Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
Phase: NA
Conditions: Human Immunodeficiency Virus
Sponsor: University of Pennsylvania

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SECONDARY DISTRIBUTION OF HIV SELF-TESTS: AN INNOVATIVE 
STRATEGY FOR PROMOTING PARTNER TESTING AND REDUCING 
RISK 
 
 
 
Principal Investigator  
Harsha Thirumurthy 
Department of Medical Ethics and Health Policy 
423 Guardian Dr, Blockley Hall 
215-898-7136 
hthirumu@upenn.edu 
Funding Sponsor 
 
National Institute of Mental Health (NIMH) 
6001 Executive Blvd. 
Rockville, MD 20852 
1-866-615-6464 
 
 
IRB Number 
 
 
 
 
NIH Grant Numbers 
 
5R01MH111602-02 
3R01MH111602-02S1 
 
 
Initial version 
 21 September 2018 
Amended 
 

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Table of Contents 
BACKGROUND AND STUDY RATIONALE ................................................................................................ 6 
1 
INTRODUCTION .................................................................................................................................. 6 
1.1 
BACKGROUND AND RELEVANT LITERATURE ..................................................................................... 6 
2 
STUDY OBJECTIVES ......................................................................................................................... 6 
2.1 
PRIMARY OBJECTIVE ...................................................................................................................... 8 
2.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ...................................................................................... 8 
3 
INVESTIGATIONAL PLAN .................................................................................................................. 8 
3.1 
GENERAL DESIGN .......................................................................................................................... 8 
3.2 
ALLOCATION TO INTERVENTIONAL GROUP [IF APPLICABLE] ............................................................... 8 
3.3 
STUDY MEASURES ......................................................................................................................... 8 
3.4 
STUDY ENDPOINTS......................................................................................................................... 8 
3.4.1 
Primary Study Endpoints ......................................................................................................... 8 
3.4.2 
Secondary Study Endpoints .................................................................................................... 8 
4 
STUDY POPULATION AND DURATION OF PARTICIPATION ........................................................ 9 
4.1 
DURATION OF STUDY PARTICIPATION .............................................................................................. 9 
4.2 
TOTAL NUMBER OF SUBJECTS AND SITES........................................................................................ 9 
4.3 
INCLUSION CRITERIA .................................................................................................................... 10 
4.4 
EXCLUSION CRITERIA ................................................................................................................... 10 
4.5 
SUBJECT RECRUITMENT ............................................................................................................... 10 
4.6 
VULNERABLE POPULATIONS: ........................................................................................................ 10 
5 
STUDY PROCEDURES ..................................................................................................................... 10 
5.1 
SCREENING AND BASELINE VISIT ................................................................................................... 12 
5.2 
FOLLOW-UP VISITS ....................................................................... ERROR! BOOKMARK NOT DEFINED. 
5.2.1 
Monthly Distribution Visits ....................................................... Error! Bookmark not defined. 
5.2.2 
6-Monthly Follow-Up ............................................................... Error! Bookmark not defined. 
5.2.3 
Qualitative Interview Visits ...................................................... Error! Bookmark not defined. 
5.2.4 
End of Study Visits ................................................................................................................ 13 
 
5.3 
UNSCHEDULED VISITS .................................................................................................................. 14 
5.4 
SUBJECT WITHDRAWAL ................................................................................................................ 14 
5.4.1 
Data Collection and Follow-up for Withdrawn Subjects ........................................................ 14 
5.5 
EARLY TERMINATION VISITS ......................................................................................................... 14 
5.6 
EFFICACY EVALUATIONS (ONLY IF APPLICABLE) .............................. ERROR! BOOKMARK NOT DEFINED. 
5.7 
PHARMACOKINETIC EVALUATION (ONLY IF APPLICABLE) .................. ERROR! BOOKMARK NOT DEFINED. 
5.8 
GENETIC TESTING (ONLY IF APPLICABLE) ....................................... ERROR! BOOKMARK NOT DEFINED. 
5.9 
SAFETY EVALUATION (ONLY IF APPLICABLE) ................................................................................... 14 
6 
STATISTICAL PLAN ......................................................................................................................... 14 
6.1 
SAMPLE SIZE AND POWER DETERMINATION ................................................................................... 14 
6.2 
STATISTICAL METHODS ................................................................................................................ 14 
6.3 
CONTROL OF BIAS AND CONFOUNDING (IF APPLICABLE, TYPICALLY OBSERVATIONAL STUDY OR IF 
RANDOMIZATION IS NOT TAKING PLACE) ...................................................... ERROR! BOOKMARK NOT DEFINED. 
6.3.1 
Baseline Data .......................................................................... Error! Bookmark not defined. 
6.3.2 
Analysis of Primary Outcome of Interest ............................................................................... 15 
6.3.3 
Pharmacokinetic Analysis (only if applicable) ......................... Error! Bookmark not defined. 
6.3.4 
Interim Analysis ....................................................................... Error! Bookmark not defined. 

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7 
SAFETY AND ADVERSE EVENTS ................................................................................................... 16 
7.1 
DEFINITIONS ................................................................................................................................ 16 
7.1.1 
Adverse Event ....................................................................................................................... 16 
7.1.2 
Serious Adverse Event .......................................................................................................... 16 
7.2 
RECORDING OF ADVERSE EVENTS ................................................................................................ 16 
7.3 
RELATIONSHIP OF SAE TO STUDY ................................................................................................ 16 
7.4 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ................................. 17 
7.4.1 
Follow-up Report ................................................................................................................... 17 
7.4.2 
Investigator reporting: notifying the study sponsor (if applicable) ......................................... 17 
7.4.3 
Data and Safety Monitoring Plan........................................................................................... 17 
8 
STUDY ADMINISTRATION, DATA HANDLING AND RECORD KEEPING .................................... 18 
8.1 
CONFIDENTIALITY ......................................................................................................................... 18 
8.2 
DATA COLLECTION AND MANAGEMENT .......................................................................................... 18 
8.3 
RECORDS RETENTION .................................................................................................................. 18 
9 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................. 18 
9.1 
STUDY MONITORING PLAN ............................................................................................................ 18 
9.2 
AUDITING AND INSPECTING ........................................................................................................... 19 
10 
ETHICAL CONSIDERATIONS .......................................................................................................... 19 
10.1 
RISKS .......................................................................................................................................... 19 
10.2 
BENEFITS .................................................................................................................................... 19 
10.3 
RISK BENEFIT ASSESSMENT ......................................................................................................... 20 
10.4 
INFORMED CONSENT PROCESS / HIPAA AUTHORIZATION .............................................................. 20 
10.4.1 
Alterations to Typical Consent Process (only include if applicable) ................................. 21 
11 
STUDY FINANCES ............................................................................................................................ 21 
11.1 
FUNDING SOURCE ........................................................................................................................ 21 
11.2 
CONFLICT OF INTEREST ................................................................................................................ 22 
11.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 22 
12 
PUBLICATION PLAN ........................................................................................................................ 22 
13 
REFERENCES ................................................................................................................................... 22 
14 
ATTACHMENTS ................................................................................................................................ 22 
15 
APPENDICES .................................................................................................................................... 25 
15.1 
EXAMPLE: TABLE 1: SCHEDULE OF STUDY PROCEDURES ............................................................ 25 
15.2 
STUDIES INVOLVING RESEARCH MRIS .......................................... ERROR! BOOKMARK NOT DEFINED. 
15.3 
STUDIES INVOLVING RESEARCH RADIATION ................................... ERROR! BOOKMARK NOT DEFINED. 
15.4 
STUDIES INVOLVING RESEARCH CT SCANS ................................... ERROR! BOOKMARK NOT DEFINED. 
15.5 
STUDIES INVOLVING NUCLEAR MEDICINE REGULATED RESEARCH PROCEDURESERROR! 
BOOKMARK 
NOT DEFINED. 
Error! 
Reference 
source 
not 
found. 
 
 
 
 
ERROR! 
REFERENCE 
SOURCE 
NOT 
FOUND.…………………………………….. 20 
ERROR! REFERENCE SOURCE NOT FOUND.15.8SOURCE 
DOCUMENTS
 
ERROR! BOOKMARK NOT DEFINED. 
15.9 
CASE REPORT FORMS (CRFS) ..................................................... ERROR! BOOKMARK NOT DEFINED. 
 

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Study Summary 
 
Title 
Secondary Distribution of HIV Self-Tests: an Innovative Strategy for Promoting 
Partner Testing and Reducing Risk 
Short Title 
Secondary Distribution of HIV Self-Tests Among High Risk Women 
IRB Number 
828100 
Methodology 
Cluster randomized case-control R01  
Study Duration 
5 Years  
Study Center(s) 
Multi-site Study: 
• 
University of Pennsylvania - prime 
• 
University of North Carolina at Chapel Hill 
• 
Impact Research and Development Organization (IRDO) 
• 
RTI International 
Objectives 
Primary: 
• 
HIV Incidence 
Secondary: 
• 
Number of male partners per participant who obtain an HIV-positive 
test result 
• 
Proportion of unprotected sexual encounters with partners who were 
HIV-positive or whose HIV status was unknown 
• 
Occurrence of intimate partner violence (IPV) 
• 
Discussion of HIV testing with partners 
• 
Occurrence of couples testing 
• 
Qualitative descriptors of how the intervention was used and 
distributed 
• 
Analysis of cost-effectiveness  
Number of Subjects 
About 2,010 subjects enrolled at IRDO, the field implementing partner in 
Kenya 

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Main Inclusion and 
Exclusion Criteria 
Inclusion Criteria:  
• 
Female 
• 
Age > 18 years 
• 
Currently reside in the study area (hotspot or beach community) 
• 
Has resided in study area for at least 6 months in the year prior to 
enrollment 
• 
Intends to stay in the region for at least 24 months 
• 
Reports two or more sexual partners within the past 4 weeks 
• 
HIV-negative 
• 
Ownership or access to a mobile phone 
• 
Willing and able to provide informed consent for participant  
• 
Not enrolled in another HIV prevention research study 
 
Exclusion Criteria: 
• 
Does not meet above inclusion criteria 
• 
Does not provide informed consent 
• 
Does not provide verbal consent to screen for eligibility 
Intervention  
 
Clusters will be randomized to an intervention group in which women will be 
given multiple HIV self-tests coupled with referral vouchers for confirmatory 
testing (for those obtaining an HIV-positive result) over a period of up to 
24months or to a comparison group that is given multiple referral vouchers 
alone for clinic-based HIV testing. The intervention’s effect on uptake of HIV 
testing and identification of HIV-infection among sexual partners of high-risk 
women, sexual behavior of high-risk women, and HIV incidence among high-
risk women will be compared between the two arms. 
Statistical 
Methodology 
The annual incidence of HIV infection will be compared between study arms 
through regression modeling using a generalized estimating equations (GEE) 
approach with a log link and assumed Poisson response distribution (the 
negative binomial distribution will be used if this distribution is not valid). An 
offset will be used in this model to account for differential follow-up times. The 
model will contain a dichotomous covariate for study group; the two-sided (α = 
0.05) statistical significance of the associated regression coefficient will be 
assessed with a Wald test performed using robust standard errors. If there are 
differences in baseline characteristics between the two study groups, a second 
regression model will be constructed that adjusts for the differing baseline 
characteristics.  
Data and Safety 
Monitoring Plan  
Data quality management will be a joint responsibility. The PI, site-PI, and 
project manager will provide regular oversight of data quality and reporting to 
all relevant parties. The implementing partner in the field also employs an 
internal research monitor who will also ensure adherence to study protocols, 
relevant guidelines, and good clinical practice. A DSMB has been formed to 
provide regular feedback on data quality and ensure patient safety. 
 

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Background and Study Rationale 
This study will be conducted in full accordance with all applicable University of Pennsylvania Research 
Policies and Procedures, all applicable US federal and state regulations, all applicable Kenyan federal 
regulations, as well as in accordance with good clinical practice guidelines.  
1 
Introduction 
This cluster randomized controlled trial will explore whether the provision of multiple oral fluid-based HIV 
self-test kits to women at higher risk of HIV can be used to promote HIV testing among their sexual 
partners, facilitate safer sexual decision-making, and ultimately reduce their risk of acquiring HIV. The 
study will recruit HIV-negative adult women who had two or more sexual partners within the past four 
weeks in the Nyanza region of Kenya. Beach communities and hotspots where women exchange sex for 
compensation will be randomized to an intervention group in which women will receive multiple oral fluid-
based HIV test kits over a period of up to 24 months, training on how to use the tests, and 
encouragement to offer tests to their sexual partners. Women in sites that are randomized to the 
comparison group will be given referral vouchers for clinic-based HIV testing over a period of up to 24-
monthsand encouraged to distribute these vouchers to their sexual partners. The primary outcome will be 
HIV incidence and secondary outcomes will include self-reported sexual behavior of participants as well 
as reported diagnoses of HIV-infected persons. Mixed methods research will be utilized to describe the 
use of self-tests by women and their sexual partners. Cost-effectiveness analyses will also be 
undertaken. 
1.1 
Background and Relevant Literature  
Widespread HIV testing in sub-Saharan Africa is the essential first step in HIV treatment and prevention 
efforts. With a number of effective interventions for prevention and treatment of HIV, the global AIDS 
community is for the first time discussing the possibility of HIV elimination. Although UNAIDS has set out 
ambitious “90-90-90” goals, most countries in sub-Saharan Africa (SSA) are far from meeting the very first 
of these targets – that by 2020, 90% of all people living with HIV should know their HIV status [1]. Uptake 
of HIV testing in SSA remains low, particularly among men [2], and this significantly limits the ability to 
reduce HIV transmission through safer sexual decision-making and effective treatment as prevention. 
While community-based testing strategies have had success [3-5], there is an urgent need for creative 
strategies to increase HIV testing among high-risk populations. 
Interventions that can identify HIV-positive persons who are unaware of their status are essential in the 
high prevalence Nyanza region of Kenya. With an adult HIV prevalence of 15.1% and 450,000 HIV-
positive adults and adolescents, data from the Kenya AIDS Indicator Survey (KAIS) suggest that 40% of 
all persons living with HIV in the country are in the Nyanza region [6]. In the urban and peri-urban sites for 
the proposed study, HIV prevalence is estimated to be 26% (Homa Bay and Siaya counties, respectively) 
[7]. While the proportion of adults who have ever tested has risen in the Nyanza region, 50% of those who 
are HIV-positive remain unaware of their status [7, 8]. The fact that so many HIV-positive individuals 
remain unaware of their status despite significant expansion of HIV testing services underscores the 
urgency of finding creative new testing strategies that can appeal to the unreached population groups. 
Promoting awareness of serostatus is especially important among high risk populations such as women 
who have multiple partners, such as women engaging in transactional sex, as well as their sexual 
partners. The vulnerability to HIV of women who engage in transactional sex has been extensively 
documented [9]. Female sex workers (FSW) in SSA have HIV prevalence that often exceeds 50% and is 
10-20 times higher than prevalence in the general population [10, 11]. HIV prevalence among FSW in the 
proposed study setting is estimated to be 56.5% [12] and recent data indicate there are 534 active FSW 
“hotspots” of commercial sex work, with an estimated 4,041 FSW [13]. Fisher folk communities (FFC) – 
also referred to as beach communities –similarly have a higher burden of HIV-1 infection than respective 
general populations [14-16]. Studies have reported HIV prevalence between 25–29% and annual 
incidence rates of 3.39-4.9% in Kenyan and Ugandan FFC. These figures are 3–4 times higher than 
respective national averages. Unlike general populations, fishing communities tend to be socially 
marginalized and often stigmatized. Due to ready cash from fishing activities coupled with staying away 
from their spouses and other family, FFC are characterized by a high presence of bars, lodges and 

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entertainment halls, transactional sex (sex for money and sex for fish), high alcohol consumption and 
multiple sexual partnerships, but very limited access to health services.  
Oral fluid-based HIV self-testing is a promising biomedical technology that has the potential to overcome 
many of the barriers to HIV testing. With self-testing, individuals collect their own sample and perform a 
simple, rapid HIV antibody test in the absence of a provider. It offers increased convenience, privacy, and 
autonomy, and has the potential to normalize regular testing. Existing research shows a high level of 
acceptability and demand for self-testing across a wide range of populations and settings, as well as good 
accuracy in the hands of lay users [17-27]. Participants in these studies – including studies we have 
conducted in Kenya – report that self-testing would reduce stigma around HIV testing, a formidable 
barrier, as well as increase convenience and confidentiality. Interest is typically highest among high-risk 
groups and those who have never tested for HIV [24]. Regulated self-testing has been included in 
Kenya’s national HIV testing guidelines since 2009 [28, 29] and a growing number of countries – including 
Kenya – are considering scaling-up self-testing [27]. Yet there is little evidence on how best to deploy 
self-tests so as to ensure that testing is increased among high-risk individuals not reached by other HIV 
testing modalities. 
A promising but under-explored approach is the provision of multiple self-tests to individuals who are then 
encouraged to distribute the tests to others in their sexual networks (i.e. ‘secondary distribution’). The use 
of networks to reach high-risk persons has proven to be successful in several areas of public health [30, 
31]. Given the need for regular repeat testing among women with multiple partners ( including those 
engaged in transactional sex and women in beach communities) as well as their sexual partners, we have 
shown in a recently completed pilot study in Kisumu that an especially promising strategy is to provide 
women with multiple self-tests that they can then use to initiate partner testing or couples testing [22]. 
This strategy has the potential to generate multiple HIV prevention benefits, including promotion of male 
partner testing and facilitation of safer sexual behaviors. 
Studies that we and others have conducted suggest that an important HIV prevention benefit of self-tests 
may stem from their potential use as a “point-of-sex” testing technology. Point-of-sex testing, particularly 
when a condom would not otherwise be used, may promote safer sexual decision-making, thereby 
functioning as an HIV prevention intervention. Secondary distribution of self-tests has been undertaken 
among men who have sex with men (MSM) in New York City [21, 32, 33]. Results from the studies with 
MSM have been encouraging – demonstrating that MSM used self-tests to screen potential sexual 
partners for HIV and decide whether to use condoms (or even avoid sex altogether) when partners 
declined to test or when an HIV-positive result was obtained. Our pilot study with FSW in Kenya obtained 
similar results, and it was the first study to explore the feasibility of secondary distribution of self-tests in 
SSA [22, 34]. Another randomized controlled trial we recently completed among pregnant and postpartum 
women in Kisumu also demonstrated the feasibility of this intervention [35]. Rigorous evaluation of such a 
strategy among high-risk women, with measurement of HIV incidence and sexual risk behaviors, is a 
natural next step.  
Women with multiple partners are an important population in which to evaluate secondary distribution of 
self-tests. Since male partners of these women are more likely to be HIV-positive than other men and are 
less likely to know their HIV status, this strategy could be an efficient way to identify HIV-positive persons 
(furthering the first of the 90-90-90 goals). Moreover, it could facilitate safer sexual decision making by 
women and thereby reduce their risk of HIV acquisition. Studies that we and others have conducted show 
suboptimal levels of condom use by FSW with their sexual partners [12, 36, 37].If women are able to use 
self-tests to identify partners who are HIV-positive and make safer sexual decisions, as our preliminary 
data suggest, it could have a transformative impact as an HIV prevention strategy. As such, the National 
AIDS and STI Control Programme (NASCOP) in Kenya and the Ministry of Health (MOH) in Siaya have 
expressed strong support for evaluating such an intervention. 

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2 
Study Aims 
2.1 
Primary Aim 
• 
Aim 1. To determine the effect of distributing multiple HIV self-tests (HIVST) on uptake of HIV 
testing, identification of HIV-infection among sexual partners of high-risk women, changes in 
sexual behavior of high-risk women, and HIV incidence among high-risk women.  
2.2 
Secondary Aims 
• 
Aim 2. Use a mixed methods approach to identify and address safety concerns and general 
perceptions regarding use and distribution of the intervention by high risk women and their sexual 
partners 
• 
Aim 3. Assess cost-effectiveness of the intervention and obtain information necessary to inform 
scale-up of the intervention in Kenya and other countries 
3 
Investigational Plan  
3.1 
General Design 
We will conduct a cluster randomized trial among HIV-negative women in the Nyanza region of Kenya. 
Clusters will be defined as hotspots where women exchange sex and FFCs along beaches in the study 
region. Clusters will be randomized to an intervention group in which women will be given multiple HIV 
self-tests coupled with referral vouchers for confirmatory testing (for those obtaining an HIV-positive 
result) or to a comparison group that is given multiple referral vouchers alone for clinic-based HIV testing. 
We will test for HIV and collect survey information, including sexual behaviors and HIVST use, from 
women at a baseline visit and every six months for up to 24 months.  
3.2 
Allocation to Interventional Group 
Clusters of geographic areas will be matched on the basis of population and type (hotspot for women who 
exchange sex or beach community) and then randomized to two study groups (receiving HIV self-test kits 
or referral cards for HTS based testing) in a 1:1 ratio. Computer-generated randomization will be used to 
determine group assignment of clusters. There will be no blinding associated with the study.  
 
3.3 
Study Measures 
An original questionnaire was developed for to assess various participant characteristics at baseline. This 
questionnaire includes questions about participant’s socio-economic characteristics, sexual behavior, HIV 
testing history as well as the PHQ-9 mental health scale and a gender-based violence assessment. 
Follow-up data will be obtained through short surveys as well as a follow-up questionnaire administered 
at approximately 6-month intervals. 
3.4 
Study Endpoints  
3.4.1 Primary Study Endpoint 
In keeping with the intervention’s potential to general multiple HIV prevention benefits, we will assess a 
primary outcome of HIV incidence and two secondary outcomes (one pertaining to HIV testing and the 
other to sexual behavior).  
 
HIV incidence. All participants will be asked to come for HIV testing at baseline/screening and every 6 
months during the follow-up period. We will use these data to measure HIV incidence among participants 
over a maximum of 24-month period. To limit attrition and obtain follow-up information, at 6-month 
intervals, participants will be offered compensation for transportation and time they take to undergo HIV 
testing and completing the follow-up surveys mentioned above. Our hypothesis is that the intervention 

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group will have lower HIV incidence than the comparison group. Obtaining a measure of HIV incidence 
among participants will also be useful for performing cost-effectiveness analyses in Aim 3. 
3.4.2 Secondary Study Endpoints 
Number of male partners per participant who obtain an HIV-positive test result. This information will be 
obtained directly from the index participants. For each participant, we will assess the number of reported 
partners who tested for HIV and obtained a reactive result. We hypothesize that the number of HIV-
positive male partners identified per participant will be higher in the intervention group than the 
comparison group. 
 
Proportion of unprotected sexual encounters with partners who were HIV-positive or whose HIV status 
was unknown. This outcome will be based on data from follow-up surveys and will assess the HIV risk 
that participants were exposed to during the follow-up period. We expect, based on pilot data, that women 
in the intervention group will be able to utilize self-tests to facilitate HIV results disclosure with sexual 
partners and make safer sexual decisions. Thus, we hypothesize that the intervention group will be less 
likely than the comparison group to have unprotected sex with a partner of unknown or HIV-infected 
status. 
Additional Outcomes. Other outcomes that we assess will include the occurrence of intimate partner 
violence (IPV), discussion of HIV testing with partners, and occurrence of couples testing. The outcomes 
of Aim 2 will be a qualitative narrative of how HIVST are perceived and used. Aim 3 will use the primary 
outcome to determine the cost-effectiveness of HIVST distribution in this setting.  
4 
Study Population and Duration of Participation  
The study will include women who report having two or more partners in the past month, including women 
who exchange sex and high-risk women residing in beach communities. In each of the selected clusters 
(hotspots or beach communities), we will sample women and assess their eligibility.  We will also 
interview male partners of women who participate in the study, to collect data on their experience. 
Women enrolled in the main study will be followed for up to two years. Male partners who are contacted 
will participate in one qualitative interview.  
4.1 
Duration of Study Participation  
Participation in the main study may entail up to two years (24 months) of follow-up from the date of 
enrollment. The qualitative interview (Aim 2) will require only one day of participation to obtain informed 
consent and complete the interview.    
4.2 
Total Number of Subjects and Sites  
We will seek to enroll about 1,980 women from a total of about 66 clusters in the Nyanza Region of 
Kenya. An average of approximately 30 women per cluster will be enrolled in the main study. 
Approximately 100 of these women will be selected to participate in an additional qualitative interview 
during the follow-up period. Among these 100 women, approximately 30 male partners will be selected 
and contacted to participate in a qualitative interview to learn more about how men perceive and use the 
HIV self-test kits. The total number of individuals enrolled in the study will therefore be approximately 
2,010.  
 
 
There are multiple sites contributing to this study. The University of Pennsylvania will serve as the prime 
implementing site, with the University of North Carolina and RTI International subcontracted to provide 
administrative and data management support until the transfer of study data to UPenn is complete. 
Impact Research and Development Organization (IRDO) is conducting all field work, including 
enrollments, follow-up, and monitoring for adverse events. 

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4.3 
Inclusion Criteria 
High-risk women who meet with study staff will be screened for the following eligibility criteria after 
providing oral informed consent: 
• 
Female 
• 
Age ≥18 years 
• 
Currently resides in the study area (hotspot or beach community) 
• 
Has resided in the study area for at least 6 months in the year prior to enrollment 
• 
Intends to stay in the region for at least 24 months 
• 
Reports two or more sexual partners within the past 4 weeks 
• 
HIV-negative* 
• 
Ownership or access to mobile phone 
• 
Willing and able to provide informed consent for participation 
• 
Not enrolled in another HIV prevention research study 
* To verify HIV status at baseline, women will be offered rapid HIV testing based on Kenyan guidelines. 
Those who test HIV-positive will be actively linked to care as per the IRDO drop-in center’s protocol or the 
Ministry of Health recommendations.  
4.4 
Exclusion Criteria 
Those who do not meet the inclusion criteria listed above, do not provide informed consent, or who do not 
provide oral consent to assess these eligibility criteria (screening) will be excluded from the study.  
4.5 
Subject Recruitment  
Given the study’s focus on reducing the risk of HIV acquisition among high-risk women in the study 
region, we will recruit HIV-negative women from the clusters that are selected for Aim 1. Our recruitment 
strategy closely resembles the strategy that we used to successfully recruit 101 HIV-negative FSW (over 
a one month period) for participation in a pilot study [22]. Specifically, from each hotspot we will recruit 
high-risk women including FSW enrolled in IRDO’s drop-in center and others who meet eligibility criteria. 
We will rely on peer educators who have pre-existing relationships with these women to initiate contact, 
provide them with general information on the study, and refer those who are interested to meet with study 
staff. Peer educators will receive transport and outreach reimbursement for their recruitment activities. 
Recruitment will end when the target sample size is reached. 
In the beach communities, we will obtain a sampling frame from the census of the study community which 
IRDO conducted towards the end of 2015; in addition, we will work with the beach management unit 
officials should we need additional information. We will then contact women to assess their eligibility to 
participate in the study. We will work with IRDO’s program staff to identify those who may be eligible to 
participate in the study and refer them to the study venue if they are interested in learning more. 
4.6 
Vulnerable Populations:  
Children, fetuses, neonates, or prisoners are not included in this research study. Pregnant women are 
neither excluded if they meet the other eligibility criteria, nor removed from the study if they become 
pregnant during the study. However, there are no study procedures that should affect the condition of the 
pregnant woman or fetus.  
5 
Study Procedures  
Participants in clusters randomized to the intervention group will be provided with multiple self-tests over 
a period of up to 24 months and encouraged to distribute the tests to individuals in their sexual networks 
with whom they may have unprotected sex. Participants will be given several HIV self-tests initially and 
informed that they can obtain additional self-tests during the intervention period. Each self-test will include 
clear instructions for use, a list of HIV testing services (HTS) clinics where those obtaining reactive self-
tests can seek confirmatory testing (as is recommended by Kenya’s testing guidelines). In order to 
encourage individuals who obtain a reactive self-test to seek confirmatory testing and to measure uptake 

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of confirmatory testing, a VCT referral voucher will be included with each self-test.  Each self-test will also 
include a study phone number that participants or male partners of participants may call to obtain 
information about how to use the test and receive information on follow-up services.  
At enrollment, participants will be trained on how to use HIV self-tests using methods and materials 
developed in our pilot study. They will be counseled on how to discuss HIV self-testing with sexual 
partners and on the importance of using their own discretion and assessing the risk of IPV when deciding 
whether to offer a self-test to a sexual partner. The concept of the HIV “window period” and the 
importance of condom use and other sexual risk reduction strategies will also be discussed. As part of the 
pilot study we carried out last year, we developed talking points for study staff to use when enrolling 
participants and giving them multiple self-tests. These talking points, as well as lessons we learned in the 
pilot study, will be fully incorporated into the education and counseling that participants will receive during 
enrollment. Participants will be reminded to use condoms whenever possible and reserve self-tests for 
primary partners as well as current and potential partners with whom unprotected sex is likely. The 
counseling message outlined in the study procedures discusses the rate of false negative results (up to 
8%) that can occur when using the kits and gives possible reasons for false negatives to occur, including: 
improper use of the test, antibodies cannot be detected because of the window period, or the HIV positive 
person is on ARVs and virally suppressed. False positives are also explained such that any “reactive” test 
does not mean HIV positive and that any reactive test should be confirmed at a local VCT clinic for a 
proper medical diagnosis. 
We will use the FDA-approved OraquickAdvance Rapid HIV-1/2 Antibody Test, which achieved 92% 
sensitivity in premarket self-testing in the US [44]. This oral fluid-based test detects antibodies to HIV-1 
and HIV-2 in 20 minutes. Currently, the Oraquick self-test is approved for use in Kenya and the 
government is considering its broader use throughout the country. In our prior study, we developed easy-
to-follow instruction materials on how to use the self-test. These instruction materials will be included with 
each self-test that is distributed to study participants. 
Participants in the clusters randomized to the control group will be provided with several HTS referral 
vouchers initially and encouraged to distribute them to their sexual partners (participants will be informed 
they can return for additional vouchers during the follow-up period of up to 24-months. As in the 
intervention group, participants in the comparison group will also be counseled on the importance of 
condom use and other sexual risk reduction strategies. Female participants will also be encouraged to 
give their male partners a phone number that they can contact if they have questions. 
For both study arms, research assistants will seek to recruit those who meet eligibility criteria. Research 
assistants will review the written informed consent form with eligible women and those who provide 
written consent to study enrollment will be administered a baseline questionnaire (described below), and 
digital fingerprint collection with a fingerprint biometric device to verify identification at follow-up visits. We 
have found fingerprinting to be highly acceptable, and it has been successful in other studies in the 
region. 
Data Collection Procedures: 
Baseline data. At the time of enrollment, participants will be administered a baseline questionnaire to 
record information such as socio-demographic characteristics, economic characteristics, sexual behavior, 
HIV testing history, and any experience of IPV.  
Distribution Visits. Participants will be offered the opportunity to collect additional HIVST or VCT referral 
coupons regularly during the follow-up period. These visits will entail the distribution of the study tools, 
retraining on important counseling messages (how to safely avoid IPV, importance of condom use, etc.) 
and collect basic information on how the study tools previously distributed were used. IPV and other 
possible adverse events will be monitored at every point of contact.  
Follow-up surveys administered at 6-month intervals. Study staff will administer tablet-based, structured 
follow-up survey questionnaires to participants in approximate 6-month intervals to learn about their 
experiences distributing self-tests (intervention group) and referral vouchers (comparison group), assess 
sexual behavior with persons who do and do not accept self-tests or vouchers, inquire about occurrence 
of IPV or other adverse events. For women who report their sexual partners had a reactive self-test, the 
questionnaires will also inquire about linkage to care. To collect these data, we will adapt questionnaires 

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we previously developed and used in our pilot study. Fingerprint data collection will take place at baseline 
and at follow-up visits in order to ensure correct identification of study participants. We will carry out the 
intervention for up to 24 months. Enrollment will be on a rolling basis, and each woman will be followed 
up for between 12-24 months dependent on her date of enrollment. 
HIV testing. At baseline and at each follow-up interview, rapid HIV antibody testing for all participants will 
take place according to Kenyan guidelines and using approved algorithms. A dried blood sample (DBS) 
will be collected and stored at the first baseline visit. If the participant becomes positive during the first 6 
months of follow-up, the DBS will be used for PCR confirmatory HIV testing to confirm the participant was 
negative at enrollment and not in the pre-detection window of the rapid tests.  
 
Does your study use MRI? (CAMRIS is the appropriate contact for all studies involving MRIs) 
 Yes  
 
 No (If No, no CAMRIS review needed) 
 
Ultrasound  
 Yes  
 
 No 
 
 
Will your study be using CT Scans? (CACTIS is the appropriate contact for studies involving CT scans)  
 Yes  
 
 No 
 
 
Studies involving Nuclear Medicine: Will subjects be undergoing any of the following procedures specific 
to research: 
 MUGA 
 
(See Nuclear Medicine-Muga Scan) 
 PET/CT Scan 
 
(See PET/CT Scan) 
 Bone /DXA 
 
(See Bone Scan) 
 
Check off all of the following procedures that will be performed in your research- each option you select 
will link to the template language document:  
 Apheresis/plasma exchange  
 Leukapheresis  
 Bone Marrow Biopsy or Aspirate  
 Use of AP clinical specimens  
 Biopsies- check those which apply  
 Blood draw  
 
5.1 
Screening and Baseline Visit 
At the screening and baseline visit, which occurs on the same day, the following procedures are 
performed: 
• 
Verbal informed consent obtained to screen for eligibility 
• 
Screening questions administered by research assistant 
• 
HIV rapid test is performed according to Kenyan HTS guidelines. Currently, this includes 
testing with Alere Determine HIV-1/2 rapid antibody test and confirming all non-negative 
results with Premier Medical Corporation First Response HIV 1-2 rapid antibody test. 
Appropriate counseling is provided by research assistants, who are certified HTS 
counselors by the Kenyan government. 
• 
Main study written informed consent obtained 

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• 
Fingerprinting enrollment process 
• 
Administration of the baseline visit questionnaire  
• 
Distribution of the HIV self-test kits or HTS referral cards, including counseling on how to 
safely use and distribute the intervention. 
• 
Reimburse participant for travel and time  
 
The screening and baseline visit is estimated to take approximately 90 minutes.  
5.2 
Follow-Up Visits 
5.2.1 Monthly Distribution Visits 
Each month, research assistants will schedule a time to visit each cluster where enrollments have taken 
place. Participants will be made aware of the venue and times that the research assistant will be 
available, and they can attend the event to replenish their stock of either HIVST kits or HTS referral cards. 
Fingerprints are collected to verify the participant’s identity and a record is kept of the serial number of the 
HIVST kits or referral cards. Participants will be asked how they used and distributed to cards to help 
guide additional discussion about the number of HIVST kits or VCT referral cards to receive and if 
relevant counseling messages need to be reiterated. The research assistants will also use this time to 
answer any questions about the study, intervention use, distribution, or adverse event reporting that the 
participants would like to disscuss. Participation in the monthly distirubtion visits is optional; if participants 
do not need to replenish their supply, have no questions, or cannot attend, there is no additional follow-up 
for these visits. These visits will take approximately 10 minutes, on average. 
5.2.2 6-Monthly Follow-Up (Months 6, 12, 18, and 24) 
The 6-monthly follow-up procedures will be used to test for HIV, collect information about the use of the 
interventions, and address any questions the participant may have. These visits will take approximately 
45 minutes. Specific procedures include: 
• 
Fingerprint verification of participant’s identity 
• 
HIV rapid test is performed according to Kenyan HTS guidelines.  
• 
Administration of the follow-up visit questionnaire  
• 
Distribution of the HIV self-test kits or HTS referral cards, to include “refresher” 
counseling session on how to safely use and distribute the intervention. 
• 
Reimburse participant for travel and time  
5.2.3 Qualitative Interview Visits 
Approximately 100 women and 30 male partners of women selected will be invited to participate in 
qualitative interviews. This interview will examine the person’s experience with the HIVST or referral 
vouchers. It will occur one or two times and take approximately 60 minutes each time. Specific 
procedures include: 
• Informed Consent (men only:  qualitative interview is described in the main study consent 
that female participants will sign at the baseline visit) 
• Interview with research assistant 
• Identify sexual partners who may be willing to participate in qualitative interview (female 
only to identify 30 men) 
• Reimburse participant for travel and time 
5.2.4 End of Study Visit  
The end of study visit is identical to the last 6-monthly follow-up visit. No results will be shared with the 
subject at this time, and no unblinding is necessary.  

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5.3 
Unscheduled Visits 
Unscheduled contact with the participant will occur most often through the study hotline number. This 
number is provided on the informed consent, HIVST instruction sheet, on the confirmatory testing card, 
and on HTS referral card. If an in-person meeting is necessary, the Study Coordinator, who manages the 
hotline number, will schedule a time for the participant to meet with a research assistant. All meetings will 
be documented in a note to file which is placed in the participant’s file at the IRDO office. If the meeting is 
to report an adverse event, appropriate steps will be taken to notify the PI’s and IRB offices.  
5.4 
Subject Withdrawal  
 
Subjects may withdraw from the study at any time without impact to their care.  They may also be 
discontinued from the study at the discretion of the Investigator for lack of adherence to intervention or 
study procedures or visit schedules, and AEs.  The Investigator or the Sponsor may also withdraw 
subjects who violate the study plan, to protect the subject for reasons related to safety or for 
administrative reasons.  It will be documented whether or not each subject completes the study.  
5.4.1 Data Collection and Follow-up for Withdrawn Subjects 
No additional data will be collected or follow-up attempted for participants who withdraw completely from 
the study.  
5.5 
Early Termination Visits   
The last 6-monthly follow-up survey form will serve as the final data collection for participants who 
withdraw. No additional data will be collected or follow-up attempted for participants who terminate their 
involvement with the study. 
5.6 
Safety Evaluation 
To ensure correct usage of self-tests (in the intervention group) and to minimize the probability of 
psychological distress due to HIV testing, we will include simple instruction materials with each self-test 
on how to use the tests, in English and local languages. These instruction materials have been developed 
by us and used in our pilot study, and they were well-received by FSW and the sexual partners. In 
addition, each self-test will include clear information on the importance of seeking confirmatory HIV 
testing (which is recommended by the WHO and the Kenyan Ministry of Health) – as such the vouchers 
and self-test will include information listing HTS clinics in the area where free HIV testing and counseling 
is available. Information will also be provided on clinics in the area where free HIV care and treatment is 
available. We will also establish a support telephone line (hotline) that study participants or their sexual 
partner can call at any time that will put them in touch with the study coordinator, who will be ready to 
provide additional information on where to seek further testing, care or treatment.  
IPV is monitored at each in-person visit, through the monthly text-message based survey, and by 
providing the 24/7 hotline for self-reporting. The Study Coordinator who mans the hotline and is 
responsible for first contact for all IPV reports will provide information and resources to the woman to 
include emergency medical treatment, support hotlines to call, and additional resources as necessary. All 
incidences of IPV will immediately be reported to the PI’s and those related to the study intervention will 
be reported to both IRBs within one day.  
6 
Statistical Plan 
6.1 
Sample Size and Power Determination 
We will seek to enroll about 1,980 women from a total of about 66 clusters. An average of approximately 
30 women per cluster will be enrolled in the study. The power analysis for this cluster randomized study 
focused on the primary outcome comparing HIV infection incidence among high-risk women between two 
groups:  the comparison group receiving vouchers for in-clinic HIV testing vs. an intervention groups 
receiving oral fluid-based HIV self-testing kits. Assuming an annual HIV infection incidence of 0.045 in the 
control group, the sample size required to detect a 50% reduction in this incidence with 80% power and a 

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type I error of 0.05 is 1,980women, with 33 clusters per study group and 30 women per cluster. This 
calculation assumes a 10% loss to follow-up over 1.5 years of follow-up and a coefficient of variation of 
0.40 [48,49].1.5 years of follow-up is conservatively assumed for the power calculation, as this is the 
expected amount of time that FSWs will be followed, even though there is a maximum of 2 years.  
6.2 
Statistical Methods 
6.2.1 Analysis of Primary Outcome of Interest 
The annual incidence of HIV infection will be compared between study arms through regression modeling 
using a generalized estimating equations (GEE) approach with a log link and assumed Poisson response 
distribution (the negative binomial distribution will be used if this distribution is not valid). An offset will be 
used in this model to account for differential follow-up times. The model will contain a dichotomous 
covariate for study group; the two-sided (α = 0.05) statistical significance of the associated regression 
coefficient will be assessed with a Wald test performed using robust standard errors. If there are 
differences in baseline characteristics between the two study groups, a second regression model will be 
constructed that adjusts for the differing baseline characteristics. 
6.2.2 Analysis of Secondary Outcomes of Interest 
The number of identified HIV-positive male partners per woman will be compared between study groups 
using the same GEE approach as described above; an offset accounting for differing numbers of partners 
will be included if possible. For each woman, the second outcome (proportion of unprotected sexual 
encounters with individuals who were HIV-positive or whose HIV status was unknown) will be defined as 
a binary variable that indicates whether the proportion is below a threshold of 0.10 – this will distinguish 
between women who engaged in a high degree of safe sexual behavior and those who did not. This 
outcome will be analyzed similarly to the first, but the GEE model of interest will assume a logit link and 
binomial distribution. 
 
Aim 2 data analysis will consist of 5 steps:1) Reading for Content: Our analysis will begin with data 
reading until content becomes intimately familiar [45]. As data are reviewed, emergent themes will be 
noted. Topics that the research has not adequately addressed and ones that emerge unexpectedly will be 
explored in continued fieldwork. 2) Coding: A list of codes will be created based on identified themes and 
assigned to specific sections of text so that the text can be easily searched. Code definitions will be 
documented in a code book[46]. Qualitative interviewers will be trained to apply the codes using 
ATLAS.ti. To ensure inter-coder reliability, 10% of data will be double-coded. 3) Data reduction: Once 
transcripts have been coded, we will work within each code to identify principal sub-themes that reflect 
finer distinctions in the data. This entails taking an inventory of what is related to the given code, 
capturing the variation or richness of each theme and noting differences between individuals or among 
subgroup[46]. 4) Data display: Matrices and tables that categorize and display data will be used to help 
facilitate comparisons. 5) Interpretation: Once text has been read and coded, and central ideas extracted, 
we will identify and explain the core meanings of the data. We will search for relationships among themes 
identified and develop diagrams in order to map out relationships in the data. 
Aim 3. Our analyses will estimate the cost per averted disability-adjusted life year (DALY) based on (a) 
increased identification of HIV-positive men, and thus higher and earlier initiation of ART; and (b) fewer 
HIV infections among women as a result of using self-tests to make safer sexual decisions. Our analyses 
will include modeled lifetime ART health benefits and costs. Our analyses will also be useful for 
estimating how many additional high-risk men can be tested and how many additional HIV infections can 
be averted by spending a fixed amount of resources on self-tests rather than conventional testing models. 
Analyses will be conducted using customized spreadsheet-based decision tree and clinical progression 
simulation modeling methods adapted from other projects. Extensive one-way, multi-way, threshold, and 
scenario sensitivity analyses will quantify the effects of input uncertainty on results. Our analytic 
perspective will be the health system, for direct medical costs, discounting future costs and DALYs at 3% 
per year.  
 

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7 
Safety and Adverse Events 
7.1 
Definitions 
7.1.1 Adverse Event 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• 
results in study withdrawal 
• 
is associated with a serious adverse event 
• 
is associated with clinical signs or symptoms 
• 
leads to additional treatment or to further diagnostic tests 
• 
is considered by the investigator to be of clinical significance 
7.1.2 Serious Adverse Event 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• 
fatal 
• 
life-threatening, including IPV 
• 
requires or prolongs hospital stay 
• 
results in persistent or significant disability or incapacity 
• 
required intervention to prevent permanent impairment or damage 
• 
a congenital anomaly or birth defect 
• 
an important medical event, including HIV seroconversion 
 
7.2 
Recording of Adverse Events 
At each in-person contact with the subject, the investigator will seek information on adverse events by 
specific questioning Information on all adverse events will be recorded immediately in a note to file that is 
kept permanently in the participant’s study file. A standard case report form is employed by IRDO to 
report adverse events and will be completed by IRDO staff.  
 
All adverse events occurring during the study period will be recorded and reported immediately to the 
site-PI, who will notify the study PI. The study PI is responsible for overseeing the investigation of the 
adverse event. The PI will also make the University of Pennsylvania and Maseno University (Kenya) IRBs 
as well as the DSMB aware of any serious adverse events within one day, as necessary. The clinical 
course of each event will be followed until resolution, stabilization, or until it has been determined that the 
study intervention or participation is not the cause.  Serious adverse events that are still ongoing at the 
end of the study period will be followed up to determine the final outcome.  Any serious adverse event 
that occurs after the study period and is considered to be possibly related to the study intervention or 
study participation will be recorded and reported. 
7.3 
Relationship of AE to Study  
The site PI will lead the investigation of all adverse events to completion or until it is decided that 
participation in the study is not the cause. For social or economic adverse events, the site PI will make 
this determination, and for medical adverse events, will work with appropriate medical staff in the clinic to 
make that decision. The relationship of the adverse event to participation in the study will be classified as: 
definitely related, probably related, possibly related, unlikely or unrelated.  

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7.4 
Reporting of Adverse Events and Unanticipated Problems 
The Investigator will promptly notify the Penn IRB of all on-site unanticipated, Adverse Events that are 
related to the research activity within one day from the time of reporting, with further follow-up as needed 
as the investigation continues. Other unanticipated problems related to the research involving risk to 
subjects or others will also be reported promptly. Written reports will be filed using the HS-ERA. 
7.4.1 Follow-up Report 
If an AE has not resolved at the time of the initial report and new information arises, such as further 
medical results or diagnoses, that changes the investigator’s assessment of the event, a follow-up report 
including all relevant new or reassessed information (e.g., concomitant medication, medical history) 
should be submitted to the IRB. The investigator is responsible for ensuring that all SAEs are followed 
until either resolved or stable.  
7.4.2 Investigator reporting: notifying the study sponsor (if applicable) 
All relevant events will be reported to NIMH, according to the criteria listed at: 
https://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-policy.shtml 
7.4.3 Data and Safety Monitoring Plan 
Data will be monitored by the project manager and the principal investigator throughout the study. Any 
adverse events will be immediately reported to both UPenn and the Kenyan IRB, and study personnel will 
follow up with the participant(s) involved to ensure linkage to appropriate care and services.  
 
We are concerned with the possibility of women being at increased risk of intimate partner violence (IPV) 
as a result of introducing self-testing with their partner, and we have put into place both preventative and 
follow up procedures to mitigate this risk. As part of the initial instruction about use of the self-test, we 
discuss the risk of violence with all research participants, how to talk about the self-test with partners, 
advise them NOT to introduce the self-test with a partner if they are concerned that there is a risk of 
violence, and provide resources to women about what to do if they experience violence (including safety 
and counseling resources). Participants will be instructed to contact our 24-hour telephone line if they 
have questions about the self-test use or if they experience violence. Furthermore, during the follow-up 
questionnaire, we will be asking whether participants experienced violence since they received the self-
test kit and if they feel the violence was a direct result of the study.  
 
We will be monitoring incidents of IPV as the study progresses and will follow up with each reported case. 
Study RAs and the study coordinator will follow up with any woman who reports IPV either through the 
hotline or during the follow up survey to provide her with safety and counseling resources and also to 
determine to what extent the IPV was a direct result of participation in our study.  
 
IRDO employs an internal research monitor that regularly audits study procedures and documentation, 
including any event reporting. A DSMB will be formed to regularly review interim data to monitor safety 
and recommend whether the trial should continue. Serious unexpected events will be disclosed to the 
Board in between meetings and if needed, meetings will be convened to discuss these events and 
recommend appropriate responses. The DSMB will also evaluate participant risk vs benefit as the trial 
progresses. The DSMB will also work closely with the investigators and biostatistician to develop study-
wide stopping rules.  
 
This study receives annual review at the Maseno University Ethics Review Board (MUERC), and has 
been reviewed by the University of North Carolina at Chapel Hill (Year 1), and by the University of 
Pennsylvania for the remainder of the study (Years 2-5).   
7.4.3.1 
Data Safety Monitoring Board  
See appended DSMB Charter 
 

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8 
Study Administration, Data Handling and Record Keeping 
8.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
• 
What protected health information (PHI) will be collected from subjects in this study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information 
• 
The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.   
 
8.2 
Data Collection and Management  
We have developed standard operating procedures for data security and confidentiality procedures at 
collection, transfer, entry and storage levels, and make these readily accessible to all staff members who 
have access to confidential study data. All study data will remain secure at UPenn for the duration of the 
study.  
All study tablets used for data collection will be password protected. After a survey is completed in ODK, 
the Research Assistant will mark it as “finalized” which automatically encrypts the survey and sends it to 
the ODK aggregate survey. Completed surveys therefore do not live on the tablet, but rather as encrypted 
data on a secure server. All electronic study data will be stored on a secure terminal server at UPenn on 
PMACS secure servers with access limited only to authorized staff. All computers and servers will be 
encrypted and password-protected with limited access. Files on PMACS servers are encrypted both in 
motion and at rest. Backup of the data will be done by designated study staff onto a secure server at 
UPenn. All electronic information will be recorded using study identification numbers, rather than 
participant names. 
Physical data collection forms will be stored at IRDO headquarters in Kisumu, which will be the operating 
headquarters of the study. No participants will have any identifier on the data forms; names and 
signatures will only be on the consent forms, which will be kept under lock and key by the Study 
Coordinator and after signing, will be accessible only to the PIs, Coordinator and IRDO’s Research 
Officer. All sensitive information is stored separately from any identifying information to prevent breach of 
confidentiality.  
. 
8.3 
Records Retention 
At the end of the study, data will be kept for up to 5 years for electronic version on the UPenn terminal 
server, and up to 2 years for paper forms, including consent forms at the IRDO facility in Kenya. 
 
9 
Study Monitoring, Auditing, and Inspecting 
9.1 
Study Monitoring Plan 
The PI and project manager will periodically monitor the study to ensure adherence to study procedures 
and national guidelines. In addition, IRDO has a dedicated research monitor who will regularly review the 
study according to study protocol, SOPs, and good clinical practice guidelines. The internal monitor will 
also review all informed consent documents that are collected to ensure accuracy, completeness, and 
adherence to proper version control. A DSMB has also been formed to perform study monitoring, as 
needed. 

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9.2 
Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, the sponsor, 
government regulatory bodies, and University compliance and quality assurance groups of all study 
related documents (e.g. source documents, regulatory documents, data collection instruments, study data 
etc.).   
 
10 Ethical Considerations 
Approvals from the University of North Carolina institutional review board and the Maseno University 
institutional review boards (IRBs) were obtained prior to initiation of any study activities, before the study 
was moved to the University of Pennsylvania. In the future, all study documents and data collection tools 
will be submitted and must be approved by both the IRB at both the University of Pennsylvania and at 
Maseno University in Kenya. 
All study staff are required to undergo training in human subjects research, and good clinical practice. 
Having received approval for the intervention in our pilot study, we are confident that the risks to 
participants and our strategies to minimize these risks will be acceptable to the IRBs.  
10.1 
Risks 
Based on our own pilot data, we believe there are relatively few risks to study participants. The results 
from our pilot study and in-depth interviews with FSW indicated that IPV and other adverse events were 
extremely rare. The primary risk involved in study participation include violence experienced by women 
due to the introduction of HIV self-testing to their sexual partners. For example, if a sexual partner uses 
an HIV self-test or seeks clinic-based testing and obtains an HIV-positive test result, there is a risk of 
adverse reactions including IPV directed toward the woman as well as adverse events experienced by the 
sexual partner. This risk may be heightened in the intervention group as self-testing is likely to occur in 
the absence of a counsellor. Our data indicated these risks are very rare and this is consistent with data 
from a number of other studies conducted in sub-Saharan Africa that also show high safety and 
acceptability of HIV self-testing. But nonetheless we will put in place study procedures (described below) 
that are intended to minimize these risks and address any adverse events that do occur. In our pilot study 
that implemented the intervention, we developed and used these procedures, and we also obtaining 
ethical approval for the procedures. 
During enrollment and over the course of a maximum 24-month follow-up period, we will be measuring 
HIV status of women who participate in the study. There may remain a small risk that the HIV status of 
study participants could be inadvertently disclosed. Precautions will be taken to avoid any inadvertent 
sharing of this information. We will make strong efforts to ensure the maintenance of privacy, 
confidentiality, and security of all study data that are obtained. Data collection and storage procedures will 
include the use of encrypted, password-protected devices and servers, and only authorized study 
investigators will have access to these data.  
As part of the study, women in the intervention group will be likely to distribute (or attempt to distribute) 
HIV self-tests to their sexual partners. Women in the comparison group will be likely to discuss clinic-
based HIV testing to their sexual partners. As mentioned above, there is a small probability that some 
sexual partners will become angry and/or violent due to the women’s suggestion of HIV testing or due to 
the results obtained from the HIV testing. In our previous study, we found that this probability was very 
small, as the 101 FSW participants distributed 370 self-tests and only 1 adverse event was reported. We 
are still acutely cognizant of this risk and have developed detailed training materials for study staff to use 
when enrolling participants as well as procedures to protect against these risks. These are described 
below.  
As with any HIV testing research there is the possibility of psychological distress for study participants 
due to testing. Study participants may feel pressured to test and if they test, may be distressed by the 
results, especially if they obtain an HIV-positive result. Our pilot study data indicate that women and their 
sexual partners reacted well to receiving their test results, even when the result indicated a person was 
HIV-positive. These data are consistent with many other studies from sub-Saharan Africa showing that 
self-testing is safe and acceptable, and that the risks of adverse reactions are very low. Proper 

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information and subsequent counseling is nonetheless necessary to minimize the possibility of distress. 
For the intervention group, we will provide detailed, easy-to-use instruction sheets on how to use self-
tests as well as a demonstration to women at the time of enrollment on how to use self-tests. We will also 
provide detailed information on the need to seek clinic-based confirmatory testing after receiving an HIV-
positive self-test result, as well as information on where individuals can receive care and treatment. 
To minimize risk we will do the following:  
Maintaining privacy and avoiding stigmatization. Study visits with participants to recruit, screen, consent, 
enroll and follow-up participants will occur at the drop-in centers or participant homes in order to reduce 
the unlikely possibility of stigmatizing study participants. Every effort will be made to ensure privacy is 
maintained during survey administration. HIV testing results will be confidential and linked to participants 
by a unique study identification number (their study ID number). Participants’ names and study number, 
and thus their HIV status and name, will never appear in a dataset together.  
Minimizing probability of violence. To minimize the likelihood of violence against study participants, we will 
train study staff to talk to participants at the time of enrollment about the importance of using their 
discretion and assessing the risk of IPV when deciding whether to introduce self-tests or offer HTS 
referral vouchers to their sexual partners. Study staff will also talk to participants about strategies for 
introducing self-testing or HTS referral vouchers to sexual partners, including potential talking points. It 
will be emphasized to study participants that they are not obligated to distribute self-tests to their sexual 
partners. Participants will be counseled to never offer a self-test or HTS referral voucher to someone who 
they will believe will become violent due to the introduction. Having developed the training materials for 
study staff and implemented the intervention successfully in our pilot study, we are confident that they will 
help minimize the risks of violence. We will also provide study participants with information on where they 
can seek help if they do experience violence or do need advice. We will establish a support telephone line 
(hotline) that study participants or their sexual partners can call at any time that will put them in touch with 
the study coordinator. The study coordinator will help arrange support for any woman experiencing 
violence. In our pilot study, we set up a hotline similar to what is proposed here. 
Minimizing probability of adverse reactions to test results. To ensure correct usage of self-tests (in the 
intervention group) and to minimize the probability of psychological distress due to HIV testing, we will 
include simple instruction materials with each self-test on how to use the tests, in English and local 
languages. These instruction materials have been developed by us and used in our pilot study, and they 
were well-received by FSW and the sexual partners. In addition, each self-test will include clear 
information on the importance of seeking confirmatory HIV testing (which is recommended by the WHO 
and the Kenyan Ministry of Health) – as such the vouchers and self-test will include information listing 
HTS clinics in the area where free HIV testing and counseling is available. Information will also be 
provided on clinics in the area where free HIV care and treatment is available. We will also establish a 
support telephone line (hotline) that study participants or their sexual partner can call at any time that will 
put them in touch with the study coordinator, who will be ready to provide additional information on where 
to seek further testing, care or treatment.  
10.2 
Benefits 
The main direct benefit of this study, is that we will provide free HIV self-testing kits to women, allowing 
them to test themselves regularly and offer tests to their partners (with the potential of also learning their 
partners’ HIV status). Additionally, enabling HIV-negative women to distribute tests to their sexual 
partners (including their clients) will help them make informed sexual decisions, thereby protecting them 
from HIV acquisition. By helping the partners of women learning their status, our study will also benefit 
these other individuals. Indirectly, the study may give rise to increased identification of HIV-positive 
persons and increased engagement in HIV care and treatment, thereby reducing the overall number of 
HIV transmissions occurring as well. 
10.3 
Risk Benefit Assessment 
The risks faced by women and their sexual partners in this study are far outweighed by the benefits to 
participants and the community, as well as the importance of the knowledge to be gained. Given the 
public health importance of achieving higher uptake of HIV testing among high-risk populations – 

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particularly women and their sexual partners, who generally have lower access to prevention services – it 
is vital to find effective new strategies that can be used to promote testing and identify HIV-positive 
persons unaware of their HIV infection. The knowledge gained from this study is particularly relevant at a 
time when countries in Africa are actively developing HIV self-testing policies and seeking optimal ways to 
scale-up HIV self-tests. Our study will also provide information on the effectiveness of secondary 
distribution of HIV self-tests by women as a strategy to reduce the risk of HIV acquisition among high-risk 
women by facilitating safer, more informed sexual decision-making. This is an important contribution to 
the HIV prevention knowledge base since women with multiple partners face extremely high risks of HIV 
infection and there is an urgent need to interventions that can prevent new infections in this key 
population. 
10.4 
Informed Consent Process / HIPAA Authorization  
Written informed consent will be obtained from all participants in the main study and qualitative interviews 
by trained research assistants. The research assistants will find a private place and provide the potential 
participant with a paper consent form (see Informed Consent document attached). The research 
assistants will carefully explain the nature and purpose of the study to each potential participant, potential 
risks and benefits, compensation for participation, and will describe the two study groups to which 
participants will be randomized. The consent process will be offered in English, Kiswahili, or Dholuo (as 
per the participant’s preferences). Our study team has prior experience in obtaining informed consent for 
research and clinical trials within the cultural context of in Kenya. The informed consent procedure has 
been designed to maximize understanding of potential risks. Participants will be told that they may decline 
to participate at any point. The consent form must be version controlled and approved by the IRB at the 
University of Pennsylvania and in Kenya. Written informed consent must be obtained before any study 
procedures can occur. In the event that a participant is illiterate, an impartial witness of the participant’s 
choice must be present during the consenting process and can document the participant’s consent. All 
participants will be given one copy of the signed consent form to take home for further review, if desired. 
10.4.1 Alterations to Typical Consent Process (only include if applicable)  
 
10.4.1.1 Waiver of Consent  
None   
 
10.4.1.2 Waiver of Written Documentation of Consent 
We are requesting a waiver of writted documentation of consent in order to verbally screen women for the 
main study. A standardized verbal consent form (see attached) will be read and verbal consent obtained 
before the interviewer begins the screening process. This verbal consent form includes consent to ask 
sensitive questions and perform a rapid HIV test. We are requesting a waiver of written consent since 
documentation of consent to screen would be the only written record linking the subject and the research 
for those women who do not later enroll in the study, presenting an unnecessary risk of breach of 
confidentiality. In the proposed verbal screening consent form, we will collect no identifying information 
that could be used to link a participant with her responses to the screening questions, or her HIV results. 
All women who successfully complete screening and are interested in the study will complete the full 
written consent before beign enrolled. 
11 Study Finances 
11.1 
Funding Source 
 
This study is financed through two grants from the US National Institute of Mental Health. This study 
received initial funding in September of 2016. A supplemental grant was awarded in July of 2017.  

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11.2 
Conflict of Interest 
All University of Pennsylvania Investigators will follow the University of Pennsylvania Policy on Conflicts of 
Interest Related to Research.  
11.3 
Subject Stipends or Payments 
Each participant attending an in-person visit with the study staff, including the screening/baseline visit and 
each 6-monthly follow-up (6,12,18,24 months) will receive Kenyan shillings (KES) 300 as compensation 
for the time to participate in study procedures. An additional amount up to KES 200  will be provided as 
reimbursement for transportation to the study venue. Refreshments will be provided during the 
screening/baseline visit.  
12 Publication Plan 
Findings from this study will be published in peer-reviewed journals and presented at scientific 
conferences. There is no projected impact on publication or presentation plans. 
13 References 
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Comparative Reports No. 30. Calverton, Maryland, USA: ICF International. 2013. 
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Suthar, A.B., et al., Towards universal voluntary HIV testing and counselling: a systematic review 
and meta-analysis of community-based approaches. PLoS Med, 2013. 10(8): p. e1001496. 
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Sharma, M., et al., Systematic review and meta-analysis of community and facility-based HIV 
testing to address linkage to care gaps in sub-Saharan Africa. Nature, 2015. 528(7580): p. S77-
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Chamie, G., et al., A “hybrid” mobile HIV testing approach for population-wide HIV testing in 
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National AIDS and STI Control Programme (NASCOP), K., Kenya AIDS Indicator Survey 2012: Final 
Report. 2014, NASCOP: Nairobi. 
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Fact Sheet 2014, Nairobi, Kenya: NASCOP. 
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Ng'ang'a, A., et al., The status of HIV testing and counseling in Kenya: results from a nationally 
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Baral, S., et al., Burden of HIV among female sex workers in low-income and middle-income 
countries: a systematic review and meta-analysis. Lancet Infect Dis, 2012. 12(7): p. 538-49. 
10. 
WHO, Preventing HIV in Sex Work Settings in sub Saharan Africa. 2011, World Health 
Organization: Geneva. 
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Beyrer, C., et al., An action agenda for HIV and sex workers. Lancet, 2015. 385(9964): p. 287-301. 
12. 
Vandenhoudt, H.M., et al., Prevalence of HIV and other sexually transmitted infections among 
female sex workers in Kisumu, western Kenya, 1997 and 2008. PloS one, 2013. 8(1): p. e54953. 
13. 
Odek, W.O., et al., Estimating the size of the female sex worker population in Kenya to inform 
HIV prevention programming. PLOS ONE, 2014. 9(3): p. e89180. 
14. 
Kiwanuka, N., et al., High Incidence of HIV-1 Infection in a General Population of Fishing 
Communities around Lake Victoria, Uganda. PLoS ONE, 2014. 9(5): p. e94932. 
15. 
Kwena, Z., et al., Predictors of extra-marital partnerships among women married to fishermen 
along Lake Victoria in Kisumu County, Kenya. PLoS One, 2014. 9(4): p. e95298. 

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16. 
Camlin, C.S., Z.A. Kwena, and S.L. Dworkin, "Jaboya" vs. "jakambi": Status, negotiation and HIV 
risk in the "sex-for-fish" economy in Nyanza Province, Kenya. AIDS Education and Prevention, 
2013. 25(3): p. 216–231. 
17. 
Choko, A.T., et al., The Uptake and Accuracy of Oral Kits for HIV Self-Testing in High HIV 
Prevalence Setting: A Cross-Sectional Feasibility Study in Blantyre, Malawi. PLoS medicine, 2011. 
8(10): p. e1001102. 
18. 
Johnson, C., et al., Realizing the potential for HIV self-testing. AIDS Behav, 2014. 18 Suppl 4: p. 
S391-5. 
19. 
Napierala Mavedzenge, S., R. Baggaley, and E.L. Corbett, A review of self-testing for HIV: 
research and policy priorities in a new era of HIV prevention. Clin Infect Dis, 2013. 57(1): p. 126-
38. 
20. 
Lee, V.J., et al., User acceptability and feasibility of self-testing with HIV rapid tests. Journal of 
Acquired Immune Deficiency Syndromes: JAIDS, 2007. 45(4): p. 449-53. 
21. 
Carballo-Dieguez, A., et al., Use of a rapid HIV home test prevents HIV exposure in a high risk 
sample of men who have sex with men. AIDS and behavior, 2012. 16(7): p. 1753-60. 
22. 
Thirumurthy, H., et al. Acceptability and feasibility of a novel approach to promote HIV testing in 
sexual and social networks using HIV self-tests. . in International AIDS Society (IAS) conference. 
2015. Vancouver, Canada. 
23. 
Choko, A.T., et al., Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting 
Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study. PLoS 
Med, 2015. 12(9): p. e1001873. 
24. 
Figueroa, C., et al., Attitudes and Acceptability on HIV Self-testing Among Key Populations: A 
Literature Review. AIDS Behav, 2015. 19(11): p. 1949-65. 
25. 
Kalibala, S., et al., Factors associated with acceptability of HIV self-testing among health care 
workers in Kenya. AIDS Behav, 2014. 18 Suppl 4: p. S405-14. 
26. 
Kalibala, S., W. Tun, and W. Muraah, Feasibility and acceptability of HIV self testing among 
health care workers: results of a pilot programme in two hospitals in Kenya, in XVIII International 
AIDS Conference, Abstract WEPDC205, Editor. 2010: Vienna, Austria 18-23 July. 
27. 
World Health Organization, Consolidated Guidelines on HIV Testing Services. 2015, World Health 
Organization: Geneva, Switzerland. 
28. 
National AIDS and STD Control Programme, Guidelines for HIV Testing and Counselling in Kenya, 
Ministry of Public Health and Sanitation Kenya, Editor. 2008, Nairobi: NASCOP. 
29. 
National AIDS and STI Control Programme, Guidelines for HIV Testing Services in Kenya. 2015, 
Nairobi: National AIDS Control Programme. 
30. 
Kimbrough, L.W., et al., Accessing social networks with high rates of undiagnosed HIV infection: 
The social networks demonstration project. American journal of public health, 2009. 99(6): p. 
1093-9. 
31. 
Golden, M.R., et al., Uptake and population-level impact of expedited partner therapy (EPT) on 
Chlamydia trachomatis and Neisseria gonorrhoeae: the Washington State community-level 
randomized trial of EPT. PLoS Med, 2015. 12(1): p. e1001777. 
32. 
Balan, I.C., et al., The Impact of Rapid HIV Home Test Use with Sexual Partners on Subsequent 
Sexual Behavior Among Men Who have Sex with Men. AIDS and behavior, 2013. 
33. 
Carballo-Dieguez, A., et al., Will Gay and Bisexually Active Men at High Risk of Infection Use 
Over-the-Counter Rapid HIV Tests to Screen Sexual Partners? J Sex Res, 2012. 
34. 
Thirumurthy, H., et al., Promoting male partner HIV testing and safer sexual decision making 
through secondary distribution of self-tests by HIV-negative female sex workers and women 
receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV, 2016. 3(6): p. 
e266-74. 

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35. 
Masters, S.H., et al., Promoting Partner Testing and Couples Testing through Secondary 
Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med, 2016. 13(11): p. e1002166. 
36. 
Shannon, K., et al., Global epidemiology of HIV among female sex workers: influence of structural 
determinants. Lancet, 2015. 385(9962): p. 55-71. 
37. 
Jakubowski, A., et al., Large price premiums for unprotected sex among female sex workers in 
Kenya:  a potential challenge for behavioral HIV prevention interventions. JAIDS Journal of 
Acquired Immune Deficiency Syndromes, 2015. in press. 
38. 
Alary, M. and C.M. Lowndes, The central role of clients of female sex workers in the dynamics of 
heterosexual HIV transmission in sub-Saharan Africa. AIDS, 2004. 18(6): p. 945-7. 
39. 
Voeten, H.A., et al., Clients of female sex workers in Nyanza province, Kenya: a core group in 
STD/HIV transmission. Sex Transm Dis, 2002. 29(8): p. 444-52. 
40. 
Skovdal, M., et al., Masculinity as a barrier to men's use of HIV services in Zimbabwe. 
Globalization and health, 2011. 7: p. 13. 
41. 
Bwambale, F.M., et al., Voluntary HIV counselling and testing among men in rural western 
Uganda: implications for HIV prevention. BMC Public Health, 2008. 8: p. 263. 
42. 
World Health Organization, Guidance on couples HIV testing and counselling including 
antiretroviral therapy for treatment and prevention in serodiscordant couples: recommendations 
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43. 
Kumwenda, M., et al., Factors Shaping Initial Decision-Making to Self-test Amongst Cohabiting 
Couples in Urban Blantyre, Malawi. AIDS Behav, 2014. 
44. 
Orasure Techonologies, I., OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Package Insert. 
Accessed 14 September 2011 http://www.orasure.com/products-infectious/products-
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45. 
Bernard, H.R., Research Methods in Anthropology. 1995, Walnut Creek Altamira Press 535. 
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Miles, M.H., A.H., Qualitative Data Analysis: An Expanded Sourcebook, 2nd Edition 1994, 
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14 Attachments 
Attached to this application for ethics review are the following documents: 
• 
Consent Forms 
o 
Main Study ICF (3 languages) 
o 
Verbal Screening ICF (3 languages) 
• 
Survey Instruments 
o 
Baseline Questionnaire (3 languages) 
o 
SMS Women Questionnaire (3 languages) 
• 
Participant Instruction Sheets 
o 
HIVST Instructions (3 languages) 
o 
Vaginal Swab Instructions (3 languages) 
o 
Referral Voucher (Control) 
o 
Confirmatory Testing Card (Intervention) 
• 
Previous Approval Letters 
o 
University of North Carolina at Chapel Hill 
o 
Maseno University 
• 
Personnel Biosketches and Ethics Training Certificates 
• 
DSMB charter 
• 
IPV Reporting Log (Adverse Event Reporting) 
 
 

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15 Appendices     
15.1 
 Table 1: Schedule of Aim 1 Study Procedures 
Study Phase: 
Screening/Baseline 
Monthly 
Distribution 
Monthly Text 
Message 
Surveys 
6-Monthly 
Follow-up 
Assess Inclusion Criteria 
X 
 
 
 
Informed Consent 
X 
 
 
 
HIV rapid test 
X 
 
 
X 
STI test 
X 
 
 
X 
Fingerprint Verification 
X 
X 
 
X 
HIVST demonstration 
(intervention group only) 
X 
As Needed 
 
X 
Distribution counseling 
message given 
X 
As Needed 
 
X 
HIVST or referral cards given 
to participants 
X 
X 
 
X 
Survey questionnaire 
administered 
X 
 
X 
X 
IPV risk assessed 
X 
Self-reported 
X 
X