Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
Phase: NA
Conditions: HIV Infections
Sponsor: University of California, Los Angeles

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Use of HIV Self-Test Kits to Increase Identification of HIV-Infected In-
dividuals and Their Partners 
 
 
 
Sponsored by: 
USAID/PEPFAR 
 
 
 
 
 
Protocol Chair: Kathryn Dovel PhD, MPH 
 
Protocol Vice Chairs: Risa Hoffman MD, MPH and Mike Nyirenda 
 
 
 
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Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their 
Partners 
 
TABLE OF CONTENTS 
 
 
Abbreviations and Acronyms ................................................................................................. 8 
Investigators ............................................................................................................................ 9 
Schema ................................................................................................................................... 10 
1 INTRODUCTION  ...................................................................................................................................... 12 
1. 
Background..................................................................................................................................... 12 
2. 
Rationale ........................................................................................................................................ 13 
3. 
Hypotheses ..................................................................................................................................... 13 
2. 
Aim 1: Group Self-Testing ............................................................................................ 13 
2.1. Objectives ....................................................................................................................................... 13 
2.1.1. Primary Objectives: ................................................................................................... 13 
2.1.2. Secondary Objectives:................................................................................................ 13 
2.2. Study Population ............................................................................................................................. 13 
2.2.1. Inclusion Criteria ....................................................................................................... 15 
2.2.2. Exclusion Criteria ...................................................................................................... 15 
2.3. Study Design .................................................................................................................................. 15 
2.3.1. Description of Randomization and Study Arms ........................................................ 15 
Description of Study Arms .................................................................................................................................. 16 
2.3.2. Recruitment and Enrollment Process ......................................................................... 16 
Standard of care arm ............................................................................................................................................. 16 
Optimized standard of care arm  ...................................................................................................................... 17 
Group self-testing arm .......................................................................................................................................... 18 
2.3.3. Informed Consent ....................................................................................................... 19 
2.3.4. Participant Withdrawal or Termination from the Study ............................................ 19 
2.4. Study Procedures ........................................................................................................................... 19 
2.4.1. Standard of Care Arm ................................................................................................ 19 
2.4.2.1   Standard of Care ..................................................................................................................................... 19 
2.4.1.2. Demographic Data Collection .............................................................................................. 19 
2.4.2.3 Additional Data Collection for those who: (1) test HIV positive that same day; (2) have not 
tested but want to test for HIV that same day ..................................................................................... 19 
2.4.2. Optimized Standard of Care Arm .............................................................................. 20 
2.4.2.1  Provider Initiated Testing and Counseling (PITC) .................................................................... 20 
2.4.2.2. Demographic Data Collection .............................................................................................. 20 
2.4.2.3 Additional Data Collection for those who: (1) test HIV positive that same day; (2) have not 
tested but want to test for HIV that same day ..................................................................................... 20 
2.4.3. Group Self-Testing Arm ......................................................................................................... 21 

 
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A trained study member will meet with clients waiting in the OPD and STI waiting spaces and read 
the oral consent script explaining that participation in self-testing and study procedures is voluntary. 
The HDA will then provide group education in the OPD and STI waiting areas about (1) the benefits 
of HIV testing and treatment, (2) a demonstration of how to use a self-test kit and who should use 
the kit for testing, and (3) and group counseling about follow-up needed for both HIV negative (re-
testing at regular intervals) and positive results (referral for confirmatory testing and ART initiation 
and follow-up). All individuals 15 years of age and older in the waiting area will be offered a self-
test kit.  ................................................................................................................................................ 21 
2. 
 Test Interpretation and Confirmatory Testing........................................................... 21 
2.4.3.4. Demographic Data Collection .............................................................................................. 21 
2.4.3.4 Additional Data Collection for those who: (1) test HIV positive that same day; (2) have not 
tested but want to test for HIV that same day ..................................................................................... 22 
2.4.4. Post-Intervention Interview........................................................................................ 22 
2.5. Statistical Methods .......................................................................................................................... 22 
2.5.1. Outcome Measures ..................................................................................................... 22 
Power Calculations and Statistical Analysis for Primary Outcome Measures ............................... 23 
Qualitative Analysis for Secondary Outcome Measures ......................................................................... 23 
2.6. Cost and Cost-Effectiveness Methods ............................................................................................ 23 
2.6.1. Costs to Provider (HIV Diagnostic Assistant) ........................................................... 23 
2.6.2. Cost-Effectiveness ..................................................................................................... 24 
2.6.3. Accrual ....................................................................................................................... 24 
Monitoring by the Protocol Team .................................................................................................................... 24 
Monitoring  ................................................................................................................................................................ 24 
3. 
Aim 2: Partner Self-Testing .......................................................................................... 25 
3.1. Objectives ....................................................................................................................................... 25 
3.1.1. Primary Objectives: ................................................................................................... 25 
3.1.2. Secondary Objectives:................................................................................................ 25 
3.2. Study Population ............................................................................................................................. 25 
3.2.1. Inclusion Criteria ....................................................................................................... 25 
3.2.2. Exclusion Criteria ...................................................................................................... 25 
3.3. Study Design .................................................................................................................................. 26 
3.3.1. Description of Randomization and Study Arms ........................................................ 26 
Description of Study Arms .................................................................................................................................. 26 
3.3.2. Recruitment, Screening, and Enrollment Process ...................................................... 27 
Standard of care arm ............................................................................................................................................. 27 
There will be no study “interventions” at the sites. A random subset of individuals will be re-
cruited to complete a survey at the time they complete ART visits. Individuals will be 
screened to confirm they meet inclusion criteria, including having at least one partner of un-
known status living within the facility catchment area at the time of their last clinical visit. 
After oral informed consent has been obtained, enrolled participants will complete a brief 
anonymous survey.  ............................................................................................................................................... 27 

 
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Optimized standard of care arm ....................................................................................................................... 27 
Partner self-testing arm ....................................................................................................................................... 28 
1. 
Informed Consent ....................................................................................................... 28 
2. 
Participant Withdrawal or Termination from the Study ............................................ 28 
4. 
Study Procedures ........................................................................................................................... 28 
4.1. 
Standard of Care Arm ................................................................................................ 28 
Follow-up Visit of Index Clients ........................................................................................................................ 29 
4.2. 
Optimized Standard of Care Arm .............................................................................. 29 
4.2.1. ..........................................................................................................................  
Partner Notification and Referral ........................................................................................ 29 
Follow-up Visit of Index Clients ........................................................................................................................ 30 
4.3. 
Partner Self-Testing Arm ........................................................................................... 30 
3.4.4.1  Baseline Visit for Index Client ............................................................................................................ 30 
3.4.4.3 Follow-up of Partner Self-Testing ..................................................................................................... 31 
3.4.4.4  Follow-up Visit of Index Clients ........................................................................................................ 31 
5. 
Statistical Methods .......................................................................................................................... 32 
5.1. 
Outcome Measures ..................................................................................................... 33 
3.5.1.1  Sample Size and Statistical Analysis for Primary Outcome Measures .............................. 33 
Qualitative Analysis for Secondary Outcome Measures ......................................................................... 33 
6. 
Cost and Cost-Effectiveness Methods ............................................................................................ 33 
6.1. 
Costs to Provider ........................................................................................................ 34 
6.2. 
Cost-Effectiveness ..................................................................................................... 34 
6.3. 
Sample Size and Accrual ........................................................................................... 34 
Monitoring by the Protocol Team .................................................................................................................... 34 
4. 
Data Handling and Record Keeping ............................................................................ 35 
4.1. Data Management Responsibilities ................................................................................................. 35 
5. 
Site Monitoring .............................................................................................................. 35 
6. 
Safety Assessment, Monitoring, and Reporting ......................................................... 35 
7. 
Human Subjects Protections ....................................................................................... 35 
7.1. 
Institutional Review Board/Ethics Committee Review and Approval Including Informed Consent .. 35 
7.2. Potential Benefits ............................................................................................................................ 35 
7.3. Potential Risks and Discomforts ..................................................................................................... 36 
7.4. Reimbursement/Compensation ...................................................................................................... 36 
7.5. Privacy and Confidentiality ............................................................................................................. 36 
7.6. Management of New Information Pertinent to Study Participation.................................................. 36 
8. 
Administrative Procedures .......................................................................................... 36 
8.1. Regulatory Oversight ...................................................................................................................... 36 
8.2. Study Implementation ..................................................................................................................... 37 
8.3. Protocol Deviation Reporting .......................................................................................................... 37 
9. 
Publications .................................................................................................................. 37 
10. 
References .................................................................................................................... 37 

 
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ABBREVIATIONS AND ACRONYMS 
 
 
 
ARV: antiretrovirals 
ART: antiretroviral therapy 
CMC: clinical Management Committee 
DSMB: data safety and monitoring board 
CRF: case report form 
EC: ethics committee 
HDA: HIV diagnostic assistant 
HSA: health surveillance assistant 
IRB: Institutional Review Board 
NHSRC: National Health Science Research Committee 
OPD: outpatient department 
PEPFAR: President’s Emergency Plan for AIDS Relief 
PID: Patient Identification Number 
PIH: Partners in Hope 
PITC: provider-initiated testing and counseling 
SOC: standard of care 
SOP: Standard Operating Procedure 
STI:  sexually transmitted infection 
TA: Technical Assistance 
USAID: United States Agency for International Development 
 
 
 

 
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Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their 
Partners 
 
INVESTIGATORS 
 
Primary Investigator: 
Kathryn Dovel PhD, MPH 
Associate Research Director, Partners in Hope 
and UCLA 
Partners in Hope Medical Center 
PO Box 302 
Lilongwe, Malawi 
Email: kdovel@mednet.ucla.edu 
 
Co-Primary Investigators:  
Mike Nyirenda 
Deputy Chief of Party, EQUIP 
Partners in Hope Medical Center 
PO Box 302 
Lilongwe, Malawi 
Email: mhnyirenda@gmail.com 
 
Risa Hoffman MD, MPH 
UCLA Division of Infectious Diseases 
10833 Le Conte Ave 37-121 CHS 
Los Angeles, CA 90046 
T: 310 825 7225 
Email: rhoffman@mednet.ucla.edu 
 
Co-Investigators 
Joseph Kasola 
HIV Testing Services Program Officer 
Ministry of Health, Dept of HIV/AIDS 
Lilongwe, Malawi 
Tele: +265 888524616 
Email: josephkasola@gmail.com 
 
Khumbo Ng’ona Namachapa 
HIV Testing Services Program Officer  
Ministry of Health, Dept of HIV/AIDS 
Lilongwe, Malawi 
Tele: +265 999649021 
Email: khumbongona@yahoo.com 
 
Khumbo Phiri 
Research Coordinator  
Partners in Hope 
PO Box 302, Lilongwe, Malawi 
 
Alan Schooley MD 
Country Director USAID Programs in Malawi 
Partners in Hope 
PO Box 302 
Lilongwe, Malawi 
T: +2659 9442 5691 
Email: aschooley@mednet.ucla.edu 
 
 
Protocol Statistician 
Marjan Javanbakht 
Associate Professor Dept of Epidemiology 
UCLA School of Public Health 
Box 951772 
46-082 CHS 
Los Angeles, CA 90095 
Email: javan@g.ucla.edu 
 
Protocol Health Economist 
Brooke Fokker, PhD 
HERO, Wits Health Consortium 
Postnet Suite 212, Private Bag X2600, Hough-
ton, 2041 
South Africa 
Email: brooke.e.nichols@gmail.com

 
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Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their 
Partners 
 
SCHEMA 
 
Purpose: 
To evaluate the feasibility and cost-effectiveness of self-testing strategies within 
health facilities compared to standard of care in the following settings:  
(1) group self-testing in outpatient departments (OPD) and sexually transmitted 
infection (STI) clinics compared to standard of care and optimized standard of 
care HIV testing and counseling; and  
(2) self-testing for partners of HIV+ index clients compared to standard of care 
and optimized standard of care partner notification strategies. 
 
Design: 
Unblinded cluster-randomized controlled trial  
 
Study Population: 
Aim 1: Individuals 15 years of age and older not already known to be HIV-posi-
tive 
 
Aim 2: HIV-positive individuals 15 years of age and older with at least one sex-
ual partner with unknown HIV status 
 
Sample Size: 
Aim 1: 15 clusters with a total of 15,000 participants (5,000 per arm, 1,000 per 
site) 
 
Aim 2: 15 clusters with a total of 7,500 participants (2,500 per arm, 500 per site) 
 
Intervention: 
Aim 1: To test the feasibility and cost-effectiveness of group HIV self-testing in 
outpatient department (OPD) and sexually transmitted infections (STI) clinics 
 Arm 1: Standard of care for provider-initiated testing and counseling 
(PITC)  
 Arm 2: Optimized  standard of care for PITC  
 Arm 3: Group HIV self-testing 
Aim 2: To test the feasibility and cost-effectiveness of partner HIV self-testing  
 Arm 1: Standard of care for partner testing  
 Arm 2: Optimized standard of care for partner testing  
 Arm 3: HIV self-testing 
                                                                                                                                                              
Study Duration: 
Approximately 18 months total 
 
Aim 1: To test the feasibility and cost-effectiveness of group HIV self-testing for patients in waiting areas 
of outpatient department (OPD) and sexually transmitted infections (STI) clinics 
Primary Objectives: 
 To determine whether group self-testing in waiting areas of OPD and sexually transmitted STI 
clinics is superior in regard to number of individuals HIV tested compared to optimized stand-
ard of care (provider-initiated testing and counseling; PITC) 
 To determine whether group self-testing in waiting areas of OPD and STI clinics is cost-effec-
tive compared to optimized standard of care using PITC 
Secondary Objectives: 
 To assess the acceptability of self-testing in waiting areas of OPD and STI clinics 

 
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 To determine whether group self-testing in waiting areas of OPD and STI clinics is superior in 
regard to number of HIV+ individuals identified (testing yield) 
 To determine whether group self-testing in waiting areas of OPD and STI clinics is superior in 
regard to linkage rates for those who identify as HIV-positive compared to standard of care 
and optimized standard of care (PITC) 
 
Aim 2: To evaluate the feasibility and cost-effectiveness of self-testing for partners  
Primary Objectives: 
 To determine whether providing index clients with HIV self-test kits for partners results in a 
greater number of partners tested as compared to optimized standard of care for partner notifi-
cation and testing (referral slip) 
 To determine whether providing index partners with HIV self-test kits is cost-effective com-
pared to optimized standard of care using referral slips 
Secondary Objectives: 
 To assess the acceptability of giving self-test kits to index clients for partner testing 
 To determine whether providing index partners with HIV self-test kits is superior to optimized 
standard of care in regard to identifying HIV+ partners (yield of testing) 
 To determine whether providing index partners with HIV self-test kits is superior to optimized 
standard of care in regard to linkage rates among those who identify as HIV-positive 
 To determine whether providing self-test kits to index clients and their partner is superior to 
optimized standard of care in regard to partner disclosure by the index client 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1 INTRODUCTION  
 
1. 
BACKGROUND 
Despite increased access to HIV services, use of HIV testing in sub-Saharan Africa remains low. 
In Malawi, only 42% of the adult population received an HIV test in the last year.1 Men are less 
likely to test than women (82% of women have ever tested in their lifetime compared to 70% of 
men).1 In order to reach the UN 90-90-90 goals, innovative solutions must be approached to iden-
tify and test individuals living with HIV. Two initiatives promise to increase testing and yield: 
Provider Initiated Testing and Counseling and Partner Notification Services. 
 
Provider initiated testing increases the ability to test people who are already attending health ser-
vices and are either unwilling or unable to independently seek an HIV test.2,3 The strategy is pri-
oritized for high-risk clients (ANC, OPD, STI, and TB clients) and is an efficient and cost-effec-
tive way to identify new HIV cases among these groups.4 However, PITC is rarely implemented 
in routine care.5-8 Furthermore, men are still underrepresented in PITC efforts.4,9 
 
Partner Notification Services, also known as Contact Tracing, have also been identified to aug-
ment HIV case finding.10,11  The feasibility and effectiveness of Partner Notification Services in 
Sub-Saharan African countries has been demonstrated with much success.12-16  Within study set-
tings in Malawi and Cameroon, active partner notification was effective with high rates of partner 
testing, 51% and 66.8% respectively, and positivity rates between 50-64%.13,14   
 
Partner notification services have the potential for high impact in new case identification as the 
rate of HIV cases among partners has been shown to be tenfold higher than the national preva-
lence.10,13,14 Early case identification is also key in preventing late stage patient presentation with 
high morbidity and less efficacious treatment outcomes. The case finding effectiveness of Partner 
Notification Services can result in earlier diagnosis of individuals, earlier initiation of ART, and 
prevention of HIV transmission. However, men are being missed in Partner Notification Services, 
limiting the strategy’s impact. The percent return rates of men during passive referral is half that 
seen by women partners.14 Strategies to improve testing of men are needed. 
 
Prior Research on Self-Testing 
A recently introduced method of HIV self-test screening within Malawi has shown high testing 
uptake among men. A study piloting the use of HIV self-testing demonstrated high uptake in ado-
lescent men (89.3% in men aged 16-19 years of age) with rates remaining as high as 60% among 
men up to age 39 (compared to only 42% of the general male population who have been tested in 
the previous year).1,17 Self-test screening also promotes partner testing and can be used to facili-
tate status disclosure.18,19  
 
Overall, feasibility and uptake of self-test screening has been successfully demonstrated within 
Malawi allowing self-test screening to serve as a new key tool in increasing access to test-
ing.17,18,20,21,22 HIV self-test screening has been shown to be accurate, safe, and cost/quality of life 
analysis has also demonstrated its usefulness.17,18,20, 22-25 However, self-test kits have been primar-
ily distributed in community settings outside the standard health care system. To date, self-test 
kits have not been distributed within health facilities nor studied for partner testing. Combining 
self-testing with existing health systems may improve the scalability of self-test kits at a national 
level. 
 

 
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This study compliments the existing STAR study conducted in Malawi and elsewhere. STAR fo-
cuses primarily on non facility-based distribution, such as communities and schools. We examine 
self-test integration for routine health services, addressing a gap in self-test knowledge. 
 
2. 
RATIONALE 
While self-testing and partner notification strategies have been studied separately, these strategies 
have never been examined jointly as a means to improve partner disclosure and testing. Further-
more, self-test kits have not been piloted within existing health systems, limiting the feasibility of 
self-test kits outside study settings.  
 
We propose to study the role of self-testing in identifying HIV-positive individuals and to deter-
mine whether self-test kits can be given to index clients as a means to facilitate partner disclosure 
and partner testing. 
 
3. 
HYPOTHESES 
 Aim 1: Group self-testing will (1) increase the number of OPD and STI clients tested for 
HIV, (2) increase HIV testing yield, and (3) be cost-effective compared to the optimized 
standard of care  
 Aim 2: Self-test kits given to index clients will (1) increase the number of index partners 
who test for HIV; (2) increase yield of partner testing, and (3) be cost-effective compared 
to the optimized standard of care for partner notification and testing, and will (4) increase 
partner disclosure by the index client  
 
 
2. 
AIM 1: GROUP SELF-TESTING 
 
2.1. OBJECTIVES 
 
2.1.1. Primary Objectives: 
 To determine whether group self-testing in waiting areas of outpatient departments (OPD) and 
sexually transmitted infection (STI) clinics is superior in regard to number tested compared to 
optimized standard of care (provider-initiated-testing-and-counseling; PITC) 
 To determine whether group self-testing in waiting areas of OPD and STI clinics is cost-effec-
tive compared to optimized standard of care using PITC 
 
2.1.2. Secondary Objectives: 
 To assess the acceptability of self-testing in waiting areas of OPD and STI clinics 
 To determine whether group self-testing in waiting areas of OPD and STI clinics is superior in 
regard to number of HIV+ individuals identified (testing yield) 
 To determine whether group self-testing in waiting areas of OPD and STI clinics is superior in 
regard to linkage rates for those who identify as HIV-positive compared to standard of care 
and optimized standard of care (PITC) 
 
2.2. STUDY POPULATION 
This aim will be conducted among 15,000 individuals 15 years or older who seek OPD or STI 
services at participating health facilities. The aim will be conducted in 15 clusters (facilities) in 
Malawi. 
 

 
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Sites have been selected in collaboration with the Ministry of Health and represent medium to 
large health facilities in areas of high HIV prevalence. Sites represent a mixture of facility types 
(hospital versus health centre) and are balanced with regard to the number that have separate STI 
clinics (versus STI services offered within OPD clinics). Figure 1 outlines potential sites to be 
included in the study.  
 
 
FIG 1. STUDY SITES BY FACILITY TYPE, REGION, AND STUDY ARM 
 
Facility Name 
Facility Type 
Region 
Study Arm 
Likuni Mission Hospital 
CHAM  
Central 
HIVST 
Mponela Rural Hospital 
Rural Hospital  
Central 
HIVST 
Nsanje District Hospital 
District Hospital  
South  
HIVST 
Masenjere Health Centre 
Health Centre 
South  
HIVST 
Mgabu Rural Hospital 
Health Centre  
South  
HIVST 
St. Gabriel Mission Hospital 
CHAM  
Central 
OSOC 
Kasungu District Hospital 
District Hospital  
Central 
OSOC 
Kalulu Health Centre 
Rural Hospital   
South  
OSOC 
Sorgini Health Centre 
Health Centre 
South  
OSOC 
Kalemba Health Centre  
Health Centre  
South  
OSOC 
De Young 
CHAM  
Central 
SOC 
Chikwawa District Hospital 
District Hospital  
South  
SOC 
Mkumaniza Health Centre 
Health Centre    
South  
SOC 
Gaga Health Centre 
Health Centre 
South  
SOC 
Chankhungu Health Centre 
Health Centre  
Central 
SOC 
 
 
 
 

 
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2.2.1. Inclusion Criteria 
All of the following criteria must be met in order for an individual to be included in Aim 1:   
 15 years of age or older 
 Being seen for OPD or STI services at the time of the study 
 
We include children ages 15-18 years of age if they actively seek OPD or STI services and con-
sent to participate in the study. Under Malawian law, children 15-18 are able to receive an HIV 
test without being accompanied by a parent or receiving parental consent. 
 
2.2.2. Exclusion Criteria 
Individuals will be excluded from the study if any of the following exclusion criteria are present:  
 Less than 15 years of age 
 Not being seen for OPD or STI services at the time of the study 
 Guardians attending clinics with OPD or STI clients 
 
2.3. STUDY DESIGN 
The study design for Aim 1 will be a cluster randomized trial comparing HIV testing rates and 
cost-effectiveness of group HIV self-testing compared to standard of care and optimized standard 
of care among OPD and STI clients (see Fig. 2). Clusters will be comprised of individual facili-
ties in Malawi. Individuals waiting to receive OPD and STI health services who meet the inclu-
sion criteria will be asked to participate in the study.  
FIG 2. OVERVIEW OF STUDY DESIGN 
 
 
 
 
2.3.1. Description of Randomization and Study Arms 
Randomization will be conducted at the level of the cluster (1 cluster = 1 health facility). We will 
randomize 15 clusters evenly to one of three arms: (1) standard of care; (2) optimized standard of 
care (optimized with support for delivery of standard of care services including support for staff 
training, job aids, and quality of service delivery); or (3) group HIV self-testing. All patients en-
rolled at the site will follow the HIV testing assignment for the cluster in which they are random-
ized. We will use block randomization, blocking on variables that might predict outcomes, in-
cluding facility type (hospital/health center), location (rural/urban), region (central or southern), 
and whether facilities have separate or combined STI and OPD clinics. This will help minimize 
residual confounding that can result in cluster randomized trials. We will then randomly allocate 
one cluster from each block to each of the three study arms. Clusters will be randomized to 
achieve a 1:1:1 allocation to each study arm. 
 
Clust
Stand
Stand
Demo
Opti
Opti
Demo
Grou
Grou
Demo
Post-

 
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Description of Study Arms 
Microsoft Excel will be used to randomly assign clusters. Clusters will be assigned to one 
of three arms: 
 
1. Standard of care arm: Facilities randomized to the standard of care arm will con-
tinue with standard of care without any intervention from the study team. Pro-
vider-initiated-testing-and-counseling (PITC) is standard of care for both OPD 
and STI clients. OPD or STI providers tell patients about HIV testing and refer 
them to the standard HIV testing services room at the health facility. HIV test-
ing activities completed under standard of care will vary by facility based on ad-
herence to national guidelines for PITC.  
 
2. Optimized standard of care arm: Facilities randomized to the optimized standard 
of care arm will perform PITC for OPD and STI clients as per Ministry of 
Health National Guidelines. Facilities will be supported by the study team with 
initial trainings on the importance of HIV testing, the role of HIV testing as part 
of outpatient and STI care, and strategies used to discuss HIV testing with pa-
tients. The study team will also provide job aids to remind providers about the 
importance of referring patients for HIV testing and assist in the monitoring and 
evaluation of PITC implementation. When clients are referred for testing, they 
will use the standard HIV testing services room located in the same health facil-
ity. Testing will be available during all clinic hours and completed by trained 
HIV Diagnostic Assistants (HDA) who work at the facility (i.e., non-study 
staff). 
 
3. Group self-testing arm: Facilities randomized to the group self-testing arm will 
have an HDA provide group education about HIV testing in the waiting areas of 
OPD and STI clinics. Education will include (1) information about the benefits 
of HIV testing and treatment, (2) a demonstration of how to use a self-test kit 
and who should use the kit for testing, and (3) and information about follow-up 
required for both HIV negative (re-testing at regular intervals) and positive re-
sults (referral for confirmatory testing and ART initiation and follow-up). Self-
test kits will be distributed to eligible clients waiting for OPD or STI services 
and those who wish to use the kit will be free to do so. Group education and the 
distribution of self-test kits will take place every several hours to ensure that 
newly arriving OPD and STI clients are given the opportunity to participate in 
the study. Completed self-test kits will be anonymous and can be placed in a 
locked box in the waiting area or given to the standard OPD or STI service pro-
vider for interpretation of the result and further counseling. Trained HDAs will 
also be available in the OPD and STI waiting area in order to answer any ques-
tions that arise. Those with a positive self-test who disclose the result to the pro-
vider will be referred to undergo confirmatory testing by an HDA using the 
standard HIV testing services room located in the same health facility. 
 
 
2.3.2. Recruitment and Enrollment Process 
Standard of care arm 
Facilities randomized to the standard of care arm will proceed with standard HIV testing 
within the facility. There will be no study “interventions” at the standard of care sites.  

 
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After completing the OPD or STI consultation, clients aged 15 years and older will be 
asked to participate in a brief 10 minute, anonymized exit survey to assess if they were 
offered testing, if they were tested, and why they chose to test or not. We will recruit all 
eligible OPD and STI clients for the survey – including clients who tested and those who 
did not.  Survey participation is completely voluntary and can be refused at any point. 
Those who self-report as testing HIV positive during OPD or STI services will complete 
written consent and will provide identifiable information so the study can prospectively 
track linkage to care. 
 
HIV testing registers, ART registers, OPD registers, and STI registers will be reviewed to 
measure (1) the number of individuals attending OPD and STI clinics over the study pe-
riod (denominator), (2) the number of OPD and STI clients tested for HIV (numerator), 
(3) the proportion of those tested who are identified as HIV-positive (defined as a posi-
tive HIV test from two different types of tests – Determine and Uni-Gold), and (4) the 
proportion of those identified as HIV-positive who linked to ART services. All data will 
be anonymized from existing registers. Records from OPD and STI clients aged 15 years 
and older will be included in the study.  Over the study period, we will be able to deter-
mine the proportion of all STI and OPD patients who receive an HIV test, the proportion 
of those tested who are HIV-positive, and the proportion of HIV-positive clients who link 
to ART services. We will also be able to determine differences by age sex, and service 
type.  Because study data will be abstracted from existing clinic records in an anony-
mized format, no informed consent will be obtained.  
 
Optimized standard of care arm  
Facilities randomized to the optimized standard of care arm will provide standard PITC 
as recommended by the Ministry of Health. Facilities will be supported by the study team 
to implement standard PITC guidelines. HIV testing services will be available during all 
clinic hours and completed by trained HIV Diagnostic Assistants (HDA) who work at the 
site (non-study staff).  
 
After completing the OPD or STI consultation, clients aged 15 years and older will be 
asked to participate in a brief 10 minute, anonymized exit survey to assess if they were 
offered testing, if they were tested, and why they chose to test or not. We will recruit all 
eligible OPD and STI clients for the survey – including clients who tested and those who 
did not.  Survey participation is completely voluntary and can be refused at any point. 
Those who self-report as testing HIV positive during OPD or STI services will complete 
written consent and will provide identifiable information so the study can prospectively 
track linkage to care. 
 
HIV testing registers, ART registers, OPD registers, and STI registers will be reviewed to 
triangulate the (1) number of individuals attending OPD and STI clinics over the study 
period (denominator), (2) number of OPD and STI clients tested for HIV (numerator), (3) 
proportion of those tested who are identified as HIV-positive (defined as a positive HIV 
test from two different types of tests – Determine and Uni-Gold), and (4) proportion of 
those identified as HIV-positive who linked to ART services. All data will be anony-
mized from existing registers. Records from OPD and STI clients aged 15 years and older 
will be included in the study.  Over the study period, we will be able to determine the 
proportion of all STI and OPD patients who receive an HIV test, the proportion of those 
tested who are HIV-positive, and the proportion of HIV-positive clients who link to ART 
services. We will also be able to determine differences by age sex, and service type. 
 

 
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Group self-testing arm 
OPD and STI clients in the waiting areas for these clinics will receive a health education 
talk from a trained HDA while waiting for their clinical consultation. Staff will review 
the oral consent script explaining that participation in HIV self-testing and study proce-
dures is voluntary and that all data are anonymous. All OPD and STI clients aged 15 
years and older will be offered a self-test kit. Those who would like to opt-out will be 
asked to take a kit and give the unopened kit to the study team during a brief exit survey.  
 
Those who choose to participate in self-testing will be asked to keep the used kit in an 
opaque bag and give the anonymized self-test kit to the study team during the brief exit 
survey. The study team will NOT look at the test results, but will staple the opaque bag 
closed, link the unique identification number on the test bag to the exit survey, and drop 
the self-test kit into a secure lockbox. Those who do not want to directly give the self-test 
kit to the study team will be allowed to dispose their test kit in a lockbox located in the 
waiting area or a lockbox located in the provider consultation room.  
 
After completing the OPD or STI consultation, clients aged 15 years and older will be 
asked to participate in a brief 15 minute, anonymized exit survey about their experience 
with self-testing why they chose to use the kit or not. We will recruit all eligible OPD and 
STI clients for the survey – including clients who used self-testing and those who opted-
out of self-testing.  Survey participation is completely voluntary and can be refused at 
any point. Those who self-report as testing HIV positive with a self-test kit will complete 
written consent and will provide identifiable information so the study can prospectively 
track linkage to care.  
 
HIV testing registers, ART registers, OPD registers, and STI registers will be reviewed to 
triangulate the (1) number of individuals attending OPD and STI clinics over the study 
period (denominator), (2) number of OPD and STI clients tested for HIV (numerator), (3) 
proportion of those tested who are identified as HIV-positive (defined as a positive HIV 
test from two different types of tests – Determine and Uni-Gold), and (4) proportion of 
those identified as HIV-positive who linked to ART services. All data will be anony-
mized from existing registers. Records from OPD and STI clients aged 15 years and older 
will be included in the study.  Over the study period, we will be able to determine the 
proportion of all STI and OPD patients who receive an HIV test, the proportion of those 
tested who are HIV-positive, and the proportion of HIV-positive clients who link to ART 
services. We will also be able to determine differences by age sex, and service type. 
 
At the end of Aim 1 implementation, focus group discussions will be conducted with pro-
viders at participating OPD, STI, and HTC clinics to understand perceptions and accepta-
bility of group self-testing at OPD and STI clinics. All core providers and supporting 
staff involved with the self-test intervention will be asked to participate (estimated 5 pro-
viders and 8 supporting staff at each site). Each site will complete two focus groups; one 
with providers and one with supporting staff (10 focus groups in total). Only providers 
over 18 years of age, actively involved in the self-test intervention, and willing and able 
to consent will participate.  Focus groups will last approximately 45 minutes.  
 
 

 
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2.3.3. Informed Consent 
For the group self-testing arm, oral informed consent will be obtained before any study-specific 
procedures are performed.  The informed consent process will include information exchange, de-
tailed discussion, and assessment of understanding of all required elements of informed consent, 
including the potential risks, benefits, and alternatives to study participation.  Oral consent will be 
gained before being given an HIV self-test kit. 
 
For all arms, oral consent will be obtained before completing a brief, anonymized exit survey 
about their experience with testing. The informed consent process will include information ex-
change, detailed discussion, and assessment of understanding of all required elements of informed 
consent, including the potential risks, benefits, and alternatives to study participation.  
For a subset of clients in the self-test arm, oral consent will also be obtained before completing an 
in-depth interview to gain more information about their experience with and acceptability of self-
testing. During the brief exit survey, clients who self-report as (1) testing HIV positive that same 
day or (2) having not tested but wanting to test for HIV that same day will be taken through writ-
ten informed consent and identifiable information will be collected to allow the study to track 
their uptake (linkage) and retention in ART. Identifiable information will NOT be collected for 
any other client group. 
 
 
2.3.4. Participant Withdrawal or Termination from the Study 
Individuals may withdraw from the study at any time. Participants may also be terminated from 
the study by the site investigator or designee under the following circumstances: 
 Site investigator or designee determines that continued participation in the study would 
be unsafe or otherwise not in the best interest of the participant  
 The study is stopped or canceled by the sponsors, government or regulatory authorities, 
or site IRBs. 
 
2.4. STUDY PROCEDURES 
An overview of the study procedures is provided below. The same data collection processes will 
be used for ALL study arms. 
 
2.4.1. Standard of Care Arm 
2.4.2.1   Standard of Care 
Facilities in the standard of care arm will provide routine HIV testing services. No intervention 
activities will be conducted. HIV testing will follow Ministry of Health National Guidelines using 
HDAs who will provide individual counseling and serial testing with Determine and Uni-Gold 
HIV test kits. Discordant results will result in re-testing using the MOH guidelines. Those with 
positive HIV tests will be counseled and referred to ART services following routine care.  
 
2.4.1.2. Demographic Data Collection 
Clients in the optimized standard of care arm who complete an OPD/STI consultation visit will 
meet briefly with a study staff member after their visit. The study staff member will collect anon-
ymous demographic data including age, gender, highest level of education, and reason for visit to 
OPD/STI clinic. It will also capture if clients were offered testing, if they were tested, self-re-
ported test result, and why they chose to test or not. 
 
2.4.2.3 Additional Data Collection for those who: (1) test HIV positive that same day; (2) 
have not tested but want to test for HIV that same day, Participants who self-report as 
having (1) tested HIV positive that same day or (2) not tested but want to test for HIV 

 
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11 October 2017 
that same day will be asked to complete written consent for collection of identifiable in-
formation in order to track linkage and retention to ART.  
 
2.4.2.4 Registry Data for Triangulation and Linkage  
HIV testing, ART, OPD, and STI registers will be reviewed to measure the number of individuals 
seen in OPD and STI over the study period, the number tested from OPD and STI clinics, the pro-
portion of those tested who are identified as HIV-positive, and the proportion of those identified 
as HIV-positive who link to ART services. All data will be anonymized from existing registers. 
Records from OPD and STI clients aged 15 years and older will be included in the study.   
 
2.4.2. Optimized Standard of Care Arm 
2.4.2.1 
Provider Initiated Testing and Counseling (PITC) 
Facilities randomized to the optimized standard of care arm will provide standard PITC as recom-
mended by the Ministry of Health. Facilities will be supported by the study team with initial 
trainings on the importance of HIV testing, the role of HIV testing as part of outpatient and STI 
care, and strategies used to discuss HIV testing with patients. The study team will also provide 
job aids to remind providers about the importance of referring patients for HIV testing and assist 
in the monitoring and evaluation of PITC implementation. When clients are referred for testing, 
they will use the standard HIV testing services room located in the same health facility. Testing 
will be available during all clinic hours and completed by trained HIV Diagnostic Assistants 
(HDA) who work at the facility (i.e., non-study staff).  HIV testing for OPD and STI clients will 
follow Ministry of Health National Guidelines using HDAs who will provide individual counsel-
ing and serial testing with Determine and Uni-Gold HIV test kits. Discordant results will result in 
re-testing using the MOH guidelines. Those with positive HIV tests will be counseled and re-
ferred to ART services following routine care. 
 
 
2.4.2.2. Demographic Data Collection 
Clients in the optimized standard of care arm who complete an OPD/STI consultation visit will 
meet briefly with a study staff member after their visit. The study staff member will collect anon-
ymous demographic data including age, gender, highest level of education, and reason for visit to 
OPD/STI clinic. It will also capture if clients were offered testing, if they were tested, self-re-
ported test result, and why they chose to test or not. 
 
2.4.2.3 Additional Data Collection for those who: (1) test HIV positive that same day; (2) have 
not tested but want to test for HIV that same day, Participants who self-report as having 
(1) tested HIV positive that same day or (2) not tested but want to test for HIV that 
same day will be asked to complete written consent for collection of identifiable infor-
mation in order to track linkage and retention to ART. 
 
2.4.2.3. Registry Data for Triangulation and Linkage 
HIV testing, ART, OPD, and STI registers will be reviewed to measure the number of individu-
als attending the clinics during the period of the study (denominator), the number HIV tested 
(numerator), the proportion of those tested who are identified as HIV-positive (yield), and the 
proportion of those identified as HIV positive who link to ART services. All data will be anony-
mized from existing registers. Records from OPD and STI clients aged 15 years and older will 
be included in the study.  Over the period of the study, we will be able to determine the propor-
tion of all STI and OPD patients who receive an HIV test, the proportion of those tested who are 
HIV-positive, and the proportion of HIV positive clients who linked to ART services. 
 

 
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2.4.3. Group Self-Testing Arm 
 
A trained study member will meet with clients waiting in the OPD and STI waiting spaces and 
read the oral consent script explaining that participation in self-testing and study procedures is 
voluntary. The HDA will then provide group education in the OPD and STI waiting areas about 
(1) the benefits of HIV testing and treatment, (2) a demonstration of how to use a self-test kit and 
who should use the kit for testing, and (3) and group counseling about follow-up needed for both 
HIV negative (re-testing at regular intervals) and positive results (referral for confirmatory testing 
and ART initiation and follow-up). All individuals 15 years of age and older in the waiting area 
will be offered a self-test kit.  
 
Clients who tested HIV negative within the past 3 months, previously tested HIV positive, are 
currently taking ART, are uncomfortable administering the self-test kit, or would like to receive 
an assisted HIV test either through standard HIV testing protocols or a provider observed HIV 
self-test kit will be advised to opt-out from the HIV self-test. Those who would like to opt-out for 
any reason will be asked to take a kit and give the unopened kit to the research team during a 
brief exit survey. 
 
Those who would like to take the self-test will perform the test while waiting for their appoint-
ment. In order to avoid unintended disclosure to participants sitting in the waiting area, after the 
sample is obtained, individuals will be instructed to put the kit into the opaque testing bag while 
waiting for the test results in order to ensure privacy and minimize risk of adverse outcomes due 
to unintended disclosure (approximately 20 minutes). Participants will be allowed to perform the 
self-test while seated in the waiting area or may move to a more private location on the facility 
grounds. A private space (tent or other sectioned off area of the waiting area) will be available for 
individuals who wish to read their test before entering the provider consultation room. After com-
pleting the test, participants may do any of the following: 
 
 Individuals who are willing to share the result with the provider will be asked to bring 
their kit to the provider for interpretation and counseling.  
 Individuals will be asked to give the anonymized self-test kit to the study team during the 
brief exit survey. The study team will NOT look at the test results, but will staple the 
opaque bag closed, link the unique identification number on the test bag to the exit sur-
vey, and drop the self-test kit into a secure lockbox. Those who do not want to directly 
give the self-test kit to the study team will be allowed to dispose their test kit in a lockbox 
located in the waiting area or a lockbox located in the provider consultation room.  
 
Trained research assistants and an HDA will be available in the waiting area to answer any ques-
tions.  
 
2. 
 Test Interpretation and Confirmatory Testing 
Participants who test positive with the self-test method and disclose results to the provider will be 
referred to an HDA to have confirmation testing conducted with routine Ministry of Health test-
ing guidelines. These individuals will receive standard of care counseling by facility HDAs and 
be referred for ART initiation if their confirmatory HIV test is positive.  
 
2.4.3.4. Demographic Data Collection 
Participants in the group self-test arm who complete an OPD/STI consultation visit will meet 
briefly with a study staff member after their visit. The study staff member will collect anonymous 
demographic data including age, gender, highest level of education, and reason for visit to 

 
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11 October 2017 
OPD/STI clinic. They will also ask whether or not participants performed the HIV self-test, what 
motivated them to use/not use the self-test, and self-reported test result (if willing to disclose). 
For those willing, the study staff member will also collect the self-test kit, staple the opaque bag 
closed (if used), link the unique identification number on the test bag to the exit survey, and drop 
the self-test kit into a secure lockbox. The study staff member will NOT look at test results. 
 
2.4.3.4 Additional Data Collection for those who: (1) test HIV positive that same day; (2) have 
not tested but want to test for HIV that same day 
Participants who self-report as having (1) tested HIV positive that same day or (2) not tested but 
want to test for HIV that same day will be asked to complete written consent for collection of 
identifiable information in order to track linkage other HIV services.  
 
2.4.4. Post-Intervention Interview 
A random subset of 60 OPD/STI clients (30 men and 30 women) in the group self-test arm will 
be asked to participate in an in-depth qualitative interview. These individuals will be selected 
from at least three different facilities in the group self-test arm and stratified by sex, use of self-
testing (or not), and among those self-reporting a positive self-test result, HIV status. In the inter-
view, participants will be asked about their experience with group self-testing, including concerns 
about privacy, problems performing or interpreting the test, and any perceived harms or benefits 
resulting from group self-testing.  
 
2.4.4.1. Registry Data for Triangulation and Linkage 
HIV testing, ART, OPD, and STI registers will be reviewed to measure the number of individu-
als attending the clinics during the period of the study (denominator), the number HIV tested 
using routine testing strategies (numerator), the proportion of those tested through routine test 
strategies who are identified as HIV-positive (yield), and the proportion of those identified as 
HIV positive who link to ART services. All data will be anonymized from existing registers. 
Records from OPD and STI clients aged 15 years and older will be included in the study.  Over 
the period of the study, we will be able to determine the proportion of all STI and OPD patients 
who received a routine HIV test (Determine and Uni-Gold HIV test kits), the proportion of 
those tested who are HIV-positive, and the proportion of HIV positive clients who linked to 
ART services. 
 
2.4.6.2. Focus Group Discussions with Providers 
At the end of Aim 1 implementation, focus group discussions will be conducted with providers at 
participating OPD, STI, and HTC clinics to understand perceptions and acceptability of group 
self-testing at OPD and STI clinics. All core providers and supporting staff involved with the self-
test intervention will be asked to participate (estimated 5 providers and 8 supporting staff at each 
site). Each site will complete two focus groups; one with providers and one with supporting staff 
(10 focus groups in total). Only providers over 18 years of age, actively involved in the self-test 
intervention, and willing and able to consent will participate.  Focus groups will last approxi-
mately 45 minutes.  
 
 
2.5. STATISTICAL METHODS 
 
2.5.1. Outcome Measures 
 

 
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Power Calculations and Statistical Analysis for Primary Outcome Measures 
We have 15 clusters available for randomization, and therefore, estimated our sample size 
assuming a fixed number of clusters (k) and an equal number of clusters per arm (k=5). 
We also assumed an equal number of participants per cluster (n=1,000) for a total sample 
size of 5,000 participant per arm (15,000 total). Assuming a type I error of 0.05,  an intra-
cluster correlation of 0.004, we would expect at least 95% power to detect study arm test-
ing coverage of 5% in study arm 1, at least 10% in study arm 2, and 60% in study arm 3.    
 
We will calculate descriptive statistics, including mean/median, variation (standard devi-
ation, kurtosis), range, and frequency distributions for the demographic and clinical char-
acteristics, overall and by study arm. The outcomes of interest include the proportion of 
participants tested and HIV-positivity among those tested. Differences in the prevalence 
of each of the outcomes of interest will be examined by study arm as well as by other fac-
tors of interest including demographic characteristics (e.g., age, gender), clinical charac-
teristics (e.g., reason for clinic visit), and structural factors (e.g., geographic location).  
The differences will be evaluated using t-tests, Mann-Whitney U test (or other non-para-
metric tests), chi-square methods, and Fisher’s exact test as appropriate.  In order to as-
sess factors associated with HIV testing/positivity, we will use hierarchical linear models 
in order to account for clustering of effects within each clinic.  Separate models will be 
developed for each outcome of interest and covariates of interest include patient charac-
teristics (e.g., age, gender) and other structural and contextual factors.    
 
Qualitative Analysis for Secondary Outcome Measures 
Our secondary outcomes measured will be feasibility and acceptability of group self-test-
ing including privacy concerns, problems with performing or interpreting self-tests, and 
perceived harms or benefits resulting from self-testing. Qualitative methods (semi-struc-
tured in-depth interviews) will be conducted on a subset of individuals (n=40) from the 
group self-testing arm. Interviews will be translated and transcribed by trained personnel. 
Interviews will be analyzed in Atlas.ti v.6.2 using thematic analysis. Two investigators 
will code the first five interviews by themes and compare coding to reach a consensus. A 
codebook will be developed, and two coders will independently code all transcripts and 
compare codes to reach a consensus. For each theme, we will describe the range, central 
tendency, and context in which each theme emerges. 
 
2.6. COST AND COST-EFFECTIVENESS METHODS 
It is expected that group self-testing will be cost-effective compared to standard of care and opti-
mized standard of care for HIV testing. For facilities, fewer HDA staff would be needed to 
achieve testing coverage, and it is possible that more positives will be identified. The study will 
estimate differences in overall costs for both standard of care arms and group self-testing. Costs 
of HIV testing will be estimated as the average cost per individual who completes an HIV test.  
 
Using the average cost per patient tested we will estimate the cost for identifying each HIV-posi-
tive individual. We will compare average cost per HIV-positive individual identified among the 
three study arms with the primary comparison of optimized standard of care compared to group 
self-testing. To provide information for HIV program budgets, we will also estimate the annual 
cost of providing HIV testing at a site under the three strategies evaluated, independent of out-
comes. 
 
2.6.1. Costs to Provider (HIV Diagnostic Assistant) 
Costs will be measured from the perspective of the HDA (the “provider” of HIV testing).  We 
will use micro-costing methods to estimate the cost of HIV testing in each study arm.25, 26, 27 We 

 
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11 October 2017 
will first create an inventory of all the resources used to achieve the observed study outcomes. 
Resources to be captured will include: 
 HIV self-test kits  
 Standard of care HIV testing supplies - Determine and Uni-Gold test kits 
 Other services provided (e.g. counseling interactions) 
 Fixed costs of patient care (building space, equipment, human resources) 
 
For each study patient, the quantity (number of units) of resources used will be determined. Unit 
costs of resources, which are not human subjects data, will be obtained from external suppliers 
and the site’s finance and procurement records and multiplied by the resource usage data to pro-
vide an average cost per study patient across centers in each study arm. Costs will be reported as 
means (standard deviations) and medians (IQRs) in U.S. dollars, using the exchange rate prevail-
ing during the follow-up period.  
 
2.6.2. Cost-Effectiveness 
Using the average cost per patient as described above, we will then estimate the cost per outcome 
achieved in each arm. Two measures of effectiveness will be utilized for the cost-effectiveness 
analysis: the proportion of individuals tested for HIV and the cost per HIV-positive individual 
identified. We will calculate the difference in cost divided by the difference in effectiveness be-
tween study arms for both measures of effectiveness.  
 
The price of the self-test (if self-testing were to become widely available in Malawi) is currently 
uncertain. As such, we will conduct a sensitivity analysis where all costs and outcomes remain 
constant, and the price of self-tests alone is varied. This analysis will then provide a plausible 
range of the cost-effectiveness of self-testing. 
 
2.6.3. Accrual 
 
Monitoring by the Protocol Team 
 
The Protocol Team is responsible for continuous monitoring of study progress, including 
timely achievement of key milestones and quality of study conduct.   
 
The team will closely monitor participant accrual based on reports that will be generated 
at least monthly. The team will monitor the timing of site-specific study activation, which 
will determine when each site will begin accruing participants and actual accrual follow-
ing activation. For any site that is delayed in completing the study activation process or 
that falls short of its accrual projections, the team will work with the research assistant 
assigned to the site to identify the barriers the site has encountered and the operational 
strategies and action plans to address these.   
 
The Protocol Team will similarly review key indicators of the quality of study conduct 
(e.g. data quality, and data and specimen completeness) based on reports and take action 
with study sites as needed to ensure high quality study conduct.  
 
Monitoring  
 
Operational futility may be considered if the observed accrual patterns are exceedingly 
different than planned, and the protocol team has had a chance to address the shortcom-
ings of accrual.  

 
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3. 
AIM 2: PARTNER SELF-TESTING 
 
3.1. OBJECTIVES 
 
3.1.1. Primary Objectives: 
 To determine whether providing index clients with HIV self-test kits for partners results in a 
greater number of partners tested as compared to optimized standard of care for partner notifi-
cation and testing (referral slip) 
 To determine whether providing index partners with HIV self-test kits is cost-effective com-
pared to optimized standard of care using referral slips 
 
3.1.2. Secondary Objectives: 
 To assess the acceptability of giving self-test kits to index clients for partner testing 
 To determine whether providing index partners with HIV self-test kits is superior to optimized 
standard of care in regard to identifying HIV+ partners (yield of testing) 
 To determine whether providing index partners with HIV self-test kits is superior to optimized 
standard of care in regard to linkage rates among those who identify as HIV-positive 
 To determine whether providing self-test kits to index clients and their partner is superior to 
optimized standard of care in regard to partner disclosure by the index client 
 
3.2. STUDY POPULATION 
This study will be conducted among approximately 1,800 individuals 15 years or older who have 
at least one sexual partner with unknown HIV status. The study population may include partici-
pants from Aim 1 who test HIV-positive under any of the three study arms. 
 
The study will be conducted in the same 15 clusters used in Aim 1. The cluster randomization 
will be retained for Aim 2 such that sites identified as intervention sites for Aim 1 will remain in-
tervention sites for Aim 2 (likewise for standard of care and optimized standard of care sites). 
 
3.2.1. Inclusion Criteria 
All of the criteria listed below must be met in order for an individual to be included in this study.   
 At least 15 years of age or older 
 Willing and able to provide informed consent for participation in this study 
 HIV-positive  
 Have at least one sex partner in the catchment area with an unknown HIV status at the 
time of study enrollment (defined as never testing for HIV or testing HIV negative more 
than 6 months ago) 
 No history of intimate partner violence in the past 12 months 
 No fear of intimate partner violence as a consequence of participating in the study 
 Not enrolled in the INTERVAL study (no co-enrollment) 
 
 
3.2.2. Exclusion Criteria 
Individuals will be excluded from the study if any of the following are identified during screening 
or any other time during the study:  
 HIV-negative 
 Younger than 15 years of age 

 
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11 October 2017 
 No sex partners with unknown HIV status in the catchment area at the time of study en-
rollment 
 Experienced intimate partner violence during the past 12 months 
 Fear of intimate partner violence as a consequence of participating in the study 
 Enrolled in the INTERVAL study 
 Unwilling or unable to provide informed consent 
 
3.3. STUDY DESIGN 
The study will utilize the cluster randomization of Aim 1 and compare use of HIV self-test kits 
for index clients to provide to partners compared with index partner testing using standard of care 
and optimized standard of care partner notification strategies (Fig. 3).  
 
FIG 3: OVERVIEW OF STUDY DESIGN 
 
 
 
3.3.1. Description of Randomization and Study Arms 
Randomization from Aim 1 will be accomplished such that facilities randomized to the self-test 
intervention in Aim 1 will be self-test intervention sites for Aim 2 and sites randomized to stand-
ard of care and optimized standard of care for Aim 1 will continue as standard of care and opti-
mized standard of care sites for Aim 2.  
 
Description of Study Arms 
 
1. Standard of care arm: Facilities randomized to the standard of care arm will use 
MOH approved referral mechanisms, without any intervention from the study 
team. Standard of care quality will vary by facility and may include some level 
of partner referral services for index partners such as referral slips. Referral slips 
may be given at HIV testing or ART clinics. Sites will be asked to counsel cli-
ents to have their partners bring referral slips back to the clinic to document the 
number of partners presenting for HIV testing. A random subset of HIV-positive 
clients in the standard of care arm will complete an anonymous survey to an-
swer questions about whether they used referral slips and whether they know if 
partners came to a health facility for testing.  
 
Rand
Stand
Demo
Opti
Opti
Demo
Partn
Partn
Demo
Post-

 
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11 October 2017 
2. Optimized standard of care arm: Facilities randomized to optimized standard of 
care will be supported by the study team to systematically perform referral ser-
vices following Ministry of Health Guidelines. Providers will receive an initial 
refresher training on partner testing followed by regular mentoring visits. Job 
aids will also be used to remind providers about the importance of partner test-
ing. Standard of care procedures involve counseling HIV-positive individuals 
about the importance of partner testing and providing ‘referral slips’ to the index 
client to distribute to every sexual partner within the prior 12 months. Referral 
slips will be used to encourage partners to come to the facility for HIV testing. 
Sites will be asked to counsel clients to have their partners bring referral slips 
back to the clinic to document the number of partners presenting for HIV test-
ing. A random subset of participants in the optimized standard of care arm will 
complete an anonymous survey to answer questions about whether they used 
referral slips and whether they know if partners came to a health facility for test-
ing. 
 
3. Partner self-testing arm: Facilities randomized to partner self-testing will have 
study staff give self-test kits to index clients to distribute to every sexual partner 
with unknown status who lives in the facility catchment area within the prior 12 
months (up to three sexual partners). They will also be given self-test kits for 
themselves so they can participate in couples testing if they choose. All index 
clients will be counseled on the importance of partner notification and testing 
and receive a demonstration on how to perform the self-test, so they can show 
partners. Self-test kits will contain information on how to use the test and a re-
ferral card. The referral card will contain information on where to present for 
confirmatory testing and where partners can receive ART, including a map to 
the facility.  Index clients will be counseled to tell their partner to drop the com-
pleted test in a lockbox at the local health facility. A study phone number will 
also be provided in order to facilitate community-based collection of kits if par-
ticipants are unwilling or unable to attend the facility. Written instructions, pic-
ture instructions, and maps will also be provided to the index client to give to 
the index partner. Index clients will also be counseled to encourage partners to 
present to the facility for routine HDA testing if they are unable or uncomforta-
ble completing the self-test. 
 
3.3.2. Recruitment, Screening, and Enrollment Process 
 
Standard of care arm 
There will be no study “interventions” at the sites. A random subset of individuals will be re-
cruited to complete a survey at the time they complete ART visits. Individuals will be screened 
to confirm they meet inclusion criteria, including having at least one partner of unknown status 
living within the facility catchment area at the time of their last clinical visit. After oral informed 
consent has been obtained, enrolled participants will complete a brief anonymous survey.  
 
Optimized standard of care arm 
Recruitment, screening, and enrollment will be the same as described above for standard 
of care sites. 
 

 
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Partner self-testing arm 
Individuals will be recruited and initially screened by providers (HDAs and/or ART pro-
viders) who will identify HIV-positive clients 15 years of age and older with at least one 
partner who has unknown HIV status. Screening will be performed in a private space 
where no other clients or staff can hear the exchange of information. Eligible index cli-
ents will be referred to study staff for further screening (see 2.2.1 and 2.2.2 for inclu-
sion/exclusion) and those who provide written informed consent will be enrolled.  
 
1. 
Informed Consent 
Written informed consent will be obtained before any study-specific procedures are performed.  
The informed consent process will include information exchange, detailed discussion, and assess-
ment of understanding of all required elements of informed consent, including the potential risks, 
benefits, and alternatives to study participation.  For standard of care and optimized standard of 
care arms (arms 1 and 2), informed consent will include a broad, general description of study ob-
jectives. Specific descriptions about the primary outcome of interest (index partner testing) will 
not be discussed in detail as the discussion may influence client behavior regarding partner test-
ing, skewing findings. For the intervention arm (arm 3, self testing), the process will emphasize 
the randomized nature of the study and the differences that participants may experience as part of 
the study relative to current local standards of care.  
 
2. 
Participant Withdrawal or Termination from the Study 
Individuals may withdraw from the study at any time. Participants may also be terminated from 
the study by the site investigator or designee under the following circumstances: 
 
 Site investigator or designee determines that continued participation in the study would 
be unsafe or otherwise not in the best interest of the participant  
 The study is stopped or canceled by the sponsors, government or regulatory authorities, 
or site IRBs 
 
4. 
STUDY PROCEDURES 
 
4.1. 
Standard of Care Arm 
 
3.4.1.1  Provision of Services 
Facilities in the standard of care arm will provide routine services. No intervention activi-
ties will be conducted. Standard of care procedures involve counseling HIV-positive indi-
viduals about the importance of partner testing and providing ‘referral slips’ to the index 
client to distribute to sex partners. Partner testing will follow Ministry of Health National 
Guidelines using serial testing with Determine and Uni-Gold. Those that test positive will 
be counseled and referred to ART services following routine care.  
 
3.4.1.2  Baseline Visit for Index Client 
A random sample of individuals will be screened and consented as they exit their ART 
visit. This will include ART clients who report having a sexual partner with an unknown 
HIV status. After written informed consent has been obtained, study staff will collect 
basic socio-demographics (including age, gender, marital status, and number of partners), 
HIV characteristics (date of HIV diagnosis, whether on ART and date started), and the 
number of eligible sexual partners who qualify for index testing referral slips. Individuals 
will also be asked whether they were offered a referral slip on the day of the survey. 
 

 
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Follow-up Visit of Index Clients 
All index clients will be seen by study staff when they come for their next ART follow-
up visit. A brief survey will be performed to collect information about whether the client 
disclosed their HIV status to their sex partner(s), whether they gave referral slips to their 
partner(s), and knowledge about whether partners completed a test, knowledge of their 
partner’s test result, and knowledge about their partner’s linkage to care. We will also 
survey the index client to determine whether any gender-based violence or fear of gen-
der-based violence resulted from use of the self-tests. Index clients who do not return for 
their ART follow-up visit (more than two weeks late) will be traced through standard site 
protocols and surveyed either in the community or at the facility, if they return to care. 
 
HIV testing registers will also be reviewed to measure the number of individuals tested 
through partner referrals and the proportion of partner referral tests who were identified 
as HIV-positive. All registry data will be anonymized. Records from partner notification 
clients aged 15 years and older will be included in the study. For those who are HIV-pos-
itive, the HTC and ART registers will be reviewed to determine if the patient started ART 
and presented for their four-week follow-up visit. 
 
4.2. 
Optimized Standard of Care Arm 
 
4.2.1.  Partner Notification and Referral 
The study team will provide trainings, job aids, and regular mentorship to promote opti-
mized standard of care in regards to partner notification and referral strategies for HIV-
positive clients with partners who have an unknown HIV status. Under optimized stand-
ard of care, providers will ask clients at every ART visit whether they have current or re-
cent (within 12 months) sex partners with unknown HIV status or tested negative for HIV 
more than 6 months ago. Clients will be counseled on the importance of partner notifica-
tion and testing and given a partner notification slip to assist in partner notification and 
testing referral. Individuals will be counseled to ask their partners to return the referral 
slips when they come for testing. Partners who present at the facility for HIV testing will 
be tested in private rooms by trained HDAs following Ministry of Health guidelines. 
HDAs will ask all clients presenting for testing whether they were referred by a partner 
and this will be indicated in a column in the HIV testing register. Serial HIV testing will 
be performed with Determine and Uni-Gold as per standard of care. Those that test posi-
tive will be counseled and referred to ART services. ART initiation will follow standard 
clinic protocols under the universal treatment (Test and Treat policy). 
 
3.4.2.2 Baseline Visit for Index Client 
A random sample of individuals will be screened and consented as they exit their ART 
visit. This will include ART clients who report having a sexual partner with an unknown 
HIV status. After written informed consent has been obtained, study staff will collect 
basic socio-demographics (including age, gender, marital status, and number of partners), 
HIV characteristics (date of HIV diagnosis, whether on ART and date started), and the 
number of eligible sexual partners who qualify for index testing referral slips. Individuals 
who consent will also be asked whether they were offered a referral slip on the day of the 
survey.   
 

 
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Follow-up Visit of Index Clients 
All index clients will be seen by study staff when they come for their next ART follow-
up visit. A brief survey will be performed to collect information about whether the client 
disclosed their HIV status to their sex partner(s), whether they gave referral slips to their 
partner(s), and knowledge about whether partners completed a test, knowledge of their 
partner’s test result, and knowledge about their partner’s linkage to care. We will also 
survey the index client to determine whether any gender-based violence or fear of gen-
der-based violence resulted from use of the self-tests. Index clients who do not return for 
their ART follow-up visit (more than two weeks late) will be traced through standard site 
protocols and surveyed either in the community or at the facility, if they return to care. 
 
HIV testing registers will also be reviewed to measure the number of individuals tested 
through partner referrals and the proportion of partner referral tests who were identified 
as HIV-positive. All registry data will be anonymized. Records from partner notification 
clients aged 15 years and older will be included in the study. For those who are HIV-pos-
itive, the ART register will be reviewed to determine if the patient started ART and pre-
sented for their four-week follow-up visit. 
 
At the time of follow-up, a random sample of 40 index clients (20 men and 20 women) 
will be selected and asked to participate in semi-structured, in-depth interviews to explore 
the feasibility and acceptability of providing referral slips to partners, including chal-
lenges with disclosure and questions around harm or perceived risk of harm due to dis-
tributing the referral slip.  
 
4.3. 
Partner Self-Testing Arm 
 
3.4.4.1  Baseline Visit for Index Client 
A random sample of individuals will be screened and consented as they exit their ART 
visit. This will include ART clients who report having a sexual partner with an unknown 
HIV status. After written informed consent has been obtained, study staff will collect 
basic socio-demographics (including age, gender, marital status, and number of partners), 
HIV characteristics (date of HIV diagnosis, whether on ART and date started), and the 
number of eligible sexual partners they plan to give self-test kits. 
 
The study staff will counsel the index client on how to administer an HIV self-test and 
will provide one self-test kit for each sexual partner within the last 12 months with un-
known status (or HIV-negative more than 6 months ago) who lives within the catchment 
area of the facility and for whom the index client is willing to provide the test kit (up to 
three sexual partners). Index clients will also be given self-test kits for themselves if they 
wish to use them to complete couples counseling. All HIV self-test kits will be labeled 
with a unique ID linked to the index client participant. The ID will also be used to link 
index client survey responses with returned self-test kits. 
 
The number of partners and the number of kits provided will be documented by study 
staff. Each self-test kit will be in a package that also contains a referral card. The referral 
card can be used for (1) those who test HIV-positive and need to present for confirmatory 
testing and link to care, (2) those who do not want to use the self-test kit and would rather 
test with an HDA, or (3) clients who experience difficulty or discomfort with the self-test 
kit and choose to test at a facility. The referral card will include information about the fa-

 
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cility, including a map. The card will also contain a notation that if it is returned to an-
other facility, the facility should contact the study team so that the card can be collected 
and recorded as “returned”. Study staff will periodically visit nearby testing sites to deter-
mine if any referral cards have been returned to those sites. 
 
3.4.4.2 Partner Self-Testing 
Index clients will provide their partners with the following instructions verbally. The fol-
lowing instructions will also be provided on the referral form in picture form and in the 
local language: 
1. Complete HIV self-test 
2. If the self-test is positive, bring the self-test kit and referral card to the clinic for 
confirmatory testing and linkage to care.   
3. If the self-test is positive and the client does not wish to present for further care, 
the self-test kit should be disposed of in the lockbox at the HSA house.  
4. If the test is negative, the client will be instructed to dispose the self-test kit in a 
lockbox at the HSA house in the local community or may bring the kit to the 
lockbox at OPD/STI. 
 
Any individual who has difficulty with the self-test kit or needs help with interpretation 
can come to the facility with the kit and the referral card and be seen by an HDA for as-
sistance and/or standard of care HIV testing. 
 
3.4.4.3 Follow-up of Partner Self-Testing 
The number of index partners tested will be determined based on the number of self-test 
kits returned to village and health facility lockboxes and triangulated with self-reports 
from a follow-up survey with the index client. Additionally, partners with a positive self-
test kit who present to the facility for confirmatory testing and linkage to care, and/or 
partners who did not use the self-test kit but present to the facility for HIV testing will be 
accounted for through the returned referral cards. Like self-test kits, referral cards will be 
identified with a unique code, allowing the partner to be linked to the index client.  
 
For those who are HIV-positive and present to the clinic for care, the ART register will 
be reviewed four weeks later to determine if the patient starts ART and presents for their 
four-week follow-up visit. All data from registers will be anonymized for use by the 
study team. In addition, index clients will provide self-reports about partner linkage to 
ART during a follow-up survey. 
 
3.4.4.4  Follow-up Visit of Index Clients 
All index clients will be seen by study staff when they come for their next ART follow-
up visit. A brief survey will be performed to collect information about whether the client 
disclosed their HIV status to their sex partner(s), whether they gave self-test kits to their 
partner(s), and knowledge about whether partners completed the test, knowledge of their 
partner’s test result, and knowledge about their partner’s linkage to care. We will also 
survey the index client to determine whether they were able to successfully show their 
partner(s) how to use the kit and whether any gender-based violence or fear of gender-
based violence resulted from use of the self-tests. Index clients who do not return for their 
ART follow-up visit (more than two weeks late) will be traced through standard site pro-
tocols and surveyed either in the community or at the facility, if they return to care. 
 

 
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A random sample of 40 index clients (20 men and 20 women) and 40 index partners (20 
men and 20 women) will be selected and asked to participate in semi-structured, in-depth 
interviews to explore the feasibility and acceptability of providing self-test kits to part-
ners, including challenges with disclosure and questions around harm or perceived risk of 
harm due to distributing the kits.  
 
2.4.4.5  Follow-up Visits with Index Partners 
Index partners will be recruited for in-depth interviews through index clients (n=40). 
During follow-up visits with index clients, a random subset of clients will be given a 
study invitation card to be given to their sexual partner who was given a self-test kit. The 
study invitation card will describe the in-depth interview they are being recruited for and 
provide a study-specific phone number the index partner can call in order to participate in 
the study. In addition, index clients will be asked if the study team could call the ran-
domly selected partner to discuss the study. Index clients will be told the purpose of the 
call. If index clients give permission to contact the index partner, up to 2 phone numbers 
will be collected. Index partners will be called up to 3 times over a 2-week period for re-
cruitment into the study. If the index partner cannot be reached after the third try, the 
partner will be listed as “unreachable” and excluded from the study.  
 
For index partners contacted by the study staff, oral consent for screening and eligibility 
screening will take place via phone.  Those who agree and are deemed eligible for the 
study will decide on a time and place for completing full oral consent to participate in the 
study and completing one in-depth interview. Interested respondents will choose the loca-
tion of their choice, either at the facility or in their local community.  Interviews will last 
approximately 60 minutes. Interviews will provide additional information about the feasi-
bility and acceptability of providing self-test kits to partners, including challenges with 
completing the test, questions around harm or perceived risk of harm, and challenges 
linking to care at health facilities. 
 
 
 
 
 
 
 
 
 
 
5. 
STATISTICAL METHODS 
 

 
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5.1. 
Outcome Measures 
 
3.5.1.1  Sample Size and Statistical Analysis for Primary Outcome Measures 
We will have 15 clusters (facilities) available for randomization, and therefore, estimated 
our sample size assuming a fixed number of clusters (k) and an equal number of clusters 
per arm. We also assumed an equal number of participants per cluster.  The below calcu-
lations were determined using a minimum sample size. Assuming a type I error of 0.05, 
an intracluster correlation of 0.004 and sample sizes of 600 HIV-positive patients per 
arm, we have 89% power to detect a difference in testing coverage of 20% in study arm 2 
(optimized standard of care) and 40% in study arm 3 (self-testing). Because we are uncer-
tain about the proportion of partners who will test under each arm, we have considered a 
range of possibilities, with the majority of scenarios providing at least 87% power to de-
tect a difference between the two arms of interest (optimized standard of care and self-
testing) (Figure 4).  
 
We will calculate descriptive statistics, including mean/median, variation (standard devi-
ation, kurtosis), range, and frequency distributions for the demographic and clinical char-
acteristics, overall and by study arm. The outcomes of interest include the proportion of 
partners tested and HIV-positivity of partners. Differences in the prevalence of each of 
the outcomes of interest will be examined by study arm as well as by other factors of in-
terest including demographic characteristics (e.g., age, gender), clinical characteristics 
(e.g., reason for clinic visit), and structural factors (e.g., geographic location).  The differ-
ences will be evaluated using t-tests, Mann-Whitney U test (or other non-parametric 
tests), chi-square methods, and Fisher’s exact test as appropriate.  In order to assess fac-
tors associated with partner’s HIV testing/positivity, we will use hierarchical linear mod-
els in order to account for clustering of effects within each clinic.  Separate models will 
be developed for each outcome of interest and covariates of interest include patient char-
acteristics (e.g., age, gender) and other structural and contextual factors.    
 
Qualitative Analysis for Secondary Outcome Measures 
Our secondary outcomes measured will be feasibility and acceptability of partner self-
testing, privacy concerns, problems with performing or interpreting self-tests, and per-
ceived harms or benefits resulting from self-testing. Qualitative methods (semi-structured 
in-depth interviews) will be conducted on a subset of index clients (n=30) from the part-
ner self-testing arm and 30 from the optimized standard of care arm (n=30). Qualitative 
methods will be the same as those outlined in Aim 1. 
 
6. 
COST AND COST-EFFECTIVENESS METHODS 
It is expected that partner self-testing will be cost-effective compared to optimized standard of 
care. For facilities, fewer HDA visits by patients should save the time of HDA staff. Partner self-
testing may also lead to an increase in HIV-positive individuals identified because clients may be 
more comfortable doing the test in a private place. The study will estimate differences in overall 
costs for both optimized standard of care and partner self-testing. The average cost per successful 
outcome (index partner completes an HIV test) will be calculated.  
 
Using the average cost per patient as described above, we will then estimate the cost for each 
newly identified HIV-positive partner. We will compare average cost per HIV-positive individual 
identified between study arms. To provide information for HIV program budgets, we will also 
estimate the annual cost of providing HIV testing under the two main strategies being evaluated 
(optimized standard of care and self-testing), independent of outcomes. 

 
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6.1. 
Costs to Provider 
Costs will be measured from the provider perspective.  We will use micro-costing methods to es-
timate the cost of HIV testing in all three study arms.25, 26, 27 We will first create an inventory of 
all the resources used to achieve the observed study outcomes. Resources to be captured will in-
clude: 
 HIV self-test kits 
 Standard of care HIV testing supplies 
 Other services provided (e.g. counseling interactions) 
 Fixed costs of patient care (building space, equipment, human resources) 
 
For each study patient, the quantity (number of units) of resources used will be determined. Unit 
costs of resources, which are not human subjects data, will be obtained from external suppliers 
and the site’s finance and procurement records and multiplied by the resource usage data to pro-
vide an average cost per study patient across centers in each study arm. Costs will be reported as 
means (standard deviations) and medians (IQRs) in USD, using the exchange rate prevailing dur-
ing the follow up period.  
 
6.2. 
Cost-Effectiveness 
Using the average cost per patient as described above, we will then estimate the cost per outcome 
achieved in each arm. The main measure of effectiveness for the cost-effectiveness analysis will 
be both the primary study outcome of proportion of partners tested as well as yield (newly identi-
fied HIV-positive partners of index cases). We will calculate the difference in cost divided by the 
difference in effectiveness among study arms for both effectiveness measures.  
 
The price of the self-test itself is currently uncertain because it is not widely available in Malawi. 
As such, we will conduct a sensitivity analysis where all costs and outcomes remain constant, and 
the price of self-tests alone is varied. This analysis will then provide a plausible range of the cost-
effectiveness of partner self-testing. 
 
6.3. 
Sample Size and Accrual 
 
Monitoring by the Protocol Team 
The Protocol Team is responsible for continuous monitoring of study progress, including 
timely achievement of key milestones and quality of study conduct.   
 
The team will closely monitor participant accrual based on reports that will be generated 
at least monthly. For any site that falls short of its accrual projections, the team will com-
municate with the site research assistants and leadership to identify the barriers the site 
has encountered and the operational strategies and action plans to address these.   
 
The Protocol Team will similarly review key indicators of the quality of study conduct 
(e.g. data quality and data completeness) based on reports and take action with study sites 
as needed to ensure high quality study conduct.  
 
 
 
 

 
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4. 
DATA HANDLING AND RECORD KEEPING 
 
4.1. DATA MANAGEMENT RESPONSIBILITIES 
Study sites must maintain adequate and accurate research records containing all information perti-
nent to the study for all screened and enrolled participants, including CRFs and supporting source 
data. Depending on capacity and infrastructure of sites/regions, data will either be collected by 
hand and entered into a database or collected electronically with data uploaded to a database.    
 
All data must be transferred to the central database within timeframes specified in the forms’ in-
structions; queries must also be resolved in a timely manner.  
 
5. 
SITE MONITORING 
Site monitors will visit study sites to inspect study facilities and review participant study records 
including consent forms and CRFs, to ensure protection of study participants, compliance with 
the IRB/EC approved protocol, and accuracy and completeness of records. Site investigators will 
make study facilities and documents available for inspection by the monitors.   
 
6. 
SAFETY ASSESSMENT, MONITORING, AND REPORTING 
Participant safety will be carefully assessed, monitored, and reported at multiple levels through-
out this study.  
 
7. 
HUMAN SUBJECTS PROTECTIONS 
 
7.1. 
INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE REVIEW AND AP-
PROVAL INCLUDING INFORMED CONSENT 
Prior to study initiation, site investigators must obtain IRB/EC review and approval of this proto-
col and ICFs; subsequent to initial review and approval, IRBs/ECs must review the study at least 
annually.   
 
All IRB/EC policies and procedures must be followed, and complete documentation of all corre-
spondence to and from the IRBs/ECs must be maintained in site essential document files.  Sites 
must submit documentation of both initial review and approval and continuing review to the 
EQUIP Protocol Team. 
 
Informed consent will be obtained before any study-specific procedures are performed.  The in-
formed consent process will include information exchange, detailed discussion, and assessment of 
understanding of all required elements of informed consent, including the potential risks, benefits, 
and alternatives to study participation.  The process will emphasize the randomized nature of the 
study and the differences that participants may experience as part of the study relative to current 
local standards of care.    
 
7.2. POTENTIAL BENEFITS 
There may be no direct benefit to participants who take part in this study, though participants who 
are randomly assigned to the self-testing study arms may benefit from the convenience and pri-
vacy of completing an HIV test at a location and time of their choosing. Information learned in 
this study may be of benefit to participants and others in the future, particularly information that 
may lead to optimized testing guidelines. 
 

 
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7.3. POTENTIAL RISKS AND DISCOMFORTS 
Most study procedures are routine clinical care associated with minimal to no risk in participants.  
Participation in the group self-testing arm in Aim 1 may feel some psychological stress or dis-
comfort from testing and receiving HIV test results in a public setting. Participation in surveys 
and qualitative interviews may also cause some psychological stress or discomfort. Participants 
may decline to participate in the self-testing or decline to answer any questions that make them 
uncomfortable. Participants in Aim 2 will be screened for risk of intimate partner violence, and 
those with any risk will be excluded.  
 
7.4. REIMBURSEMENT/COMPENSATION 
Participants who complete qualitative interviews will be reimbursed/compensated for their time 
and any transport costs. Participants in the self-testing arm of AIM 2 (partner self-testing) will 
also be reimbursed/compensated for their time. Index partners participating in a in-depth inter-
view will be reimbursed for transport costs associated with the interview if they choose to con-
duct the interview at the health facility. The amount of reimbursement will be deemed appropriate 
by the Malawi NHSRC. 
 
7.5. PRIVACY AND CONFIDENTIALITY 
All study procedures will be conducted in private, and every effort will be made to protect partici-
pant privacy and confidentiality to the extent possible.  Participant information will not be re-
leased without written permission to do so except as necessary for review, monitoring, and/or au-
diting. 
 
All study-related information will be stored securely.  Participant research records will be stored 
in locked areas with access limited to study staff.  All laboratory specimens, CRFs, and other doc-
uments that may be transmitted off-site will be identified by PID only.  Likewise, communica-
tions between study staff and protocol team members regarding individual participants will iden-
tify participants by PID only.   
 
Study sites are encouraged to store study records that bear participant names or other personal 
identifiers separately from records identified by PID.  All local databases must be secured with 
password-protected access systems.  Lists, logbooks, appointment books, and any other docu-
ments that link PID numbers to personal identifying information will be stored in a separate, 
locked location in an area with limited access.   
 
7.6. MANAGEMENT OF NEW INFORMATION PERTINENT TO STUDY PARTICI-
PATION 
Study staff will provide participants with any new information learned over the course of the 
study that may affect their willingness to participate.   
 
8. 
ADMINISTRATIVE PROCEDURES 
 
8.1. REGULATORY OVERSIGHT 
This study is sponsored by USAID/PEPFAR and implemented through Partner in Hope (PIH)-
EQUIP.  PIH-EQUIP staff will perform monitoring visits.  As part of these visits, monitors will 
inspect study-related documentation to ensure compliance with all applicable regulatory require-
ments. 
 

 
Version 1.4 
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Site-specific ICFs will be reviewed and approved by the EQUIP key personnel, and sites will re-
ceive an Initial Registration Notification from EQUIP that indicates successful completion of the 
protocol registration process.  A copy of the Initial Registration Notification should be retained in 
the site's regulatory files. 
 
For any future protocol amendments, upon receiving final IRB/EC and any other applicable regu-
latory entity approvals, sites should implement the amendment immediately.  Sites are required to 
submit an amendment registration packet to the EQUIP Protocol Team.  EQUIP key personnel 
will review the submitted protocol registration packet to ensure that all the required documents 
have been received.   
 
8.2. STUDY IMPLEMENTATION 
Study implementation at each site will also be guided site-specific standard operating procedures 
(SOPs). These SOPs should be updated and/or supplemented as needed to describe roles, respon-
sibilities, and procedures for this study. 
 
8.3. PROTOCOL DEVIATION REPORTING 
All protocol deviations must be documented in participant research records.  Reasons for the de-
viations and corrective and preventive actions taken in response to the deviations should also be 
documented.  
 
Deviations should be reported to site IRBs/ECs and other applicable review bodies in accordance 
with the policies and procedures of these review bodies.  Serious deviations that are associated 
with increased risk to one or more study participants and/or significant impacts on the integrity of 
study data must also be reported to the Protocol Team as soon as possible. 
 
9. 
PUBLICATIONS 
All presentations and publications of data collected in this study are governed by EQUIP and 
USAID/PEPFAR policies.  
 
10. 
REFERENCES 
 
1. 
NSO & ORC Macro. Malawi Demographic and Health Survey 2016. Calverton, MD: NSO & 
ORC Macro. 2016. 
 
2. 
Topp SM, Li MS, Chipukuma JM, et al. Does provider-initiated counselling and testing (PITC) 
strengthen early diagnosis and treatment initiation? Results from an analysis of an urban cohort of 
HIV-positive patients in Lusaka, Zambia. J Acquir Immune Defic Syndr. 2012;15(2). 
 
3. 
WHO/UNAIDS. Guidance on provider-initiated HIV testing and counseling in health facilities. 
Geneva: World Health Organisation; 2007. 
 
4. 
Roura M, Watson-Jones D, Kahawita TM, Ferguson L, Ross DA. Provider-initiated testing and 
counselling programmes in sub-Saharan Africa: a systematic review of their operational imple-
mentation. AIDS. 2013;27(4):617-626. 
 
5. 
Fetene NW, Feleke AD. Missed opportunities for earlier HIV testing and diagnosis at the health 
facilities of Dessie town, North East Ethiopia. BMC Public Health. 2010;10:362. 
 

 
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6. 
Sendagire I, Schreuder I, Mubiru M, van der Loeff MS, Cobelens F, Konde-Lule J. Low HIV 
testing rates among tuberculosis patients in Kampala, Uganda. BMC Public Health. 
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7. 
Ministry of Health [Malawi]. Malawi antiretroviral treatment programme quarterly report (Re-
sults up to March 31 2014). Lilongwe, Malawi: Ministry of Health [Malawi]. 2014. 
 
8. 
MacPherson P, Lalloo DG, Choko AT, et al. Suboptimal patterns of provider initiated HIV testing 
and counselling, Antiretroviral Therapy eligibility assessment and referral in primary health clinic 
attendees in Blantyre, Malawi. Trop Med Int Health. 2012;17(4):507-517. 
 
9. 
Kranzer K, Meghji J, Bandason T, et al. Barriers to provider-initiated testing and counselling for 
children in a high HIV prevalence setting: a mixed methods study. PLoS Med. 
2014;11(5):e1001649. 
 
10.  
UNAIDS: Global HIV/AIDS response: epidemic update and health sector progress towards uni-
versal access: progress report 2011. Accessed 1 March 2014. 
 
11.  
Bocour A, Renaud TC, Udeagu CC, Shepard CW. HIV partner services are associated with 
timely linkage to HIV medical care. AIDS. 2013;27(18):2961-3 
 
12. 
Hogben M, McNally T, McPheeters M, Hutchinson AB. The effectiveness of HIV partner coun-
seling and referral services in increasing identification of HIV-positive individuals a systematic 
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