is visible
variable stages of development and predilection on the surface of the tongue and buccal
for extremities, though it can involve trunk and mucosa. Typically, the base of the membrane
face with significant itching marks. Excoriation bleeds upon scraping it.
results in pigmentation, scarring and nodules.
Treat with topical steroid and oral antihistamines. Oesophagitis is frequently made on clinical
However, it is often refractory to treatment and grounds, but when facilities are available upper
hence short course prednisolone may be used. GI endoscopy with or without biopsy or contrast
ART is often effective. imaging may be done.

5.8.3. Dysphagia and odynophagia Treatment

Dysphagia (difficulty in swallowing) and Oral candidiasis: Oral and pharyngeal thrush
odynophagia (painful swallowing) are symptoms are treated with oral miconazole gel 2% applied
of esophagitis occurring at advanced stages twice daily; patients should not eat/drink for
of AIDS. They are usually caused by candida, two hours after applying the gel. If this does
HSV, CMV, and aphthous ulcers. Esophagitis not work or is unavailable, use fluconazole
seriously impairs the patient’s nutritional status. 100mg daily for 14 days. Nystatin can also be
Therefore, prompt diagnosis and treatment are used in place of miconazole as follows: apply
mandatory to avert nutritional complications suspension 5 times daily (after each meal and
and inability to swallow prescribed medications. between meals) for 7 days (or until 48 hours
Children will present with reluctance to eat, after lesion resolves).
excessive salivation, or crying while feeding.
If thrush is associated with dysphagia, Dysphagia and/or odynophagia are treated
odynophagia, and/or retrosternal pain, consider as oesophageal candida on clinical grounds,
oesophageal candidiasis but this can also occur in particular when oropharyngeal candida is
in the absence of oral thrush. present. Patients are empirically treated with
Fluconazole in presumptive oesophageal

124
candida. If the response is unsatisfactory, they Ethiopian setting is often a major challenge.Thus,
should be referred or investigated if facilities this unit attempts to guide the management
are available, to rule out other causes. of common opportunistic infections and other
treatable conditions in the nervous system.
■ Drug of choice: Fluconazole 200 mg (3mg/
Neurological complications in HIV patients may
kg/day in children) PO daily for 14 days.
be due to:
■ Alternative: Ketoconazole 200 mg(3-6mg/
■ HIV (HIV encephalopathy)
kg/day daily in children) twice daily for 4
weeks. ■ OIs (toxoplasmosis, cryptococcal
meningitis)
Risk of recurrence after completing treatment
may be high. If the patient is on ART, s/he ■ Neurosyphilis
should be investigated for treatment failure.
■ Malignancies (primary CNS lymphoma);
Take necessary precautions regarding drug
and
interactions especially with ketoconazole.
Patients may need hospital admission for ■ Drugs (e.g. EFV, etc.)
supportive care till the oesophageal symptoms
improve and necessary long term treatments Diagnosis of neurological disorders in HIV in our
are started. If diagnosis suggests HSV setting depends on the history and standard
eosophagitis use acyclovir 400mg po five times neurological examinations. In view of this,
for 14 to 21 days. health care providers must be able to perform
a physical examination to detect neurological
5.9.HIV related Neurological abnormalities.
conditions
There can be single or multiple abnormal
Neurological manifestations of HIV can occur at neurological findings in the same patient
any time from viral acquisition to the late stages necessitating holistic neurological evaluation.
of AIDS. They are varied and may affect any Thus, the examination should include
part of the nervous system including the brain, assessment of:
spinal cord, autonomous nervous system and
the peripheral nerves. HIV affects the nervous ■ Mental status comprising cognitive function,
system in 70-80% of infected patients. The orientation and memory.
effect may be due to direct effect of the virus,
opportunistic infections and/or malignancies. ■ Cranial nerves.
For certain neurological manifestations, a single
■ Motor function including deep tendon
aetiology is responsible while in others it is due
reflexes (DTR).
to multiple causes.
Most life-threatening neurological complications ■ Sensation.
of HIV occur during the severe immunodeficiency
state and specific aetiological diagnosis in the

125
5.9.1.Toxoplasma gondii encephalitis organism in a clinical sample. In the absence of
imaging support, empirical treatment is justified
Toxoplasmic encephalitis (TE) is caused by when patients present with focal neurological
the protozoan Toxoplasma gondii. Disease findings and the CD4 count is < 200 cells μl.
appears to occur almost exclusively because Failure to respond to conventional therapy,
of reactivation of latent tissue cysts. Primary based on presumptive clinical diagnosis within
infection occasionally is associated with a week or two of initiation of therapy, suggests
acute cerebral or disseminated disease. Sero- the diagnosis to be unlikely.
prevalence varies substantially in different
communities; in Ethiopia, general prevalence is With empirical treatment for toxoplasmosis,
about 80%. nearly 90% of patients will demonstrate clinical
improvement within days of starting therapy.
Clinical Manifestations Radiological evidence of improvement is usual
after 14 days of treatment.
Among patients with AIDS, the most common
clinical presentation of T. gondii infection is Treatment
focal encephalitis with headache, confusion, or
motor weakness and fever. Patients may also First line regimen in the Ethiopia:
present with non-focal manifestations, including
only non-specific headache and psychiatric ■ Adult: Trimethoprim/sulfamethoxazole
symptoms. Focal neurological abnormalities 80/400, oral, 4 tablets 12 hourly for 28 days,
may be present on physical examination, and in followed by 2 tablets 12 hourly for 3 months
the absence of treatment, disease progression in adults.
results in seizures, stupor, and coma.
■ Children: 10mg of trimethoprim + 50mg
Diagnosis of sulfamethoxazole/kg per dose every 12
hours for 28 days followed by maintenance
HIV-infected patients with TE are almost therapy at 50% reduced dosage for three
uniformly seropositive for anti-toxoplasma months.
immunoglobulin G (IgG) antibodies. The
absence of IgG antibody makes a diagnosis of Secondary prophylaxis: use co-trimoxazole
toxoplasmosis unlikely but not impossible. Anti- 960mg daily for adults and in children. Refer to
toxoplasma immunoglobulin M (IgM) antibodies Table 4.1
usually are absent. Quantitative antibody
titres are not useful for diagnosis. Definitive Alternative regimen
diagnosis of CNS toxoplasmosis requires a
I.Sulfadiazine, 1-2 gm PO QID for six weeks or
compatible clinical syndrome; identification
3 weeks after resolution of lesion
of one or more mass lesions by CT, MRI, or
Side effects: crystal urea, rash
other radiographic testing; and detection of the

126
Contraindication: severe liver, renal Anticonvulsants should be administered to
and haematological disorders; known patients with a history of seizures but should not
hypersensitivity to Sulphonamides. be given routinely for prophylaxis to all patients
Dosage/form: 500 mg tablets, with the presumed diagnosis of TE. Careful
attention needs to be paid to any potential drug
PLUS
interactions.
Pyrimethamine: loading dose of 200 mg once,
followed by 50-75 mg/day.
5.9.2.Cryptococcal infection

Side effects: rash, fever and bone Cryptococcal meningitis is one of the most
marrow suppression (neutropenia and important opportunistic infections and a major
thrombocytopenia). contributor to high mortality before and after ART
Contraindication: folate deficiency is initiated. The main reasons for this high death
Dosage/form: 25 mg tablets rate include delayed presentation, together
with poor availability and high cost of treatment.
PLUS Most HIV-associated cryptococcal infections
Folinic acid (Leucovorin): 10-20 mg/d are caused by Cryptococcus neoformans.
Side effects: allergy In HIV-infected patients, cryptococcosis
Dosage/form: 5 and 10 mg tablets commonly presents as a subacute meningitis
or meningoencephalitis with fever, malaise, and
OR headache. Classic meningeal symptoms and
II. Pyrimethamine and Folinic Acid (Leucovorin): signs, such as neck stiffness and photophobia,
(standard dose) occur in only one-quarter to one-third of patients.
Some patients experience encephalopathic
PLUS symptoms, such as lethargy, altered mentation,
personality changes, and memory loss that
Clindamycin: 600 mg QID
are usually a result of increased intracranial
Side effects: toxicities include fever, rash, nausea
pressure, thought to result from impaired CSF
and diarrhoea (including pseudomembranous
absorption, or yeast infection of the brain.
colitis or diarrhoea related to Clostridium difficile
toxin). Diagnosis
Adjunctive corticosteroids should be used for
patients with radiographic evidence of midline 1. Lumbar puncture (LP) and CSF analysis:
shift, signs of critically elevated intracranial
■ The opening pressure may be markedly
pressure or clinical deterioration within the
elevated.
first 48 hours of therapy. Dexamethasone 4 mg
every six hours (0.15mg/kg/dose every 6 hours ■ CSF analysis
for children) is usually chosen and is generally
tapered over several days and discontinued as ■ Protein:30-150 mg/dl
soon as possible.

127
 ■ WBC: 0-100 /mm3 (monocyte) ■ Two weeks of Amphotericin B deoxycholate
(1.0 mg/kg per day) + Fluconazole (1200
■ Culture: positive 95-100% mg daily, 12 mg/kg per day for children and
adolescents up to a maximum of 800 mg
■ Indian ink: positive 60-80% daily).

■ Cryptococcal Ag (CrAG) > 95 % sensitive 2.Consolidation phase (8 weeks)

and specific
Option A: Fluconazole 800 mg/day (In children
■ If it is not possible or contraindicated to do 12mg/kg/day)
LP, serum cryptococcal antigen can be used Option B: Fluconazole 400-800 mg/day
for diagnosis. Maintenance treatment (or secondary
prophylaxis)- Fluconazole 200 mg daily (in
Management children 6mg/kg/day).

Requires hospitalization and evaluation by Additional points about cryptococcal

physician meningitis

Phases of management: 1)Management of elevated intracranial

pressure (ICP):
1.Induction phase
The following is recommended as the preferred Management of increased ICP is critical as
induction regimen. >90% of deaths in the first two weeks and
40% of deaths in weeks 3-10 are due to
■ For adults, adolescents and children, a increased ICP. Failure to manage elevated ICP
short-course (one-week) induction regimen is the most common and most dangerous
with Amphotericin B deoxycholate (1.0 mg/ mistake in management (since the ICP is non-
kg per day) and flucytosine (100 mg/kg per communicating hydrocephalus there is no
day, divided into four doses per day) is the risk of CSF tapping within the recommended
preferred option for treating cryptococcal volume).
meningitis among people living with HIV.
■ Daily serial LP should be done to control
The following induction regimens are increased ICP by drawing 20-30 ml of
recommended as alternative options. CSF based on patient’s clinical response.
Signs of ICP include headache, altered
■ Two weeks of Fluconazole (1200 mg daily, 12
mental status, meningismus and changing
mg/kg per day for children and adolescents)
in hearing or vision should be closely
+ Flucytosine (100 mg/kg per day, divided
monitored, if possible opening pressure
into four doses per day).
should be measured.

128
■ There is no role for acetazolamide, mannitol, Prevention of cryptococcal disease
or corticosteroids to reduce intracranial
pressure. According to a pilot study conducted in Ethiopia
from June 2015 to July 2016, in 22 high case
2) Discontinuation of maintenance treatment load facilities in all regions, the proportion of
(secondary prophylaxis) newly enrolled clients with CD4 count less than
100 cells/mm3 was 25.88%. In the same study,
When patients are stable and adherent to ART the prevalence of clients screened positive for
and anti-fungal maintenance treatment for at cryptococcal antigenemia was high (9.9%).
least one year and have a CD4 cell count of
greater than or equal to 200 cells/mm3 (two The use of routine serum or plasma CrAg
measurements six months apart). screening in ART-naive adults followed by pre-
emptive antifungal therapy if CrAg screening
3) Timing of ART initiation is positive to reduce the development of
cryptococcal disease, should be considered
■ Immediate ART initiation is not prior to ART initiation:
recommended in HIV-infected patients with
cryptococcal meningitis due to the high risk ■ Where patients with a CD4 count less than
of IRIS, which may be life-threatening. 100 cells/mm3; and

■ ART initiation should be deferred until there ■ Where this populational so has a high
is evidence of a sustained clinical response prevalence (>3%) of cryptococcal
to anti-fungal therapy usually 4-6 weeks antigenemia.
from the initiation of antifungal treatment.
The following algorithm or decision-making
■ Poor prognostic signs guide shows how to decide whether a patient
needs prophylactic fluconazole treatment to
■ Extra CNS manifestation (especially CrAg screening positive and asymptomatic
pulmonary) patients with CD4 count less than 100 cells/
mm3.
■ Altered mental status

■ Low CSF WBC count less than 20cells/µL

■ High CSF cryptococcal antigen titer

129
 Perform diagnostic LP and
do CrAg test from CSF CSF -ve

CSF +ve

Figure 5.6. Decision-Making Guide for Cryptococcal Screening

130
5.9.3. Peripheral neuropathies Treatment

Peripheral neuropathies are among the most ■ Avoid the offending agent if identified.
common causes of painful legs in HIV infection;
they arise as a complication of HIV infection ■ Remove other drugs associated with
itself, of drug therapy, or of other metabolic or peripheral neuropathy.
organ dysfunction or nutritional deficiencies.
■ Supplemental vitamin intake for all patients
Distal symmetrical sensory polyneuropathy including concomitant administration of
is the most common presentation but mono- pyridoxine with INH.
neuropathies can also occur. The neuropathies
associated with HIV can be classified as: ■ Adjuvants for pain management (such as
Amitriptyline, carbamazepine) indicated for
■ Primary, HIV-associated. patients with pain and paraesthesia.

■ Secondary causes related to medications Monitoring of events

(INH), OIs or organ dysfunctions.
■ Recognize presence of peripheral
Diagnosis neuropathy.

Peripheral neuropathy diagnosis in HIV-infected ■ Assess severity at each clinical visit.

patients is based on the clinical picture presenting
with pain, tingling sensations, paraesthesia or ■ Avoid drugs causing neuropathy.
numbness. Physical examination can reveal
depressed or absent ankle reflex, decreased 5.10. Visceral leishmaniasis
sensitivity to different modalities of sensation
and in severe cases, difficulty in walking. The Visceral Leishmaniasis (VL) is a systemic
feet and sometimes the hands are involved in parasitic illness, transmitted primarily by the
symmetrical distribution. The diagnosis can phlebotomine sand fly from animal or human
be supported by electro diagnostic studies reservoirs. Visceral Leishmaniasis is endemic in
including electromyography (EMG) and nerve Ethiopia, with patchy distribution in the southern
conduction studies (NCS) when available. and north-western lowlands. The causative
Blood tests are frequently obtained to exclude parasite is L. Donovani. VL has emerged as a
other causes of neuropathy. In most instances, major OI associated with HIV. In HIV patients,
however, diagnosis is almost always clinical. VL represents reactivation of latent infection
with Leishmania parasite.

131
Clinical features Molecular Techniques-Compared to the other
diagnostic techniques available, the molecular
The cardinal signs of VL in patients with HIV approaches remain expensive and technically
infection are unexplained fever, splenomegaly, highly demanding. Their applicability in the
and pancytopenia (anemia, leucopenia and endemic areas is highly questionable.
thrombocytopenia). Presentation may not
be typical. The bone marrow is packed with Treatment:
parasites but two-thirds of cases have no
detectable anti Leishmanial antibodies. CD4+ Ambisome 40mg/kg, require longer treatment
cell count in co-infected patients is usually and more liable to relapse.
<300cells/ml.
Treatment of relapsed patients: These are
Diagnosis patients who are slower to respond and have
a higher chance of further relapse and of
Parasite Detection-Visualization of the becoming unresponsive to anti-monial drugs.
amastigote form of the parasite by microscopic Treatment is the same as above.
examination of aspirates from lymph nodes,
bone marrow or spleen aspiration. *Culture
improves the detection of the parasites.
However, this technique remains restricted to
referral hospitals or research centers.

Antibody Detection-DAT and rK39 have been

extensively evaluated and used for the diagnosis
of VL in the field and in laboratory settings.

Antigen Detection Test-It is more specific than

the antibody-based immunodiagnostic test.
Evaluation of the performance of a urine latex
agglutination (KATEX) at the Indian subcontinent
and East Africa has shown that this test has a
good specificity but only a low to moderate
sensitivity.

132
CHAPTER SIX:
SERVICE DELIVERY
Introduction

Most of the time health services are organized This chapter provides broad guidance on four
primarily to provide episodic acute care. As operational and service delivery areas:
HIV begins to become a manageable chronic
condition, program managers and care 6.1. Differentiated care: addressing the
providers need to consider how current health diversity of needs of people in care.
delivery systems can be reorganized to provide
chronic care. 6.2. Recommendations to strengthen the
continuum of treatment and care:
Once people are diagnosed and enrolled in
chronic care, follow-up visits should be scheduled ■ Disclosure
and planned. Waiting until people present with
symptoms or preventable complications is ■ Retention;
costly and inefficient. PLHIV require care that
■ Adherence;
anticipates their needs at different stages of the
care continuum. Compared with the acute care
■ Task shifting;
model, planned chronic care models provide
opportunities for prevention, early identification ■ Decentralization;
of issues and timely intervention.
■ Integration;
Chronic care requires broad support for PLHIV
from their communities and health care teams ■ Adolescent-friendly health services.
to stay in care, adhere to treatment and cope
with stigma. PLHIV and their families need to be ■ Improving the quality of HIV services
informed about HIV infection and the anticipated
side effects of medicines and supported to 6.3. Pharmaceuticals supply and management
adhere to treatment. Health care teams play an system
important role in linking people living with HIV
with community-level interventions, resources 6.4. Laboratory and diagnostic services.
and support.

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6.1. Differentiated HIV service and differentiated models of service delivery;
delivery the principles of differentiating service delivery
according to the needs of different groups has
Differentiated care is a client-centered approach also been extended to improving the uptake of
that simplifies and adapts HIV services across HIV testing and prevention.
the cascade to reflect the preference and
expectations of various groups of PLHIV while The New WHO 2021 Guideline defines being
reducing unnecessary burdens on the health established on ART should be applied to all
system. Continuing to provide ART to a large populations, including those receiving second-
and growing number of individuals poses and third-line regimens, those with controlled
a significant challenge to health systems comorbidities, children, adolescents, pregnant
in resource limited setups where there is and breastfeeding women and key populations.
a shortage of clinical staff. The challenge is It also suggests, considering people’s clinical
highlighted by substantial rates of attrition needs, differentiated service delivery for HIV
reported across ART programs. The pace of treatment should also consider the specific
ART enrolment will likely further increase in the populations and contextual settings. There is
coming years with recommendations issued by also increasing experience of how such models
WHO in 2016 to change the eligibility criteria for have been adapted in settings with lower HIV
ART initiation as Ethiopia has also endorsed the prevalence, acute conflict or other emergency
recommendations. responses.

The challenges of further scaling up ART to Differentiated service delivery for HIV treatment
those in need and improving retention in care is based on four building blocks (Figure. 6.1.). In
for those on ART require continued adaptations any given differentiated service delivery model
in the models of healthcare delivery to the for HIV treatment, the building blocks need to
reality of people’s lives. As national, regional and be defined separately for clinical consultations,
district teams address the various challenges, ART refills and psychosocial support.
lessons from innovative models of ART delivery
can help shape the next stages of HIV care and
treatment scale-up.

The previous guidance which was adopted

from WHO was concerned that Differentiated
service delivery for HIV treatment has focuses
primarily on people who are clinically stable
(established on ART). Subsequently, the need
has been recognized to adapt services for those
with advanced HIV disease, high viral load and
comorbidities through simplified care packages

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Fig. 6.1. The building blocks of differentiated service delivery for HIV treatment

To accommodate this, our country adopted are not missed during the clinical visits of the
Appointment Spacing Model/6MMD of HIV clients.
care as the first model of differentiated HIV
service delivery in 2017. Ethiopia then scaled Differentiated care applies across the HIV
up other models such as Fast Track ART continuum to all the 95-95-95 targets.
Refill, 3MMD, Health Extension Professional Differentiated care includes models of testing
Managed Community ART groups (CAGs), people unaware of their HIV status to treatment
Peer Led Community ART Group/ Distribution and care to viral suppression of HIV clients
(PCAG/D), Adolescent ART group, Advanced enrolled in care. Based on the level of stability
HIV Disease (AHD), MCH and Key Population of the clients, DSD models can be based in the
service delivery models. facility or in the community.

All these approaches have reduced the burden Eligibility criteria for less intensive DSD
for patients (reduced time and cost of travel models
to clinic and less income loss) and the health
system (reduced clinic attendance), while After appropriate classification based on the
maintaining high retention in care (more than criteria below, clients should be informed and
90% retained in care across multiple time give verbal consent on the type of the service
points). Therefore, providers should ensure delivery model they prefer.
all required packages of care in the standard

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The following are the eligibility criteria for less ■ Children with age greater than five years*
intensive DSD models:
■ A Patient who doesn’t have current
■ Patients who are on ART at least six months Opportunistic Infections

■ No current illness, which does not include ■ A Patient with no adverse drug reactions
well-controlled chronic health conditions and doesn’t need careful clinical monitoring.

■ Good understanding of life long adherence; ■ A Patient who is willing or provide consent
adequate adherence counseling provided (a to get the ART service based on his/her
patient with adherence of 95% for the last preferred DSD models.
6 months)
*WHO 2021 guidance did not put age limit for
■ Evidence of treatment success (at least established DSD models but since all children<
one suppressed viral load result (i.e < 50 5 years are considered to have AHD, age ≥5
c/ml) and if no Viral Load result, a patient years is considered for age limit.
with rising CD4 cell count or CD4 cell count
above 200 cells/millimeter cubes).

Figure 6.2. Differentiated service delivery model (DSD) framework in Ethiopia

*Less Intensive Model: This individual and *** KP _DSD: Can be implemented both at
group model is intended for clients who are facility and community level
established on ART. It includes both facility and
community-based approaches. It requires less **** DSD for adolescent is categorized under
frequent clinic visits and focuses on education more intensive models assuming that most
and empowerment of clients. of the adolescents require close follow up
and adherence support. However, for stable
**More Intensive Model: This Model is adolescents providers may decide based on
intended for clients who need close follow up the above eligibility criteria and additional
and frequent clinic visits. It includes clients conditions.
with OI, unsuppressed viral load adolescents,
pregnant women and those with psycho social These classification of DSD models are adapted
barriers to adhere and retention. from CQUIN documents

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6.1.1 Less intensive DSD models For children taking 3MMD, the caregiver should
be allowed to pick up the child’s medication
6.1.1.1 Appointment Spacing Model without bringing the child unless the child is
(ASM/6MMD) due for a clinical visit. For clients requiring Co-
trimoxazole, a 3-6-month supply should be
In the appointment spacing care model, stable provided at the same time as ART pickup. TPT
clients will be appointed every six months should also be given in multi-month intervals
for clinical visit and medication refill. Clients at the same time as ART pickup. For children
in this model should get additional supports (especially those who are younger) starting a
like arrangement of treatment supporter at new medication, administration of the first dose
home level among their family members and should be done before the child and caregiver
arrangement of adherence reminders like leave the ART site. At least monthly virtual
alarm and education on how to maintain the follow up shall be provided using phone calls and
drug quality at home level. Clients should be other communications mechanisms for children
counselled and encouraged to disclose their <30KG body weight for dose adjustment, for
status and to participate in peer support groups clients with co-morbidities, for clients with high
or to be a member of PLHIV associations. viral load and other clients with concerns. In
Those clients who disclosed their status will get addition, clinicians need to make every effort to
adherence support from PLHIV associations via align the visit dates and service delivery sites
home visits or telephone follow up. for children and their parents receiving ART.

6.1.1.2 Three Months ARV Dispensing 6.1.1.3. Fast Track ARV Drugs Refill Model
(3MMD)
Fast Track ARV drugs Refill (FTAR) is one
In the three months ARV dispensing model, of the facility based Differentiated Service
clients who are eligible but not willing to be Delivery Models of HIV care where patients
enrolled in 6 MMD (ASM) will be appointed categorized as stable make clinical visit once
every three months for both clinical visit and every six months but collect their medication
medication refill. every three months from pharmacy. The clinical
visit at 6 months’ interval is meant to ensure
The MOH interim guidance for provision of HIV the standard package of care is delivered to
Services in the context of COVID-19 Pandemic the clients and to review if the patient still
clearly guides provision of 3 months ARV dose meets the stable criteria. The facility-based
(3MMD) for PMTCT clients, children, newly fast track system for ART refills can provide
identified clients including Key Populations an opportunity for those ASM clients who, for
(KPs), clients on second or third line ART and various reasons, faced difficulty in taking all of
any other clients who do not need admission the prescribed six-months of ARV drugs to their
(Advanced HIV Disease, High Viral Load (HVL), home at once from the ART pharmacy as in the
those on EAC, etc). ASM framework.

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6.1.1.4. Health Extension Professional 6.1.2 More intensive DSD models
Managed Community ART refill group
6.1.2.1. Health care worker managed
(HEP_CAG)
DSD Model for adolescent living with
Community ART refill groups (CAGs) are groups HIV (DSD for ALHIV)
comprising of stable clients on ART living DSD for adolescents has three core elements
in the same community/locality that have a which include ART refill, clinical consultation
shared understanding. This model is managed and psychosocial support. This model is
by health extension professionals (HEPs) who coordinated by trained health care workers
already have roles in HIV testing and other HIV (HCWs), and regularly meet on weekends and
service provision as one of their packages. The share psychosocial supports. Young adults who
ART refill is for three months and each CAG will already passed through psychosocial support
have one community refill in between the heath program and transitioned out from Pediatric ART
facility visits that will happen every six months. also facilitate the program voluntarily. During
Clients can return or referred to the facility at this peer session, adolescents interact, learn
any point in the cycle for any issues that may and share experience among their peers and
arise between scheduled health facility visits. from facilitators. Understanding the treatment,
adherence to treatment and viral suppression
6.1.1.5. Peer lead community based ART are main parts of their discussion. Making the
distribution/Group (PCAD/G) clinical, ARV refill and viral load monitoring
service available over the weekends together
The peer led Community based ART distribution with the psychosocial support program will
(PCAD) groups are groups of PLHIV comprising make comprehensive HIV service a one stop
of stable clients living in the same community/ shopping model for adolescents living with HIV.
locality. In PCAD, group members will take
turns to pick up ARVs at the health facility and Eligibility criteria for Adolescent clients on
distribute among the other group members DSD model:
in the community. Each client will get clinical
■ Adolescent clients who disclosed their
evaluation and lab monitoring service as
HIV status and willing or provide consent
per the standard of care package. They will
to get the ART service based on his or her
manage their own health and take action with
preferred DSD models.
the support of community and facility-based
healthcare workers and this will help to align ■ Health care facility where there is functional
with the clinical consultation visits at health pediatric psychosocial support program,
facilities as the recommended, in our set up is ■ Adolescents, 10- 19 years, fully disclosed,
every six months. enrolled in the pediatric psychosocial
support program,
■ No restriction on stability- including both
with suppressed and unsuppressed viral
load test result

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6.1.2.2 DSD for key population (for person; in some cases, the benefits of being
FSWs) seen in person may outweigh the risks of
COVID-19 acquisition in health care facilities. As
In Ethiopia there are efforts to make public an alternative to in person visits, close virtual
and private facilities KP friendly by building the monitoring may also be considered.
capacity of providers and arranging service
delivery approach to match their needs. Alarming symptoms that support in person
Confidentiality clinics and drop in centers clinical assessment include, but are not limited
(DICs) were established around hot spot areas to, fever, cough, shortness of breath, weight
in major towns in the country that provide loss, severe diarrhea intractable headache and
comprehensive HIV services to female sex inability to walk unaided. For children, alarming
workers. The KP friendly services delivered at symptoms include fever, tachypnea, cough,
drop in centers have significantly improved HIV lethargy, convulsions, poor oral intake, and
prevention, care and treatment service access persistent vomiting or diarrhea, and warrant in
to FSWs. Therefore, enhancing the coverage and person health facility visit and evaluation by a
quality of HIV prevention, care and treatment clinician with pediatric training and experience.
services for KP (FSWs) through initiating DSD Further visits or decision to admit a client to
for key population is deemed necessary. health facility should be done by an experienced
clinician and based on clinical and diagnostic
6.1.2.3 DSD for Advanced HIV Disease evaluation findings.
and PLHIV at high risk Disease
Progression In addition, extra effort should be taken to ensure
that these patients with higher risk of severe
For adults and adolescents, and children older outcomes from HIV infection have sufficient
than five years, advanced HIV disease is defined medications to avoid interruptions in treatment
as CD4 cell count <200cells/mm3 or ‘WHO and unnecessary trips to a health facility. The
stage 3 or 4’ event. All children under 5 who national interim guidance for continuation of
are not on effective ART are considered to have HIV services in the face of COVID 19 pandemic
advanced disease because of high viremia and recommends 3 months dispensation of ART (3-
rapid disease progression with high mortality. MMD) for patients with advanced HIV disease.
For patients with advanced HIV disease, the However, patients should be advised to look for
frequency of clinical visit is recommended concerning symptoms that warrant in person
every month. evaluation. In addition to ART, it is critical to
ensure the availability and provision of other
Frequency of visits and MMD for patients medications that have been shown to reduce
with advanced HIV disease in the era of mortality in Advanced HIV Disease, including
COVID-19 pandemic cotrimoxazole and TB preventive therapy (TPT)
once active TB has been ruled out. The general
Careful consideration should be given to package of Care is outlined in Table 4.1.
whether persons with AHD should be seen in

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6.1.2.4 MCH _DSD 6.2. Recommendations to
strengthen the continuum of
Mothers living with HIV and their infants are
treatment and care
important target population for differentiated
service model (DSD). There are various models 6.2.1 Disclosure
of care used to support MCH/HIV services.
Some of the DSD models in Ethiopia includes Disclosure is a process that involves ongoing
family planning service integration to HIV discussions about the disease as the child
care, point of care (POC) EID testing for HEIs matures cognitively, emotionally and sexually.
and provision of 3 month ARV dispensing for
HIV positive pregnant and breast feeding Commonly used Terminologies in Disclosure:
women during COVID 19 pandemic. For detail
information refer to PMTCT guideline 2021. Full Disclosure to a person who is HIV positive
means telling him/her that they have HIV. It can
The role of PLHIV and PLHIV associations in also include the reason for taking medicines.
DSD Example: You have HIV and we are giving you
ARVs/medicines to help your body fight the
PLHIV and CSOs are meaningfully engaged virus.
in implementation, evaluation and oversight
of DSD. Representatives from PLHIV are Partial Disclosure to a person who is HIV
actively engaged as member of DSD technical positive means sharing information about
working groups. Networks of PLHIV offer a key his/ her illness but not using the word “HIV”.
mechanism for enhancing support to those Example: Your body is sick and we are giving
who are affected, and improving negative you medicines to help keep your body healthy.
experiences of living with HIV. As programs
encourage greater involvement of PLHIV, Complete Non-Disclosure to a person who is
there is increasing engagement of affected HIV positive means not telling a person anything
communities in national responses to HIV, about their condition. Example: A HCW may
and PLHIV networks have the potential to assess the person’s health status and give him/
maximize stakeholder contributions. In addition, her medications without explaining anything
approaches that increase engagement and about what the medicines are for or why the
empowerment can potentially shift the focus person must take them.
of PLHIV’s roles from representation to the
building of individual and community capacity Deception is when a person who is HIV positive,
to promote health. is intentionally told something untrue. Example:
You are taking medicines because you have TB.

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6.2.1.1 Disclosure in Children Disclosure can:

Pediatric disclosure is an ongoing process and ■ Help create a sense of closeness in the
even in the best of circumstances may be family.
difficult. Adults struggle with the question of
where, when or how to tell children that they ■ Help reduce feelings of anxiety and isolation
have HIV, often agonizing over how to find the on the part of the parents/ caregiver.
right words. All families are unique and there
are no set rules regarding when and how to ■ Relieve the burden of living with the secret
disclose to children. of being HIV-positive.

Children react to HIV disclosure in different ways ■ Help build social support networks.
and it is not uncommon for relatives to disagree
■ Reduce the anxiety children experience
about disclosing HIV-related information to
when they suspect something is wrong;
children. Even amongst the HIV/care team there
they will now have information to make
may be disagreement on the best approach.
better sense of the situation.
Disclosure has to be individualized taking into
consideration the particular child, parent/s,
■ May improve adherence in a non-adherent
family, household and community.
child.

HIV disclosure is not a topic that comes

naturally for family discussion, especially when
children are involved. The best way for a child to
learn about his/her HIV status is through age-
appropriate information shared by a loving and
trusted caretaker. Disclosure to children should
never happen casually, inadvertently or in the
heat of anger or conflict. A child’s maturity
and cognitive capacity varies and is not only
dependent on age. It is important to tailor the
discussion to the child’s cognitive level and to
the child’s personal and individual situation. It
is important to assess readiness of the entire
family for disclosure and address potential
barriers to disclosure. It is also important to
discuss benefits of disclosure which have both
short and long term impact on the family.

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 Assessing readiness for disclosure

The child
■ Is the child symptomatic? Taking medications?

■ How old is the child?

■ Is the child living with a sick parent or family member?

■ Is the child asking questions about HIV?

■ Does the child appear distressed, anxious or worried?

■ Is the child sexually active and at risk of contracting or spreading HIV?

The parent or caregiver

■ Has the parent or caregiver been tested for HIV?

■ Is the parent or caregiver infected? Symptomatic? Taking medication?

■ Is the adult ill? Is s/he in need of help from children in the household?

■ Is the infected adult an important attachment figure for the child?

The family or household

■ Are there any adults in the household with HIV infection? Who is aware?

■ Are other children in the household HIV-infected? Who is aware?

■ How many family members are taking HIV-related medications?

■ Is the family unit cohesive, or characterized by separations and/or conflict?

The community
■ Are testing and treatment generally available in the community?

■ Are there people in the community who are open about their own HIV status? Does the child
know anyone in the community who is open about his/her HIV status?

■ How strong is the stigma surrounding HIV in the community?

■ Are there risks to the family (isolation, discrimination) if unintentional disclosure occurs?

■ Are there resources within the community for children – a youth group and/or trusted adults
they can talk to?

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6.2.1.1 Planning for disclosure ■ Use visual aids such as drawings or media

Disclosure is not an event or a one-off ■ Emphasize the concept of health, wellness

conversation. It is a PROCESS that takes and body
time and constant communication in an age-
appropriate manner. It is important to prepare Adolescents 11 years and older: These age
adequately for disclosure. This involves groups view body as system, understands
preparation, education, planning and follow-up. illness is within body and caused by external
Once the decision has been made to disclose agent
to the child, it is important to understand that
the topic will have to be visited over and over ■ Visual aids like books
again. It is important to give a clear message
and listen actively; take clues from the child ■ Use slightly more complex language to
and avoid lecturing; the emphasis should be on convey interactions between health, illness
asking directly and indirectly and listening. The and treatment (“HIV is a type of infection
following examples can serve as a guide: that destroys your immune system’s CD4
cells”)
Age group of (2-6 years old):
Assuring children and adolescents that their
These are too young to comprehend and may HIV status and what they say is confidential,
still be unable to explain the link between is also very important. Issues of disclosure
the cause and the illness. Younger children if to others should be discussed while allowing
symptomatic generally want to know what will the adolescent to make his/her own decisions
happen to them. They do not need to know their about.
diagnosis but the illness must be discussed
with them. Young children may feel responsible 6.2.1.2 Stages of disclosure
for the parent’s illness or just pretend nothing is
happening. It is important to give reassurance Stage 1 This is for children around the age of
and take cues from younger children. six. If they are symptomatic they want to know
what will happen to them. They do not need to
■ Use visual aids such as drawing, media or
be informed of their diagnosis but the illness
puppets in addition to stories to illustrate
must be discussed with them.
concepts

■ Emphasize the concept of health, wellness Stage 2 This stage is for school age children
and body concrete observation, (7-10years). The illness can be discussed as
a germ that can weaken their body soldiers
School aged children (7-10 years): These without specifying the diagnosis.
age group think systematically about multiple
topics more easily. Child’s illness descriptions Stage 3 Make sure the child and caregiver are
progress from belief that disease is transferred ready for disclosure. Some may have difficulty
through contact. Hence, coping with disclosure information leading to

143
changes in behavior (acting out in school, i.e. adolescent children can cognitively understand
fights, low grades, truancy, anger, crying fits, the concepts about the virus but may be less
and no expression of emotion). Others may likely to think of the future implications, such as
have concerns that other children in the school transmission risks and safe sexual practices. As
or community will make fun of them. Encourage the child ages and matures, he/she will slowly
them to ask questions; do not be disappointed understand and integrate the implications of the
if they do not react in the manner you expected. diagnosis into his/her life. Children’s perception
At this stage words like HIV and CD4 should of self, health, illness, and death evolve as they
be introduced and check the understanding at mature through different developmental stages.
each visit.
Some children who learn of their HIV status
N.B: Full disclosure can be provided to most may experience guilt and shame and may
children over 10 years. Each steps of disclosure isolate themselves as a result of the stigma
should be documented on the patient’s chart. and secrecy surrounding the disease. Changes
in behavior and school functioning may occur
Adolescents 11 years and older in these children and may be symptoms of
depression. Patients and families who have a
Adolescents should know of their HIV status. difficult adjustment to HIV disclosure without
They should be fully informed in order for them progress over time should be referred for
to appreciate consequences for many aspects mental health services and additional support.
of their health, including sexual behavior and In young adolescents it will be important to
treatment decisions. Be supportive and non- discuss about modes of HIV transmission,
judgmental. sexuality and reproductive health.

6.2.1.3 Post –disclosure assessments 6.2.1.3 Disclosure in adults

and follow-up
Among other priorities, testing and counselling
Disclosure is a process that does not end with programs emphasize the importance of people
telling an HIV-infected child the name of their with HIV disclosing their HIV status, particularly
illness or diagnosis. After the HIV diagnosis has to sexual partners. Informing the sexual partners
been disclosed to the infected child, follow- of an individual’s HIV infection is not only an
up visits are needed to monitor the child and effective means of halting the transmission of
family’s understanding of the illness and their HIV, but informing partners allows access to
emotional and psychological adjustment. care and support as well as further prevention
efforts among the client’s partners and family.
Once the diagnosis has been explained to a
child, it needs to be reinforced or regularly Two main processes for informing partners
discussed as the child develops because of an individual’s HIV infection are disclosure
many children will not have understood the and partner notification. Disclosure refers to
full implications of the disease or diagnosis actions by individuals themselves to notify
at the time of disclosure. For example, pre- their partners of their HIV Sero-status. UNAIDS

144
and WHO strongly recommend disclosure, physical abuse, discrimination and stigma that
when appropriate, as this process is voluntary, may result from partner notification. Ideally,
respectful of the autonomy and dignity partners of infected individuals should be
of the affected individuals and mindful of encouraged to seek HIV testing and counseling,
maintaining confidentiality. Providers of testing as this is a critical prevention and treatment tool
and counseling prefer that individuals use in the control of HIV.
disclosure to inform those who need to know
that they are infected. For the individual, his How to discuss disclosure in adults
or her sexual partners, and family, disclosure
allows for greater openness about HIV in ■ Ask the patient if he/she has disclosed his/
communities and meets ethical imperatives. To her HIV test result or is willing to disclose
encourage disclosure, it is needed to establish the result to anyone.
safe social and legal environments in which
more people are willing and able to get tested ■ Discuss concerns about disclosure to
for HIV and are empowered and encouraged partner, children, other family and friends.
to change their behavior according to the
■ Assess readiness to disclose HIV status
results. This can be done by expanding access
and to whom.
to counseling, testing, care and treatment
services; by protecting people from stigma and
■ Assess social support and needs (refer to
discrimination and removing legal barriers.
support groups).

Disclosure can be difficult as people may be

■ Provide skills for disclosure (rehearsal can
afraid of the consequences: for example, the
help).
threat of rejection and violence by partners
and family or discrimination in the community ■ Help the patient make a plan for disclosure
and workplace. In some cases, people may if now is not the time.
have limited knowledge of their partners and
how to locate them, or may not know the ■ Encourage attendance of the partner to
identity of their partners or where they can be consider testing and explore barriers. As
located. Although evidence of effectiveness of couples may have different HIV status,
partner notification is limited in resource-limited partner testing is important.
settings, it is advised that partner notification
or ethical partner counseling be based on the ■ Reassure the patient that you will keep the
informed consent of the source client, and result confidential and that disclosure is
maintain the confidentiality of the source client, voluntary.
and where possible, protect individuals from

145
If the patient does not want to disclose the ■ Anticipated consequence of involving
result: and testing the partner: danger of blame,
possible violence, abandonment. Health
■ Reassure that the results will remain worker should assess the risk of violence
confidential. or suicide and discuss possible steps to
ensure the physical safety of patients.
■ Explore the difficulties and barriers to Health worker should try to counsel the
disclosure. Address fears and lack of skills couple together, when possible.
(help provide skills).
6.2.2. Retention
■ Continue to motivate the client.
Ensuring retention for people living with HIV
■ Advise the client not to harm others. across the continuum of care is essential for
optimal health outcomes. For people living with
■ Offer to assist in disclosure (for example, HIV who are receiving treatment, uninterrupted
talk with spouse). ART and continual monitoring are essential
for sustained viral suppression and optimal
■ Offer another appointment and more help treatment outcomes. Retention in ART program
as needed (such as peer counselors or is more challenging in pediatric populations,
trained counselors). postpartum women. Multiple factors may play
a role in lost to follow-up, including distance to
For women, discuss benefits and possible
health facilities, lack of transport or inability to
disadvantages of disclosure of a positive result
cover travel expenses, stigma and disclosure-
and involving and testing male partners. Men
related issues, being too sick and lack of
are generally the decision makers in most
understanding of the need for lifelong care.
families and communities. Involving them will
have greater impact on: 6.2.2.1 Good practices to optimize
retention
■ Increasing acceptance of condom use,
practicing safer sex and making appropriate
Optimizing retention in HIV care requires
reproductive choices.
interventions at multiple levels of the health
care system. Given the broad array of challenges
■ Helping to decrease the risk of suspicion
and heterogeneity of barriers across settings,
and violence.
no single approach is likely to work for everyone
in all settings. Improving the understanding of
■ Helping to increase support to their partners.
barriers and innovative strategies to address
■ Motivating to get tested. them are important.

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Related transport costs and loss of income ■ Peer adolescent support groups for
while seeking care serve as discouragements adolescent pregnant women living with HIV.
when health facilities are located far from the
person’s home. Bringing services closer to ■ They should have the choice to continue
communities, where feasible, reduces the receiving their ART through the differentiated
indirect costs of care for the PLHIV and their ART delivery model or to have their ART
families and improves retention. delivery integrated within their maternal,
newborn and child health care.
Waiting times at the facility during consultation
are frequently high, especially in settings with 2) Children
a high burden of HIV infection. Reorganizing
Caregivers are responsible for understanding
services, such as systems for appointment,
the importance of ensuring retention for children
triage, separating clinical consultation visits
in care, especially younger children. Disclosure
from visits to pick up medicine, integrating and
to children typically occurs late, making it
linking services and family-focused care may
challenging to discuss the importance of
reduce waiting times at the health facility.
follow-up. WHO recommends age appropriate
disclosure to children. This is based on their
Interventions harnessing social support have
judgement of the overwhelming benefits of
emerged as a promising approach to counteract
the intervention in increasing retention in the
the structural, economic, service delivery and
testing to treatment cascade.
psychosocial constraints that affect retention.
Interventions include:
6.2.2.2 Specific population
■ Supporting caregivers to attend for regular
considerations
follow-up.
1) Pregnant and breastfeeding women ■ Reinforcing to the caregivers the importance
of the process of disclosing to the child;
For pregnant women living with HIV, the this can begin early with age-appropriate
transition between ART care and antenatal messaging and tools.
care/MNCH services is a potential point for lost
to follow-up. 3) Adolescents

Interventions include: Frequent clinic visits, time spent waiting for

■ Monitoring approaches to ensure that services and having to miss school discourages
registers are aligned and that women are adolescents’ engagement in care. Negative
tracked and followed across different ART health care provider attitudes, concerns
service delivery points; regarding privacy and confidentiality and limited
opportunity to discuss their concerns also act as
■ Peer support, such as mothers-to-mothers barriers to retention for adolescents. Distance
program, may improve transition across to facilities and out of pocket expenses may
service delivery settings, and restrict their engagement.

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Interventions include: ■ Close monitoring of adolescents’
engagement in care, rapid proactive follow-
■ Strengthen the adolescent DSD based at
up and implementation of strategies for re-
Health Facility level.
engagement.
■ Implementing adolescent friendly health
service approaches to improve quality; 4. Key populations

■ Providing adolescent services at specific Specific consideration, especially in settings

times or in separate areas with flexible in which people are criminalized because of
appointment systems that accommodate their behavior or identity, requires delivery
school hours; community and peer-based options to support
people to retain in care.
■ Comprehensive services that address
multiple needs, including psychosocial Table 6.1. Factors related to the health system
support and sexual and reproductive health, and people receiving ART influencing retention
and and adherence with respective potential
interventions.

Factors Possible interventions

■ ART and related diagnostics and services free of

charge at the point of care.
■ Decentralize ART where feasible.
■ Scheduled facility visits
High direct and indirect costs of
■ Reduce waiting time at the facility level.
receiving care.
■ Client centered appointment system.
■ Separate clinical consultation visits from
appointments for picking up medicines.
■ Link, integrate and coordinate care.

■ Optimize pharmaceutical supply management

systems to forecast, procure and deliver ARV drugs.
■ Ensure regular & accurate reporting and requisition
Stock-outs of ARV drugs.
system using RRF.
■ Use fixed-dose combinations to simplify forecasting
and supply management systems.

■ Implement systems for patient monitoring across

Lack of a system for monitoring
the continuum of care, including cohort analysis and
retention
patient tracking systems.

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Factors Possible interventions

■ Interlinked patient monitoring system across

Lack of a system for transferring services for HIV, TB, maternal and child health and
people across different points of PMTCT; system for transitioning from pediatric to
care. adolescent and adult services and from maternal
and child health and TB services to chronic HIV care.

Pill burden and complex ARV drug ■ Use fixed-dose combinations to reduce the pill
regimens. burden and simplify the regimens.

■ Engage and integrate community health workers,

Lack of accurate information for
case managers, adherence supporters, volunteers,
patients and their families and peer
PLHIV in peer support, patient education and
support.
counseling, and community-level support.

■ Task shifting for involving case managers,

adherence supporters and community health
workers.
■ Linking with community-level interventions
Adherence support and resources such as peer adherence support
(community adherence support groups).
■ Using known effect reminder methods
■ Peer support also provides opportunities for in-
person reminders.

■ Train health workers on how to reduce stigma;

improve treatment preparedness, adherence and
Gaps in relationship between
retention; provide adherence support and care for
patient and care provider.
key populations; and provide simplified approaches
for educating patients and their families.

■ Task shifting and sharing among clinic team

members.
Lack of time for educating people in
■ People living with HIV as expert patients and peer
HIV care.
supporters.
■ A team approach to care.

■ Preparedness and knowledge of how and when to

self-manage adverse effects and when to return to
the clinic.
Adverse drug effects
■ Implement monitoring and report of adverse drug
reactions through implementing pharmacovigilance
system.

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 Factors Possible interventions

■ Using reminder to keep patients engaged.

Forgetfulness, life stress, stigma ■ Peer and family support.
and discrimination.
■ Link to community support group.

Comorbidity, substance and alcohol ■ Manage HIV with mental health disorders, alcohol
use disorders and mental health and other substance use disorders and link with
disorders. community and social support.

Patient knowledge and beliefs ■ Integrate the education of patients and their
related to HIV infection, its course families and counseling, broader community literacy
and treatment. and education and community engagement.

■ Implement strong counseling system and engage

Trust in faith and other herbal
faith based organizations in providing education in
remedies
adherence and retention.

6.2.3. Adherence to ART

WHO defines treatment adherence as “the Individual factors: may include forgetting
extent to which a person’s behavior – taking doses; being away from home; changes in daily
medications, following a diet and/or executing routines; depression or other illness; a lack of
lifestyle changes – corresponds with agreed interest or desire to take the medicines; and
recommendations from a health care provider”. substance or alcohol use.
For ART, a high level of sustained adherence
is necessary to suppress viral replication and Medication-related factors: may include adverse
improve immunological and clinical outcomes; events; the complexity of dosing regimens; the
decrease the risk of developing ARV drug pill burden; and dietary restrictions.
resistance; and reduce the risk of transmitting
HIV. Health system factors: may include requiring
people with HIV to visit health services
6.2.3.1. Barriers to adherence frequently to receive care and obtain refills;
travelling long distances to reach health services;
Multiple factors related to the health care and bearing the direct and indirect costs of
delivery systems, the medication and the care. Lack of clear information or instruction on
individual taking ARV drugs may affect medication, limited knowledge on the course of
adherence to ART. HIV infection and treatment and adverse effects
can all be barriers to adherence to ART.

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Specific population groups face additional Infants and young children
challenges to adherence, and these should
be considered when implementing the Successfully treating a child requires the
recommended interventions. commitment and involvement of a responsible
caregiver. Parents and other family members
Pregnant and postpartum women of CLHIV may themselves be living with HIV,
and suboptimal HIV care and treatment for
The pregnancy and postpartum period family members could result in suboptimal
presents significant biological, social and care for the child. Other challenges include
economic challenges that may affect treatment lack of nutrition support, limited choice of
adherence. Pregnancy-related conditions such pediatric formulations, poor palatability of liquid
as nausea and vomiting may negatively affect formulations, high pill or liquid volume burden,
treatment adherence. Other individual factors large pill size, frequent dosing requirements
include suboptimal understanding of HIV, ART and difficulties in swallowing tablets.
and PMTCT, lack of partner disclosure and
support, and fear of stigma and discrimination. People with mental health conditions and
Service delivery barriers include poor-quality substance use
clinical practices, gaps in provider knowledge
and training, poor access to services and health People with HIV with uncontrolled depressive
worker attitudes symptoms are more likely to have poor
adherence to ART. Adherence is complicated
Adolescents by mental health comorbidity that results in
forgetfulness, poor organization and poor
Adolescents face specific challenges, including comprehension of treatment plans. Similarly,
psychosocial issues such as peer pressure, the use of alcohol and other substances may also
perceived need to conform and inconsistent contribute to poor adherence to ART. Alcohol
daily routine. Adolescents are often left out and substance use can lead to forgetfulness,
of decisions and have limited opportunities to poor organization and diversion of monetary
discuss their concerns, and there is limited resources.
availability of adolescent-specific treatment
literacy and adherence counselling tools. For 6.2.3.2. Supportive interventions
adolescents who are transitioning from pediatric
to adolescent care, additional challenges may Several interventions may also be of value in
include assuming increased responsibility for addressing specific challenges that impact
their own care, issues relating to disclosure to on adherence and/or viral suppression.
peers or partners, difficulties in navigating the Interventions to optimize adherence to
health-care system, lack of links between adult ART includes using fixed-dose combination
and pediatric services and inadequately skilled regimens for ART and strengthening drug
health workers. supply management systems to reliably

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forecast, procure, and deliver ARV drugs and Reminder and engagement tools
prevent stock-outs. Efforts to support program-
level interventions for improving adherence to Mobile phone calls can be considered as a
ART include: avoiding imposing and maximize reminder tool for promoting adherence to ART
adherence should begin before ART is initiated. as part of a package of adherence interventions.
Developing an adherence plan and education Other patient reminder tools include alarms,
are important first steps. Initial patient education phone calls, diaries and calendars can be used
should cover basic information about HIV, the to as a reminders about the timing of ARV
ARV drugs themselves, expected adverse drugs, drug dosage and appointments.
effects, preparing for treatment, and adherence
to ART. 6.2.3.3 Monitoring adherence to ART in
routine program and care settings
Patient education, counseling and peer
support Objective monitoring of adherence to ARV
drugs is necessary for effective and efficient
Patient education and counseling are essential treatment planning and ongoing support. Each
both when ART is initiated and throughout the facility visit brings opportunity for assessing
course of treatment. Informing and encouraging and supporting treatment adherence. Effective
people receiving ART and their families and monitoring of adherence requires a combination
peers are essential components of chronic HIV of approaches based on human and financial
care. resource capacity, acceptability to PLHIV and to
health workers and the local context.
Substance use and mental health
interventions Viral load monitoring

Studies indicate that improving well-being by Viral load monitoring is considered as a gold
treating depression and managing substance standard and recommended to diagnose
use disorders improves HIV treatment and confirm treatment response and failure.
outcomes. Although treatment failure is often caused by
lapses in adherence to ART, it may also result
Nutritional support from other factors such as drug resistance, drug
stock-outs, drug interactions or malabsorption.
Nutrition assessment, counseling and support Viral load monitoring must therefore be
are essential components of HIV care. HIV combined with other approaches to monitoring
programs should ensure that existing national adherence. These approaches should also
policies on nutritional support are observed be considered as a way to provide additional
when it is necessary and feasible to maximize information about possible causes of virological
adherence to ART and achieve optimal health failure or to support adherence monitoring in
outcomes in food-insecure settings. settings where viral load testing is not available.

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Following an initial viral load result (>50-1000 environment that promotes and enables
& >1000 copies/ml), enhanced adherence honest reporting of non-adherence are critical
intervention should be carried out prior to components of monitoring adherence to ART in
conducting a second viral load test. Viral load routine care settings.
monitoring also has a high potential to motivate
adherence. Pill counts

Pharmacy refill records Counting the remaining pills in bottles may help
to assess adherence. Pill counts usually take
Pharmacy refill records provide information on place at routine health care visits. However,
when PLHIV pick up their ARV drugs. When some people may throw away tablets prior to
people obtain pharmacy refills at irregular health care visits, leading to overestimated
intervals, this may indicate non-adherence to adherence. Although unannounced visits at
ART; however, in many routine care settings, people’s homes could lead to more accurate
people may pick up their medications when estimates, this approach poses financial,
receiving care irrespective of their adherence logistical and ethical challenges. Counting pills
level. This behavior could lead health care also requires health care personnel to invest
providers to overestimate adherence by solely significant time and may not be feasible in
using pharmacy refill records. In many settings, routine care settings. Pill count can perform
pharmacy refill records are already a part of better when combined with self-reported
national monitoring and evaluation frameworks adherence.
and can also provide additional information on
adherence to ART when used in combination 6.2.4. Task shifting for HIV treatment and
care
with other tools.

Reorganizing, integrating and decentralizing HIV

Self-report
treatment and care will require re-examining the
roles and tasks of teams of health care providers
Asking people living with HIV or their caregivers
involved in delivering chronic HIV care. Task
how many doses of medication they have
shifting involves the rational redistribution of
missed since the last visit (or within a specified
tasks among health workforce teams. With this
number of days in the past) can help to estimate
approach, specific tasks are reassigned, where
non-adherence.
appropriate, from highly qualified health workers
However, although this method is commonly to health workers with shorter training and fewer
used, people may not remember missed doses complementary qualifications to efficiently and
accurately or may not report missed doses effectively use the available human resources.
as they may want to be perceived as being Task shifting should be implemented alongside
adherent and to avoid criticism. Counselling other strategies designed to increase the total
on the importance of remembering and/ numbers and capacity of all types of health
or documenting ARV drug doses and an workers.

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The quality of care in task shifting should be 6.2.6 Integrating and linking services
ensured by;
Chronic care requires integrating and linking
a) Providing training, mentoring, supervision
related services to ensure comprehensive
and support for nurses, non-physician clinicians
and consistent patient management over time
and community health workers;
including provision of related services in single
b) Stating clear indications for patient referral; settings, systems to share information and
c) Implementing referral systems and effective referrals across settings and providers.

d) Implementing monitoring and evaluation

Integrating and linking services are likely to
systems.
reduce missed opportunities for initiating ART,
Both initial and ongoing training and mentoring, enhance long-term adherence support and
supportive supervision and administrative optimize patient retention. Programs for HIV,
planning have been critical to the success of sexual and reproductive health, maternal and
program that has implemented task shifting. child health, mental health, non-communicable
Program need to train and establish a system diseases, viral hepatitis and TB need to
for routine supportive supervision of health collaborate to successfully implement ART and
workers, including lay providers. related services at different levels of the health
system.
6.2.5 Decentralizing HIV treatment and
care Delivering HIV services in antenatal care,
maternal and child health settings
Although rapidly scaling up HIV programs
has significantly improved access to ART and HIV testing should be offered to all pregnant
increased the health and survival of PLHIV, it women through provider-initiated approaches
also poses significant challenges to health as an essential component of MNCH services.
systems. Decentralizing ART to primary It is also recommended to provide couple and
care settings will ease the burden of routine risk screening based partner HIV testing for all
management on other parts of the health pregnant women and their partners in maternal
system and will improve equity by promoting and child health care settings.
access to ART in rural areas. Decentralizing HIV
care and treatment could reduce the workload ART should be initiated and maintained in all
for health care personnel, thereby reducing pregnant and postpartum women and in infants
waiting times for people with HIV and people at maternal and child health care settings, with
receiving care at hospitals for other conditions linkage and referral to ongoing HIV care and
and bring HIV services closer to people’s homes. ART, where appropriate.
Decentralization and scale-up of HIV care and
treatment services will continue based on need
assessments to address community groups
with high HIV prevalence.

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Delivering HIV services in TB treatment lack of health outcome data for this age group,
settings emerging evidence indicates that adolescents
living with HIV are underserved by current HIV
All confirmed and presumptive tuberculosis services including access to ART. Adolescents
patients should be offered HIV testing services are at high risk of lost to follow-up both before
in TB clinics. TB patients co-infected with HIV and after ART initiation. Adolescents and youths
should be initiated with ART through linkage to aged 15–24 years and those attending services
HIV care and ART services. All PLHIV enrolled to for the PMTCT of HIV are particularly at risk.
HIV care need to be screened for TB and those
with no sign and symptoms of active TB should All adolescents, including those living with HIV,
be provided with TPT. PLHIV who develop TB face significant barriers to accessing health
after the initiation of ART, should be linked to TB services, due to inadequate health literacy,
clinics for TB treatment. limited ability to navigate health services, legal
requirements for parental or caregiver consent,
Sexual Transmitted Infection, family planning and insufficient resources to pay direct and
and cervical cancer screening services in HIV associated service costs. Adolescents face
care settings significant levels of stigma and discrimination.

Sexually transmitted infections, family planning Poor quality of services also limits adolescent
and cervical cancer screening services should engagement in health care. Adolescents often
be integrated within HIV care settings. WHO perceive health services as unacceptable due
recommends routine offer of HIV testing to concerns about confidentiality and negative
services for persons with an STI in all epidemic health provider attitudes. Services are often not
settings and for family planning clients in organized to accommodate adolescent needs,
generalized epidemic settings. Likewise, all have inconvenient service schedules, inflexible
PLHIV should be screened for STIs and treated appointments and unwelcoming environments.
as per the National Guidelines for Syndromic Without sufficient consideration and support,
Management of STI. Family planning services adolescents can be lost between paediatric and
should be provided in HIV care/ART clinics to adult services. The rapid developmental and
avoid unintended pregnancy among women social changes that occur during adolescence
living with HIV. Women living with HIV aged 15 exacerbate the impact of such barriers and can
years should be screened for cervical cancer as have a profound impact on the way adolescents
per the National Guidelines for Screening and engage with health services.
Management of cervical cancer.
Due to their unique needs, adolescents living
6.2.7. Adolescent-friendly health services with HIV require quality and comprehensive
services. These includes care & support
There is a growing cohort of adolescents living
access, continuity in treatment, adherence,
with HIV, which includes those infected from
psychosocial support, sexual & reproductive
birth and those who have acquired HIV later in
health and mental health care. According to the
childhood and adolescence. While there is still a
WHO quality of care framework, adolescent

155
friendly health service is defined as follows: Establishing linkages and referral pathways to
ensure a comprehensive continuum of care,
■ Equitable: all adolescents, not just certain
especially for the transition from paediatric to
groups, are able to obtain the health services
adult HIV services.
they need.
■ Accessible: Adolescents are able to obtain 6.2.8. Improving the quality of HIV care
the services that are provided. services

■ Acceptable: Health services are provided HIV program should be innovative in addressing
in ways that meet the expectations of local challenges and aim to strengthen
adolescent clients. programme monitoring and the routine use
■ Appropriate: The right health services that of programme data to improve the quality
adolescents need are provided. of services. Quality of care emphasizes that
services should be effective in achieving desired
■ Effective: The right health services are
health outcomes and that health-care practices
provided in the right way and make a positive
should be people-centred and safe. Strategies
contribution to the health of adolescents.
to improve the quality of HIV care services are
■ Adolescent-friendly HIV prevention, care needed both at the programme management
and treatment service implementation level and at health facility and community levels
considerations include: where HIV care services are provided. If an
■ Aligning approaches for HIV service delivery intervention is to achieve the desired health
with national adolescent-friendly health outcomes, it needs to be evidence based, of
service standards, protocols and activities; high quality and achieve a level of coverage that
brings desired outcomes at the population level.
■ Including implementation of adolescent-
friendly approaches in HIV health service
Quality care means that people living with HIV
supervisory and monitoring systems;
receive the care they require to maintain their
■ Ensuring training, research and personal health and quality of life. For HIV program and
development opportunities for health service health-care providers, quality HIV care optimizes
providers on adolescent HIV treatment and programme effectiveness and efficiency. For
care; policy-makers and funding agencies, quality
■ Engaging service providers, adolescents care is an important requirement for maintaining
and other key stakeholders to identify health at the population level and ensuring the
acceptable and feasible activities; optimal use of available resources.

■ Implementing adolescent-friendly health Quality of care should not be seen as an

service approaches in all HIV services used additional activity to routine HIV services or a
by adolescents, including antenatal care for short-term project to address implementation
pregnant adolescents living with HIV; and issues and gaps; it should be incorporated into
daily activities at all levels, from service delivery
to national programme management.

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6.3. Pharmaceuticals Supply Selection of ARV drugs and related supplies
Management System
Product selection is done based on existing
6.3.1. Supply Chain Management national policies and ART guidelines. Products
are selected from or become part of a National
The overarching objective of pharmaceuticals Essential Medicines List (EML) and are based
supply management system is to support on standard treatment guidelines. If a selected
national policy with the adequate and continuous ARV drug is not on EML and/or not registered
availability of the most safe, effective, quality- in the country, HIV program managers should
assured ARVs and related pharmaceuticals at coordinate with Ethiopian Food and Drug
service delivery sites in the right quantity, at the Administration (EFDA) and request that these
lowest possible cost and in a timely manner. drugs be put on the list and registered.

The new recommendation that ART should be Quantification

initiated in all PLHIV regardless of CD4 cell count
will require an integrated national strategic National quantification of ARV and related
response that considers the resources available pharmaceuticals is conducted by EPSA in
and enables strong supply chain management collaboration with MOH, FHAPCO, other
systems at all levels of the health system. stakeholders and development partners. The
MOH, EPSA and other stakeholders need to national quantification is done every year
work together to ensure that the national supply covering a three-year forecast. Based on the
system is functioning well in accordance with forecast produced, supply plan for one year
the increasing national demand and achieve the consumption will be prepared considering
95-95-95 targets. stock for procurement lead time and safety
stock which can allow sufficient flexibility to
Ethiopian Pharmaceuticals Supply Agency accommodate minor consumption fluctuations
(EPSA) is responsible for quantification, due to unforeseen events.
procurement, storage and distribution of
pharmaceuticals to health facilities. Health Procurement
facilities obtain HIV pharmaceuticals primarily
through the Integrated Pharmaceutical All ARV and related pharmaceuticals for use in
Logistics System (IPLS), a single reporting the public and private sector should be procured
and distribution system managed by EPSA. at affordable prices, with assured quality and
Pharmaceuticals used for HIV programs are adequate shelf life, from a reliable supplier.
also managed through IPLS. ARVs and related commodities are procured by
EPSA.

The procurement process follows the national

and international procurement regulations,
which is a competitive approach through
international bidding.

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Storage and distribution

Proper storage facilities, including refrigeration, system and it extends from the central level
is critical to maintain the quality of the drugs to health facilities. Central EPSA will have a
and related supplies Since the commodities major role of delivering the products to its
required for HIV program are increasing, there Hubs; subsequently the hubs distribute the
should be adequate storage space, warehouse commodities to health facilities based on orders
material handling equipment and distribution placed by health facilities to EPSA hubs.
facilities need to be ensured at various levels.
Figure 6.3 Flow of pharmaceuticals and information in the
Pharmaceuticals and health products integrated pharmaceutical logistics system.
distribution will follow the existing delivery

Inventory Control Information System (HCMIS) is an electronic

inventory control system which is currently
Inventory control system is mandatory to utilized at EPSA central, hubs and some health
maintain an appropriate stock level of products facilities whereas the remaining health facilities
at all level of the supply chain to avoid shortage are utilizing a paper based system. HCMIS
and wastage (due to overstock and/or expiry) need to be strengthened to improve inventory
of products. IPLS dictates the implementation control and data visibility at all levels of the
of max-min inventory control system where supply chain. EPSA is responsible for collecting,
there is a set of maximum and minimum validating, analyzing, and utilizing product
months of stock to be kept at each level of the information to ensure an uninterrupted supply
supply chain. Health Commodity Management of health products.

158
Quality Assurance ■ Confidential documentation system of
patient information sheet
Mechanisms must be put in place to assure
the quality of drugs entering the country ■ Identifying ADR, drug interactions,
through pre-procurement certification and post- adherence of ART clients using patient
marketing surveillance. Appropriate quality information sheet
assurance mechanisms for pharmaceuticals is
developed and implemented by EFDA. Quality ■ Record patient appointment date for easily
standards should also define storage conditions tracking of patients for follow up
at EPSA warehouses and health facility stores.
The national laboratory must have the capacity ■ Timely trace lost for follow up patient and
to assure the quality of ARV pharmaceuticals. make adherence support
Quality assurance of drugs and supplies will
be maintained using simple visual inspection ■ Register basic patient data on daily basis to
methods and a First-Expiry-First-Out (FEFO) summarize the data for informed decision
system to avoid expiration and ensure fresh making.
supplies are available at all levels.
■ Summarize data from registers to
6.3.2. ART Pharmacy Services consumptions summary

The ART Pharmacy unit is determined to take ■ Generate monthly report and share to
responsibility and make all the necessary follow respective bodies.
up to improve the ART pharmacy services.
Pharmaceutical care provider who is working in ■ Analyze and interpret monthly report for
ART Pharmacy is expected to play an important decision making purpose
role in the follow-up of adherence, monitoring
■ Properly provide services for PEP and
treatment outcomes, monitoring and preventing
Emergency clients
drug interactions, detecting and reporting ADEs,
and other medication related issues. There
Pharmaceuticals Management Information
is also a need for strict pharmacovigilance of
Systems
ARVs since new ARVs are constantly entering
the market.
The management of patient related data serves
two basic purposes among others: it enables
Key activities and processes in ART pharmacy
the Pharmaceutical care provider to follow-
The pharmacist assigned to provide ART up adherence, treatment outcomes, prevent
pharmacy unit should minimally accomplish the adverse drug reactions, drug interactions
following: and other medication related issues; and the
information obtained is crucial for decision-
■ Filling of patient information sheet for
making on the selection and quantification
specific patient
of ARVs. Accordingly, the system will allow

159
the effective and efficient documentation and recent years, to optimize ART and achieve
reporting that is important in the management national treatment targets, new regimens and
and monitoring of patient uptake and regimen service delivery models have been introduced.
profile at national, regional and health facility Hence, ensuring the proper use of new
levels. Moreover, the overall prescribing regimens using methodologies such as drug
and dispensing practices at facility level will use evaluation (DUE) should be given a priority.
be improved. It will also contribute to the DUE is an ongoing, systematic, criteria-based
identification of discrepancies in treatment program of medicine evaluations that helps
protocols in an effort to improve adherence to ensure appropriate medicine use is provided.
latest ART guidelines. Hence, the information If therapy is determined to be inappropriate,
generated at health facilities is being utilized for interventions with providers or patients will
decision- making throughout the drug supply be necessary to optimize pharmaceutical
management cycle of the country. therapy. The drug and therapeutics committee
(DTC) is responsible for identifying medicine
Tools and systems in ART pharmacy Services: use problems and implementing strategies
to alleviate these problems. All DTCs should
■ Patient information sheet (PIS) ensure that medicines are being used correctly
so that patients receive the maximum benefit
■ Patient tracking chart (PTC) from their pharmaceutical therapy.

■ ARV drugs dispensing registers (Adult, ARV drugs safety monitoring and reporting
Pediatric, PEP, Emergency) (Pharmacovigilance)

■ Drug Therapeutic Problem (DTP), Pharmacovigilance is the science and

activities relating to detecting, assessing,
■ Monthly consumption summary and
understanding and preventing adverse effects
or any other possible drug related problems.
■ Monthly activity report.
Pharmacovigilance is a key component of
Medicine Use Evaluation comprehensive patient care and the safe use
of medicines. Failure to monitor, understand
In order to sustain the benefits of ART, and manage these events can result in poor
continuous availability of ARVs should go hand adherence and treatment failure and can
in hand with rational medicine use practices reduce confidence in antiretroviral therapy
of prescribing, dispensing, and patient use. among both PLHIV and the care providers.
However, there are reports of non-adherence Pharmacovigilance is required not only for
to treatment protocols. Irrational use of long term antiretroviral therapy but also for the
medicines contributes to drug resistance, antiretroviral drugs used for PMTCT, PrEP and
treatment failure, and resource wastage. In PEP.

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Even though there are advances in HIV ■ Cohort event monitoring is a prospective
treatment, adverse drug events (ADEs) observational cohort study of adverse events
associated with antiretroviral medicines (ARVs) associated with one or more medicines. All
still poses a challenge to patient safety. Usually, adverse events occurring to a person taking
ADEs occur in the context of comorbidities antiretroviral drugs are collected regardless
and pill fatigue due to the lifelong treatment of the causality or relationship with the
regimens. Advances in HIV treatment would antiretroviral drugs.
also mean continuous introduction of newer
■ Targeted spontaneous reporting is a
regimens whose safety profiles have not been
method that builds on the principles of
well studied and established in various settings
both spontaneous reporting and cohort
and population groups such as children, elderly,
event monitoring. Targeted spontaneous
pregnant women, people with co-morbid
reporting enables focus on a specific drug of
conditions (TB, hepatitis and others). These facts
interest (such as DGT, Tenofovir), a specific
call for strong prevention, early identification,
population of interest (such as women,
management, and reporting of adverse events.
children) or a specific adverse drug reaction
And WHO recommends enhanced monitoring
(such as anemia).
and surveillance of toxicity on transition
to new ARV drugs in HIV programs. EFDA Reporting of adverse events
has established and coordinates a national
Adverse drug events should be reported to the
pharmacovigilance center to strengthen this
responsible authority body, Ethiopian Food and
effort. Professionals involved in prescribing and
Drug Authority (EFDA). The adverse events that
dispensing as well as patients are encouraged
need to be reported includes medicine-related
to monitor and report ADEs to the center.
injuries, with at least a reasonable possibility
The information obtained through the national
to be caused by the direct pharmacological
pharmacovigilance system enables the HIV
mechanism of a medicine, an individual’s
program to make informed decision on the
particular vulnerability, drug interactions,
safety profile of ARVs. Therefore, EFDA will
unexpected therapeutic ineffectiveness (e.g.
avail reporting tools and build the capacity of
resulting from drug interactions, product
providers through trainings and face to face
quality, problems or antimicrobial resistance),
discussions as appropriate.
medication errors, and product quality defects.
The main pharmacovigilance methods include
In line with this, adverse events associated
spontaneous reporting, cohort event monitoring
with the drugs should be reported using either
and targeted spontaneous reporting.
the standardized adverse event reporting
■ Spontaneous reporting system is the most format (yellow form), using hot line 8482 (toll
widely used system. Health professionals free line) or Telephone 01115523142(direct)
and pharmaceutical manufacturers or 0115524122(via operator), electronically on
voluntarily submit suspected adverse drug e-reporting of ADR available on the apps or
reactions to the national regulatory authority. website of EFDA (www.fmhaca.gov.et) and
A serious limitation here is underreporting. Using a mobile app Medsafety by health care
providers and public health programs.

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General Reporting approach and Timeline for active DSM

6.4. Laboratory and diagnostic services

The consolidated national HIV guidelines services should be carried out to ensure
support an increased access to HIV care and appropriate use and cost–effectiveness. To
treatment and laboratory diagnostic services. enhance implementations of essential and
To ensure that laboratory services are accurate timely patient care, minimum packages of
and reliable, relevant quality assurance systems laboratory tests need to be provided as per the
need to be strengthened in multiple HIV schedule or as needed. Minimum laboratory
diagnostic settings, as well as other laboratory testing services packages for people with
testing services (eg. Viral Load, CD4 chemistry, HIV are: treatment monitoring tests, HIV drug
CBC etc.). Therefore, strategic planning for resistance tests, OI screening/co-infection
proper placement and harmonization of HIV assessment monitoring test and toxicity
screening platforms and other laboratory monitoring test.

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Table 6.4.Summary Components of minimum Laboratory service packages for PLHIV

Laboratory tests Period

Complete Blood Count Baseline and every 6 months

CD4 cell count Baseline and as needed

Kidney Function Tests: (Blood Urea

Nitrogen and Creatinine)

Liver Function Tests: ALT (alanine

aminotransferase), AST (aspartate Baseline and as needed
aminotransferase), Bilirubin, Alkaline
Phosphatase, GGT (gamma glutamyl
transpeptidase), LDH (lactic dehydrogenase)

Blood Sugar: High blood sugar can be a

Baseline and as needed
side effect of the HIV protease inhibitors.

HIV Viral Load tests See ART monitoring section

HIV drug resistant testing For second line treatment failure

AFB/MTB/RIF As needed

For patients with ≤200 cells/mm3 (inpatient)

≤100cells/mm3 (outpatient) Or any CD4 count
LF-Urine LAM
with TB symptoms or if seriously ill
At baseline and as required

for patients with CD4 cell count <100 cells/

Cryptococal Antigen(CRAG) tests
mm3

As needed, for HPV DNA refer CxCa HPV

Others STIs( HBsAg, HCV, HPV)
DNA PCR testing

This guidance emphasizes the importance ■ To support the expansion of diagnostic

of leadership and governance to ensure services to include testing at the point of
implementations of minimum laboratory care;
service packages, strengthen high-quality
■ To train and certify health workers who
laboratory services, expanding testing services
perform the testing;
and developing the health workforce:
■ To ensure high-quality laboratory services
■ To strengthen and expand laboratory testing
and plans for implementation, including
services;
quality assurance; and
■ To support a dedicated specimen referral
system; ■ To ensure appropriate deployment of
laboratory diagnostic technologies to
■ To increase access to HIV viral load testing;
increase their efficient and optimal use.

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1) Strengthening and Expanding Laboratory 2) Strengthen a dedicated Specimen Referral
Testing Services System

The following areas are important to strengthen Laboratory referral systems and procedures for
the network of laboratory services for collecting and processing specimens need to
implementing the national guidelines: be strengthened to increase access to viral load
testing and other laboratory testing (for example,
■ Expanding and strengthening current CD4 and early infant diagnosis). Providing for
laboratory networks with efficient specimen and strengthening a dedicated, efficient, safe
referral mechanisms to support and monitor and cost-effective specimen referral system
the decentralization and integration of requires reliable specimen transport with
laboratory services or to provide access adequate conditions for whole blood, plasma
to laboratory tests which are available at and dried blood spot specimens(DBS) and
limited number of sites (e.g. HIV viral load rapidly and dependably reporting test results
testing, DNA PCR, CD4 count etc.). back to the referring sites to support for timely
patient care.
■ Standardizing testing methods to streamline
procurement, quality assurance and training. 3) Increasing Access to HIV Viral Load Testing

■ Incorporating new testing approaches and The guideline recommends the use of viral
systems into national laboratory strategic load testing to monitor treatment response and
plans and policies. diagnose treatment failure and the use of dried
blood spot samples for hard-to-reach sites for
■ Evaluating diagnostics for their performance viral load testing. This will require strengthening
and operational characteristics to validate the existing laboratory services and phased
testing algorithms (with back-up options) expansion of monitoring services into peripheral
before introduction. facilities and can include:

■ Carrying out strategic planning for properly ■ Strengthening and leveraging existing
placing and harmonizing testing platforms specimen transport and result receiving
to ensure appropriate use and cost– networks;
effectiveness.
■ Ensuring that laboratories have adequate
■ Allocating appropriate resources to ensure infrastructure, technical testing expertise
the availability of testing services, including and quality assurance and quality
human and financial resources. improvement programs;

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■ Ensuring an appropriate mix of high-volume 5) Expanding point-of-care(POC) testing
centralized laboratory testing and point of Technologies
care testing technologies. Point-of-care
Viral load testing prioritized for the following Decentralizing laboratory services requires
populations groups: that all aspects of testing be in place before
implementing services, including:
■ Pregnant and breastfeeding women
■ Using only high-quality, evaluated and
■ Infants, children and adolescents reliable diagnostic tests;

■ People requiring a repeat viral load after a ■ Supervising and monitoring POC testing for
first elevated viral load quality and reliability;

■ People for whom treatment failure is ■ Implementing a strategy for managing

suspected supply chain and equipment service; and

■ People presenting sick, living with advanced ■ Establishing data management systems
HIV disease or having a known opportunistic for timely identification of quality issues at
infection (TB, cryptococcal infection, etc.) regional and national data reporting.

■ First scheduled viral load test for people re- 6) Implementing Comprehensive Quality
entering care Management Systems

■ The use of dried blood spots as a tool to Implementing comprehensive quality

increase access to viral load testing. management system including quality control,
External Quality Assessment (EQA) and quality
4) Planning for appropriate use of CD4 Improvement project is essential. The quality
count testing as access to viral load testing management system should:
increases
■ • Be implemented within the laboratory
The country has formally quitted CD4 count- network and all remote testing sites
dependent treatment initiation thresholds
and viral load monitoring replaces monitoring ■ Be incorporated into the routine testing
with CD4 cell count. However, CD4 cell count procedures and periodically monitored
testing will continue as part of HIV programs for
baseline assessment, monitoring OI prophylaxis ■ Ensure that testing sites undertake quality
and other clinical assessments, even in settings control, as appropriate
with full access to viral load testing.
■ Ensure that testing sites are enrolled in

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 an external quality assessment scheme 7) Providing guidance for developing
(proficiency testing program and on-site health workers’ capacity, including staff
evaluation) training and certification

■ Ensure the use of standard operating Supplementing guideline for developing

procedures for all processes, including health care worker capacity building includes;
specimen collection and processing, test qualification of personnel who will perform
methods, interpreting results and reporting the laboratory tests, training requirements for
specific tests and the process for certification
■ Ensure the use of standardized logbooks or and re-certification. The guideline also indicating
electronic data management and identifying that, all health workers assigned to perform
errors and potential misclassification and POC and other laboratory testing services must
be trained, proficient on the testing procedure,
■ Ensure the implementation of preventive specimen collection and quality assurance
and corrective measures for equipment before implementing these services.

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CHAPTER SEVEN:
GUIDANCE FOR PROGRAM MANAGERS
AND LEADERS
Policy development and review is a dynamic 7.1 Guiding principles
process. Policies change and/or revision like
strategic shifts, evolvement of new initiatives The following guiding principles are expected
as well as evidence and knowledge change to lead the implementation of the national HIV
over time at national, regional and global level program and services provision:
are happening according to the lessons learnt
during the implementation of the HIV program. I. Ownership and commitment: An effective
Policies set early in the development of HIV response to HIV/AIDS requires ownership and
program may negatively affect implementation active involvement of the community and all
and need to be revised. Policies, therefore, other sectors. It also seeks strong leadership
need to be able to respond to the current commitment at all levels.
changes. Program managers and leaders
should be cognizant of changes and challenges II. Multi-sectoral: A multi-sectoral approach
affecting the development and implementation that includes partnership, consultations, and
of HIV/AIDS policies. These include political coordination with all stakeholders in the design,
commitment, financial implications, global implementation, and service provision as well
directions, administrative and structural as monitoring and evaluation of the response
reforms, community engagement, meaningful are crucial to maximize the effectiveness of the
involvement of PLHIV and basic legislation. response.

The key benefits to the global and country III. Gender Responsiveness: Gender sensitivity
HIV response have enabled governments, must be considered as a corner stone for the
programmers, organizations like partners success of HIV/AIDS response with greater
and CSOs, communities, and individuals and sustained positive impact as the epidemic
to achieve epidemic control by addressing and its response is highly impacted by gender
individual, community and societal level HIV inequalities.
fueling factors. These include matters related
to sexual behavior, injecting drug use, socio- IV. Inclusiveness: An inclusive and people-
cultural practice, stigma associated with HIV/ centered approach that recognizes different
AIDS, gender inequality, poverty, political prevention, care, and treatment options that
commitment, structural barriers, right to access individual may choose and benefited at different
HIV related services and human rights that stages of their lives have to be designed and
need to be addressed. implemented.

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V. Equity: Inequalities in health outcomes will The NSP has set the following impact targets
be addressed through rights-based programing to be achieved by the end of the 5-year period:
and through improving the understanding of,
■ Number of new HIV infections reduced
and response to, human rights and gender
to less than 1 per 10,000 population
related barriers to accessing services.
(Disaggregated by sex, age, region and
population group)
VI. Resource mobilization and proper
utilization: to sustain the gain in HIV response ■ AIDS related deaths reduced to less than 1
and attain epidemic control, mobilizing domestic per 10,000 populations.
and external resource, ensuring efficiency,
transparency and accountability in use and ■ Incidence Mortality Ratio reduced to less
proper allocation and effective utilization of than 1 (Target: From 1.08 to 0.9)
resources are essential in the national response ■ Percentage of child HIV infections from
to HIV/AIDS epidemic at all levels. HIV- positive women delivering in the past
12 months reduced from 16.9 % in 2019 to
VII. Service Integration and Linkage: HIV
less than 5% by 2025; and less than 2% by
services must be gradually integrated with
2030.
existing health services in the health facilities
and effectively linked within the facility and to The Strategic Plan has Six Strategic Objectives
community based services. to achieve the set goal.

VIII. Evidence Based Response: HIV program 1. Reach 90% of Key and Priority populations
implementation will be based on coordinated with targeted combination HIV prevention
joint planning, review, monitoring and evaluation interventions by 2025.
and strategic information generation and
2. Enhance HIV case finding to attain 95% of
use for decision with implementers and key
PLHIV knowing their HIV status and linked to
stakeholders at all levels.
care by 2025.

7.2. Overview of the HIV/AIDS 3. Attain virtual elimination of Mother to Child

National Strategic Plan 2021-2025 Transmission (MTCT) of HIV and Syphilis by
2025
The 2021-2025 HIV/AIDS National Strategic plan 4. Enroll 95% of PLHIV who know their status
was developed being informed by situation and into HIV care and treatment and attain viral
response analysis and investment case analysis suppression to at least 95% for those on
based on Goals Modeling using existing national antiretroviral treatment.
data for geographic, population and intervention
5. Mobilize resources and maximize efficiencies
prioritization. The strategic plan aims to attain
in allocation and utilization.
HIV epidemic control nationally by 2025, by
reducing new HIV infections and AIDS mortality 6. Enhance generation and utilization of
to less than 1 per 10,000 population. Strategic Information (SI) for an accelerated
evidence-based response.

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In addition, ten social and programmatic and its response is needed. This concept is
enablers are identified to maximize the reach known as the ‘know your epidemic, know
and impact of Ethiopia’s HIV/AIDS response. your response’ approach, which is the starting
point for combination prevention planning and
A. Gender and Gender based Violence. programming, and is comprised of a series of
exercises to help categories an epidemic (such
B. Stigma and discrimination
as whether it is ‘generalized’ – i.e., within the
C. The role of civil society, communities, PLHIVs general population – or ‘concentrated’ within
and the private sector certain groups within the population, often
referred to as ‘key affected populations’). This
D. Embracing a Human rights approach to the
involves looking at factors such as modes of
HIV response
HIV transmission, key affected populations,
E. Health Systems (supply and laboratory) and key epidemiological trends as well as the
response to the epidemic.
F. Human resources for health/ HIV response
In the planning process, programmers,
G. Governance, leadership, coordination, and
managers, leaders, and policy makers are
accountability
recommended to follow is described below:
H. Addressing policy and legal issues
Inclusiveness of the planning process: Ensure
I. Partnership, Multi-sectoral Collaboration, Civil the participation of all relevant stakeholders,
society, and the Private Sector including government officials, community
leaders, civil society organizations, donors, and
J. Private for-Profit Sector Strategic Interventions
most importantly, people affected by HIV and
AIDS.
Program managers and leaders must
understand the scope of NSP and its strategic Identify modes of transmission and the most
approaches for the standardization of program affected populations: Identify factors that
approach across the country. fuel HIV transmission and understand how
HIV is spread, identify the most common
7.3. Program Performance and modes of transmission, and the most affected
Response Analysis populations, identify geographic variations in
HIV prevalence, such as urban Vs. rural areas,
All combination prevention programs require know the size of key affected populations.
a strong community empowerment element
Ensure the availability and utilization of the
and collective efforts to address legal and
appropriate tools to collect, review, analyze,
policy barriers, as well as the strengthening
monitor, evaluate and data use for program
of health and social protection systems, plus
improvement.
actions to address gender inequality, stigma
and discrimination. Identify and understand structural barriers
that might fuel HIV prevalence, analyze social,
Before deciding on a package of HIV prevention
legal, economic, and cultural drivers of HIV
interventions for a specific HIV epidemic, a clear
epidemic. Upon completion of the ‘know
and evidence-informed picture of that epidemic

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your epidemic, know your response’ planning 7.4. HIV response in the context of
process, a combined component of coordinated COVID 19
behavioral, biomedical, and structural HIV
prevention interventions can be developed and Individuals living with HIV, especially those
implemented. with co-morbid condition and/or advanced HIV
disease may be at greater risk for COVID-19
Determining whether current HIV prevention, complications and related impact. During the
care and treatment programs are adequate to current pandemic, PLHIV that utilize health
address the needs that have been identified care institutions were often sicker than they
requires understanding of, who is currently would have been in the past, due to delays in
accessing these services. Programmers should seeking care. Thus, coordinated efforts from
assess existing HIV prevention, case finding community stakeholders, civil society, public
efforts, ART and viral load service coverage health agencies, healthcare providers and
levels, linkage to care and adherence to program managers is essential for addressing
treatment and viral suppression among the health inequities for PLHIV resulting from social
general population as well as key and priority stigma and poor access to Personal Protecting
populations. They also need to assess the Equipment (PPE), preventative services and
overall outcome and impact of the response treatment. The present critical challenges for
including decline in incidence and mortality. PLHIV that need to be addressed during the
Disaggregated data for various groups enable COVID-19 pandemic are access to their ART
assessment of HIV prevention, care and drug refills, maintaining of their psychosocial
treatment needs and establishment of priorities wellbeing, and sustaining their economic
for delivering services. welfare.

Data on case finding yield, linkage to care, Furthermore, access for HIV testing and
adherence, retention, and viral load suppression prevention service for PLHIV partners and other
are keys to assess the quality of the services KPPs still critical challenges amid COVID-19
provided. Surveillance of transmitted and pandemic
acquired HIV drug resistance can also be
instrumental in informing decisions on optimal To ensure the health of PLHIV as well as
regimen choices for ART program. maintaining the continuity of HIV services in the
era of COVID-19 pandemic, program managers
A review of epidemiological and programmatic need to monitor the implementation of the
data is incomplete without a deeper national standard response guideline to be
understanding of what drives HIV vulnerability updated to prevent the HCPs and PLHIV from
and how various political, social, economic, and COVID-19 which includes COVID-19 testing,
legal factors affect the ability and willingness vaccine and treatment must be accessible for
of various groups to seek and access health PLHIV.
services. Stigma, discrimination, poverty, gender
inequality, education and migration status are
key elements that should be considered to
inform effective HIV programming.

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7.5. Key parameters for decision- Cost–effectiveness analysis is one of the
making several economic evaluation tools used to
measure the value of delivering services.
Ethics, equity, and human rights Economic evaluation measures the costs
and consequences of alternative programs,
Multiple legal, social, and normative obstacles which are then compared to assess how the
have resulted in inequitable access to HIV greatest health benefits can be generated. In
prevention, testing, treatment, and care. Global cost–effectiveness analysis, impact is often
and national commitments require providing measured using indicators related to a change
HIV prevention, care, and treatment services to in health status, such as disability-adjusted life-
everyone in need, following the human rights years gained, which includes the estimated
principles of non-discrimination, accountability, number of deaths and infections averted.
and participation. National HIV strategies should
be planned and implemented from the outset As the experience of scaling up ART in low-
with the goal of delivering the full package of and middle-income countries demonstrates,
services and interventions recommended in the cost–effectiveness of health interventions
these guidelines as soon as possible. also changes over time, as costs fall because of
gains in scale, improvements in technology or
Key ethical principles of fairness, equity and the design of more efficient delivery systems.
urgency should also be observed in the process
of reviewing and adapting guidelines. The Although evaluating cost–effectiveness and
design of effective and equitable policies implies health impact may be useful in systematically
that strategies should focus comprehensively comparing various program interventions, they
on addressing barriers to access testing, should be considered in the light of the ethical,
prevention, and treatment services, particularly equity and human rights implications associated
those faced by key and priority populations. with different courses of action, especially
in settings in which not all eligible individuals
Impact and cost–effectiveness currently have access to ART.

Realizing positive impact for a population is an Investments in social and programmatic

important goal of public health programs and enabler programs (such as integrated treatment
policies. Examples of the impact of HIV programs and rights literacy programs, legal services,
include reduced HIV incidence, prevalence, stigma and discrimination reduction programs,
morbidity and mortality and improved quality of training for health care workers and law
life. Impact is often a result of a complex set enforcement, Gender, CSO, CBO and, PLHIVs
of factors and a combination of diverse inputs involvement, Human rights, governance,
and activities or processes, and it is often not leadership, coordination, and accountability,
attributable to a single intervention or program. policy and legal issues, partnership, Multi-
sectoral Collaboration, and the Private Sector

171
Interventions) can play a role in overcoming Decentralization of services and task shifting
barriers to accessing treatment and other HIV- in service provision is crucial to improve the
related services and keeping people connected access to HIV services in which both facility and
to care. As such, these programs can contribute community based interventions like targeted
to overall cost–effectiveness, in addition to SBCC, and demand creation, HIV self-testing,
achieving other important objectives, such as and other differentiated service delivery models
reducing discrimination. need to be strengthened. As coverage of ART
increases and programs matures, expanding
Opportunities and risks access to second line regimens and ARV drugs
resistance monitoring increasingly becomes
The recommendations in these guidelines
a programmatic priority. Access to third-line
have the potential to further reduce HIV-related
regimens for PLHIV who fail on second-line
mortality, improve the quality of life, reduce
regimens should be considered too. Scaling-
the number of people acquiring HIV infection
up viral load monitoring is vital to adequately
and enhance treatment effectiveness. The
identify treatment failure and to avoid switching
benefits accumulated from implementing
unnecessarily to second-line or third line
them are likely to considerably outweigh the
regimens. Viral load monitoring is also likely to
upfront investment needed and have the
play a central monitoring role in places in which
potential to fundamentally change the course
ART is being broadly expanded to reduce HIV
of the epidemic. Nevertheless, domestic
incidence.
factors (such as budget cuts, shortage of ARV
drugs, and attrition of trained health workers
and emergence of drug resistance) and
7.6. Roles and responsibilities
external contingencies (such as withdrawal of
As the response to HIV involves a wide diversity
external financial support, political instability,
of actors, coordination at various levels of
and natural disasters) could negatively affect
the system becomes important to ensure
their implementation. It is essential to design
coherence and cohesion of efforts. HIV program
strategies to mitigate such events so that
managers should ensure effective coordination
continued service delivery can be assured,
with other health programs, among the HIV
especially for those most in need.
activities in the health sector and those in other
Implementations sectors, and between the different levels of the
health system (National, regional and district).
At the virtue of epidemic control with low
prevalence among the general population, it Ministry of Health
is critical to identify opportunities to expand
access to HIV prevention, testing, treatment, The role of Ministry of Health is to lead and
and care including case identification using coordinate the health system which includes
high yield strategies focusing to key and priority to provide policy guidance, regulation, ensuring
populations. accountability for health, capacity building,

172
resource mobilization (domestic and external) Ethiopian Public Health Institute (EPHI)
for HIV, health intelligence and building
partnership across all health actors. EPHI will have a leading role in strategic
information generation and ensure quality
The Ministry of Health should also ensure that laboratory services for the national HIV/AIDS
health services are quality and equitable; the response. The institute has also greater role in
HIV program managers should serve as a leader, monitoring and coordinating the third 95 target
manager, coordinator, facilitator, innovator, and of the response through uninterrupted viral load
liaise regularly with other health program and monitoring services.
HIV actors.
Ethiopian Pharmaceutical Supply Agency
The role of Ministry of health has been (EPSA)
decentralized up to Woreda /district/ and
community levels. For effective implementation EPSA has leading role in supply chain
and follow-up, national strategic plans must management of HIV related commodities and
be linked and cascaded to all levels. RHB and ensuring uninterrupted supply.
Zonal/Woreda Health Offices are mandated to
manage and coordinate the operation of primary Ethiopian Food and Drug Authority (EFDA)
health care services at the respective levels;
they are responsible for planning, financing, EFDA has the lead role in quality control of the
monitoring, and evaluating of all HIV programs HIV commodities and services.
and service deliveries in the regions and zones/
Partners
Woredas and community levels.

The roles and responsibilities of local and

Federal HIV/AIDS prevention and control
international partners include:
office (FHAPCO)

■ Technical and financial support for

FHAPCO has a role of leading the HIV primary
implementation of the newly adopted and
prevention and overall coordination of the
existing innovative HIV interventions.
national HIV prevention and control program,
domestic and external resource mobilization for
■ Participate in the national and regional HIV
HIV, ensure partnership with various government
program coordination mechanisms.
ministries, regional president’s, non-
governmental organizations, and people living ■ Support the joint planning, monitoring and
with HIV, faith-based organizations, and private evaluation of the different program areas.
sector and development partners. Respective
multi-sectoral response coordinating units at
sub-national levels will play leading role in HIV
primary prevention and over all coordination of
the response.

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CSO/FBOs/CBOs response against HIV/AIDS is coordinated by
Federal HIV/AIDS Prevention and Control Office
CSOs/FBOs/CBOs are responsible for with leadership of MOH, the National AIDS
implementation of HIV prevention, care and council and Management board on top. The
treatment interventions at grass-roots level. high level coordination mechanism includes
They are responsible for building community National AIDS Council meeting, Joint Planning
capacity and mobilizing communities to and Review Meeting with key sectors.
plan, implement, and monitor & evaluate the
response. They also have key role in reaching Donor coordination mechanisms
KPPs with intervention articulated in this
guideline and taking part in community led Some funding agencies, such as the Global
monitoring of the response. Fund to fight AIDS, TB and Malaria, the
President’s Emergency Plan for AIDS Relief
7.7. Coordination mechanisms (PEPFAR) and other donors have own types of
mechanisms for coordinating their in-country
Coordination in the health sector efforts. However, the health sector is involved
and often a key member of these coordinating
High level coordination mechanisms such as mechanisms and should always work to ensure
the executive committee which is composed consistency and harmonization.
of the Minister, state ministers, and director
generals of agencies, Joint Consultative Forum Stewardship and advocacy for the HIV
(JCF) meetings are held regularly between response in other sectors
MOH and donors, Health Sector Joint Steering
Committee, which involves the heads of The health sector can provide the evidence
the Regional Health Bureaus, oversee the necessary to leverage action for HIV in other
performance of different programs in the health sectors. The Ministry of Health and Federal
sector. The committee is chaired by senior HHIV/AIDS prevention and control office have
officials in the Ministry of Health and provides a crucial role in using its stewardship and
general guidance to the health sector. Technical advocacy power to ensure that HIV issues are
level coordination between health programs addressed in all policies. This includes engaging
might occur through technical advisory/working ministries of education, social development,
groups. gender, transport, and other strategic sectors.

Multi-sectoral Coordination

The HIV response needs multi-sectoral

collaboration with different social and
development sectors. The multi-sectoral

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CHAPTER EIGHT:
MONITORING AND EVALUATION
8.1. Introduction to HIV/AIDS Program Monitoring & Evaluation (M&E)

Effective HIV prevention, care and treatment activities/processes, outputs, outcomes and
require standardized recording and reporting impact. In addition, selection of indicators needs
system. Recording and reporting is used to to be through full participation of stakeholders
systematically monitor and evaluate progress and maintaining relevance and comparability.
of program performance.
The process needs also to utilize past and
The reporting of HIV prevention, care and existing data collection efforts (e.g. DHS, BSS
treatment activities is integrated into the DHIS-2 and Sentinel Surveillance) to assess national
and all forms and registers are standardized trends.
in line with it throughout the country. Health
facilities are the primary sources of data. The main sources of data for HIV monitoring
Any information concerning PLHIV should be could be:
recorded completely and correctly. Recording ■ Routine data sources such as DHIS2, CBS,
and reporting tools should be kept neat and EMR-ART
maintained properly.
■ Surveys like EDHS and EPHIA
This guide on monitoring and evaluation of HIV
in the health sector brings together the various ■ Estimations such as Spectrum, CSA
elements of monitoring and evaluation systems estimates and research
for HIV program.
4. Routine Monitoring: For HIV results at all
In order to establish a functional national HIV levels to be measured, the entire spectrum of
M&E system, the following key elements are input, output, outcome and impact data are
important. needed. Input and output monitoring data are
important, as these answer questions about
1. Presence of an M&E unit: Established M&E
the resources and interventions needed and
unit with qualified staff and enough budget.
provided, and whether planned programs have
The unit also needs to build links with regions,
been implemented. Input and output monitoring
sector ministries, research institutions, NGO,
data are collected through routine monitoring
FBOs, civil associations and donors.
systems. A plan for data collection and analysis:
2. Clear goals and objectives of the program: An overall national level data collection and
It needs well-defined national program goals, analysis plan is important. The plan also has to
objectives and targets where regular reviews/ address data collection and analysis systems at
evaluations of the progress of the implementation lower levels.
of the National/Regional program is undertaken.
5. A clear plan for data dissemination and
Guidelines and guidance need to be put in place
use: Establishment of an overall national level
on the M&E to regions and sectors.
data dissemination plan is important.
3. A core set of indicators and targets: It is
important to identify priority/core indicators and
additional indicators that cover program inputs,

175
8.2. Key Indicators

1. Number of individuals receiving Pre-Exposure Prophylaxis

Number of individuals, inclusive of those newly enrolled, that received

Definition oral antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV
infection during the reporting period.

Number of clients that received Pre-exposure Prophylaxis during the

Formula
reporting period

This indicator intends to measure number of clients who are taking

PrEP within the reporting period.

It counts the number of individuals that received PrEP at ANY point

during the reporting period. It includes those who have been enrolled
Interpretation in the previous period and receiving PrEP and those who are newly
enrolled in the reporting period. It excludes those who have been
enrolled to PrEP but stopped taking it due to different reasons.

Use of PrEP may cease once an individual is no longer at risk for HIV.
Once they cease taking PrEP, they will not be counted.

PrEP New and PrEP Current

Age
Sex
Disaggregation
Client Category:
■ Female sex workers (FSW)
■ Discordant Couples

Sources PrEP Register and Tally Sheet

Reporting level HC/ Clinic/ Hospital

Reporting
Monthly
frequency

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2. Number of persons provided with Post-Exposure prophylaxis

Number of persons provided with post-exposure prophylaxis (PEP)

Definition for risk of HIV infection through occupational and/or non-occupational
exposure to HIV.

Number of persons provided with post-exposure prophylaxis (PEP)

Formula
for risk of HIV infection as per the national guideline.

The indicator can be generated by counting the number of individuals

receiving PEP for occupational and non-occupational purposes. And
individuals should only be counted if they have received PEP drugs.
PEP services for occupational exposure include a comprehensive
package of services for occupationally exposed health care workers
and patients. PEP services for non-occupational exposure include
sexual violence.
Interpretation Individuals should be counted only if they have received PEP drugs (in
accordance with national protocols). This indicator does not intend to
capture the type and quality of PEP services provided. PEP services
include first aid, counseling, testing, provision of ARVs, medical
care, trauma counseling, linkages with police, and other follow-up
and support. Simple monitoring of PEP availability through program
records does not ensure that all PEP-related services are adequately
provided to those who need them.

Exposure type:
■ Occupational,
Disaggregation
■ Sexual Violence
■ Other non-occupational

Sources Post Exposure Prophylaxis Register

Reporting level HC/ Clinic/ Hospital

Reporting frequency Monthly

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3. Percentage of people living with HIV who know their status.

Definition Percentage of people living with HIV who know their status

Number of people living with HIV who know their status

Formula X 100
Estimated Number of people living with HIV
This indicator can be used as a proxy for the first 95 target of the 95-
95-95 HIV targets. It is Critical to determine the proportion of people
living with HIV who know their HIV status, as this knowledge is the
entry point to the continuum of care for PLHIV. The three 95s are:
■ 1st 95 = 95% of all people living with HIV will know their HIV
status.
■ 2nd 95 = 95% of all people with diagnosed HIV infection will
receive ART
■ 3rd 95= 95% of all people receiving antiretroviral therapy will have
viral suppression
The numerator should be the sum of:
Interpretation
■ PLHIV who were reported as currently on ART in the previous
reporting month
■ Total new HIV positives identified through HTS in the reporting
period
■ Total number of lost in the reporting period.
Limitation of this indicator: This indicator may miss those previously
identified positives and who are alive and not started on ART. At onal,
Woreda and facility levels, it is difficult to get estimates of PLHIV to
compute the first 95. Therefore, these levels should monitor HCT
uptake (Number of people tested for HIV) and its yield (Number of
people tested positive for HIV).
Age/Sex
HIV test result: Positive, Negative
Testing modality: VCT, PITC, ICT
Disaggregation
Population groups: FSW, IDUs, Long distance drivers, Mobile worker
/Daily Laborers, Prisoners, OVC, Children of PLHIV, Partners of PLHIV,
Other PPs (Widowed, Divorced, Separated, Re-Married), General
population
Sources PITC tally and VCT register, PMTCT Register, ART register
Reporting level HC/ Clinic/ Hospital
Reporting frequency Monthly

178
4. Number of individual HIV self-test Kits Distributed

Definition It is the number of HIV self-test kits distributed

Numerator: Number of individual HIV self-test kits distributed

Formula
Denominator: N/A

This indicator aims to monitor trends in the distribution of HIV self-

test kits at the lowest distribution point. HIV self-testing refers to
a process in which a person collects his or her own specimen (oral
fluid or blood), performs an HIV test, and then interprets the results.
This is often done in a private setting, either alone or with a trusted
person. HIV self-testing is a screening test and requires self-testers
with a reactive (preliminary positive) result to receive further testing
from a trained provider using a validated national testing algorithm.
HIV self-testing approaches range from unassisted self-testing
(with limited or no instruction provided) to directly assisted self-
Interpretation
testing (where a testing provider demonstrates how to use the
self-test kit). Self-test kits can be distributed in various ways (i.e., by
providers or outreach workers, over the counter, etc.). Secondary
distribution of HIV self-test kits may also occur (e.g., to partners of
ANC attendees, or clients of FSWs). Data for the numerator should
be generated by counting the number of individual HIV self-test
kits distributed and NOT the number of individuals receiving an HIV
self-test kit. Data is captured and reported at the lowest distribution
point. This is to prevent double counting between the various higher
supply chain levels.

Type of self-testing: Directly assisted and Unassisted

Number of Test kits distributed by Age/Sex
■ Total Number of clients reported having reactive self-test result
Disaggregation by Age/Sex
■ Total Number of clients reported having reactive result and
confirmed to conventional HIV testing service (HTS) using the
national algorithm Age/Sex

Sources Self-Test Register (KP Register)/HTS Logbook

Reporting level HP/HC/Clinics/Hospital

Reporting frequency Monthly

179
5. Proportion of STI cases tested for HIV

Definition Proportion of STI cases tested for HIV in the reporting period.

Number of STI cases tested for HIV in the reporting period

Formula X 100
Total number of STI cases in the reporting period

This indicator is intended to provide information on the proportion

of STI cases that are tested for HIV. It is helpful to measure the
magnitude of the HIV and STI co-infection and to intensify the HIV
Interpretation prevention interventions. It also helps to track the number of STI
cases. Additionally, the proportion of STI cases detected can be tracked
by dividing the number of detected STI cases by the estimated number
of STI cases in the catchment area.

HIV test result (Positive/Negative) by Age/Sex: <15M/F, >15 M/F

Disaggregation
By syndrome type/Age /Sex: <15M/F,>15 M/F

Sources PICT Tally, OPD and IPD registers

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

6. Number of newly identified HIV positive adults and children clients linked
to treatment and care

Definition Number of adults and children linked to care and treatment

Number of clients linked to care and treatment in the reporting

Formula
period

Programmatically very important to monitor the status of newly

identified HIV positives clients before initiate ART. In addition, helps
Interpretation
to track variation between newly identified positive and those who
started treatment in a specified period.

By Age/Sex
Disaggregation
Pregnancy Status: pregnant, non-pregnant

Sources Positive tracking Register

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

180
7. Percentage of people living with HIV receiving ART

Percentage of adults and children currently receiving antiretroviral therapy

Definition
(ART)
Number of adults & children receiving ART at the
end of the reporting period
Formula X 100
Estimated number of people living with HIV

This indicator measures the ongoing scale-up and uptake of ART and
retention in ART programs as a critical step in HIV service provision
and assesses progress towards coverage of ART. It also measures the
progress towards providing antiretroviral therapy to all people living with
HIV and the extent to which ART needs are met. Provision of Antiretroviral
therapy has been shown to reduce HIV-related morbidity and mortality
among those living with HIV, and onward HIV transmission. This indicator
measures the 2nd 95 target.
Data for this indicator is generated by counting the number of adults and
children who are currently receiving ART in accordance with the nationally
approved treatment protocol at the end of the reporting period. Patients
who have died, stopped treatment, transferred out, lost (patient not seen
for 1 to 3 months from last visit) and dropped out (patient not seen for >
Interpretation
3 months from last visit) are NOT counted. Patients on ART who initiated
or transferred in during the reporting period should be counted. Some
people pick up several months of antiretroviral medicines (ARVs) at one
visit, and efforts should be made to include these people in the numerator
as receiving antiretroviral even if they do not attend the clinic in the last
month of the reporting period.
As it will be difficult to get the PLHIV estimate or the expected number
of individuals who know their status at the Zone/woreda and lower
levels, this indicator will be calculated at these levels based on the target
allocation during the planning phase. This indicator includes currently
receiving ART clients at ART clinic and those currently receiving ART at
PMTCT clinic. All PMTCT only sites are expected to report ART currently
receiving clients on monthly basis.
Age/Sex by Regimen:
ARV Dispensing Quantity by Months of dispensing Age/Sex:
■ <3 months of ARVs (not MMD) dispensed to patient by: <15 F/M, 15+
Disaggregation F/M,
■ 3-5 months of ARVs dispensed to patient by: <15 F/M, 15+ F/M,
■ 6+ months ARVs dispensed to patient by: <15 F/M, 15+ F/M,
Pregnancy Status: pregnant, non-pregnant
Sources ART Register, PMTCT register, ART regimen tally, EMR-ART Software
Reporting level Heath center /Clinic/ Hospital
Reporting frequency Monthly

181
8. Number of adults and children with HIV infection newly started on ART

Number of adults and children newly enrolled on antiretroviral

Definition
therapy (ART) in the reporting period

Number of adults and children newly enrolled on antiretroviral

Formula
therapy (ART) in the reporting period

The indicator measures the ongoing scale-up and up-take of ART

program This measure is critical to monitor along with number of
patients currently on ART in relation to the number of PLHIV that
are estimated to be eligible for treatment to assess progress in the
Interpretation program’s response to the epidemic in specific geographic areas and
population as well as at the national level.
This indicator includes newly initiated clients at ART clinic and
those newly started ART at PMTCT clinic. All PMTCT only sites are
expected to report ART new initiation on monthly basis.

Age/Sex by Regimen
Disaggregation
Pregnancy Status: pregnant, non-pregnant

ART Register, PMTCT register, ART regimen tally, EMR-ART

Sources
Software

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

182
9. ART retention rate

Percentage of adults and children known to be on treatment 12 months

Definition
after initiation of antiretroviral therapy (net current cohort)
Number of adults and children who are still on
treatment at 12months after initiating ART
Formula Total number of adults and children who started X 100
ART in the 12 months prior to the beginning of the
reporting period
This indicator measures the proportion of adults and children with HIV
known to be on treatment 12 months after initiation of antiretroviral
therapy and it is one important measure of program success and is a
proxy for overall quality of program.
The Numerator: Number of adults and children still alive and on ART at
12 months after initiating treatment. A 12-month outcome is defined as
the outcome (i.e. whether the patient is still alive and on ART, dead or lost
to follow-up) 12 months after starting. The numerator does not require
patients to have been on ART continuously for the 12-month period.
Patients may be included in the numerator (and denominator) if they have
missed an appointment or drug pick-up or temporarily stopped treatment
during the 12 months since initiating treatment, as long as they are
recorded as still being on treatment at month 12. On the contrary, those
patients who have died, stopped treatment, or been lost to follow-up as of
12 months since starting treatment are not included in the numerator. The
number of adults and children on ART at 12 months includes patients who
Interpretation have transferred in (and their initiation date is known) at any point from
initiation of treatment to the end of the 12-month period and excludes
patients who have transferred out during this same period to reflect the
net current cohort at each facility.
The Denominator: Number of adults and children in the ART start-
up groups initiating ART at 12 months prior to the end of the reporting
period (The denominator is the total number of adults and children in the
(monthly) ART start-up groups who initiated ART at a point 12 months
prior to the beginning of the reporting period, regardless of their 12-month
outcome. This includes all patients, both those on ART as well as those
who are dead, have stopped treatment or are lost to follow-up at month
12. Again, the denominator includes patients that have transferred in (and
their initiation date is known) and excludes patients that transferred out
during the time period.
The net current cohort is the number of patients in the start-up group plus
any transfers in, minus any transfers out.

Age/Sex by Regimen
Disaggregation
Pregnancy Status: pregnant, non-pregnant

Sources ART Register, PMTCT register, ART regimen tally, EMR-ART Software

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

183
10. Number of ART Clients Interrupted Treatment

Number of ART patients (who were on ART in the previous reporting

Definition month) and then had no clinical contact for greater than 28 days since
their last expected contact

Number of ART patients (currently on ART) with no clinical contact or

Formula ARV pick-up for greater than 28 days since their last expected clinical
contact or ARV pick-up

This indicator is intended to: (1) help better understand fluctuations

or steady growth in Currently on Treatment over time, (2) encourage
tracing of patients when a patient has had no clinical contact for
greater than 28 days since their last expected contact and (3)
promote timely identification of patient outcomes among patients
Interpretation
known to have missed clinical visits or drug pickups. Serious and
repeated attempts should be made to reengage any such patients
and return them to treatment. In case of death, mortality data should
be analyzed and investigated to determine causes of death, where
possible.

Outcome by Age/Sex
Died by Age/Sex
Lost after on Treatment for <3 months by Age/Sex
Disaggregation
Lost after on Treatment for >3 months by
Transferred Out by Age/Sex
Refused (Stopped) Treatment by Age/Sex

Sources ART Register, PMTCT register, ART regimen tally, EMR-ART Software

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

11. Proportion of PLHIV currently on Differentiated Service Delivery Model (DSD)

Total number of eligible/stable Adults on 1st line regimen currently on DSD

Definition
in the reporting period
Total Number of Clients on DSD
Formula X 100
Total number of eligible/stable Adults on 1st line regimen

Important for service follow up and to show the performance of

Interpretation
differentiated HIV Service Delivery
Age/Sex: <15M/F,>15 M/F
Disaggregation
By different models: ASM, FTAR, CAG, PCAD
Sources DSD Register and Tally Sheets
Reporting level Heath center /Clinic/ Hospital
Reporting frequency Monthly

184
12. Viral load suppression

Percentage of patients on ART with a suppressed viral load (<50 copies/

Definition
ml) in the past 12 months

Number of ART patients with suppressed VL results (<50

copies/ml) documented within the past 12 months
Formula X 100
Number of ART patients with a VL test result documented
within the past 12 months

This indicator could provide information that can contribute to quality

improvement activities designed to maximize rates of viral suppression in
patients on ART and prevent the acquisition of HIV drug resistance. The
viral load of patients receiving ART provides an indication of adherence
to treatment, patient compliance with disease monitoring and the quality
of care delivered. Measuring viral suppression is a key programmatic
indicator related to effective treatment. It helps as a proxy indicator to
monitor the third 95 of UNAIDS’ 95-95-95 treatment target, that 95%
of people receiving ART will have viral suppression by 2030. For the
Interpretation numerator: It is the actual number of PLHIV on ART that have a document
suppressed VL result at the end of the reporting period. It is expected
that viral load testing should be routine rather than episodic. If there is
more than one VL result for a patient during the past 12 months, the most
recent result should be reported.

For the denominator: It is the actual number of PLHIV on ART that have
documented VL test. Only patients who have been on ART for at least 3
months should be considered. Note: Viral load tests for PMTCT clients
should also be included in this indicator.

By Age/Sex
Disaggregation
By Pregnancy status: non-pregnant and pregnant or breastfeeding

Sources ART and PMTCT registers

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

185
13. Proportion of clinically undernourished People Living with HIV (PLHIV) who received
therapeutic or supplementary food

The proportion of individuals receiving therapeutic or supplementary food

Definition among those whose nutritional status was assessed and found to be
undernourished
No. of clinically undernourished PLHIV on ART who received
therapeutic or supplementary food
Formula X 100
No. of PLHIV on ART who were nutritionally assessed &
found to be clinically undernourished.
Provision of nutritional treatment, care and support for those
undernourished PLHIVs is important to prevent morbidity and mortality.
Under nutrition significantly increases mortality risk for HIV-infected
individuals regardless of treatment status. Among the clinically
undernourished PLHIVs, those with severely undernourished (SAM)
cases will receive the Ready-To-Use Therapeutic Food (RUTF) and
those with moderately undernourished (MAM) cases receive Ready-To-
Supplementary Food (RUSF) based on availability of supplies.
Severe Acute Malnutrition (SAM):
Adult: -BMI less than 16 kg/m2.
Pregnant and lactating: -MUAC less than 19 cm
Children: -under 5: MUAC <11cm or WFH (weight for height) <70%
or median <- 3 Z score,
Interpretation
5-18 years of age: BMI -for-Age <-3 z-score
Moderate Acute Malnutrition (MAM):
Adult: BMI 16-18.49 kg/m2
Pregnant and lactating: MUAC 19-23 cm
Children: -under 5: MUAC 11cm to <12cm or WFH (weight for height/
length) <-3 Z or ≥ 70% to < 80% median or ≥ -3 Z to < -2 Z score
5-18 years of age: BMI-for-Age between -2 and -3 z-score
Normal/No Under nutrition:
Adult: BMI >18.5, or MUAC >23cm,
Children: WHZ >-2 or WHM>80%, MUAC ≥ 12 cm,
BMI for Age: 5-18 years >-2 Z- score.

Nutritional Status (MAM and SAM) by Age / Sex

Disaggregation
Pregnancy status: Non-pregnant and Pregnant,

Sources ART Register, PMTCT register, ART regimen tally, EMR-ART Software

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

186
14. Percentage of non-pregnant reproductive age women living with HIV on ART using a
modern family planning method

Percentage of non-pregnant women living with HIV on ART using a

Definition
modern family planning method

Number of non-pregnant women on ART aged 15-49 Years

reporting the use of any method of modern family planning
Formula X 100
Total number of non-pregnant women on ART aged 15-49
Years

This indicator will be used to monitor HIV/FP integration at ART sites.

This indicator is a subset of contraceptive prevalence rate but focuses
specifically on HIV-infected women to measure progress in prong 2
(“prevent unwanted pregnancies among women living with HIV”)
of the four prongs of PMTCT. Preventing unintended pregnancies
in women living with HIV is a critical step towards reducing mother-
to-child transmission and is a core component of the international
standards for a comprehensive approach to PMTCT. Inherent within
this indicator is the principle that integrated HIV/FP program activities
Interpretation must respect a client’s right to make informed decisions about her
reproductive life. This means that clients should have access to an
appropriate and comprehensive range of contraceptive options; and/
or to safer conception/pregnancy counseling depending upon their
fertility desire and intentions. All non-pregnant PLHIV women on ART
reporting the use of modern contraceptive irrespective of where the
service provided will be reported as using modern family planning
method. All non-pregnant PLHIV women on ART reporting the use of
modern contraceptive irrespective of where the service provided will
be reported as using modern family planning method.

Age
Disaggregation
Method: Injectable, Implant, IUD, Other methods

Sources ART Follow-up form, ART Registers and EMR-ART

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

187
15. Proportion of patients enrolled in HIV care who were screened for TB

The proportion of patients on ART who were screened for TB during

Definition
the reporting period

Number of patients on ART whose TB status was

assessed during the reporting period
Formula X 100
Total number of eligible patients on ART who had visit
during the reporting period

PLHIV enrolled in HIV care includes all those continuing in care and
those newly enrolled during the reporting period. The numerator is
taken from ART registers by counting the number of patients whose
TB status was assessed during the reporting period. Any patient who
started on ART during the reporting period should be counted in the
ART register. The denominator is those currently on ART during the
reporting period. It is taken from ART registers by counting the number
of patients with a visit during the reporting period.
This indicator is intended to provide information on the proportion of
Interpretation HIV positive patients in HIV care and treatment who are screened for
TB at the last visit. It measures the burden of known TB co-morbidity
among people in HIV care. It might be used in drug supply planning
for ART drug substitution in people treated for TB. An increase in this
indicator suggests that a higher proportion of HIV patients are being
screened for TB and other increased efforts such as: developing
a standard screening algorithm, training HIV staff, revising cards/
registers, etc. A decrease in this indicator suggests that a lower
proportion of PLHIV are being screened for TB and alert the program to
make the appropriate decision to improve the service.

Age/Sex: <15M/F, 15+ M/F

Start of ART by Screen Result:
Disaggregation
■ New on ART/Screen Positive
■ Previously on ART/Screen Positive

Sources ART Follow-Up form, ART Registers and EMR-ART

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

188
16. Proportion of ART patients who started on a standard course of TB
Preventive Treatment (TPT)

Proportion of ART patients who started on a standard course of TB

Definition
Preventive Treatment (TPT) in the reporting period

Total number of adults and children previously enrolled

in HIV care who start (are given at least one dose of) TPT
Formula during the reporting period. X 100
Total number of eligible adults and children previously
enrolled in HIV care during the reporting period

All clients eligible for TPT in the previous reporting period should be
initiated on treatment.. It helps to determine TPT consumption /uptake
Interpretation
/Backlog clearance of TPT among patients previously enrolled on ART
and in filling gaps in determining national TPT coverage.

TPT Status by Age, Sex and Type of Prophylaxis:

■ TPT Started in the reporting period
INH<15 F/M, 15+ F/M
Disaggregation 3HP<15 F/M, 15+ F/M
■ Enrolment status
■ Among New on ART
■ Among Currently on ART

Sources ART Register, Follow-Up form, individual record form, EMR-ART

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

189
17. Proportion of ART patients who completed Standard Course of TB
Preventive Treatment (TPT)

Proportion of ART patients who started on a standard course of

Definition TB Preventive Treatment (TPT) in the previous reporting period and
completed therapy

Number of patients completed TPT in the reporting period

Formula X 100
Number of ART patients initiated on any course of TPT
during the previous reporting period

This indicator measures the performance of HIV programs in scaling

up TPT, with the goal of preventing progression to active TB disease
among PLHIV and decreasing ongoing TB transmission in this
population. ART patients should be monitored for proper completion
and the effectiveness of the TPT initiative in the HIV/AIDS program. As
part of a cascade from treatment current to TB screening, this indicator
will inform programs on the pace of scale-up, and the proportion will
allow for monitoring of cohorts through completion of therapy.
Interpretation
The numerator is generated by counting the number of PLHIV on ART
from the previous reporting period who were documented as having
received at least six months of IPT or having completed any other
standard course of TPT (such as 3-HP).
The denominator is generated by counting the total number of
patients who were started on ART who were started on any course of
TPT during the reporting period prior to the one being reported.

TPT Status by Age, Sex and Type of Prophylaxis:

■ TPT Started in the reporting period
■ INH<15 F/M, 15+ F/M
Disaggregation ■ 3HP<15 F/M, 15+ F/M
a. TPT Completed in the current reporting period
■ INH<15 F/M, 15+ F/M
■ 3HP<15 F/M, 15+ F/M

Sources ART Register, Follow-Up form, EMR-ART

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

190
18. Proportion of HIV positive women (15+) on ART screened for Cervical Cancer

Proportion of HIV- positive women on ART screened for Cervical Cancer

Definition
during the reporting period

Number of HIV-positive women on ART screened for Cervical

cancer during the reporting Period
Formula X 100
Total Number of women (15+) on ART Eligible for cervical
cancer screening during the reporting Period

This indicator is vital for understanding and estimating the demand for
screening services and forecasting and planning for the resources required
to meet that demand and the resulting treatment needs. Disaggregation
enhances sensitivity of this indicator in order to help identify the need for
further outreach, as well as trigger further situational investigation at lower
levels of the health system. Cervical Cancer screening and treatment
should be analyzed together at the woreda or sub-regional level that
includes sites where both screening and treatment would occur, in order
to monitor the percentage of positive women who receive treatment
Interpretation
while accounting for patient referrals between facilities.
The term “Eligible” in the denominator refers to those HIV-positive
women – only women being screened for the first time in their lifetime or
re-screened after 2 years negative cervical cancer screening test result or
post-treatment follow-up screening.
For Visual inspection of cervix with acetic acid (VIA) the benchmark of 5%-
25% screen-positivity for women (aged 30-60) screened for the first time
should be used when monitoring performance.

Screening Visit Type and Result by Age:

1st time screened (Negative, Positive, Suspected Cancer) by age
45-49, 50+, Unknown Age
Disaggregation
■ Re-screened after previous negative (Negative, Positive, Suspected
Cancer) by age
■ Post-treatment follow-up (Negative, Positive, Suspected Cancer) by age

Follow-Up form, Cervical Cancer Screening and Treatment Register, EMR-

Sources
ART

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

191
19. Proportion of women (15+) on ART Cervical Cancer screen –
positive who received Treatment

Proportion of cervical cancer screen-positive women who are HIV-positive

Definition and on ART eligible and who received cryotherapy, thermocoagulation or
LEEP during the reporting period

Number of HIV-positive women on ART cervical cancer screen-

positive who received treatment during the reporting period
Formula X 100
Total 15+ women on ART who are cervical cancer screen
positive during the reporting period

This indicator is vital to capture the number of individual HIV-positive

women on ART who required and received treatment for precancerous
cervical lesions. Cervical cancer screening and treatment should be
analyzed together at the woreda or sub-regional level that includes sites
where both screening and treatment would occur, in order to monitor the
Interpretation percentage of positive women who receive treatment while accounting
for patient referrals between facilities.
The globally accepted benchmark of at least 90% eligible for treatment
of precancerous lesions receiving treatment should be used when
monitoring performance.

Disaggregation Screening Visit Type and Treatment Type by Age:

Follow-Up form, Cervical Ca Screening individual record form, EMR-

Sources
ART

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

192
20. Proportion of PLHIV on ART Screened for Viral Hepatitis

Proportion of PLHIV on ART screened for Viral Hepatitis during the

Definition
reporting period

Number of PLHIV on ART screened for Viral Hepatitis during

the reporting period
Formula X 100
Total Number of PLHIV on ART eligible for Viral Hepatitis
screening during the reporting period

PLHIVs are among high-risk groups for hepatitis infection. Higher

prevalence of hepatitis infection is reported among HIV co infected
individuals.
This indicator measures the burden of Hepatitis infection among PLHIV.
It also helps to generate data to enhance the compelling efforts in
awareness creation and promotion of safer sex as part of the overall
national HIV prevention and control efforts. It also helps to understand
Interpretation and estimating demand for hepatitis screening services, forecasting, and
planning for the resources required to meet that demand and the resulting
treatment needs. Screening and treatment should be analyzed at woreda
/zonal or regional levels which includes sites where both screening and
Treatment would occur. It also helps to assess Progress in implementing
the health sector response to viral hepatitis. Eligibility and frequency
of screening could be determined based on the national strategy for
prevention and control of Viral hepatitis.
Status of Test result by Age/Sex:
Pos _HBV: <15 M/F >=15 M/F
Disaggregation
Pos_HCV, <15 M/F >=15 M/F
Neg: <15 M/F,>=15 M/F

Sources Hepatitis Testing and Treatment Register

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

193
21. Proportion of PLHIVs diagnosed with Hepatitis infection who received treatment

Proportion of PLHIV screened and diagnosed with Hepatitis B and C

Definition
infection who received treatment in the reporting period

Number of hepatitis screen - positive PLHIV on ART who

received Treatment in the reporting period
Formula X 100
Total Number of hepatitis screen –positive PLHIV on ART in the
reporting period

PLHIVs are among high risk groups for hepatitis infection. Higher
prevalence of hepatitis infection is reported among HIV-coinfected
individuals.
Interpretation This indicator helps to monitor whether PLHIV requiring (eligible for)
treatment for hepatitis B and C infection received treatment. It helps
to assess Progress in implementing the health sector response to viral
hepatitis

Status of Test result by Age/Sex:

Pos _HBV: <15 M/F >=15 M/F
Disaggregation
Pos_HCV , <15 M/F >=15 M/F
Neg: <15 M/F ,>=15 M/F

Sources Comprehensive Lab Register (Serology) and Treatment Register

Reporting level Heath center /Clinic/ Hospital

Reporting frequency Monthly

194
22. Percentage of Key and Priority Population (KPP) members reached with HIV defined
packages of services who were linked to HTS providing facilities

Percentage KPP members reached with HIV defined packages of services

Definition
who were linked to HTS providing facilities

Number of KPP members who were linked to HTS providing

facilities
Formula X 100
Number of KPP members reached with HIV prevention defined
packages of services

This indicator can be used as a proxy for the quality of community-based

HIV prevention services. It is critical to determine the proportion of KPP
members reached with defined HIV prevention packages who are linked
for HTS service as these are hard to reach population who can mostly be
accessed through their peer service providers.
The denominator should be the sum of:
1 KPP members reached with defined HIV prevention packages
through peer service providers
2) KPP members reached with defined HIV prevention packages
Interpretation through facility-based modalities (e.g. KPP friendly clinics)
3) KPP members reached with defined HIV prevention packages
through other community-based service provision modalities including
DICs, CSOs
The numerator should be the number of KPP reached with the HIV
prevention packages and linked to HTS providing facilities.
Please refer to key and Priority Populations HIV prevention Minimum
Service Package (FHAPCO, January 2019).
Limitation of this indicator: data incompleteness might be a problem
because it is collected from multiple sources.

By Population groups: FSWs, PWID, Prisoners, High risk AGYW, Long

Disaggregation distance drivers, Workers in hot spot areas, Widowed and Divorced men
and women and partners of PLHIV

Sources Community HIV prevention SBCC Register

Reporting level Community based services providers/ WoHO

Reporting frequency Monthly

195
23. Percentage of KPPs tested HIV positive at community programs
who were linked to care and treatment

Percentage of KPPs tested HIV positive at community programs who

Definition
were linked to care and treatment

Number of identified HIV positive KPP members linked to care

and treatment during the reporting period
Formula X 100
Number of KPP members tested HIV positive at community
programs during the reporting period

This indicator can be used as a proxy for the quality of community-based

HIV prevention services. It is critical to determine the proportion HIV
positive KPP members identified positives at community level who are
Interpretation linked to care and treatment to be enrolled in ART.
Limitation of this indicator: data incompleteness might be a problem
because it is collected from multiple sources.

By Population groups: FSWs, PWID, Prisoners, High risk AGYW, Long

Disaggregation distance drivers, Workers in hot spot areas, Widowed and Divorced men
and women and partners of PLHIV

Sources Community HIV Testing Register

Reporting level Community based services providers/ WoHO

Reporting frequency Monthly

196
8.3. Data reporting, data flow and quality assurance

Routine HIV HMIS data are assembled and next level. Annual reports include additional
reported on a monthly, quarterly and annual data that are not collected quarterly. These
basis. Facilities aggregate and review their reports follow the same line and principles
data monthly and report to their respective of disaggregation as the quarterly reports.
facility and administrative offices quarterly. Data aggregation methodology is maintained
The administrative office aggregates the throughout the reporting chain so that it is
data it receives, adds its own administrative possible to disaggregate data by facility type
figures, and monitors its own performance and ownership even at the federal level. DHIS-2
based on these reports and self-generated Data flow from the facilities to the federal level
data. It then forwards the DHIS-2 report to the is depicted below.

Figure 8.1 HMIS data flow and feedback loop

8.3.1. Data quality assurance

Data quality check is one of the components elements from the monthly reports are checked
of the M&E system. Once data are collected, against the register or source of the report. The
the data are checked for any inaccuracies and findings are then compared to a standard Data
obvious errors at every level. The data quality Accuracy Table. The same procedure is done at
assurance (DQA) is done at two levels: facility district health offices on quarterly basis before
level and administrative level (district health the data are sent to the next higher reporting
offices). At facility level, such a mechanism is unit. Hence, in HMIS all reports are quality
the Lot Quality Assurance Sampling (LQAS) checked at every level, from the healthcare
methodology which is done on monthly basis. institution to the federal level.
In this procedure randomly selected data
197
8.4. HIV/AIDS Program Monitoring
8.4.1. Supportive Supervision

Supervision aims at ensuring and improving with workable solutions for the problems and
quality, effectiveness and efficiency of challenges encountered. They are key elements
services provided; it should also enhance for program management. Furthermore, review
competence and satisfaction of the staff at meetings are forums for exchange of ideas and
all levels. Supervision consists of observation, experiences among the health professionals
discussion, support and guidance. Since it is an and program coordinators. In these meetings,
essential tool in the management of staff and program coordinators from the next lower levels
facilities, it should be done on a regular basis. will present activity reports of their respective
The overall aim of supervision is the promotion area, including major achievements and
of continuous improvement in the performance challenges or constraints encountered during
of the staff. the period under review. Integrated review
meeting is conducted on regular bases at every
Supervisions at all levels are conducted in an level. In this manner, activities taking place at
integrated manner using standardized checklist all levels will then be brought forward to the
clearly identified in the Integrated Supportive respective review meeting sessions where HIV
Supervision (ISS) guideline. It is done from and TB/HIV program performance is reviewed
every administrative level to the respective as part of the overall review meeting.
office and health facility. The ISS guideline
shows the actual process of implementation, 8.5. Other Monitoring
team composition and checklist. Considerations
Besides ISS, in-depth HIV program-specific Programs are increasingly moving beyond
supervisions using standardized HIV and TB/ coverage indicators to focus on critical
HIV supportive supervision tool can also be outcomes, such as viral load suppression and
conducted whenever critical gaps that require immune reconstitution, and on the broader
intensive technical approach are identified impact of HIV treatment, including HIV-related
during the ISS. mortality and HIV incidence. However, programs
also need to measure potential unintended
8.4.2. Program Performance Review
outcomes, such as HIV drug resistance and
Review meetings organized at various levels ARV-related toxicities. Periodic evaluations and
create a very good opportunity to review implementation research are also central to
the status of program implementation, reviewing programs.
achievements and challenges and come up

198
Evaluation, including impact and program 8.6. Recording and reporting
performance, and implementation research Tools in HIV/ AIDS Program
Routine monitoring should be complemented Different tools are used for routine recording
by systematic evaluations and program reviews and reporting of HIV /AIDS Program. List of
to assess the performance and effects of HIV recording reporting tools used includes : HTS
programs, either comprehensively or with Logbook ,PrEP register, PEP register , VCT
respect to specific priority areas. Social science register ,HIV Self-test Register , OPD /IPD
and implementation research are important registers , Positive Tracking Register , PMTCT
to assess perceptions and values of service register , ART register ,EMR-for ART , Follow-
recipients and communities along with barriers, up forms , DSD Register, VL Register , Cervical
facilitators and experiences in delivering and Cancer Screening and Treatment Register,
receiving services. Impact indicators, such as Hepatitis Screening and Treatment Register
incidence, morbidity and mortality, are often and Tally sheets( PITC/VCT/ICT/DSD/Clinical
difficult to measure. Care) .

Mathematical modeling is often undertaken to

project various scenarios for program planning
and evaluating impact. Ensuring the availability
of robust data is especially important when
estimating the prevention impact of ARV drugs
at the population level, as multiple sources of
information and uncertainty come into play.
Specific data collection efforts and models for
particular contexts may provide more accurate
estimates.

199
200
CHAPTER NINE: ANNEXES
Annex 1: KP Minimum Service Package

Frequency Resources
Provider Support Formats and HIV
KP Minimum Services Package of Service (Equipment / Remarks
Tools Registers Coordination
Delivery Supplies)

I. Community based KP Outreach Services

Providing peer education (home based) on HIV ■ Peer Navigator

benefits of HIV Counseling and Testing including Outreach activity
HIVST by Trained Peer Navigators. monitoring
Daily
Register
Distributing of male condoms.
(Amharic
Distributing IEC / BCC Materials Version)
■ HIVST Client
Organizing and forming - up support groups (Positive information ■ Peer Navigator
Once ■ HIVST kits
and Negative FSWs) card HIVST Register
Conducting LTFU tracing (For HIV Positive FSWs who ■ Condoms (Amharic
Daily ■ KP mapping Version)
lost from treatment & declined to be enrolled) Peer
tool
■ Penile model Navigators
Updating data on mapping of venues, FSWs hotspot ■ Peer Navigator
sites ■ Service one to one HE
■ Leaflet &
Quarterly directory Template
Conducting an update on FSWs distribution broachers

Following – up of the migration / movement of FSWs ■ Peer Navigator

Monthly
Reporting
Monthly outreach activity reporting to facility KP focal Template
Monthly
person
 Frequency Resources
Provider Support Formats and HIV
KP Minimum Services Package of Service (Equipment / Remarks
Tools Registers Coordination
Delivery Supplies)

II. Health Facility Based KP Friendly Clinical Services

A. HIV Services Accessibility & Acceptability

All FSWs have the right to choose receiving KP

friendly service at public, private and NGO health Clients
facilities.

All HIV prevention, testing, care & treatment HF CEO/

services should be provided at KP-DSD friendly Medical
clinical service clinic. Director

KP-DSD services should provide by ART & KP trained

nurse and/or health officer.
■ Roles and
All HIV prevention, testing, care & treatment Responsibilities HF Medical
services to be available during off working hours of Health Care director
(Lunch break and Weekends). Providers
24 Hours ■ Poster at the ■ KP Workflow
/7 Days gate Chart
All FSWs & their sexual partners should be screened ■ Roles and
and Offred HIV testing & prevention services. Responsibilities
of Peer KP Service
All FSWs who doesn’t wish to come HFs should Navigators Providers &
offer directly assisted HIVST using PNs and PNs
Unassisted HIVST for those who doesn’t want to be
assisted.

KP friendly community outreach service will be

provided by trained Peer Navigators.
HF Medical
director
KP friendly clinical service will be provided by trained
health professional.

201
 Frequency Resources

202
Provider Support Formats and HIV
KP Minimum Services Package of Service (Equipment / Remarks
Tools Registers Coordination
Delivery Supplies)
B. HIV Testing & Prevention Services for HIV Negative FSWs
Conduct Retesting of HIV Negative FSWs every six
months
■ HIV rapid ■ HIV Negative
■ Post Test
Conduct Screening, diagnosing and managing STIs FSWs Follow Up
test & HIVST Counseling
using the Syndromic Case Management approach Card
kits Wall Chart
■ PrEP screening
Conduct Screening, diagnosing and managing TB ■ STI’s Drugs ■ STI’s
tools for
Syndromic
24 Hours eligibility
■ Condom & Management KP Service
Promoting on and providing Family Planning Services
/7 Days FP methods Wall Charts Providers
including male condoms. ■ HIVST Register
Promoting and providing Pre- Exposure Prophylaxis ■ ARV drugs ■ CEMs for ■ PrEP Register
(PrEP) services for PrEP &
PrEP
PEP ■ KP Register for
Promoting and providing Post Exposure Prophylaxis
(PEP) services HIV Negative
FSWs
Promotion and provision of Gender Based Violence
(GBV) services
C. HIV Prevention, Care & Treatment Service for HIV Positive FSWs
Referring and linking HIV Positive FSWs for HIV Care ■ HIV Reporting
and Treatment Services. ■ Chair ■ Post-Test Form
Counseling
Conducting initial and follow up adherence ■ Guest chairs Wall Chart ■ IPV Risk
assessment
Screening Tool
Provide 3MMD ART for newly diagnosis FSWs and ■ Tables ■ STIs
6MMD ART for previously enrolled HIV Positive Syndromic ■ Referral Forms
24 Hours ■ Shelves Management
FSWs.
/7 Days Examination Wall Chart ■ ART register
Conduct Screening, diagnosing and managing STIs Coach
using the Syndromic Case Management approach. Speculum ■ Linkage to ■ ART FU Card
(medium & Care Flow
Conduct Screening, diagnosing and managing TB.
large size) Chart
■ ASM Register
Promoting and providing mental illness screening
and management
 Frequency Resources
Provider Support Formats and HIV
KP Minimum Services Package of Service (Equipment / Remarks
Tools Registers Coordination
Delivery Supplies)
Promoting and providing cervical cancer screening
and management 24 Hours ■ Examination ■ LTFU Tracking ■ VL Monitoring ART & KP
gloves SOP Register Service
Promoting and providing Family Planning Services /7 Days
Providers
including male condoms. ■ Penile model ■ ART Desktop
Reference ■ HVL FU
Promoting and referring HIV Positive pregnant FSWs Register
■ Condoms
to access PMTCT services
b(Males) ■ P & FB ICT
Counseling ■ VL Request
Promoting and providing Pre- Exposure Prophylaxis
■ HIV Testing Script Form
(PrEP) services for partners of HIV Sero-discordant
couples. kits including
HIVST ■ P & FB ICT
■ P & FB ICT Register
Promoting and providing Post Exposure Prophylaxis
(PEP) related services ■ Waste SOP
disposal ■ P & FB ICT
Conducting intimate partner violence (IPV) risk Screening Tools
screening and Post Violence care (PVC) services items (for
including referrals. IP) ■ PrEP Register
Complete HIV case based reporting form for
■ PrEP FU card
assessing clients for eligibility for recency testing.
Conducting HIV recency testing for all eligible FSWs. ■ HIVST Register
Promoting and providing P & FB ICT services ■ Mental Health
Conducting HTS for all HIV Positive Index-FSWs Illness Screening
elicited HIV unknown status contacts. Tools

Offering Unassisted HIVST for all HIV Positive Index- ■ Referral Register
FSWs elicited HIV unknown status contacts who
doesn’t wish to come HFs.
■ Retesting
Conducting viral load test every 6, 12 and 12 months. Register
Promoting and providing EAC sessions for HVL
FSWs.
Referral service for support groups for HIV Positive
FSWs.

203
 Annex 2: Immunization schedule for HIV exposed infants

204
Route/Site of
S/NO Vaccines Target diseases to be prevented Age
administration
At birth or within 24 hours of birth.
Hep-B Vaccine Birth If child is born out of HFs or at
1 Hep B Virus Infection IM, left anterolateral Thigh
dose home, track baby and vaccinate
until the age of 14 days.

At Birth or as soon as possible

2 BCG Severe forms of Tuberculosis
after birth

Meningitis and pneumonia associated with Intramuscular (IM), Right

3 PCV Weeks 6,10 & 14
Streptococcus pneumonia bacteria anterolateral thigh

4 OPV Poliomyelitis Birth (OPV0), weeks 6,10 & 14 Oral drops

IM, right anterolateral thigh

5 IPV Poliomyelitis Week 14 2.5 cm apart from the
injection site of PCV
Diphtheria, Pertussis, Meningitis, and
pneumonia associated with Hemophilus
6 DPT-Hib-Hep-B Weeks 6,10 & 14 IM, Left anterolateral thigh
influenzae bacteria and Liver disease due to
Hepatitis B virus.

Measles containing Subcutaneous (SC), Left

7 MCV 9 and 15 months
vaccine deltoid

8 Rota virus vaccine Rota virus associated gastero-enteritis. Weeks 6 & 10 Oral only
 Annex 3: Growth curves

205
206
207
208
209
210
Annex 4. Instruction for MUAC measurement

211
 Annex 5a. HIV Risk assessment tool for children <15 years of age

212
Name ______________ Age ______ Date: ____/ ___/ ____

For a child <18 months of age

A. Mother’s HIV status
If Negative……… No action
Known:
If Positive………...Test child unless mother is on PMTCT care and child/infant is on follow up.

B. Mothers HIV status

Test mother and decide according to the above options (“A”)
Unknown
C. If Child is orphan Test the child
For a Child > 18 months of age
1. Unknown
Step 1. Assess for Child’s HIV Status 2. Known Positive & on ART
3. Negative
Step 2. If Child’s HIV status is unknown, assess for the criteria below: If “Yes” to one of them, Child is eligible for HIV testing. Test the child.

1. Are child’s biological parents living with HIV? Y  N

2. Is the child Orphan or vulnerable with unknown parental HIV status? Y  N

3. Is the child diagnosed to have ANY ONE of the following? (If yes tick) ()
■ Confirmed or suspected TB ( ),
■ Recurrent lower respiratory infections (pneumonia) of > 2 in the past 6 months ( ),
■ Prolonged fever (> 2 weeks) ( ),
■ Chronic ear discharge ( ),
■ Chronic or recurrent diarrhea ( ),
■ Recurrent or extensive skin lesion ( ),
■ Severe malnutrition or failure to thrive ( ),
■ Developmental delay / regression ( ),
 4. Unexplained poor-health in the last three months. Y  N 

5. History of repeated admissions to hospital for medical illnesses. Y  N 

If the child is older than 10 years of age (10 to 14 years)

6. Is the child having ANY ONE of the following? (If yes tick) ()

■ Is the child sexually active or sexually exploited? ( )

■ Is the child living on street? ( )
■ Is the child leading a family? ( )
■ Does the child use substance or alcohol? ( )
■ Is the child out of school or missed schools repeatedly? ( )
■ Does the child have history of STI? ( )

If Yes or () to any one the above, child is Eligible for HIV testing. Test the child. Eligible  Non Eligible 
HIV test result

Positive  Negative 

213
 Annex 5b. HIV Risk assessment tool for adults and adolescents > 15 years of age

214
Direction: Evaluate clients using the tool and offer HTS services if a client is eligible. Note that a known HIV positive client should not
be tested for HIV and a client who received HIV testing less than 3 months ago may not need HIV testing. Please refer to the current
consolidated HIV Prevention, Care and Treatment guideline for details.

MRN: ……………………… Age: ……… Sex: …… Date: ………/………/………

Exam room: ………….
1. OI’s & Vulnerability Status
1.1. Does the client have clinical signs/symptoms of HIV/AIDS? (Refer clinical S/S Job aid):
Yes  No  if yes offer HTS. If no, go to number 1.2.
1.2. Is the client a partner or biological child of an index case?
Yes  No  if yes offer HTS. If no, go to number two.
2. Marital Status
2.1. Is the client divorced or Widowed or widower?
Yes  No  if yes offer HTS.If no, go to number three.
3. KP/PP; Others
3.1. Does the client have Occupational HIV risk or other risks stated below?
Yes  No  if yes offer HTS.
{1. Female sex worker, 2. Prisoners, 3. PWID, 4. Long distance truck driver, 5. High risk
workers in hotspot areas, 6. Daily laborer and mobile workers, 7. Others: GBV survivors,
Homeless/street dweller; having multiple sexual partners; Substance and Alcohol abuse.}

KEY: if “yes” (√) to one of the criteria, Patient/client will be eligible for HIV testing
Conclusion: Eligible …………… Non-Eligible …………………….
 Annex 6a. Clinical Conditions that make eligible for HIV Testing Service in adults and adolescents

■ Persistent Generalized Lymph adenopathy ■ Unexplained pancytopenia ( anemia -< 8gm/dl,

neutropenia<
■ Unexplained weight loss ( > 10% of body weight )
■ 0.5*109 , or thrombocytopenia < 50*109 /L)
■ Unexplained persistent hepatosplenomegaly
■ PCP ( Pneumocystis (Jirovicini ) Pneumonia )
■ Unexplained Chromic diarrhea > 1 month
■ Esophageal Candidiasis (candidiasis of Trachea , Bronchi or
■ Recurrent Respiratory tract Infections ( sinusitis, tonsillitis,
Lungs )
otitis media , pharyngitis )
■ Extra Pulmonary Tuberculosis
■ Herpes Zoster
■ Kaposi Sarcoma
■ Angular Cheilitis
■ CMV Infections ( Retinitis or infection of Other Organs )
■ Recurrent Oral ulcerations
■ CNS Toxoplasmosis
■ Popular Pruritic Eruptions
■ Extra pulmonary Cryptococosis (eg . Meningitis )
■ Fungal nail Infections
■ Disseminated Non tuberculosis mycobacterial Infections
■ Seborrheic Dermatitis
■ PML ( Progressive Multi focal Leukoencephalopathy )
■ Unexplained Persistent Fever > 1 month
■ Chronic Isosporiasis
■ Persistent oral candidiasis
■ Chronic Crypto Sporadiosis )
■ Oral Hairy Leukoplakia Pulmonary TB.
■ CNS Lymphoma ( B_ Cell NHL )
■ Recurrent /Severe Bacterial Infections ( Pneumonia ,
Empyema, ■ Recurrent Septicemia ( Including non-typhoid Salmonella)
■ Pyomyosities, Bone or joint Infections , meningitis , ■ Invasive Cervical Carcinoma
Bacteremia)
■ Visceral Leishmaniosis
■ Atypical Disseminated Leishmaniosis

215
 Annex 6b. Clinical Conditions that make eligible for HIV Testing Service in children

216
■ Persistent Generalized Lymphadenopathy ■ PCP ( Pneumocystis jiroveci Pneumonia )
■ Unexplained persistent hepatosplenomegaly ■ Recurrent severe bacterial infections (Empyema,
Pyomyosities, Bone or joint Infections , meningitis ,
■ Recurrent or chronic upper respiratory tract infections (Otitis Bacteremia excluding pneumonia )
media, Otorehea, sinusitis, tonsillitis )
■ Esophageal Candidiasis (candidiasis of Trachea , Bronchi or
■ Herpes Zoster Lungs )
■ Lineal gingival erythema ■ Extra Pulmonary Tuberculosis

■ Recurrent oral ulceration ■ Kaposi Sarcoma

■ CMV Infections ( Retinitis or infection of Other Organs with
■ Popular Pruritic eruptions
onset at age more than 1 month )
■ Fungal nail Infections
■ CNS Toxoplasmosis ( after neonatal period)
■ Extensive wart virus infections ■ Extra pulmonary Cryptococosis (eg. Meningitis )
■ Extensive molluscum contagiosum ■ Disseminated Non tuberculosis mycobacterial Infections
■ Unexplained malnutrition( moderate or severe ) not ■ PML ( Progressive Multi focal Leukoencephalopathy )
responding to therapy ■ Chronic Isosporiasis
■ Unexplained persistent diarrhea (> 14 days ) ■ Chronic Crypto Sporadiosis )
■ Unexplained persistent fever (>1month) ■ CNS Lymphoma ( B_ Cell NHL )
■ Persistent oral candidiasis ( after 6weeks of life) ■ Symptomatic lymphoid Interistial pneumonitis

■ Oral hairy leukoplakia ■ Acute necrotizing ulcerative gingivitis

■ Unexplained anemia , neutropenia or chronic
■ Lymph node TB Pulmonary TB
thrombocytopenia
■ Severe recurrent pneumonia
 Annex 6b. Clinical Conditions that make eligible for HIV Testing Service in children

■ Excessive dryness of the skin (Xerosis cutis)

■ Scabies
■ STI (Sexually Transmitted Infections)
■ Herpes Zoster
■ Popular Pruritic Eruptions
■ Fungal nail Infections (Dermatophytosis, thrush, deep fungal infections)
■ Seborrheic Dermatitis
■ Kaposi Sarcoma
■ Bacterial Skin Infections (Cellulitis, Impetigo, Carbuncle)
■ Viral Infections (Recurrent Herpes Simplex infections on the mouth, Genital Herpes Simplex Infection)
■ Genital warts

217
Annex 7: Dosage of antiretroviral drugs for adults and adolescents

Nucleoside reverse-transcriptase inhibitors (NRTIs)

Abacavir (ABC) 300 mg twice daily or 600 mg once daily

Emtricitabine (FTC) 200 mg once daily

Lamivudine (3TC) 150 mg twice daily or 300 mg once daily

Zidovudine (AZT) 250−300 mg twice daily

Nucleotide reverse-transcriptase inhibitors (NtRTIs)

Tenofovir (TDF) 300 mg once daily

Non-nucleoside reverse-transcriptase inhibitors (NNRTIs)

Efavirenz (EFV) 400−600 mg once daily

Etravirine (ETV) 200 mg twice daily

Proteases inhibitors (PIs)

Atazanavir + ritonavir (ATV/r) 300 mg + 100 mg once daily

800 mg + 100 mg once dailya or 600 mg + 100 mg twice

Darunavir + ritonavir (DRV/r)
dailyb

Lopinavir/ritonavir (LPV/r) 400 mg/100 mg twice daily

Considerations for individuals receiving TB therapy

In the presence of rifabutin, no dose adjustment required.

In the presence of rifampicin, adjusted dose of LPV/r:
LPV 800 mg + RTV 200 mg twice daily or LPV 400 mg +
RTV 400 mg twice daily).or, SQV/r (SQV 400 mg + RTV
400 mg twice daily), with close monitoring.

Integrase strand transfer inhibitors (INSTIs)

Dolutegravir (DTG) 50 mg once daily

Raltegravir (RAL) 400 mg twice daily

a For individuals with no previous use of protease inhibitors.

b For individuals with previous use of proteaseinhibitors.

218
 Annex 8: Dosage of antiretroviral drugs in children
Table 8a: Solid and oral liquid formulations for once-daily dosing for infants and children > 4 weeks of age

Dose as number
Formulations (tablet, Dose as number of tablets by weight band of tablets or ml by
capsule or oral liquid) and Adult tablets & weight band
Drug
strength (mg/tab. or mg/ strength in mg
ml for liquids) 25- 30-
3– 5.9Kg 6-9.9kg 10-13.9kg 14-19.9kg 20-24.9kg
29.9kg 34.9kg

DTG 50mg tablet - - - - 1 50mg 1 1a

10mg tablet (scored,

DTG** 0.5 1.5 2 2.5 Use the film coated DTG 50mg tablet, 1 tablet daily.
dispersible)

600mg tablet - - - 1 1
DRV b 600mg 1 1
150mg tablet - - - 4 4

25mg tablet 4 4
RTV c 100mg 1 1
50mg tablet 2 2

120mg/60mg
ABC/3TC 1 1.5 2 2.5 3 1 1
(scored, dispersible tablet) 600mg/300mg

60mg/30mg 600mg/300mg
ABC/3TC 2 3 4 5 6 1 1
(scored, dispersible tablet)

200mg tablet - - 1 1.5 1.5 200 tab 2 2

EFV d
50mg capsule - - 4 6 6 600mg

219
220
Table 8b: Solid and oral liquid formulations for twice-daily dosing for infants and children > 4 weeks of age

Dose as number of tablets/capsules or ml by weight band, morning (AM) and Dose by

Formulations (tablet,
evening (PM) Adult tablets and weight band
capsule or oral liquid)
Drug 3 – 5.9Kg 6-9.9 kg 10-13.9kg 14-19.9kg 20-24.9 kg their strength in 25 – 34.9 KG
and strength (mg/tab.
mg
or mg/ml for liquids) AM PM AM PM AM PM AM PM AM PM AM PM
Solid formulations
120mg/60mg
ABC/3TC 0.5 0.5 0.5 1 1 1 1 1.5 1.5 1.5 600mg/300mg tab 0.5 0.5
(scored, dispersible tab)
60mg/30mg
AZT/3TC 1 1 1.5 1.5 2 2 2.5 2.5 3 3 300mg/150mg tab 1 1
(scored, dispersible tab)
100mg/25mg tablet - - - - 2 1 2 2 2 2 - 3 3
b,c
LPV/r 40mg/10mg oral pellets
2 2 3 3 4 4 5 5 6 6 200mg/50mg 2 1
per capsule
DRV 75mg tablet - - - - - - 5 5 5 5 - - -
RTV 25mg tablet - - - - - - 2 2 2 2 100mg tab 2 2
100 mg, chewable tablet - - - - - - 1 1 1.5 1.5 1 1
RAL 400mg tab
25mg, chewable tablet 1 1 2 2 3 3 4 4 6 6 1 1
Liquid formulations
AZT 10mg/ml 6ml 6ml 9ml 9ml 12ml 12ml - - - - - -
NVP d 10mg/ml 5ml 5ml 8ml 8ml 10ml 10ml - - - - - -
LPV/r e 80mg/20mg/ml 1ml 1ml 1.5ml 1.5ml 2ml 2ml 2.5ml 2.5ml 3ml 3ml - -
RTV 80mg/ml 0.5ml 0.5ml 0.5ml 0.5ml 0.5ml 0.5ml - - - - - -

c RTV should only be used as a boosting agent in combination with DRV.

d Two EFV 50mg capsules is administered in combination with EFV 200mg tablet for children weighing 14-24.9KG.
 Annex 9: Pediatric ARV drug formulations, side effects and special considerations in children

Drug / Formulation Dosing recommendation and instructions Side Effects

Nucleoside reverse transcriptase

Lamivudine (3TC) : Instruction for dosing/administration: Side effects of 3TC:

■ Can be given with food. Common: head ache, nausea, abdominal
Formulations: Fixed-Dose
■ For those who can’t swallow whole tablet, dispersible tablets can pain.
Combination Tablets
be dissolved with 2 teaspoons (10ml) water in a small and clean Less common: pancreatitis, neutropenia,
■ With Abacavir : container and taken immediately. increased LFTs.
3TC60mg+120mgABC, ■ Scored tablets can be broken to administer lower doses for younger Hepatitis may exacerbate after
children as recommended in the national ART guidelines. discontinuation of lamivudine in the
scored and dispersible
Note: setting of chronic Hepatitis B virus
tablet ■ Adult formulations are to be used for children older than 10 years infection. For those patients with HBV
With Zidovudine : with body weight > 35kg. and HIV co-infection please consult “the
■ Please see dosing Chart for dose recommendation. national guideline on management of HBV
■ Storage: infection-2021.”
■ Can be stored at room temperature

Abacavir (ABC) : Instruction for dosing/administration: Side effects of ABC:

Formulations: Fixed-Dose ■ Can be given with food. Common: head ache, GI upset and rash.
Combination Tablets ■ For those who can’t swallow whole tablet, dispersible tablets can Less common: lactic acidosis,
be dissolved with 2 teaspoons (10ml) water in a small and clean hepatomegaly with steatosis.
With Lamivudine : container and taken immediately. Life threatening: potentially fatal
■ Scored tablets can be broken to administer lower doses for younger hypersensitivity reaction (fatigue, rash,
ABC120mg+3TC60mg, scored
children as recommended in the national ART guidelines. nausea and vomiting, sore throat, joint and
and dispersible tablet
Note: muscle pain, cough, and dyspnea).
■ Adult formulations are to be used for children older than 10 Occurrence of hypersensitivity reactions
years with body weight > 35kg. requires immediate and permanent
■ Please see dosing Chart for dose recommendation. discontinuation of ABC.
Storage: Advise patients/care givers what to do if
hypersensitivity reactions occur at home.
■ Can be stored at room temperature
DO NOT re-challenge after hypersensitivity
reaction.

221
222
Drug / Formulation Dosing recommendation and instructions Side Effects

Zidovudine (AZT or ZDV) Instruction for dosing/administration: Side effects of AZT:

■ Can be given with food. Common: neutropenia, anemia,
Formulations:
■ The syrup is for infant prophylaxis. granulocytopenia, macrocytosis, and head
Oral solution, 50mg/5ml, 100 ml ■ For those who can’t swallow whole tablet, dispersible tablets can ache.
be dissolved with 2 teaspoons (10ml) water in a small and clean Less common: myositis, myopathy,
container and taken immediately. mitochondrial disease.
■ Scored tablets can be broken to administer lower doses for younger
children as recommended in the national ART guidelines.
Note:
■ Adult formulations are to be used for children older than 10 years
with body weight > 35kg.
■ Please see dosing Chart for dose recommendation.
Storage:
■ Can be stored at room temperature
■ Syrup is light sensitive, store in a brown glass jar and protect from
sun light.

Nucleotide reverse transcriptase inhibitor

Tenofovir (TDF) TDF is only approved for use for children 2 years and older. Target dose: Chronic kidney disease
8 mg/kg or 200 mg/m2 (maximum 300 mg). Acute kidney injury and
In case of TDF toxicity, substitute with AZT or ABC. Do not initiate TDF Fanconi syndrome
at eGFR <50 mL/min.
Decreases in bone mineral density
Lactic acidosis or severe hepatomegaly
with steatosis
 Drug / Formulation Dosing recommendation and instructions Side Effects

Non-nucleoside reverse transcriptase:

Efavirenz (EFV) Instructions for dosing/administration: Side effects of EFV:

Formulations: ■ Used only for children > 3 yrs. Common: skin rash, dizziness, somnolence,
Efavirenz 200 mg, scored tablet. ■ Can be given with food but avoid administration with a high-fat meal insomnia, abnormal dreams, confusion,
because of potential for increased absorption that leads to CNS hallucinations, impaired concentration,
Efavirenz 50 mg, tablet or
toxicity. psychosis, seizures, and suicidality.
capsule
■ Bedtime dosing is recommended, particularly during the first 2 to 4 Less common: increased LFTs.
weeks of therapy, to improve tolerability of central nervous system
side effects.
■ Scored tablets can be broken to administer lower doses for younger
children as recommended in the national ART guidelines.
■ Efavirenz can be swallowed as a whole capsule or tablet. For
children who can’t swallow the whole capsule/tablet, the capsule
content can be administered by sprinkling on food to avoid/mask
peppery taste of EFV.
For sprinkling:
■ Hold capsule horizontally over a small container and carefully twist
to open to avoid spillage.
■ Gently mix capsule contents with 1–2 teaspoons of an age-
appropriate soft food (e.g. yogurt or banana or infant formula milk) at
room temperature.
■ Administer the mixture that contains the sprinkle using a 10-mL
syringe.
■ After administration, an additional 2 teaspoons of food or infant
formula must be added to the container, stirred, and dispensed to
the patient.
Note:
■ Adult formulations are to be used for children older than 10
years with body weight > 35kg.
■ Please see dosing Chart for dose recommendation.

Storage:

223
■ Can be stored at room temperature.
224
Drug / Formulation Dosing recommendation and instructions Side Effects

Nevirapine (NVP) Instructions for administration: Side effects of NVP:

Formulations: Can be given with food. Common: skin rash, head ache, nausea,
Nevirapine oral syrup, 50mg/5ml The syrup is for infant prophylaxis diarrhea. Patients should be warned of rash.
(10mg/ml) Do not escalate dose if rash occurs.
Storage:
Less common: increased LFTs.
Store at room temperature.
Life threatening: Steven Johnsons
syndrome, TEN, fatal hepatitis.
For SJS and TEN discontinue drug and do
not re-challenge.

Protease Inhibitors

Lopinavir ( LPV) Instructions for administration: Side effects of LPV

Formulations: ■ Do not administer to neonates before a post-menstrual age of 42 Common: diarrhea, head ache, nausea,
Combined with Ritonavir: weeks and a postnatal age of at least 14 days. vomiting,, increase in blood lipids
Oral syrup, (LPV ■ Should be taken with food. Less common: pancreatitis, diabetes,
80mg+RTVLPV20mg)/ml ■ For the capsules: open the capsules, add the pellets from the hyperglycemia, hepatic toxicity, fat
capsule content onto small soft or milk (not more than 2ml) and redistribution.
Oral pellets,
(LPV40mg+Ritonavir10mg) / administer immediately.
capsule ■ Tablets should not be opened or crushed, swallow whole. Tablets
Tablet, are for older children.
(LPV100mg+Ritonavir25mg) ■ Liquid has low volume but bitter taste.
Caution: Multiple drug interactions.

Note:
■ Adult formulations are to be used for children older than 10
years with body weight > 35kg.
■ Please see dosing Chart for dose recommendation.

Storage:
■ For the syrup, store it in a refrigerator at least until dispensed. Can
be stored at room temperature (250C) for 60 days.
■ For tablets and oral pellets, store at room temperature.
 Drug / Formulation Dosing recommendation and instructions Side Effects

Ritonavir (RTV) Take with food to increase absorption and reduce GI side effects. Side effects of RTV:
Formulations: Oral solution must be refrigerated. Common: N/V, diarrhea, headache,
Combined with Lopinavir or Can be kept at room temperature (250C) if used within 30 days. abdominal pain, anorexia
Atazanavir: Bitter taste, coat mouth with peanut butter or chocolate milk. Less Common: circumoral paraesthesia,
increased LFTs, lipodystrophy, elevated
cholesterol and triglycerides, hyperglycemia.

Danuravir (DRV) Substitute with LPV/r. When it is used in third-line ART, limited options Hepatotoxicity; severe skin and
75 mg tab; chewable tablets 25 are available. For hypersensitivity reactions, substitute with another hypersensitivity reactions
mg; 100 mg/ml liquid therapeutic class.

225
 Annex 10: Grading of toxicity in adults and adolescents

226
Grade 4 (Severe life-threatening
Item Grade 1 (Mild toxicity) Grade 2 (Moderate toxicity) Grade 3 (Severe toxicity*)
toxicity)

■ Marked limitation in ■ Life-threatening, extreme

activity, some assistance limitation in of activity,
usually required, significant assistance
■ Transient or mild medical intervention/ required, significant medical
■ Moderate limitation of intervention/ therapy
discomfort, no therapy required, and
activity, some assistance required, hospitalization/
Peripheral limitation of activity. hospitalization possible.
might be needed. hospice care.
neuropathy ■ No medical ■ Severe discomfort and/
■ Non-narcotic analgesia ■ Incapacitating or not
intervention/ or severe impairment
required. responsive to narcotic
treatment required. (decrease or loss of
sensation up to knees or analgesia.
wrists) narcotic analgesia ■ Sensory loss involves limbs
required. and trunk.

Erythema multiforme or
Cutaneous/Rash/ Diffuse, maculopapular rash Vesiculation or moist suspected Stevens-Johnson
Erythema, pruritus
Dermatitis** or dry desquamation desquamation or ulceration* syndrome or Toxic Epidermal
Necrolysis (TEN).

Continue ARV; provide careful clinical monitoring; and Stop ARV and consult
Management Substitute responsible drug
consider change of a single drug if condition worsens. experienced physician.
 Annex 11- Grading of adverse events in children

Grade 4 Severe Life-

Parameter Grade 1 Mild Grade 2 Moderate Grade 3 Severe
threatening

Transient or intermittent Life-threatening

Persistent episodes of
episodes of unformed Grossly bloody diarrhea or consequences (e.g.
unformed to watery stools
Diarrhoea stools OR increase of ≤3 increase of ≥7 stools per Hypotensive shock).
or increase of 4-6 stools
stools over baseline per day or IV fluid replacement
≥1 year of age over baseline per day. Liquid stools resulting in
day. indicated.
severe dehydration with
<1 year of age Liquid stools with
Liquid stools (more Liquid stools with aggressive rehydration
increased number of stools
unformed than usual) but moderate dehydration. indicated or hypotensive
or mild dehydration.
usual in number. shock.

Persistent nausea resulting Persistent nausea with

Transient (<24 hours) or
Persistent nausea resulting in minimal oral intake for no or minimal oral intake
intermittent nausea with
Nausea in decreased oral intake for >48 hours or aggressive resulting in dehydration
no or minimal interference
24-48 hours. rehydration indicated (e.g. with aggressive
with oral intake.
IV fluids). rehydration indicated.

Persistent vomiting
Transient or intermittent
Frequent episodes of resulting in orthostatic Life threatening
vomiting with no or
Vomiting vomiting with no or mild hypotension or aggressive consequences (e.g.
minimal interference with
dehydration. rehydration indicated (e.g. hypotensive shock).
oral intake.
IV fluids).

Generalized urticaria or
Localized urticaria with
angio oedema with medical Acute anaphylaxis or life-
Acute systemic Localized urticaria (wheals) medical intervention
intervention indicated threatening bronchospasm
allergic reaction lasting a few hours. indicated or mild angio
or symptomatic mild or laryngeal oedema.
oedema.
bronchospasm.

227
228
Symptomatic and Symptomatic and Life-threatening
hospitalization not hospitalization not consequences (e.g.
Pancreatitis NA
indicated (other than indicated (other than Circulatory failure,
emergency treatment). emergency treatment). haemorrhage, sepsis).

Diffuse macular, Extensive or generalized

maculopapular, or bullous lesions or Stevens-
Diffuse macular, morbilliform rash with Johnson syndrome or
maculopapular, or vesicles or limited number ulceration of mucous
Rash Localized macular rash
morbilliform rash or target of bullae or superficial membrane involving two
lesions. ulcerations of mucous or more distinct mucosal
membrane limited to one sites or Toxic Epidermal
site. Necrolysis.

Alteration in Alteration causing no or Alteration causing greater Alteration causing inability Behavior potentially
personality- minimal interference with than minimal interference to perform usual social and harmful to self or others
behavior or usual social and functional with usual social and functional activities and or with life-threatening
mood activities functional activities. intervention indicated. consequences.

Mild lethargy or Onset of confusion,

Changes causing no or somnolence causing memory impairment,
Altered Mental minimal interference with greater than minimal lethargy, or somnolence Onset of delirium,
Status usual social and functional interference with usual causing inability to perform obtundation, or coma.
activities social and functional usual social and functional
activities. activities.

Source: Antiretroviral therapy of HIV infection in infants and children in resource-limited settings. WHO 2006
 Annex 12. Laboratory grading of adverse events in adults and adolescents (ACTG)

Laboratory Test Abnormalities

Item Grade 1 toxicity Grade 2 toxicity Grade 3 toxicity Grade 4 toxicity

Haemoglobin 8.0-9.4 g/dL 7.0-7.9 g/dL 6.5-6.9 g/dL <6.5 g/dL

Absolute
1,000-1,500 mm3 750-990 mm3 500-749 mm3 <500 mm3
Neutrophil Count

Platelets -75,0000- 99,000 50,000-74,999 20,0000-49,999 mm3 <20,000

ALT 1.25-2.5 X upper normal limit 2.5-5 X upper normal limit 5.0-10 X upper normal limit 10 X upper normal limit

Bilirubin 1-1.5XULN 1.5-2.5 X ULN 2.5-5 x upper limits of normal >5 x upper limits of normal

Amylase/lipase 1-1.5XULN 1.5-2 X ULN 2-5 x upper limits of normal >5x upper limits of normal

Triglycerides * 200-399mg/dL 400-750 mg/dL 751-1200mg/dL >1200mg/dL

Cholesterol * 1.0 –1.3 X Upper normal limit 1.3-1.6 X Upper normal limit 1.6-2.0 X Upper normal limit 2.0 X Upper normal limit

Continue ARV Stop ARV and consult

Substitute responsible drug
Repeat test 2 weeks after initial test and reassess experience physician
Management
Lipid imbalances could be managed with diet, exercise and pharmacologically with the use of fibrates.
ALWAYS SEEK EXPERT ADVICE IN CASE OF DOUBT

Grade 1 (Mild reaction): are bothersome but do not require changes in therapy
Grade 2 (Moderate reaction): consider continuation of ART as long as feasible. If the patient does not improve in symptomatic therapy, consider single-drug substitution.
Grade 3 (Severe reaction): Substitute offending drug without stopping ART. Closely monitor using laboratory and clinical parameters.
Grade 4 (Severe life-threatening reaction): Immediately discontinue all ARV drugs, manage the medical event with symptomatic and supportive therapy, and reintroduce
ARV drugs using a modified regimen (i.e. with an ARV substitution for the offending drug) when the patient is stabilized. Life-threatening toxicity includes severe
hepatitis, pancreatitis, lactic acidosis or Steven-Johnson syndrome.

229
Annex 13 -Grading toxicities in children by
selected laboratory findings

Grade 4
Grade 1 Grade 2 Grade 3
Parameter Severe Life
Mild Moderate Severe
threatening
Haemoglobin (g/
8.5 – 10.0 7.5 –<8.5 6.5 – <7.5 <6.5
dL)
ANC (mm3 ) 750 – <1,000 500 – 749 250 – 500 <250
100,000 – 50,000–
Platelets (mm3 ) 25,000 – <50,000 <25,000 or bleeding
<125,000 <100,000
ALT (SGPT) 1.25 – 2.5 x ULN 2.6 – 5.0 x ULN 5.1 – 10.0 x ULN >10.0 x ULN
AST (SGOT) 1.25 – 2.5 x ULN 2.6 – 5.0 x ULN 5.1 – 10.0 x ULN >10.0 x ULN
Bilirubin (>2
1.1 – 1.5 x ULN 1.6 – 2.5 x ULN 2.6 – 5.0 x ULN >5.0 x ULN
weeks of age)
Lipase 1.1 – 1.5 x ULN 1.6 – 3.0 x ULN 3.1 – 5.0 x ULN >5.0 x ULN
Pancreatic
1.1 – 1.5 x ULN 1.6 – 2.0 x ULN 2.1 – 5.0 x ULN >5.0 x ULN
amylase
Cholesterol
(fasting, <18 170 – <200 200 – 300 >300 NA
years old) mg/dL
Glucose, serum,
Nonfasting (mg/ 116 – <161 161 – <251 251 – 500 >500
dL)
Glucose, serum,
high: Fasting 110 – <126 126 – <251 251 – 500 >500
(mg/dL)
Increased Increased lactate
lactate with pH with pH <7.3 with
2.0 x ULN <7.3 without life threatening
<2.0 x ULN
Lactate without acidosis life threatening consequences (e.g.
without acidosis
consequences or neurological findings,
related condition coma) or related
present condition present

Triglycerides:
NA 500 – <751 751 – 1,200 >1,200
Fasting (mg/dL)

Source: Antiretroviral therapy of HIV infection in infants and children in resource-limited settings. WHO
2006

230
 Annex 14: Pediatric TB screening tool

Follow Up Visit
Children TB screening questions Date: Date: Date: Date: Date:
1. Current cough
2. Fever
3. Poor weight gain*
4. Close Contact history with TB pt.
*poor wt gain = reported wt loss, very low wt (<-3 Z-score), or underwt (< -2 Z-score), or confirmed wt loss (> 5%) since the last visit, or growth
curve flattening
Evaluation for positive TB screening
Bacteriology: date ordered
Gastric date result received
Aspirate/
Induced
sputum/ result (+, -ve, Not Done)
Sputum for AFB
date ordered
Radiology: CxR, date received
etc. result (Suggestive, inconclusive, other dx, Not
Done)
date ordered
Other: FNA, etc date received
result (+, -ve, Not Done)
TB diagnosis date: / / Circle type of TB: PTB :- smear pos, smear neg, EPTB TB Rx start date / /

Is the child eligible for IPT? Yes___ No____ If no, reason If yes, start IPT and use the chart below

Contraindications for IPT: Active TB, active hepatitis, allergy to INH, peripheral neuropathy

231
 TB Symptoms Hepatitis Sx [abd

232
Neurologic Sx Adherence
[cough, fever, pain, nausea,
[numbness, (≥95% =good;
Date INH collected failure to gain wt vomiting, Rash (yes, no) Remark
tingling, 85-94%= Fair
or wt loss] (yes, abnormal LFT]
paresthesia](yes, <85%=Poor)
no) (yes, no)

___/____/__

___/___/___

___/___/___

___/___/___

___/___/___

___/___/___

Outcome of IPT (Write Date): Completed __ /___ /____ Defaulted____ /____ /____Died ____ /____ /____ /
Interrupted for any reason______ /_______ /______
Note:
■ If there are symptoms suggesting TB during follow up, stop INH and work up for TB.
■ If there are symptoms suggesting hepatitis, hold INH. Can resume when liver function normalizes.
■ If there are neurologic symptoms, continue INH and give pyridoxine 50mg daily. This side effect is rare if the child is already on pyridoxine skin rash
is very rare, if occurs and is extensive, discontinue INH, and give anti histamine.
 Annex 15: Adult TB screening tool

Follow Up Visit
Children TB screening questions Date: Date: Date: Date: Date:
1. Current cough
2. Fever
3. Weight lose
4. Night seats
Evaluate for TB if “yes” to anyone of the above (positive TB screening)

Done = yes/no
Bacteriology: Sputum for
AFB (+/- induced)
result (+, -ve, unknown )

Done = yes/no
Radiology: CxR, etc.
Result (Suggestive, inconclusive, other dx, Not Done)

Done = yes/no
FNA, culture, ultrasound
etc
If done result

TB diagnosed Yes (write type of TB)/No

Is patient eligible for IPT Yes/No

Contraindications for IPT: Active TB, active hepatitis, allergy to INH, peripheral neuropathy

IPT start date __________________________________

233
234
TB Symptoms Hepatitis Sx [abd
Neurologic Sx Adherence
[cough, fever, pain, nausea,
[numbness, (≥95% =good;
Date INH collected failure to gain wt vomiting, Rash (yes, no) Remark
tingling, 85-94%= Fair
or wt loss] (yes, abnormal LFT]
paresthesia](yes, <85%=Poor)
no) (yes, no)

___/____/__

___/___/___

___/___/___

___/___/___

___/___/___

___/___/___

Outcome of IPT (Write Date): Completed __/___/____

Defaulted__/___ /______Died/___/____/Patient stopped______/________/______
Stopped ______/________/______ Transferred out ___/___/____
 Annex 16: Follow-up form for Clients Whose Viral Load Result >50 copies/ml

1. Patient Information

Name: _______________________Age: ___ Sex: __ UAN: _______________MRN:_____________

2. ARV Information Viral Load Results

ARV Regimen (circle the regimen type) Date of Initiation (dd/mm/yy) e.c:
1st result>50 copies/ml: _______Copies/ml Date: ____/____/____
1. 1st line ____/____/____
Date of 1st EAC1 given: ____/__/___
2. 2nd line ____/____/____
Cohort Month: _____________ (Refer High VL Register)
3. 3rd line ____/____/_____

3. Communicate the viral load test result and explain the following to the client

■ Viral Load is the number of HIV copies in the blood

■ High VL result can be due to poor adherence to medication or can be due to primary resistance.
■ When VL result is high in the blood, the CD4 count decreases, OIs will flare up and disease progresses.
■ High VL can be reduced as a result of good adherence to medication within three months.
■ Note: Enhanced Adherence Counseling(EAC) will be provided for 1st results >50 copies/ml

4. Assess current adherence to treatment and document

4.1. How many ARV dose/s do you take/day? Once or Twice

4.2. Did you miss ARV doses in the past one month? Yes/No

Adherence Rate >95%, Good 85-94%, Fair <85%, Poor

Once per day ≤ 2 doses 3-4 doses ≥ 5 doses

4.3. If yes, how many dose/s did you miss? __
(select one) Twice per day ≤ 3 doses 4-9 doses ≥ 9 doses

235
 5. Explore Medical and Psychosocial Reasons for High VL

236
5.1. Identify Medical Reasons for High Viral Load EAC-1 Session
5.1.1. Did you take other drugs than ARVs without consulting your physician? (Yes, No),
If Yes, identify the drug/s, review interaction with ARVs, counsel the client & take measure
5.1.2 Have you ever developed recurrent OIs including cough, fever, weight loss, night sweat, diarrhea, and vomiting in the past?
(Yes, No). If yes, investigate for TB and chronic diarrhea and manage
5.1.3. Have you ever developed severe ARV drugs side effects in the past? (Yes, No),
If Yes, investigate and manage for ARVs side effects.
5.1.4 Have you ever taken ART/PMTCT prophylaxis in the past prior to ART initiation? (Yes, No),
If Yes, suspect primary resistance and consult ART physician
5.1.5. Did you discontinue your ARV in the past? (Yes, No), If Yes, identify reasons and develop treatment plan with the client.
5.1.6 If the client is a child, check proper dosing for weight by reviewing chart and
readjust ARV dosing for weight
5.2 Identify Psychosocial Reasons for High Viral Load
5.2.1 Cognitive barriers: understanding and expectation - counsel and explain expected outcomes
■ What were the reason/s for missing your ARV dose/s in the past? Identify the reason/s, counsel and motivate the client
to develop medication taking plan.
5.2.2. Socio-economic barriers: lack of social support, disclosure, stigma, & poor living condition
■ Have you disclosed your HIV status to anyone? If No, provide disclosure counseling and encourage
■ Do you have treatment supporter? (Yes, No) If No, counsel to designate treatment supporter
5.2.3 Behavioral barriers: attitude, motivation, confidence & skills educate, motivate, and empower client to manage medication
taking and develop reminder
■ What do you do to remind yourself to take drugs on time?
■ Are you confident to take your ARV openly at home? If no, advise reminder mechanisms
5.2.4 Psychological/Emotional barriers: common mental illness: depression, PTSD, substance abuse, and psychosis – link to
psychiatric clinic for psychotherapy & treatment
■ Have you ever felt sad for more than 2 weeks? Have you ever lost interest in activities that usually give you pleasure for
more than 2 weeks? Have you regularly taken alcohol or chew Khat?
If yes, counsel the client to avoid alcohol and/or Khat.
 6. Follow-up EAC Sessions
Repeat three EAC Sessions for clients whose confirmatory viral load
Subsequent EAC Sessions
> 50 and ≤ to 1000 copies/ml(Low Level Viremia)
6.1. Assess current
adherence to treatment Rate at EAC-2 Rate at EAC-3 Rate at EAC-1 Rate at EAC-2 Rate at EAC-3
and circle adherence
rate >95% 85 to <85% >95% 85 to <85% >95% 85 to <85% >95% 85 to <85% >95% 85 to <85%
Good 94% Poor Good 94% Poor Good 94% Poor Good 94% Poor Good 94% Poor
Fair Fair Fair Fair Fair

6.2. If Yes, One

≤2 3-4 ≤2 3-4 ≥5 ≤2 ≤2 3-4 ≤2 ≤2 3-4 ≤2 ≤2 3-4 ≤2
how many per day
dose/s did Two
you miss? ≤3 4-9 ≤3 4-9 ≥9 ≤3 ≤3 4-9 ≤3 ≤3 4-9 ≤3 ≤3 4-9 ≤3
per day

7. Follow-up status of EAC 2 EAC 3 EAC-1 EAC-2 EAC-3

identified Reasons for
High VL Date: ___/___/_____ Date: ___/___/_____ Date: ___/___/_____ Date: ___/___/_____ Date: ___/___/_____

7.1. Medical reason/

s(y/N)
7.2 Psychosocial
7.2.1. Cognitive
barriers(Y, N):
7.2.2. Socio-economic
barriers(Y,N):
7.2.2. Behavioral
Barriers(Y,N)
7.2.3. Psychological/
emotional(Y,N):
8. Outcome of EAC Sessions

Did the patient attend all the appointments? (Yes No) If no, any reason? __________________________________________________________________________
Note: Client should have three consecutive good adherences before confirmatory(2nd) VL test
2nd Viral Load - Date ordered: __/__/___, 2nd Viral Load Result: _________ copies/ mL, Date Received __/__/___,
Measure Taken
1. Continue 1st Line, 2. Continue 2nd line 3. Continue Third line 4. Switched to 2nd Line, 5. Switched to 3rdLine

237
Comment: ___________________________________________________________ ART Physician:/ART clinician ____________________Date: ____/____/________
238
Annex 17 Cohort register for clients with unsuppressed viral load(>50copies/ml)
Cohort Register for client with Unsuppressed Vial Load(>50 copies/ml)
Facility Name: _____________________ Month:_____________________ Year:_____________________
Repeat Three
PMTCT Clinic Only 1st VL Test Code EAC Session Date 2nd VL Test
Session Reason if
for
measure
Order 1st VL Order
Pregnant Postnatal not taken
Date result Date Measure
Taken (code)
Current 1. 1= Remain
Recieved Recieved
Regimen >1000 on 1st line
Date Date
(select c/ml
2= Remain
Name Address one) on 2nd line
For clients whose 1. TO Measure
SN of UAN MRN Age Sex (Kebele & confirmatory vial Remark
1st Line Three Consecutive 3= Remain Taken Date
Client Telephone) Load >50 and
Gestational Breast EAC’s on 3rd line 2. Lost
2nd Line ≤1000 copies /ml
Age Feeding 2. >50 4= Remain 3. Died
(Low Level Viremia)
(Months) (Yes/No) 3rd Line to on 2nd line
VL Result VL Result 4. Other,
≤1000 5= Remain
c/ml on 3rd line Specify

__ / __ / __ EAC 1 __ / __ / __ __ / __ / __ EAC 1 __ / __ / __

__ / __ / __ EAC 2 __ / __ / __ __ / __ / __ EAC 2 __ / __ / __ __ / __ / __

VL= EAC 3 __ / __ / __ VL= EAC 3 __ / __ / __

__ / __ / __ EAC 1 __ / __ / __ __ / __ / __ EAC 1 __ / __ / __

__ / __ / __ EAC 2 __ / __ / __ __ / __ / __ EAC 2 __ / __ / __ __ / __ / __

VL= EAC 3 __ / __ / __ VL= EAC 3 __ / __ / __

Annex 18: Screening with VIA testing using see and treat approach

239
Annex 19: Screening with HPV testing followed by VIA triage algorithm

240
Annex 20: Brief mental health disorders symptom screening tool
and referral tool for PLHIV

Patient’s Name:_______________________________ Sex:_____ Age:_____ MRN:________________

This checklist is to assist you in assessing and making a timely referral of the client to the treatment team. All
behaviors listed below are important and should be taken seriously; they are also designed to help you decide
if you should refer the client to the treatment team for further assistance. An answer of “yes” to any one of
the following questions should prompt further referral and evaluation by the treatment team or mental health
professional. Please put a (√) to indicate a yes answer.

1. Questions to Identify Depression: In the past 3 5. Questions to Identify Substance Abuse.

months; ( ) Have you ever felt the need to cut down on
( ) Was there ever a time when you felt sad/ your use of alcohol or drugs?
hopelessness for more than 2 weeks in a row?
( ) Has anyone annoyed you by criticizing your
( ) Was there ever a time lasting more than 2 weeks use of alcohol or drugs?
when you lost interest in most things like hobbies,
( ) Have you ever felt guilty because of something
work, or activities that usually give you pleasure?
you’ve done while drinking or using drugs?
2. Questions to identify suicidal ideation: Since
( ) Have you ever taken a drink or used drugs to
your last visit [or in the last 2 months];
steady your nerves or get over a hangover (eye-
( ) Have you wished you were dead, or wished you opener)? A total of ≥2 may be suggestive of a
could go to sleep and not wake up? problem.
( ) Have you had actual thoughts of killing yourself? 6. Questions to Identify Psychosis: Observe or ask
( ) Have you ever attempted to harm/kill yourself? families whether the patient (in the last 3 months);
( ) Talking & acting strangely or becoming very
3. Questions to Identify
quiet and avoid talking.
Anxiety: In the past 3 months;
( ) Claiming to hear voices or see things that other
( ) Did you ever have a period lasting more than 1
people don’t.
month when most of the time you felt worried and
anxious? ( ) Being very suspicions, perhaps claiming that
other people are trying to harm him/her.
( ) Did you have a spell or an attack when all of a
sudden you felt frightened, anxious, or very uneasy 7. Questions to Identify Dementia: Interview the
when most people would not be afraid or anxious? patient or families whether the patient (in the last
3 months);
( ) Did you ever have a spell or an attack when
for no reason your heart suddenly started to race, ( ) Has trouble with memory.
you felt faint, or you couldn’t catch your breath?
( ) Has poor concentration.
4. Questions to Identify Mania: In the past 3
( ) Has diminished executive function.
months;
( ) Has diminished orientation to time, place &
( ) When not high or intoxicated, did you ever feel
person.
extremely energetic or elated or irritable and more
talkative than usual?

241
8. Questions to Identify Epilepsy: 9. ( ) others
( ) Did you ever have partial or generalized fits 10. No identified mental health problem
[sharp, shaky movements] accompanied by frothing
or loss of control of bowel or bladder function,
sudden loss of consciousness, and stiff limbs?

Referred by: _______________________

Date: _______________________

Feedback(confirm the assessment)

The patient has:
(___) Mental Health Disorder (specify) ________________
(___) Non Mental Health Disorder

Name of clinician: _________________________

Date: ___________________

The patient has:

(___) Mental Health Disorder (specify) ________________

(___) Non Mental Health Disorder

Name of clinician: _________________________

Date: ___________________

242
Annex 21: DSD model of HIV care client classification tool/
Assessment form

A. Client’s Current data(initial Assessment)

1. Client Name____________________ Fathers’ Name ____________________

Grand Fathers ‘Name___________________
For child only: - Mother’s /Fathers Name: ____________________________________
2. Age: _____________years/months for < 1years Sex: O M O F
3. Address: Region___________ Zone/Sub city______________Woreda_____________
Kebele _________ House No.________ Telephone ________________
4. Marital Status: O Never Married O Married O Divorced O Widowed
5. Level of education:
O No education O Primary O Secondary O Tertiary OOther/specify_________
6. Occupation: _____________
7. Client reside within the catchments area O Yes O No , If no; Counsel and encourage
for referral to a nearby facility to his/her home
8. Date ART started(EC)________________ Month on ART________________
9. Unique ART ID: _____ /_____ /________/_____________ MRN __________________
10. Current ART regimen
□ First Line Regimen:_________________ □ Date (ET) Initiated __/__/____ (dd/mm/yyyy)
□ Second Line Regimen:______________ □ Date (ET) Initiated __/__/____ (dd/mm/yyyy)
□ Third Line Regimen_______________:______________ □ Date (ET) Initiated __/__/____
(dd/mm/yyyy)
11. Current ART Adherence □ Good >95% □ Fair (85 - 94%) □ Poor <85%
12. Is the client pregnant □Yes □No Breastfeeding □Yes □No
13. CD4 count (CD4% for <5 years): Most recent (<one Year) result ____cells/ul
Date (ET) ___/___/____
14. If VL test done: Most recent (<one year) result __________ copies/ml
15. Current Clinical observations/symptoms: WHO (Treatment) Staging:
□I □ II □ III □ IV

243
B. Inclusion criteria for less intensive model

■ Patients who are on ART at least six months

■ No current illness, which does not include well-controlled chronic health conditions

■ Good understanding of life long adherence; adequate adherence counseling provided (a

patient with adherence of 95% for the last 6 months)

■ Evidence of treatment success (at least one suppressed viral load result (i.e < 50 c/ml)
and if no Viral Load result, a patient with rising CD4 cell count or CD4 cell count above 200
cells/millimeter cubes).

■ Children with age greater than five years*

■ A Patient who doesn’t have current Opportunistic Infections

■ A Patient with no adverse drug reactions and doesn’t need careful clinical monitoring.

■ A Patient who is willing or provide consent to get the ART service based on his/her
preferred DSD models.

C. Inclusion criteria for more intense

■ Patients who are on ART for < 6 months

■ A patient with Age <5 years*

■ Evidence of treatment failure (at least one low level viral load result (i.e > 50 c/ml) and if
no Viral Load result, a patient with falling CD4 cell count or CD4 cell count below 200 cells/
millimeter cubes)

■ Active current illness, which includes not well controlled chronic health conditions

■ A Patient who does have current Opportunistic Infections

■ A Patient with adverse Drug Reactions and does need careful clinical monitoring.

■ A Patient with an adherence of less than 95% for the last six months

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16. Assessed client:
1.Eligable for less intensive 2.Needs more intensive

17. Consented:
1.Yes 2.No if Consent is yes go to no.18.

18. Enrollment TO DSD Models:

1.3MMD 2. ASM/6MMD 3.FTAR 4. CAG 5.PCAD

6. DSD for Adolescent 7. DSD for KP DSD 8.DSD for MCH 9.DSD for AHD

10.Other Models Specify -----------------------