Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Phase: NA
Conditions: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral, Retroviridae Infections, Virus Diseases, Virus-HIV, RNA Virus Infections
Sponsor: University of California, San Francisco

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SELF-TEST STRATEGIES AND LINKAGE INCENTIVES TO 
IMPROVE ART AND PREP UPTAKE IN MEN 
 
Protocol Co-Chairs: 
Carol S. Camlin, PhD, MPH 
Harsha Thirumurthy, PhD 
 
Institutions: 
University of California, San Francisco 
University of Pennsylvania 
Impact Research and Development Organization 
Grant Title: Self-Test Strategies and Linkage Incentives to Improve ART and PrEP 
Uptake in Men 
Grant Number:  1R01MH120176 
UCSF CHR Study Number: 19-28205 
Funded by: National Institute of Mental Health (NIMH) 
Version Number: 11.0 
November 29, 2022 
 
 
 
 
 
 
 
 
 
 

Page 3 of 64 
 
 
Protocol chair signatures: 
 
Signature_______
___Date ___05/DEC/2022_______________________ 
Carol Camlin, PhD, MPH 
 
Signature_____
_____Date ___05/DEC/2022_______________________ 
Harsha Thirumuthry, PhD 
 
 
Signature__________________________________Date ______05/DEC/2022_____________________ 
Zachary Kwena, PhD 
 
 

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CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 
 

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PROTOCOL TEAM ROSTER 
 
Carol S. Camlin, PhD, MPH 
Principal Investigator, University of California, San Francisco 
Address:  ANSIRH Program, 1330 Broadway, Suite 1100, Oakland, CA 94612 
Phone Number: +1-510-986-8981 (USA) 
Email: carol.camlin@ucsf.edu 
 
Harsha Thirumurthy, PhD 
Principal Investigator, University of Pennsylvania 
Address:  423 Guardian Drive, 1111 Blockley Hall, Philadelphia, PA 19104-4884, U.S.A 
Phone Number:  +1-215-746-0410 
Email: hthirumu@pennmedicine.upenn.edu  
 
Zachary Kwena, PhD, MA 
Site Principal Investigator, Kenya Medical Research Institute 
Address Box 54840, Nairobi, Kenya 
Phone Number: +254-733-617503 
Email:  zkwena@kemri-ucsf.org  
 
Edwin D. Charlebois, PhD, MPH 
Investigator, University of California, San Francisco 
Address:  UCSF Box 0874, San Francisco, CA 94143-0874, U.S.A 
Phone Number:  +1-415-215-6515 
Email:  edwin.charlebois@ucsf.edu 
 
Kawango Agot, PhD, MPH, MPhil 
Investigator, Impact Research and Development Organization (IRDO) 
Address:  P.O.Box 9171-40141, Kisumu, Kenya 
Phone Number:  +254-(0)57-2020132/ (0)729-390100/ (0)736-505046 
Email:  kawango@impact-rdo.org  
 
Elizabeth A. Bukusi, MBChB, M.Med, MPH, PhD  
Investigator, Kenya Medical Research Institute 
Address:  Box 54840, Nairobi, Kenya 
Phone Number: +254-733-617503 
Email:  ebukusi@rctp.or.ke 
 
Monica Gandhi, MD, MPH 
Investigator, University of California, San Francisco 
Address:  1001 Potrero Ave, Rm 423D, Box 0874 San Francisco, CA 94110, U.S.A. 
Phone Number:  + 415-476-4082 ext. 127 
Email:  Monica.Gandhi@ucsf.edu 
 
James Moody, MD 
Investigator, Duke University 
Address:  268 Soc/Psych Bldg., Durham, NC 27708, U.S.A. 
Phone Number:  +1-919-660-5650 
Email: james.moody@duke.edu

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TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE 
1 
1 9 
2 10 
3 11 
3.1 
11 
3.2 
14 
4 15 
4.1 
15 
4.2 
16 
5 18 
6 20 
6.1 
20 
6.2 
20 
6.3 
21 
6.4 
21 
6.5 
21 
6.6 
21 
6.7 
22 
6.8 
24 
6.9 
25 
7 25 
7.1 
25 
7.2 
26 
7.3 
26 
8 26 
8.1 
26 
8.2 
27 
8.3 
27 
8.4 
28 
8.5 
29 
8.6 
29 
8.7 
32 
8.8 
32 
8.9 
33 
8.10 33 
9 34 
9.1 
34 
9.2 
35 
9.3 
35 
10 36 
10.1 36 

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10.2 36 
10.3 37 
10.3.1 37 
10.3.2 37 
10.3.3 38 
10.3.4 39 
11 40 
11.1 40 
11.2 40 
12 40 
12.1 40 
12.2 43 
12.3 43 
12.4 46 
12.5 49 
12.6 50 
12.7 50 
12.8 50 
13 50 
13.1 50 
13.1.1 51 
13.1.2 51 
13.2 53 
13.3 53 
13.4 54 
13.5 54 
13.6 54 
13.7 54 
13.8 55 
13.9 56 
13.10 56 
13.11 56 
13.12 57 
13.13 57 
14 59 
15 64 
15.1 64 
15.1.1 64 
15.1.2 64 
15.1.3 64 
15.1.4 64 
15.1.5 64 

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15.2 65 
15.2.1 65 
15.2.2 65 
15.2.3 65 
15.2.4 65 
15.2.5 65 
15.2.6 65 
15.3 65 
STUDY CONTACT CARD 
50 
STATEMENT OF COMPLIANCE 
 
The study will be carried out in accordance with International Council on Harmonization Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 
CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
 

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1 
INVESTIGATOR’S SIGNATURE 
 
The signature below constitutes the approval of this protocol and provides the necessary assurances that 
this study will be conducted according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
 
Principal Investigators: 
 
Signed: 
 
Date:05/DEC/2022 
 
 
Name: Carol S. Camlin, PhD, MPH 
 
 
Signed: 
Title: Associate Professor in Residence 
 
 
 
 
Date: 05/DEC/2022 
 
 
Name: Harsha Thirumurthy, PhD 
 
Title: Associate Professor  
Site Principal Investigator: 
 
 
Signed: 
 
Date: 
05/DEC/2022 
 
Name: Zachary Kwena, PhD, MA 
 
Title: Social Scientist & Co-Director 
 
 
Investigator Contact Information 
Carol S. Camlin, PhD, MPH 
Associate Professor in Residence 
Dept. of Obstetrics, Gynecology & Reproductive Sciences 
University of California, San Francisco 
ANSIRH Program, 1330 Broadway, Suite 1100 

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Oakland, CA 94612 
Tel. (510) 986-8981 / Fax (510) 986-8960 / Email: carol.camlin@ucsf.edu 
2 
ABSTRACT 
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to 
improve the HIV prevention and care cascades in a population of mobile men in a high priority setting 
(fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to 
distribute HIV self-tests and provide linkage support to men in their close social networks. The study will 
determine whether this social network-based approach along with small financial incentives in the form of 
transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-
testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those 
initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative 
and qualitative assessments) to identify the pathways of intervention action, and understand how the 
social network-based approach with support for linkage affects testing and ART and PrEP uptake and 
retention in men.  
 

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3 
PROTOCOL SUMMARY 
3.1 SYNOPSIS  
 
Title: 
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men 
Grant Number: 
1R01 MH120176 
Brief Summary: 
This is a randomized controlled trial to test a combination behavioral and 
biomedical intervention to improve the HIV prevention and care cascades in a 
population of mobile men in a high priority setting (fishermen in Kenya). The 
intervention strategy is to recruit and train highly socially-connected men to 
distribute HIV self-tests and provide linkage support to men in their close social 
networks. The study will determine whether this social network-based approach 
along with small financial incentives in the form of transport vouchers and 
biomedical technologies can increase men's HIV testing (within3 months linkage to 
and uptake of ART and PrEP after testing (within 3 months, and virologic 
suppression (HIV RNA < 400 c/mL) at 6 months and PrEP adherence (tenofovir 
levels of >=1500 ng/mL in urine) at 6 months. The study includes a longitudinal 
qualitative and mixed methods quantitative and qualitative assessments to identify 
the pathways of intervention action, and understand how the social network-based 
approach with support for linkage affects testing and ART and PrEP uptake and 
retention in men.   
Study Design: 
Cluster randomized controlled trial of a combination intervention to increase men's 
HIV testing uptake, increase their linkage to and uptake of ART and PrEP, and 
improve their outcomes (virologic suppression for HIV-infected men and adherence 
to PrEP in uninfected men) 
Study Population: 
     At least 650 and up to 1,800 men aged ≥18 years who are primarily working in 
the fishing industry or related activities, who reside in beach communities in Siaya.  
Study population will consist of up to 140 clusters of men with close social network 
ties with a variable number of men in each cluster. 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
Clinic sites: up to 10 beach landing sites and associated clinics, within one or more 
sub-counties, Rarieda, Bondo and Alego Usonga, in Siaya County in western Kenya  
Community sites: up to 10 Lake Victoria beach communities (with Beach 
Management Unit -governed landing sites) within sublocations in Rarieda, Bondo 
and/or Alego Usonga 
Objectives: 
 
1. Determine whether providing training and HIVST to select fishermen to distribute 
to other men in their close social networks increases men’s HIV testing uptake; 
2. Determine whether network-central promoters and small incentives can improve 
ART and PrEP uptake among men in their close social networks; and  
3. Test the impact of interventions on ART or PrEP retention and adherence. 
Approach: 
In Aim 1, following the study pilot, community selection, and preparation (see 
'recruitment and retention plan') the study team will conduct a census/BMU 
registry verification in study communities to identify the population of men eligible 
for the study. We will screen, recruit and enroll eligible men who give their 
informed consent to participate, then measure their close social networks identify 
network-central, highly-connected men (“promoters”) and randomize their close 
social network (a cluster) to 1:1 intervention and control groups. We will then 

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conduct a baseline survey to collect sociodemographic and baseline sexual behavior 
data among men in the close social networks. Following this baseline data 
collection, all promoters will be provided a training. Promoters in the intervention 
group will receive HIVST training, multiple HIVST for distribution to other men, and 
a small amount of remuneration. Promoters in the control group will receive basic 
HIV education and training about the study, and will be given vouchers that can be 
exchanged for HIV tests (standard or free HIVST kits) at nearby health facilities. 
Using follow-up survey data, we will test the hypothesis that a higher rate of HIV 
testing will be observed after 3 months among men in networks that receive the 
intervention compared to control. 
  
In Aim 2, we will test whether network-central promoters can enhance linkage to 
ART and PrEP after HIV testing among men in their close social networks. 
Promoters in the Aim 1 intervention group will be asked to distribute information 
and transport vouchers for ART or PrEP when distributing HIV self-tests to men in 
their close social networks. We will use clinic data (managed by study staff) to test 
the primary hypothesis that the intervention will result in higher rates of linkage to 
ART or PrEP (confirmatory testing and ART referral for positives, and PrEP screening 
for negatives). We also will test the hypothesis that higher ART and PrEP uptake will 
be observed within 3 months (+ about one month) in the intervention group. 
 
In Aim 3, we will measure 6 month (+ about 1 month)  VL  and 6 month (+ about 1 
month) tenofovir levels using viral load testing and a novel point of care PrEP 
adherence assay (an antibody-based assay permitting measurement of tenofovir 
levels in urine) in study sites, and test the hypothesis that higher rates of virologic 
suppression will be observed in HIV-infected men, and PrEP adherence in un-
infected men, in the intervention group. Viral load measurements will be conducted 
by drawing venous blood at a study visit scheduled at 6 months and through 
adherence assessment during a study visits scheduled at 3 and 6 months. 
Similarly, we will measure PrEP adherence utilizing the study urine assay at a 
study visit scheduled at 6 months and through adherence assessment at 3 
and 6 months.   
 
Across all aims, we will assess the pathways of intervention action using qualitative 
and mixed methods. We will identify the mechanisms of action, and barriers and 
facilitators of the social network and incentives intervention implementation, using 
qualitative and mixed methods quantitative and qualitative assessments embedded 
in Aims 1, 2 and 3. The data collection approach will include in-depth interviews 
with participants in both groups, key informant interviews with network-central 
promoters, and focus group discussions with study participants stratified by HIV 
status and study group. Data will be collected at baseline and three follow-up 
periods corresponding to the timing of quantitative outcome measurements in 
Aims 1 through 3. 
Description of 
Study 
Intervention: 
Intervention type: Behavioral intervention trial 
The intervention strategy is to recruit and train highly socially-connected men to 
distribute HIVST and provide linkage support (encouragement, along with small 

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financial incentives to offset transport costs) to other men in their close social 
network. 
Outcome 
Measures: 
Primary outcomes 
1. Self-reported HIV testing within 3 months of intervention start 
2. Linkage to care or prevention within 3 months of intervention start 
3. Viral suppression (HIV RNA <400 c/mL) at 6 and 12 months among HIV-positive 
participants 
4. PrEP adherence at 6 months  
 
Secondary outcomes 
1. Initiation of ART or PrEP within 3 months confirmatory test or PrEP eligibility 
screening 
2. Confirmatory HIV testing uptake 3 to 6 months after intervention start 
 
Study Duration 
5 Years  
Participant 
Duration: 
Approximately 30 months  
Phase or Stage: 
Phase III 
 
 

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3.2 SCHEDULE OF ACTIVITIES  
Below is a table detailing the key activities in intervention and control communities, from baseline through 
the end of the study. 
Table 1. Detailed Overview of Activities by Control and Intervention Sites 
 
 
Planning 
Baseline 
3-month 
6-month 
9-month 
12-month 
15-month 
 
INTERVENTION AND CONTROL  
Pilot survey (phone or in-person) and qualitative interviews  
X 
 
 
 
 
 
 
 
Baseline BMU Census/ Registry verification & updating 
X 
X 
 
 
 
 
 
Eligibility screening and informed consent 
 
X 
 
 
 
 
 
Baseline survey 
 
X 
 
 
 
 
 
Social network mapping and randomization 
 
X 
 
 
 
 
 
Follow up survey – (includes HIVST self-report) 
 
 
X 
 
 
 
 
Qualitative in-depth interviews and focus group discussions 
(HIVST and network support) 
 
 
X 
X 
 
 
 
Linkage to ART or PrEP 
 
 
 
X 
 
 
 
VL measurement and adherence for those initiating ART  
 
 
 
X 
 
 
 
Urine tenofovir levels measurement and adherence for those 
initiating PrEP  
 
 
 
X 
 
 
 
Qualitative in-depth interviews (Linkage and retention) 
 
 
 
X 
 
 
 
INTERVENTION  
Enhanced training (HIV basics, HIVST, PrEP, and ART) 
 
X 
X 
X 
 
 
 
 
HIVST for distribution via network-central promoters 
 
X 
X 
 
 
 
 
Voucher for cash redemption 500 KSH (at clinic linkage) 
 
X 
X 
 
 
 
 
Enhanced promoter support/training 
 
X 
X 
X 
 
 
 
Retention support via SMS/phone 
 
 
X 
X 
 
 
 
CONTROL  
Basic training (HIV basics and facility access/info) 
 
X 
 
 
 
 
 
 
Voucher for HIV test or HIVST redemption at facility  
 
X 
X 
 
 
 
 
Standard of care for ART or PrEP 
 
X 
X 
X 
 
 
 
 

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4 
INTRODUCTION 
4.1 STUDY RATIONALE  
Ending the AIDS epidemic in sub-Saharan Africa (SSA) will require further engagement of men in HIV 
testing, prevention, and treatment, a challenging task given that nearly 50% of HIV-positive men in many 
countries are unaware of their HIV status and men have lower uptake of HIV treatment and pre-exposure 
prophylaxis (PrEP).1,2 In SSA, highly mobile men such as those working in fishing communities alongside 
Lake Victoria have low uptake of HIV testing and low rates of linkage to HIV treatment and PrEP, despite 
increasing availability of these services. As a result, HIV transmission risks remain high in these 
communities. Two recent innovations – HIV self-testing (HIVST) and social network-based interventions – 
hold promise for overcoming barriers to HIV testing and linkage to services for HIV-positive and HIV-
negative men. This study seeks to determine if an HIV status-neutral, social network-based approach can 
promote HIV testing, linkage to care and prevention, and better health outcomes in men.  
We focus on a highly mobile population of men: fishermen in communities on Kenya’s Lake Victoria 
shoreline, where HIV incidence (2.4-9.3 per 100 PY)3,4 and prevalence (24-26%)5-7 remain high despite 
progress elsewhere, 3,5,8-10 and where treatment uptake is only 53-61%.5,6 Our prior work showed that 
mobility of fisher folk and a transactional sex economy contribute to their exceptionally high HIV risks.11-15 
Low rates of testing and care engagement among fishermen are influenced by the mobility inherent to 
their livelihoods, stigma in beach communities, and gender norms.16-18 new strategies specifically targeted 
to reach highly mobile men are urgently needed to increase men’s testing uptake and linkage to ART and 
PrEP  
This study will leverage new technologies and insights from behavioral economics and social network 
research to test low-cost, scalable interventions to close gaps in the prevention and care cascade. To 
increase uptake of HIV testing and existing prevention and treatment services, we will test a strategy that 
recruits and trains highly-connected, network-central men to distribute HIV self-tests and provide linkage 
support to men in their close social networks. Men due to its convenience and privacy prefer HIVST.19,20 
Policies are evolving rapidly, with WHO recommending HIVST scale-up and the Gates Foundation 
subsidizing self-test prices. Building on our studies of secondary distribution of self-tests by women,21,22 
financial incentives,23-25 and adherence metrics26-29 to objectively assess outcomes, as well as other 
research demonstrating the importance of social networks for influencing norms and behaviors,30-38 we 
will evaluate an innovative social-network based approach to promoting HIV prevention and treatment 
behaviors among men. Network-central promoters – who are well positioned to disseminate information 
and influence behaviors – will distribute HIV self-tests, transport vouchers for referral services, and 
information on ART and PrEP, to men in their networks. Specifically, we will conduct a cluster-randomized 
trial of social network-based self-test distribution and linkage intervention among 80 close social networks 
of men in Kenya.  

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4.2 BACKGROUND  
Men’s engagement in HIV prevention and care remains suboptimal, especially in high priority settings in 
sub-Saharan Africa (SSA). Ending the AIDS epidemic requires interventions that can achieve higher uptake 
of HIV testing, particularly among the ~50% of HIV-positive men in many countries who are unaware of 
their HIV status.1,2 It also requires interventions to successfully link HIV-positive individuals to existing 
services for antiretroviral therapy (ART) and high-risk HIV-negative individuals to prevention including HIV 
pre-exposure prophylaxis (PrEP). A focus on men is warranted because, relative to women, men test for 
HIV at lower rates, 39 are less likely to engage in HIV treatment and PrEP programs,1,2 have higher attrition 
from treatment programs,40-45 and have higher rates of viral failure on ART.5,46-49 This results in men’s 
lower life expectancy on ART50,51 as well as their continued onward transmission of HIV to women.52 This 
proposed study addresses the high priority research needs identified in PA-19-042, Engaging Men in HIV 
Testing, Prevention, and Care. 
We know that men’s barriers to HIV prevention and care engagement are both structural (e.g. labor-
related mobility) and cultural (e.g. gender norms). We and others have identified structural and cultural 
barriers, including men’s labor-related mobility, and gender norms that valorize risk-taking and discourage 
health-seeking behavior, that have contributed to men’s lower participation in HIV testing relative to 
women.16,53 While men’s enactment of masculinity (i.e. behavior that fulfills male gender role 
expectations) often results in personal advantage, these same constructs and associated behaviors also 
serve to configure vulnerabilities for men in terms of HIV acquisition, HIV care engagement, and HIV-
related mortality.41,43,53-61 
This study focuses on a particularly high-priority population of men residing in communities along Lake 
Victoria. HIV incidence remains high among fisher folk despite progress against the spread of HIV 
elsewhere in the region.3,5,8-10 Recent studies estimate HIV prevalence is 24-26%5-7 and incidence is 2.4-9.3 
per 100 PY,3,4 yet treatment coverage is only 53-61%.5,6 Dr. Camlin’s research has revealed that the 
mobility of fisher folk coupled with a “sex-for-fish” economy (locally called “jaboya”, in which fishermen 
give female traders access to fish in exchange for sex), contributes to their exceptionally high risks.11-15 Our 
team and others have found low rates of HIV testing and care engagement among fishermen are 
influenced by structural factors – fishermen find it difficult to access services at fixed-location clinics and 
typical clinic hours because of their mobility – and cultural factors such as HIV-related stigma and gender 
norms counter to men’s health-seeking behaviors, e.g. HIV testing “by proxy” (i.e. inferring their HIV status 
from their female partners’ test results).16-18,62 In this setting of high risks,6,63 where 10% of adults have 
undiagnosed HIV and 60% of HIV-positive people need ART,5 strategies are urgently needed to increase 
men’s testing uptake and linkage to ART and PrEP Moreover, HIV status-neutral approaches are needed to 
counter HIV-related stigma among fishermen. 
The research to date reveals several scientific and implementation knowledge gaps: What are the best 
approaches to engaging highly mobile, high-risk men to increase their uptake of HIV testing and linkage to 
ART and PrEP? Given that conventional testing and care delivery approaches have not been successful to 
date, what new strategies are needed to address men’s well-known barriers, including work-related 
mobility?  

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HIV self-testing (HIVST) presents an excellent opportunity to bridge these gaps. A growing literature shows 
that HIVST is safe and can overcome barriers to clinic-based, counselor-administered testing. With HIVST, 
individuals collect their own oral fluid sample and perform a simple, rapid antibody test in the absence of 
a provider. Studies show high acceptability and demand for HIVST across many populations and settings, 
as it offers convenience, privacy, and accuracy among lay users.19,64-73 Interest is typically highest among 
high-risk groups and those who have never tested.70  
Providing multiple self-tests to men and encouraging them to distribute tests to men in their social 
networks (i.e. ‘secondary distribution’) is a promising but untested strategy to increase men’s testing. 
Secondary distribution of self-tests within social networks may be a low-cost, efficient way to increase 
testing coverage. We and others have shown that secondary distribution of self-tests by women to their 
male partners is an effective way to promote partner and couples testing; 21,22 such approaches are now 
being implemented in many countries.74 However, this approach may not be feasible for all women and it 
does not sufficiently leverage the fact that men are highly influenced by their peers. To date no studies 
have assessed the impact of secondary distribution of self-tests in men’s social networks – an important 
evidence gap regarding HIVST.  
Countries in SSA are scaling-up HIVST to close the testing gap in priority populations – evidence is needed 
on delivery approaches that maximize testing coverage. A growing number of countries, including Kenya, 
are scaling-up HIVST after the WHO’s December 2016 guidelines called for large-scale implementation of 
HIVST.75-77 The feasibility of HIVST interventions was further enhanced by the Gates Foundation’s 2017 
decision to subsidize oral fluid-based HIV tests, bringing their price down to $2/test. What countries are 
actively seeking are optimal distribution strategies for self-tests, to ensure that testing is increased among 
high-risk individuals not reached by other HIV testing modalities.  
Social network-based approaches show promise for generating positive social influence and accelerating 
health behavior change in men. The influence of social networks on health behaviors and outcomes is well 
established78-84 and it is known that social network characteristics can influence behavior through the 
circulation of ideas and social influence.85 Network interventions are purposeful efforts to use networks to 
generate social influence, accelerate behavior change, and achieve positive health outcomes.86-91 In SSA, 
prior research has shown the influence of social networks on HIV testing, 92-94 partner concurrency, 95 and 
condom use.96 Such an approach is further supported by research showing that behavioral and 
organizational change programs are most effective when implemented by members of the group 
undergoing the change, i.e., peers.97,98 We also now know that selecting influential nodes in a network (i.e. 
individuals who are highly connected) results in superior intervention effectiveness: selecting well-
connected nodes, from a network perspective, are better than nodes chosen randomly, a finding 
demonstrated with simulations 99,100 and empirical examples.101,102 Thus, selecting highly socially 
connected men within social networks to act as ‘promoters’ may overcome long-standing barriers to HIV 
testing and uptake of additional health services.  
To maximize the HIV prevention potential of HIVST, interventions are needed to promote linkage to care 
and prevention. As with strategies including home-based and community-based HIV testing, linkage rates 
following HIVST are often suboptimal without other interventions to motivate confirmatory testing and 

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linkage to care and prevention. Given the absence of a counsellor during HIVST, it is arguably even more 
important to promote linkage interventions with HIVST. A recent WHO summary of the few HIVST studies 
conducted (usually without linkage interventions) reported that linkage after HIVST was 50-56% in general 
populations in SSA.75 In its 2016 HIVST guidelines, WHO emphasized a need for evaluation of interventions 
to facilitate linkage to care and prevention. We will directly address this “Achilles heel” of HIVST with 
social network approaches and low-cost financial incentives, both intended to promote linkage to care.  
PrEP has the potential to reduce HIV incidence in SSA, but there are many knowledge gaps concerning 
PrEP implementation, especially in men. Trials have proven the efficacy of PrEP,103-108 but varied 
protection levels have been attributed to low adherence: in trials in young women, adherence was too 
low to demonstrate effectiveness.104,106 PrEP non-use was influenced by partners and peers,109,110 and 
many women perceived themselves to be at low HIV risk. In a trial in discordant couples in which 
adherence was higher,103 only 20% of those at high risk reported they were at risk.111 while much has been 
learned about PrEP adherence among couples and young women, and current interventions (e.g. 
DREAMS) focus on these populations, much less is known about men’s demand for PrEP Our team has 
implemented PrEP in high-risk populations in the SEARCH trial,112,113 and low enrollment (~18%114) 
supports a need for strategies to stimulate uptake and adherence in this group. Moreover, self-reported 
adherence has proven limited in PrEP and objective adherence metrics using drug levels measure 
adherence more accurately.115 This study will fill key knowledge gaps by testing novel strategies to 
promote PrEP uptake, as well as to measure PrEP adherence among men. 
Behavioral economics theories provide a strong rationale for using small financial incentives to promote 
healthy behaviors such as linkage to care and prevention. Insights from psychology and economics point 
to various factors and decision-making biases, such as limited attention and present bias,116-120 that make 
financial incentives valuable strategies for promoting healthy behaviors. Studies in low-income countries 
show that providing small financial incentives results in significant behavior change.121 Trials conducted by 
our team in eastern Africa and others have shown that providing small incentives can promote uptake of 
services such as vaccinations, HIV testing and male circumcision, 23,121,122 warranting testing whether 
incentives promote linkage to appropriate available health services (ART or PrEP) after HIVST. The cost-
effectiveness of incentives as a demand creation intervention for HIV prevention has led several programs 
and countries to adopt them on a larger scale, demonstrating the potential for sustainability. For example, 
revised WHO Guidelines of VMMC include recommendations for providing small amounts of 
compensation to clients in order to offset time cost and lost wages. This study will use a rigorous design to 
assess whether incentives, embedded within a social network approach, can promote ART/PrEP linkage, 
uptake and adherence. 
 
5 
OBJECTIVES AND ENDPOINTS  
Table 2. Overview of Study Aims, Design, and Outcomes 
 
Study design and interventions 
Outcomes 

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Aim 1 
Self-reported HIV testing within 3 
months of intervention start BMU 
census / registry verification & 
updating 
1. Baseline social network data 
collection            
2. Identification of close social 
networks and network-central 
‘promoters’      
3. Baseline survey among those 
randomized to control and 
intervention 
4. RCT: Intervention: Promoters 
given training & multiple STs, & 
asked to offer STs to men in their 
social networks. Control: 
Promoters given basic training & 
vouchers for HIV testing 
(including HIVST) at clinics to 
offer to men in their networks 
5. 3-month follow-up survey 
● Self-reported HIV testing uptake within 3 
months  
● Confirmatory HIV testing uptake 3 – 6 months 
after intervention start   
 
Aim 2 
Measure impact of intervention on 
linkage to & uptake of ART & PrEP 
1. Intervention: Promoters are 
given incentives (clinic transport 
reimbursement vouchers valued 
at ~$5) & encouraged to give to 
men in their networks to 
promote linkage to ART or PrEP 
after HIV testing 
2. Control: Promoters given same 
training & info, but no linkage 
incentives  
● Linkage to ART or to PrEP within 3 months 
after self-reported HIV testing  
● Initiation of ART or PrEP (among those 
eligible), within 3 months of confirmatory 
testing (linkage)  
Aim 3 
Measure impact of intervention on 
ART & PrEP retention & adherence 
1. Men who test HIV-positive 
undertake VL testing and 
counseling at scheduled intervals 
to ascertain adherence to ART 
2. Men who test HIV-negative 
undertake rapid HIV & TFV 
testing with counseling at 
scheduled intervals and urine 
testing to ascertain PrEP 
adherence 
● Viral suppression (HIV RNA <400 c/mL) and 
adherence at 6 & 12 months  
● Adherence to PrEP (TFV levels of >=1500 
ng/mL in urine = adequate adherence28) at 6 
months  
Qualitative 
Across all aims, we will assess the pathways of intervention action using qualitative and 
mixed methods quantitative and qualitative assessment. We will identify the 

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Studies 
mechanisms of action, and barriers and facilitators of the social network and incentives 
intervention implementation, using qualitative and mixed methods quantitative and 
qualitative assessments embedded in Aims 1, 2 and 3. The data collection approach will 
include in-depth interviews with participants in both groups, key informant interviews 
with network-central promoters, and focus group discussions with study participants 
stratified by HIV status and study group. Data will be collected at baseline and at follow-
up periods corresponding to the timing of quantitative outcome measurements in Aims 
1 through 3. 
6 
STUDY DESIGN 
6.1 OVERALL DESIGN 
This study among fishermen at beach landing sites in Siaya County, Kenya, is a 5-year combination 
prevention study using both novel biomedical tools and low-cost behavioral interventions to pursue three 
outcomes corresponding to the study’s aims: 1) to increase men’s HIV testing with self-tests; 2) to improve 
care linkage to prevention or treatment among men who HIV test; and 3) to assess the long-term impacts 
of the intervention on men’s engagement in HIV care and prevention, including adherence. The study 
includes qualitative and mixed methods- quantitative and qualitative assessments in all aims, designed to 
ascertain the pathways of intervention action and to identify key implementation factors that affect 
outcomes. The study design is a cluster randomized controlled trial where the unit of randomization will 
be a clusters of men’s close social network in study communities. Prior to the study launch, we will 
conduct a pilot for the study which will test survey instruments and refine our approach for the main RCT.                      
PILOT SURVEY AND QUALITATIVE INTERVIEWS 
We will conduct a small pilot in a beach-landing site in order to refine and improve our study approach 
and data collection tools. The data collected from this pilot social network mapping will not be included in 
the main study. In order to conduct this pilot, we will, utilizing locally available data and information, 
select a beach community to conduct the activity. The consent forms, enrollment, and eligibility screening 
procedures, including incentives for participation, will outlined in the sections to follow. 
NB: COVID amendment:  
Implementing phone-based data collection. In response to COVID-19 related disruptions, and in an effort 
to avoid further delays, we may utilize phone-based data collection to collect key demographic and social 
network data during the pilot phase. In the event of COVID-19 related restrictions being lifted in June or 
July of 2020, we will resume our modified in-person data collection, adhering to local, IRB and country-
level mandated guidelines for social distancing and human subjects’ protections.    
Should it become necessary to implement phone-based data collection during the pilot phase, we will 
screen and determine eligibility using the larger study criteria detailed in section 7.1, verbal recruitment 
script and versions of the screening form- one for phone and one for in-person. We will provide incentives 
of 500 KSH via Mpesa, for all those who participate in any potential phone survey for this pilot. If pilot 
data is collected in person, the incentive will be provided in-person. We will conduct the pilot survey 
(attached to the protocol) with eligible (18 and older, men who are involved in fishing or related 

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occupations), after screening (using the pilot phone-based or in-person screening form) and consenting 
them using (the pilot phone-based consent form-verbal or the written pilot consent form) - attached to 
this protocol. Once we have conducted these surveys, we will take the information obtained to map social 
networks. Based on the data obtained from the pilot survey, we will also purposively select up to n=20 
men who will be invited for additional in-depth interviews. This rapid interview will utilize the instruments 
attached to this protocol (see qualitative pilot interview). Information obtained during this pilot phase, 
from both the surveys and subsequent qualitative interviews, will be utilized to modify, improve, and 
adjust the survey and study approach. Subsequent modifications will be submitted to IRB. 
6.2 BEACH CENSUS/REGISTRY VERIFICATION & ABSTRACTION 
Tool for the baseline BMU Census/Registry data verification, updating and abstraction is included as 
appendix to this protocol. 
6.3      SOCIAL NETWORK SURVEY  
We will contact fishermen identified during the BMU census/registry data abstraction to screen for 
eligibility in the study. Fishermen who provide informed consent will be administered a baseline survey 
that elicits      information on the close social networks of fishermen. This module will ask participants to 
name the men in their community to whom they are most closely connected to for domains such as 
health (whom they would seek health information from or share information with), finances (to whom 
they would turn to borrow money), and spending time (on work and social activities). The social network 
data obtained in this way will enable us to determine the ties and close social networks that exist in the 
community, particularly among fishermen.  The procedures for the baseline survey are described in detail 
in the study procedures section. 
The social network survey instrument is included as an attachment to this protocol. 
6.4 IDENTIFICATION OF CLOSE SOCIAL NETWORKS AND NETWORK-CENTRAL PROMOTERS 
Using the social network data obtained from the baseline survey and BMU census/ registry data along 
with a name-matching algorithm, we will identify male close social networks that exist in study 
communities. Their defining characteristic will be that individual members of any given network will be 
connected to each other on multiple domains that indicate strong ties between them. Following the 
identification of distinct close social networks in communities, we will analyze the network data to 
determine a network-central individual having a high degree of connectedness across domains within 
each network.  The network-central individual will be considered as the network-central ‘promoter’ of HIV 
testing and will be the main individual study staff will contact to implement intervention and control 
group activities and approached for consent. If a central individual is not interested in participation, we 
will approach the next most central individual. Local close networks with consenting promoters will be 
eligible for randomization. 
6.5                RANDOMIZATION OF CLOSE SOCIAL NETWORKS 
Close social networks will be randomized 1:1 to intervention and control arms using a computer algorithm 

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that performs randomization stratified by beach and network size in blocks of two networks. All network 
members will receive the study arm condition to which their network is assigned. Participation of all 
network members is not a requirement for network randomization.      
6.6 BASELINE SURVEY WITH MAPPED SOCIAL NETWORKS AND PROMOTERS SOCIAL NETWORKS  
Based on men who have agreed to be in the study and were mapped to social networks and randomized , 
we will conduct a baseline survey with all network members and their central promoters. This baseline 
survey will include socio-demographic, health and sexual behaviors, including HIV testing history and will 
serve as the baseline for a number of measures prior to the study implementation. 
The baseline survey is included as an attachment to this protocol.      
6.7 FOLLOW UP SURVEY 
Following randomization, study enrollment and participation in the baseline survey, at about 3 months we 
will conduct a follow-up survey to assess the primary outcome of HIV testing. Following this window, we 
will conduct follow up interviews with the baseline survey cohort (those who were randomized      to a 
network and participated in the baseline survey) as well as additional new participants who received a 
self-test from central network promoters. 
Three versions of the 3-month follow up survey is included as an attachment to this protocol. 
6.8      QUALITATIVE STUDIES 
6.8.1.1 OVERVIEW  
Across all aims, assess pathways of intervention action using qualitative and mixed methods. Identify 
mechanisms of action, and barriers and facilitators of the social network and incentives intervention 
implementation, using qualitative and mixed methods (quantitative and qualitative) assessments 
embedded in Aims 1, 2 and 3 (at baseline, and at follow-up time points corresponding to quantitative 
measurements in all aims).  
Analytic Approach: Mixed-methods approach of qualitative analysis of key informant interviews and focus 
groups combined with quantitative process and fidelity measures and trial outcome data.  
We will use a rigorous two-phased analysis approach, beginning with: 1) qualitative analysis of in-depth 
and key informant interview and FGD data, using a grounded theoretical approach that involves iterative 
inductive coding of empirical data (transcripts); followed by a 2) mixed-methods analysis of qualitative 
data grouped by categories defined using social network survey data, process and fidelity measures, and 
trial outcome data. This will involve analyzing qualitative data collected within categorized groups of 
participants including (but not limited to) testers vs. non-testers, linkers vs. non-linkers to ART and PrEP, 
virally suppressed vs. detectable VL, and PrEP adherent vs. non-adherent. This approach will allow us to 
identify emergent themes within groupings and to rigorously assess conceptual alignment or differences 
across groupings, with attention to evidence of contradictory findings and deviant cases in the data. 

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Primary Research Questions: Investigations will be focused on three domains (Table 2): 1) mechanisms of 
action of the intervention that result in success or failure in Aim 1 (HIVST usage), Aim 2 (linkage to ART or 
PrEP), and Aim 3 (suppressed or unsuppressed or detectable TFV levels in urine), 2) key issues impacting 
the effectiveness of individual components of the intervention, and 3) barriers and facilitators of 
implementation of the intervention.  
Table 3.  Qualitative and Mixed Methods (quantitative and qualitative) Research Domains and Topics by 
Research Aim 
Domain 
Aim 1 Topics 
Aim 2 Topics 
Aim 3 Topics 
Mechanisms of 
intervention 
action 
● Attributions for decision to test 
o Role of promoter: perceived 
influence 
o Other barriers & facilitators 
to testing 
● Attitudes & expectancies re: 
use of HIVST 
● Perceived norms re: testing 
within close social network 
● Vicarious efficacy re: HIV self-
testing (seeing peers 
successfully use HIVST) 
● Attributions for decision to link 
o Role of promoter: perceived 
influence 
o Role of incentives 
● Attitudes & expectancies re: ART 
& PrEP 
● Perceived norms re: linkage to 
ART & PrEP within close social 
network  
● Vicarious efficacy re: linkage 
(seeing peers successfully link to 
ART or PrEP) 
● Attributions for ongoing 
engagement in HIV care (ART) 
& prevention (PrEP)  
o Role of promoter: perceived 
influence 
o Role of incentives 
● Perceived norms re: 
engagement in ART & PrEP 
within close social network 
● Vicarious efficacy (seeing peers 
successfully engaged in ART or 
PrEP) 
Factors 
impacting 
effectiveness of 
intervention 
components 
● Knowledge of how to use self-
tests (effectiveness of promoter 
training) 
● Relationship factors (e.g. HIV 
status disclosure, HIV 
seroconcordant/ discordant 
status) 
● Psychological factors (e.g. 
perceived risk, fear, fatalism, 
self-efficacy to test for HIV) 
● Knowledge of benefits of ART 
and PrEP (effectiveness of 
promoter training) 
● Relationship factors (e.g. HIV 
status disclosure, partner 
support) 
● Psychological factors (e.g. 
expectancies, fear, fatalism, self-
efficacy to link) 
● Experiences with ART / PrEP 
(perceived emotional, physical 
benefits/costs) 
● Effective management of side 
effects 
● Relationship factors (e.g. 
relationship change, disclosure, 
partner support) 
● Psychological factors (e.g. 
ART/PrEP fatigue, changes in 
risk, self-efficacy) 
Barriers and 
facilitators of 
implementation 
● Role of promoter: salience, 
trust towards promoter within 
network 
● Promoters’ self-perceptions & 
motivation 
● Individual mobility and distance 
to clinic 
● Past and current experiences 
with providers / perceived 
quality of care  
● Individual mobility and distance 
to clinic 
● Past and current experiences 
with providers / perceived 
quality of care 
 
6.8.1.2 SAMPLING AND RECRUITMENT 
Qualitative Study Populations: 1) In-depth interviews (IDIs). Sample up to 40 participants, selected to be 
equally balanced across study arms (i.e. 20 men per arm); 2) Key informant interviews (KIIs). Sample up to 
15 promoters from the intervention, and 15 in the control arm. 3) Focus group discussion (FGD)     groups. 

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1-2 focus groups per study arm, with 8-12 participants in each group. FGDs will include participants from 
all study sites, stratified by HIV status. 
Sampling approach. We will use a qualitative sampling strategy drawing from grounded theory, in which 
sampling, data collection and analysis processes are iterative: we will use baseline data to define initial 
sampling categories (balance across study arms by age, fishing status (occupation) for selection of the first 
several participants in each category, and thereafter select additional participants according to new 
categories based upon emergent findings: sampling is completed when data are ‘saturated’, i.e. no 
emergent findings elicit a need for additional participants. Thresholds are defined for practical reasons of 
study schedule and budget. Recruitment will be iterative, using sample lists generated using data collected 
from the baseline BMU register review and baseline/follow up surveys, among participants who indicate 
during the informed consent process that they are willing to  participate in qualitative research. 
6.8.1.3 ANALYTIC APPROACH 
Analytic Approach: We will use a rigorous two-phased analysis approach, beginning with: 1) qualitative 
analysis of in-depth interview and focus group discussion data, using a grounded theoretical approach that 
involves iterative inductive coding of empirical data (transcripts); followed by a 2) mixed-methods analysis 
of qualitative data grouped by categories defined using social network survey data, process and fidelity 
measures, and trial outcome data. This will involve analyzing qualitative data collected within categorized 
groups of participants including (but not limited to) testers vs. non-testers, linkers vs. non-linkers to ART 
and PrEP, virally suppressed vs. detectable VL, and PrEP adherent vs. non-adherent. This approach will 
allow us to identify emergent themes within groupings and to rigorously assess conceptual alignment or 
differences across groupings, with attention to evidence of contradictory findings and deviant cases in the 
data. The qualitative instruments for the IDIs, KIIs and FGDs described are included as attachments to this 
protocol. Future follow up qualitative tools may be submitted as amendments to the protocol. 
6.9  JUSTIFICATION FOR INTERVENTION 
Social network-based approaches show promise for generating positive social influence and accelerating 
health behavior change in men. The influence of social networks on health behaviors and outcomes is well 
established78-84 and it is known that social network characteristics can influence behavior through the 
circulation of ideas and social influence.85 Network interventions are purposeful efforts to use networks to 
generate social influence, accelerate behavior change, and achieve positive health outcomes.86-91 In SSA, 
prior research has shown the influence of social networks on HIV testing,92-94 partner concurrency,95 and 
condom use.96 Such an approach is further supported by research showing that behavioral and 
organizational change programs are most effective when implemented by members of the group 
undergoing the change, i.e., peers.97,98 We also now know that selecting influential nodes in a network (i.e. 
individuals who are highly connected) results in superior intervention effectiveness: selecting well-
connected nodes, from a network perspective, are better than nodes chosen randomly, a finding 
demonstrated with simulations 99,100 and empirical examples.101,102 Thus, selecting highly socially connected 
men within social networks to act as ‘promoters’ may be overcome long-standing barriers to HIV testing 
and uptake of additional health services including HIVST.  

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Countries in SSA are scaling-up HIVST to close the testing gap in priority populations – evidence is needed 
on delivery approaches that maximize testing coverage. A growing number of countries, including Kenya, 
are scaling-up HIVST after the WHO’s December 2016 guidelines called for large-scale implementation of 
HIVST.75-77 The feasibility of HIVST interventions was further enhanced by the Gates Foundation’s 2017 
decision to subsidize oral fluid-based HIV tests, bringing their price down to $2/test. What countries are 
actively seeking are optimal distribution strategies for self-tests, to ensure that testing is increased among 
high-risk individuals not. Studies on secondary distribution of self-tests. Our pilot study on secondary 
distribution of self-tests enrolled HIV-negative pregnant women and FSW in Kisumu. Participants were 
shown how to use oral fluid-based self-tests and given 3-5 tests with easy-to-use instruction sheets. 
Overall, 90% of women reported their primary sexual partner used a self-test. Women reported high 
acceptability of HIVST among men and over 85% of men found self-tests easy to use. The proposed study 
builds on this work and targets men who are not partners of pregnant women and who may be reached 
more effectively through their peers. We followed the pilot study with an RCT that randomized pregnant & 
postpartum women to receive two self-tests or invitation cards for partners to seek clinic-based testing. 
Partner testing occurred for 91% of women in the intervention group and 52% of women in the control 
group (P<0.001). This finding was confirmed in another study in Uganda123 and several programs in SSA 
are now this approach in antenatal clinics. This work underscores a high interest in HIVST among men and 
suggests feasibility of an intervention in which men offer self-tests to their peers. While distribution of 
self-tests by pregnant women has much promise, the approach may not reach all high-risk men, which 
motivates a study on men’s social networks. 
6.10END-OF-STUDY DEFINITION 
A participant in the RCT is considered to have completed the study if he has completed at least the 6 
month (-/+ 1 month) follow-up VL assessments if HIV-positive, and the 6 month (-/+ month) PrEP 
adherence assessment (if HIV- negative and eligible for and on PrEP).  
 
7 
STUDY POPULATION 
  
The study population will include: 
● Men >=18 yrs who are primarily working in the fishing industry or fishing-related occupations, 
who reside in beach communities in Siaya County, Kenya who consent to participate in the study. 
7.1 INCLUSION CRITERIA 
 
In order to participate in the study individuals must meet all of the following criteria: 
1. Adult (18 years or older)  
2. Male 
3. Working as a fisherman or fishing-related occupation  
4. Willing and able to provide informed consent for participation 
5. Not participating in another research study related to HIV testing, treatment and/or prevention 

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7.2 EXCLUSION CRITERIA 
1. Younger than 18 years of age 
2. Female 
3. Included in another intervention study on HIV/AIDS 
4. Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the 
discretion of the study team 
The study is male only and the primary intervention is designed for men and their social networks (other 
men).  
7.3 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Up to 10 beach landing sites in Siaya County will be selected as study sites. Community preparation and 
entry will be needed to ascertain the final number of sites, as sites vary in population size. In preparation 
for the study we will confer with partners in the Siaya County Ministry of Health and implementing 
partners to select clinics sites for implementation of clinical data extraction for the study’s clinical end 
points. Clinics in Siaya County are operated by the Kenya Ministry of Health and typically staffed by a 
medical doctor, a clinical officer, and a nurse. The Siaya sub-counties bordering Lake Victoria have 70 
health facilities offering ART with 40,258 patients currently in care. The study will be conducted in 
partnership with clinics, two of which offer 24 hour and weekend services including HIV care and 
prevention.124 Study clinics will be selected with consultation with local partners, the study team, and 
based on the baseline social network mapping exercise, to be convenient for study participants. Strategies 
for recruitment will draw on previous work in the area, as well as community mobilizers, including 
members of the fishing economy. Since sustained retention and adherence is necessary to reduce 
transmission risk, in Aim 3 we will use novel measurement strategies and longer-term follow-up to assess 
impacts of the social network interventions on retention and adherence. The intervention itself is 
designed to increase retention through peer and social network based healthy behavior promoting 
strategies. 
8 
STUDY PROCEDURES  
8.1 PILOT 
 
Visit 1 for up to n=200 men 
Prior to the study start, we will conduct a small pilot among up to n=200 men in a selected beach. The 
study team will conduct a Beach Management Unit (BMU) census/registry verification in the pilot 
community to identify the population of men eligible for the pilot. Tool for the baseline BMU 
Census/Registry data verification, updating and abstraction is included as appendix to this amendment 
and is the same as the one that will be used for the main study. Conduct either in person or phone-based 
screening, recruitment and survey data collection in up to n=200 eligible men who give their informed 
consent to participate in the pilot (see consent forms for the pilot study- written and verbal versions).Men 
who provide informed consent will be administered the pilot, that elicits information on socio-

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demographic and work/livelihoods.  In addition, the baseline survey will include a module that obtains 
information on the close social networks of fishermen. This module will ask participants to name the men 
in their community to whom they are most closely connected to for domains such as health (whom they 
would seek health information from or share information with), finances (to whom they would turn to 
borrow money), and spending time (on work and social activities). The social network data obtained in this 
way will enable us to determine the ties and close social networks that exist in the community, particularly 
among fishermen.  Based on the data obtained during the pilot, we will purposively select up to n=20 men 
who will be invited for an additional qualitative interview. These interviews will utilize the instruments 
attached to this protocol. Information obtained during this pilot phase, from both the surveys and 
subsequent qualitative interviews, will be utilized to modify, improve, and adjust the study approach. 
Subsequent modifications will be submitted to IRB. 
8.2      SOCIAL NETWORK SURVEY 
 
Visit 1 (recruitment/screening) for up to n=1800 men 
Following community selection and preparation, the study team will conduct a Beach Management Unit 
(BMU) census/registry verification in study communities to identify the population of men eligible for the 
study. Tool for the baseline BMU Census/Registry data verification, updating and abstraction is included as 
appendix to this      protocol. The study team will then screen, recruit and enroll up to n=1800      eligible 
men who give their informed consent to participate in the      social network survey. Men who provide 
informed consent will be administered a      social network survey that obtains information on the close 
social networks of fishermen. This module will ask participants to name the men in their community to 
whom they are most closely connected to for domains such as health (whom they would seek health 
information from or share information with), finances (to whom they would turn to borrow money), and 
spending time (on work and social activities). The social network data obtained in this way will enable us 
to determine the ties and close social networks that exist in the community, particularly among 
fishermen.   
The social network survey is included as an attachment to this protocol. 
8.3 SOCIAL NETWORK MAPPING 
After the social network survey data collection is completed, data will be analyzed and the close social 
networks of participants will be identified. These close social networks, clusters, will then be randomized 
1:1 to intervention and control groups.  Network-central, highly socially-connected men (“promoters”) will 
be identified in each network group (one per group, with additional ‘adjacent’ alternates identified if 
primary potential promoters do not consent to participate as promoters). The study team will contact the 
potential promoters to administer informed consent to participate in the study as promoters; recruitment 
will proceed until at least n=45 and up to n=70 men in intervention, and at least n=45 and up to n=70 in 
control groups have been enrolled as promoters.       

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8.4      BASELINE SURVEY       
      
Visit 2 for up to n=1000 individuals mapped in the social networks  
Based on men who have agreed to be in the study and were mapped to social networks, and the close 
social network cluster randomized, we will conduct a baseline survey with all network members and their 
central promoters. This baseline survey will include socio-demographic, health and sexual behaviors, 
including HIV testing history and will serve as the baseline for a number of measures prior to the study 
implementation. 
The baseline survey is included as an attachment to this protocol. 
8.5      PROMOTER TRAININGS  
 
Visit 3  for up to n=140 promoters from the study population of up to n=1000 men 
All men who are enrolled/consent as promoters (i.e. in both study groups) will participate in mandatory 
core training sessions. For the intervention group, an enhanced training of up to two days will be 
facilitated by study personnel and trainers, and will orient them to the study, their role, as well as equip 
them with enhanced knowledge about HIVST, information about HIV, PrEP, and treatment, including 
learning about the benefits of HIV testing (materials are included as attachments to this protocol). 
Promoters will be trained in the usage of oral fluid-based HIV tests (Oraquick Advance, approved for use in 
Kenya and other countries), and in how to interpret the results of self-tests. Building on prior work of the 
investigative team, the study team will utilize instruction sheets (with pictures and local language text) 
that have been developed in the setting (Kenya) to explain self-test usage. The team will also train 
promoters on how to use motivational interviewing techniques to motivate others to use self-tests, and 
the importance of confidentiality as a part of the study. For the control group, a basic training will be 
provided to present the study, importance and benefit of HIV testing, care, and prevention. The training 
will also cover issues related to confidentiality. 
After the training, the intervention promoters will receive multiple HIV self-test kits for distribution to 
other men in their close social networks. The HIVST distribution will be as follows: each network-central 
promoter will receive a test kit for himself, and an addition number of kits (up to 8), for as many of his 
close network members as identified during the mapping exercise. They also will be given, and asked to 
distribute to men in their close social networks, transport vouchers for ART or PrEP after HIV self-testing. 
The voucher worth Ksh 500 (~$5) will be used for reimbursement when seeking confirmatory testing for 
HIV and screening for ART or PrEP within 3 months of self-testing at home. The amount reflects prevailing 
transport and opportunity costs of time. In the session for promoters in the control group, the promoters 
will be given vouchers with information on facilities with free HIV testing and free self-tests at nearby 
health facilities, to distribute to men in their close social networks. The control promoters will receive a 
voucher with information about where to get an HIVST or standard HIV testing within the facilities in the 
community. The voucher will not have any monetary value. All promoters, in both groups, will be given up 
to Ksh 1000 (~$10) for their participation in a full day of training. 

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Training curriculum is attached to this protocol. 
8.6 3-MONTH FOLLOW UP SURVEYS/BASELINE FOR NEW PARTICIPANTS 
Up to n=1500 participants 
Visit 1 for new participants (those not mapped in the baseline but received self-tests with incentive 
vouchers (intervention) or referral vouchers (control) from promoters 
Visit 3 for baseline mapped and surveyed participants who received self-tests with incentive vouchers 
(intervention) or referral vouchers (control) from promoters 
Visit 4 for promoters who will have participated in the social network survey, baseline survey, and 
promoter trainings (visits 1 2 and 3, respectively) 
Follow up surveys will be conducted with study participants at 3 months. Please note that at this stage of 
the data collection, there will be three possible study participants groups for which we will provide 
individualized surveys, (1) those who were mapped during the social network mapping exercise and 
identified as a part of the network where the central promoter was randomized to control or intervention, 
(2) those who were not mapped or named during the baseline social network mapping exercise but 
received an HIVST with an incentive voucher (intervention) or referral voucher (control) from a central 
promoter, and (3) central promoters themselves. These surveys will assess self-reported HIV testing 
among study participants, whether they sought confirmatory testing, whether they linked to ART or PrEP, 
interactions they had with study promoters, as well as assess health behaviors.  We will have three 
versions of the follow up survey which are attached to this protocol. 
8.7 BIOSPECIMEN COLLECTION AND CLINICAL DATA TO ASSESS CONFIRMATORY TESTING, LINKAGE TO ART AND 
PREP, AND LONG TERM OUTCOMES 
Up to n=1500 participants* 
* We do not know aprior the rate of care or prevention uptake so the total numbers are tentative. 
Visit 2 (for 6 months) for new participants (those not mapped in the baseline but received self-tests with 
incentive vouchers (intervention) or referral vouchers (control) from promoters and then linked to care 
or prevention 
Visit 4 (for 6 months) for baseline mapped and surveyed participants who received self-tests with 
incentive vouchers (intervention) or referral vouchers (control) from promoters and then linked to care 
or prevention 
Visit 5 (for 6 months) for promoters who will have participated in the social network survey, baseline 
survey, and promoter trainings (visits 1 2 and 3, respectively) and then linked to care or prevention 
We will obtain informed consent in clinics, from all of the study participants who opt to visit a study clinic 
for confirmatory testing, for the release of medical record data.  The clinical data abstraction and follow 

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up bio-specimen collection will take place for two cohorts (1) those who HIV test, link to care and are 
enrolled in care and taking ARVs, and (2) those who HIV test, are HIV-negative, screened and eligible for 
and start PrEP. The chart abstraction data focused on 6-month outcomes will be collected retrospectively 
through the end of year 4, June 2023. 
HIV-positive study participants 
For those who are identified as HIV-positive through abstraction of medical records from the MOH data 
where the study is being implemented, the study will also conduct viral load measurements utilizing 
venous blood draw a during study visit at 6 months following intervention start. Participants will also 
participate in a brief survey to assess adherence to ART at the 3 and 6 month timepoints. Participants will 
be consented and asked to have their blood drawn by a trained phlebotomist/lab technician for 
measurement of viral load. Collection of blood for testing of HIV viral load at 6  months since the start of 
the intervention (note that the MOH program includes annual VL testing, which the study will supplement 
with additional testing to ensure study measurements). Phlebotomy will be performed using universal 
precautions, and specimens will be aliquoted, assigned a unique number, and stored at -70 C until 
shipment to laboratory for processing. Viral load testing will be performed on venous blood on Abbott 
realTime HIV-1 platform and assay, with a detectable threshold of 40 cells per microlitre. The venous 
sample and results of the viral load test will only be released to the study and not the MOH facility or 
those providing the patient’s care. As a result, the measurements will majorly be for outcome 
measurements related to the trial. If requested by providers to make care decisions, and with the verbal 
consent of the study participant, we may share the results of the viral load in an effort to improve the care 
of patients and to fulfill our ethical obligations. Further, results or information will be shared with the 
participants if requested. Participants, through the consent forms, will be advised of the study purposes 
for the venous blood draw and that the results may be shared with them, if they request, or with their 
healthcare providers if requested and provided we have the patient’s verbal consent.  
HIV-negative study participants 
HIV-negative participants who screen as eligible and enroll in PrEP, and who give their informed consent 
will provide, in clinic, the urine specimen for measurement of PrEP adherence. The device used for testing 
is the PUMA Point of Care urine monitoring assay for TFV- Alere. It is not invasive and is merely a testing 
tool to determine if the patient is taking tenofovir or not at time of a clinic or study visit. Tenofovir is a 
mainstay of both HIV treatment and prevention and adherence to tenofovir-containing regimens is 
paramount for efficacy.  Given that the effectiveness of PrEP is tightly linked to adherence, a real-time 
method of measuring tenofovir adherence is desirable.  This immunoassay will test for tenofovir detection 
at a study visit using urine samples. This test is exempt because it is non -invasive (tests tenofovir 
detection in urine, which is collected noninvasively) and is diagnostic. The study will be working with 
facilities implementing PrEP (per MOH guidelines) and will work with providers to integrate real-time PrEP 
adherence monitoring for study participants only. Study participants will be provided PrEP per the MOH 
guidelines and will come in for their routine visits. At the 6-month -month visit, we will train MOH 
providers to include the PUMA assay for monitoring adherence. The providers will also administer a brief 
survey to assess participant adherence to PrEP at the 3-month and 6-month visits. As part of boosting 

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PrEP knowledge, we will use an informational sheet on PrEP available in the local languages, to provide 
standardized information to participants on PrEP’s purpose to prevent HIV acquisition.  
Performing and Interpreting Urine Tenofovir Adherence Assay 
1. Present patient with a cup and ask them to please provide a urine sample.  Of note, there is no need to 
clean the urethra prior to urine collection. The patient can just urinate into the cup (about 5-10mL).  
Please ask them to urinate into the pit latrine if they have excess urine after filling the cup to the line. 
2. Please ask the patient to screw the lid on to the urine cup after collection and bring it back out to the 
provider. 
3. The provider (using gloves) should use the dropper provided with the urine test to drip 3-4 drops of 
urine from the urine cup into the divet of the urine test strip (indicated by blue arrow on below picture).   
4. After putting the urine drops on the the urine strip test, please lay it on a paper towel and let it develop 
for 2-3 minutes 
5. Please take the sheet provided (table shown below) and write in the study ID in the first column. 
6. The control line should turn positive no matter what the adherence line shows.  Please mark the sheet 
provided in the second column with a “Y” for yes if the control line turns positive. If the control line does 
not turn positive, please mark “N” for no. 
Urine rapid strip assay picture 
 
Participant ID number 
Dark control line present (Y/N) 
Test  line present (Y/N) 
 
 
 
7. The test line will appear if the client is NOT taking his/her PrEP and be absent (not appear) if the patient 
is taking his/her PrEP.  Please mark the sheet provided in the third column with a “Y” for yes if the test line 
turns positive.  If the control line does not turn positive, please mark “N” for no. 
8. Please take a picture of the rapid strip test with the participant ID label next to record the results for the 
future.  
9. Please discard the urine test strip and remaining urine sample after marking the sheet and taking the 
picture 

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8.8 QUALITATIVE STUDIES  
Up to n=76 participants (for IDIs &FGDS) and n=30 promoters (KIIs) 
Visit 4 for new participants (those not mapped in the baseline but received self-tests) 
Visit 6 for baseline mapped and surveyed participants who received self-tests  
Visit 7 for promoters  
The qualitative data collection approach will include in-depth interviews with participants in      
intervention and control, key informant interviews with network-central promoters, and focus group 
discussions with study participants stratified by HIV status and study group. Within the sample of up to 
n=1000 men, a subsample of men will be sampled and recruited for participation in:  
1. In-depth interviews. A sample of up to 40 participants, selected to be equally balanced across 
study arms (i.e. 20 men per arm);  
2. Key informant interviews. A sample up to 15 promoters from the intervention, and 15 in the 
control arm. 
3. FGD groups. 1-2 focus groups per study arm, with 8-12 participants in each group. FGDs will 
include participants from all study sites, stratified by HIV status. 
Data will be collected at baseline and up to three follow-up periods corresponding to the timing of 
quantitative outcome measurements in Aims 1 through 3. The team will use a qualitative sampling 
strategy drawing from grounded theory (ref. K. Charmaz), in which sampling, data collection and analysis 
processes are iterative: baseline data will be used to define initial sampling categories (balance across 
study arms, sites and HIV status) for selection of the first several participants in each category. Thereafter 
the team will select additional participants according to new categories based upon emergent findings: 
sampling is completed when data are ‘saturated’, i.e. no emergent findings elicit a need for additional 
participants. Thresholds are defined for practical reasons of study schedule and budget. Recruitment will 
be iterative, using sample lists generated using data collected from the baseline BMU census and survey, 
among participants who indicate during the baseline informed consent process that they are will to be 
contacted for potential participation in qualitative research. 
8.9 ONGOING PROMOTER SUPPORT AND TRAINING  
Up to visits 8-11 for up to n=70 promoters in the intervention arm only 
Promoters in the intervention group will be invited for up to four additional  training sessions in which 
they will be encouraged to motivate men in their network who initiated PrEP or ART to come to clinics for 
periodic medication refills and consultations. Promoters will be given up to KSH 1000 (~$10) for their 
participation in each additional full day of follow up training. 

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8.10 TEXT MESSAGE REMINDERS 
To the extent that men on PrEP and ART are willing, optional cell phone appointment reminders and text 
messages motivating adherence will be sent to them (including promoters). These messages will be 
motivational, will not include any identifying information and will include generic texts such as “maintain 
your good health”, to cater for status-neutral language that can work for both HIV positive individuals 
taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.  
Sample language for these text messages are included in the table below. These sample texts will be 
further refined with the input of the community and our peer leaders to ensure that they are locally and 
culturally salient and relevant. We will ensure these messages are status-neutral and non-stigmatizing to 
ensure they are relevant and do not compromise patient confidentiality. 
Table 4.  Sample Text Messages to Facilitate Adherence 
It is important to maintain your health. 
Please prioritize your health and well-being to stay strong. 
Please remember your appointment.  
If you need support to make your appointments, please reach out to your provider. 
Your provider can help keep you healthy, please reach out if you need help. 
Be healthy, have a healthy happy family! 
Be healthy, be productive! 
8.11 INCENTIVES AND STUDY PAYMENTS 
 
Table 5 Details of Incentive Types, Amounts, Populations, and Purpose 
Incentive Type 
Amount 
Recipient 
Purpose 
Cash (in-person) or 
Mpesa (for phone 
surveys) 
500ksh (~$5) 
All participants who take part in the pilot 
survey – either in person or phone 
To offset time/wages lost 
due to participation in 
survey data collection 
Cash (in-person) or 
Mpesa (for phone 
surveys) 
500ksh (~$5) 
All participants who take part in the pilot 
survey and are then randomly selected 
for interviews – either in person or 
phone 
To offset time/wages lost 
due to participation in 
survey data collection 
Cash  
500ksh (~$5) 
All participants who take part the social 
network survey to be mapped 
To offset time/wages lost 
due to participation in social 
network survey 
Cash 
500ksh (~$5) 
All control and intervention      
participants who are mapped and 
randomized in the study and who 
participate in the baseline survey 
To offset time/wages lost 
due to participation in 
survey data collection 
Cash 
500ksh (~$5) 
All control and intervention participants 
who take part in the 3 month follow up 
survey  
To offset time/wages lost 
due to participation in 3 
month survey data collection 
Cash 
500ksh (~$5) 
All control and intervention participants 
who take part in either the in-depth 
interviews or focus group discussions- 
incentivized per data collection method 
To offset time/wages lost 
due to participation in      
data collection 

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Voucher 
500ksh (~$5) 
Only intervention participants who have 
used a HIVST and bring in their voucher 
to the health facility for cash redemption 
To encourage confirmatory 
HIV test and off set travel to 
facility 
Cash 
1000ksh 
(~$10) 
500ksh (~$5) 
200ksh (~$2) 
Only intervention and control 
participants selected to be promoters 
and those who participate in the 
promoter training 
1000 Ksh to offset 
time/wages lost due to 
participation in trainings. 
1000Ksh per      day of 
training. 
 
500ksh to buy airtime in 
order to contact men in their 
social networks for 
promotion activities 
 
Up to 200ksh to offset 
transport costs related to 
promotion activities. 
Cash 
500ksh 
Intervention and control participants 
who link to care (ART) or PrEP who come 
in for 6 month study visit for blood and 
urine samples (for adherence) 
500 ksh to offset transport  
 
 
9 
FIDELITY 
9.1 PROMOTER TRAINING AND TRACKING 
There may be heterogeneity in fidelity to intervention procedures by promoters (some may offer self-tests 
to non-network members); we will assess fidelity using follow-up survey data from promoters and 
network members. We will also try to achieve high fidelity by asking research team members to 
periodically contact promoters to check in on their activities. Adjustments, clarification, and re-training 
will be conducted as needed.  We will collect quantitative process and fidelity measures corresponding to 
each of the components of the intervention through review of administrative records, and other study 
data. Further, we will use various tools attached to the protocol to assess the outcome of the promotor 
training and the extent to which the training was delivered and received as intended. Please see the 
appendix for the tools we will use to evaluate the training effectiveness. 
Following the promoter training, the cadre of promoters will receive individual support from the study 
regional manager/nurse, who will conduct study check-ins at the beaches and be available by cell phone 
to answer questions and problem solve if issues arise. Additionally, we will use a rigorous two-phased 

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approach, beginning with: 1) qualitative of in-depth and key informant interview and FGD data, and 2) 
mixed-methods data grouped by categories defined using social network survey data, process and fidelity 
measures, and trial outcome data. This will involve analyzing qualitative data collected within categorized 
groups of participants including (but not limited to) testers vs. non-testers, linkers vs. non-linkers to ART 
and PrEP, virally suppressed vs. detectable VL, and PrEP adherent vs. non-adherent. This approach will 
allow us to identify emergent themes within groupings and to rigorously assess conceptual alignment or 
differences across groupings, with attention to evidence of contradictory findings and deviant cases in the 
data. Feedback on key recruitment, data collection and other metrics will be provided via regular data 
reports to study sites. 
9.2 MEASURES TO MINIMIZE BIAS 
The study is subject to limitations that we will take steps to address. First, it may be difficult to objectively 
ascertain self-test results, as we will not directly observe self-testing. However, we expect measurement 
error to be distributed randomly across study arms, and we will use pre-printed cluster IDs on clinic 
vouchers and on self-tests to validate our measurements of this outcome. Second, it may be difficult to 
contact mobile men for follow-up, but we will benefit from tracking procedures we are successfully using 
in ongoing studies and will strengthen them further by collecting contact details of trusted friends of 
participants. This information (names and phone numbers) will be collected using secure study forms and 
will be protected similar to other study data and discarded following the procedures outline in sections 
12.3 and 12.4. Since these trusted friends of participants are not taking part in study activities, they will 
not be consented. Third, there may be heterogeneity in fidelity to intervention procedures by promoters 
(some may offer self-tests to non-network members); we will assess fidelity using follow-up survey data 
from promoters and network members. We will also try to achieve high fidelity by asking RAs to 
periodically contact promoters to check in on their activities. Adjustments, clarification, and re-training 
will be conducted as needed. Fourth, as in most community-based interventions, there is potential for 
cross-contamination between control and intervention social networks. Our approach to this risk is to 
both minimize cross-contamination and also measure the extent to which cross-contamination occurs in 
the trial, which in turn will allow us to model how this influences effect sizes. In our training we will 
emphasize that promoter efforts should be limited to members of their own close social network and not 
to those outside or adjacent to their network. To measure cross-contamination we will include in our 
surveys questions to elicit the frequency and intensity of exposure to the intervention and control 
condition elements. We will also assess whether men who have spatial proximity to intervention clusters 
are more likely to have been tested for HIV – a proven empirical approach to testing for spillover effects. 
9.3 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
Because promoters (study participants and members of social networks) are primarily implementing the 
intervention, adherence will be encouraged by training at the outset, and periodic monitoring to ensure 
that the correct messages on HIVST, ARV and PrEP are being disseminated as needed.  
 

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1 
STATISTICAL CONSIDERATIONS  
1.1  STATISTICAL HYPOTHESES 
Primary Endpoint(s): self-reported HIV testing in the past 3 months by participants, as measured in the 3-
month follow-up surveys.  
We hypothesize that the intervention group will be more likely to test for HIV than the control 
group.  
Primary Endpoint (s): Linkage to ART or to PrEP within about 3 months and Initiation of ART or PrEP 
(among those eligible), within 3 months of linkage 
We hypothesize higher a proportion of participants linking to ART or PrEP (confirmatory testing 
and ART referral for positives, and PrEP screening for negatives among those receiving the 
intervention. We also hypothesize higher ART and PrEP uptake within 3 months among men in 
social networks assigned to the intervention group. 
Primary Endpoint (s): Viral suppression (HIV RNA <400 c/mL) at 6 months and adherence to PrEP (TFV 
levels of >= 1500 ng/mL in urine = adequate adherence 28) at 6 months.  
We hypothesize a higher proportion of individuals both retained in care and adherent to 
treatment in the intervention group compared to the control group. 
1.2  SAMPLE SIZE DETERMINATION AND POWER CALCULATIONS 
 
Aim 1 
We calculate that the study will have an 80% or greater power to detect a significant difference in the 
proportion of HIV testing associated with the intervention arm, assuming a proportion self-testing in the 
control arm of 38% (observed data from SEARCH in fishermen) if the proportion testing in the intervention 
arm is 52% or greater (odds ratio of 1.8), calculated using an Intraclass Correlation Coefficient (ICC) of 0.15 
(conservative based on SEARCH data), 70 clusters each in the intervention and control arms, average 
cluster size of 7 in both arms, and a type-1 error rate of 5%.125,126 Figure 2 shows statistical power and the 
range of detectable odds ratios over extremes of clustering effects.       
Aim 2 
For the Aim 2 combined primary outcome of successful linkage to ART or PrEP within 3 months of 
intervention start (+about 1 month), this study will have a 80% or greater power to detect a significant 
increase in successful linkage, assuming a proportion successfully linked at 3 months in the control arm of 
24% (based on observed SEARCH trial linkage rates weighted for the number of eligible PrEP HIV-negative 
men and HIV-positive men not currently in HIV care) if the observed proportion in the intervention arm is 
39% or greater (odds ratio of 2.0), using an ICC of 0.15, 70 clusters each in intervention and control arms, a 
cluster size of 7 in both arms, and a type-1 error rate of 5%. Statistical power for combined ART or PrEP 

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start is similar, with a reduction in anticipated eligible numbers per cluster reduced to 6 resulting in a 
small increase in the detectable odds ratio to 2.2 or greater.  Power for a separate analysis of ART 
initiation alone is likely to be low given the small numbers of new HIV infections in the study sample with 
odds ratios in excess of three or four required. 
Aim 3 
For the primary outcome, we will have ≥80% power to detect a significant increase in viral suppression 
and adherence in those on ART and PrEP, respectively, assuming a proportion of successes in the control 
arm of 70% or greater power (based on SEARCH trial data on viral suppression rates among fishermen and 
projected urine TFV detection rates of 70%, weighted for the likely number of men on PrEP (n=168) and 
men on ART (n=72)). We assume the observed proportion of successes in the intervention arm will be 89% 
or greater using an ICC of 0.10, a design effect from clustering of 1.7, and a type-1 error rate of 5%. For the 
combined primary outcome of retention on ART or PrEP at 6 months (+ about 1 month), this study will 
have 81% or greater power to detect a significant increase in linkage assuming a proportion retained in 
care in control arm of 81% (based on SEARCH data on retention rates weighted for the likely number of 
men on PrEP (n=168) and ART (n=72)) if the observed proportion in intervention arm is 96% or greater 
using the above assumptions.  
 
1.3  STATISTICAL ANALYSES 
1.3.1 
GENERAL APPROACH 
As a general approach, we will use methods designed for the analysis of clustered data, given the inherent 
clustered nature of the intervention design.  For the primary outcome we will utilize cluster adjusted 
Pearson’s Chi-square tests comparing the proportion of study participants’ HIV testing in the intervention 
versus the control arm and apply the analysis method in the same way for secondary analyses of linkage 
to HIV care and PrEP.  In additional secondary analyses, we will use multilevel mixed-effects logistic 
regression with cluster-adjusted standard errors using cluster levels at the close social network and beach 
levels and allowing for random effects at the cluster and beach levels. 
1.3.2 
ANALYSIS OF THE PRIMARY ENDPOINT(S) 
Primary Outcome: The primary outcome will be self-reported HIV testing in the past 3 months by 
participants, as measured in the 3-month follow-up surveys. 
Primary Predictor: Cluster (social network) Randomized Arm (intent-to-treat), Intervention or Control. 
 
Analytic Plan: For the test of the intervention effect on the primary outcome of self-reported HIV testing in 
past 3 months, we will utilize a cluster adjusted Pearson’s Chi-square test comparing the proportion of 
subjects’ HIV testing in the intervention versus the control arm. In secondary analysis, we will utilize 
multilevel mixed-effects logistic regression with cluster-adjusted standard errors and a binary outcome of 
reported HIV testing or not (including cluster as one of the levels with random effects allowed). We will 

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investigate factors that influence the probability of success of HIV testing, including characteristics of 
clusters (the close social networks’ size and composition, metrics of connectedness, mean cluster self-
testing rate), characteristics of the cluster’s promoter (age, marital, HIV, ART, PrEP status, measures of the 
promoter’s ties to close-social-network cluster members), and individual level characteristics 
(demographics, SES, prior HIV testing, duration in boat crew, self-reported HIV risk). 
1.3.3 
ANALYSIS OF ADDITIONAL ENDPOINT(S) 
Primary Outcome:  the primary outcome measure will be linkage to care or prevention within 3 months of 
the Aim 1 intervention start. Linkage will be defined for HIV-positive participants as a documented 
confirmatory HIV test result, and a documented HIV clinic visit following referral. Linkage will be defined 
for HIV-negative participants as documented evidence of evaluation for PrEP (following standard of care 
procedures) extracted from medical records. 
Secondary outcome: The secondary outcomes will be confirmatory HIV testing uptake 3 – 6 months after 
intervention start and the initiation of ART, or PrEP (among those screened as eligible), within 3 months of 
the confirmatory test or eligibility screening. HIV testing uptake will be measured via documented testing 
records in clinic records and ART start will be measured via documented prescription for ARV medications, 
and for PrEP start, via oral PrEP prescription. 
 
Third outcome: The third primary outcome is a composite measure meant to capture “success” in HIV 
prevention and/or treatment behaviors. The measure will be defined as either adequate levels of 
tenofovir, indicating PrEP adherence (defined as TFV levels of >= 1500 ng/mL in urine indicating adequate 
adherence vs. < 1500 ng/ml) among HIV seronegative individuals who screened eligible for PrEP or the 
proportion of HIV-positive participants with viral suppression (defined as HIV RNA <400 c/mL using the 
Abbott realTime HIV-1 platform and assay, with a detectable threshold of 40 cells per microliter at 6 
months. PrEP adherence will be measured at 6 months after initiation using our novel technology of point-
of-care rapid testing to assess TFV adherence in urine (developed by Co-I Gandhi in collaboration with 
Alere Rapid Diagnostics™). For both components of the measure, we will define missing values as failure 
(i.e. inadequate adherence or unsuppressed). 
Analytic Plan:  For the test of the social network-central promoters and small incentive intervention effect 
on the primary outcome of linkage to care or prevention within 3 months of intervention start we will 
utilize a cluster adjusted Pearson’s Chi-square test comparing the proportion of subjects with documented 
linkage to care or prevention in the intervention versus the control arm. In secondary analysis, we will 
utilize multilevel mixed-effects logistic regression as described in Aim 1 to investigate factors that 
influence the probability of success of linkage to care and prevention. We will also evaluate the secondary 
outcomes of ART initiation among HIV-positive persons not currently on treatment, and initiation of PrEP 
among HIV-negative persons who screen as eligible.  We will compare the initiation proportions between 
study arms using cluster adjusted Chi-square tests and additional multilevel mixed-effects logistic 
regression to identify influencing factors.  
We will measure the combined outcome of 1) Proportion of HIV-positive participants with viral 
suppression (HIV RNA <400 c/mL) at 6 months missing=failure (unsuppressed) and 2) Proportion of 
participants adherent to PrEP (TFV levels of >=1500 ng/mL in urine indicating adequate adherence) at 6 

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months missing=failure (nonadherent). PrEP adherence will be measured at 6 and 12 months after 
initiation using our novel technology of point-of-care rapid testing to assess TFV adherence in urine). (+     
about 1 month for all measures) 
Secondary Outcomes: HIV testing uptake 3 to 6 months after intervention start and retention on ART at 6 
months or PrEP at 6 months. Using clinic records, we will assess whether men had confirmatory HIV 
testing and those who initiated PrEP and ART attended scheduled appointments and record VL results. (+ 
about 1 month for all measures) 
Analytic approach: We will utilize a cluster adjusted Pearson’s Chi-square test comparing the proportion of 
successes (HIV viral suppression and adequate TFV levels) among men (on ART and PrEP, respectively) in 
the intervention and control networks. For the outcome of retention on ART or PrEP at 6 months. We will 
utilize a cluster adjusted Pearson’s Chi-square test comparing the proportion of subjects on ART or PrEP at 
3 months post trial start who are retained in care at 6 months in intervention versus control group. In 
secondary analysis, we will utilize Cox proportional hazards regression to investigate factors that influence 
time to discontinuation of ART or PrEP We will also use multilevel mixed-effects logistic regression to 
investigate factors that influence the probability of viral suppression and TFV detection in urine. (+ about 1 
month for all measures) 
1.3.4 
ANALYSIS OF QUALITATIVE DATA 
For the qualitative study aims throughout aims 1-3, we will conduct semi-structured in-depth interviews 
and FGDs in the local languages spoken in the region, by gender and language-matched trained qualitative 
researchers. Interviews will be conducted at a venues agreed upon by the participant while maintaining 
privacy and confidentiality. FGDs and Interviews will be audio recorded; recordings marked with study IDs 
will be transferred to secure servers and encrypted laptops for transcription, translation, and analysis. 
After FGDs and IDIs are conducted, the interviewers will transcribe and translate the audio recorded 
interviews into English and import into a qualitative software for analysis by the full team. The team will 
collaboratively develop an inductive coding framework on the basis of the interview/FGD guides and 
previous research. The inductive code list will be applied to the first set of transcripts; the team will meet 
periodically to review the coding framework and iteratively refine the coding framework, adding new 
codes through a deductive approach. Overlapping (blind coding) to achieve inter-rater reliability. All the 
qualitative interpretation activities will be guided by constructivist grounded theoretical approaches. 
Coding and analysis will take team-based approach to ensure rigor. We will use a two-phased analysis 
approach, beginning with: 1) qualitative analysis of in-depth and key informant interview and FGD data, 
using a grounded theoretical approach that involves iterative inductive coding of empirical data 
(transcripts); followed by a 2) mixed-methods analysis of qualitative data grouped by categories defined 
using social network survey data, process and fidelity measures, and trial outcome data. This will involve 
analyzing qualitative data collected within categorized groups of participants including (but not limited to) 
testers vs. non-testers, linkers vs. non-linkers to ART and PrEP, virally suppressed vs. detectable VL, and 
PrEP adherent vs. non-adherent. This approach will allow us to identify emergent themes within groupings 
and to rigorously assess conceptual alignment or differences across groupings, with attention to evidence 
of contradictory findings and deviant cases in the data. 
 

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2 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
2.1  DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
Participants who discontinue from the intervention will also be discontinued from the overall study; 
however they may continue to receive care at clinics according to country standard of care guidelines.   
2.2  PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request.  An investigator 
may discontinue a participant from the study for the following reasons: 
● The participant meets a previously unrecognized exclusion criterion 
● Significant non-compliance with the study 
● Any event or situation that occurs such that continued participation would not be in the best 
interest of the participant 
The reason for discontinuation and date of discontinuation will be documented in the study participant 
withdrawal/move case report forms (CRFs). 
 
3 
ETHICAL CONSIDERTATIONS 
3.1 KNOWN POTENTIAL RISKS  
HIV self-testing. Based on our own studies conducted in the past two years and several other studies, we 
believe there are relatively few risks to study participants. We have conducted research in the Nyanza 
region among female sex workers (FSW) as well as pregnant and postpartum women. Women in these 
studies were given multiple self-tests and encouraged to offer them to their male partners at their own 
discretion. One of our key objectives was to assess intimate partner violence (IPV) and other adverse 
events experienced by women. Our findings indicate that IPV and other adverse events were extremely 
rare – both for the women themselves and for their male partners who accepted and used the self-tests. 
These findings are consistent with other studies highlighted in WHO guidelines showing that self-tests are 
easy to use safely. The proposed study includes men only, who are rarely victims of IPV in this setting. The 
primary risk involved in study participation include emotional discomfort related to decision-making 
surrounding the decision to test for HIV and the receipt of test results in the absence of a counselor. HIV 
self-testing is designed reduce anxiety about testing for HIV because it enables self-test users to conduct 
the tests privately at a time and location of their choosing, and it does not require observation or help 
from others. However, as with any HIV testing research, if a study participant 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 
psychological distress due to testing. There is also a risk that study participants may feel pressured by their 
peers to test and if they test, may be distressed by the results, especially if they obtain an HIV-positive 
result.  

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Our pilot study data indicate that women and their male partners reacted well to receiving their test 
results, even when a reactive result was obtained. These data are consistent with studies from sub-
Saharan Africa showing that risks of adverse reactions following HIVST are very low. Proper information 
and subsequent counseling is nonetheless necessary to minimize the possibility of distress. We will put in 
place study procedures (described below) that are intended to minimize 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 IRB approval for the procedures. Below we outline potential risks to 
study participants and the steps we are taking to minimize these risks. 
In the close social network clusters assigned to the intervention, men will likely receive oral fluid-based 
HIV tests from the network central promoters who will receive multiple tests and be encouraged to offer 
them to other men in their networks. Each test will include instructions on how to use the oral fluid-based 
tests. Promoters will also be trained on test use so they can offer guidance to their male peers. We will 
provide detailed, easy-to-use instruction sheets on how to use self-tests as well as a demonstration to 
men at the time of enrollment on how to use self-tests, and a ‘train the trainer’ component to help them 
learn to instruct other men in the self-test usage. 
Men in comparison networks will be asked to distribute (or attempt to distribute) referral vouchers that 
can be used to exchange for a free HIV self-test kit at the local study clinic, to the men in their close social 
networks. We will also provide detailed information to men in both groups 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.  Moreover, the study includes additional information about 
the benefits of screening for enrollment in HIV pre-exposure prophylaxis, for those who receiving an HIV-
negative self-test result.  
For the Aim 2 study, linkage to a local health facility for HIV care and treatment following confirmatory 
testing, and to PrEP eligibility screening, as well as uptake of either ART or PrEP, is measured for 
individuals in the Aim 1 study who report having used a self-test. In the intervention group only, incentives 
(vouchers to be exchanged for a small remuneration of the cost of transport to the local health facility), 
will be offered by network-central promoters to the men in their close social networks. 
Network-central promoters in intervention clusters may be asked for HIV self-tests by individuals who are 
not part of their defined cluster (i.e. close social network) but are members of their community. 
Promoters may feel stress arising from not being able to comply with these requests. In our training of 
promoters and community sensitization and preparation, we will explain the purpose of the study 
carefully to ensure that promoters and members of communities understand that not all people in the 
community will receive HIV self-tests through the promoters. We will instruct the promoters to refer 
anyone interested in HIV testing to the nearest testing venue (the standard of care), and will ensure they 
have lists of appropriate nearby venues, including those where HIV self-tests are freely available. We will 
coach promoters in how to explain that they were given a limited number of self-tests for specific BMU 
members in their close social networks. In our experience with secondary distribution of HIV self-tests, we 
have found that the distribution of self-tests does not tend to be a public activity. We do not anticipate, 

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based on other studies that it will be common for men to approach with numerous requests for self-tests, 
but will have contingencies and messaging in place to handle these situations should they occur. 
Incentives.  A risk stems from the use of incentives to promote confirmatory testing and linkage to care. 
However, the value of the incentives will be relatively low – on par with certain costs of confirmatory 
testing such as transportation and opportunity costs. This means that most participants are unlikely to 
experience a significant economic gain because of coming for confirmatory testing, thereby minimizing the 
risk of coercion. A recent publication by the Ethics Working Group of HPTN has also made the case that 
the use of incentives for health promotion does not necessarily undermine individual autonomy. Instead, 
the incentives can help overcome economic obstacles or motivational deficiencies; they can promote 
engagement in health-related behaviors that participants regard as beneficial or worthwhile, but do not 
undertake due to behavioral biases such as present-biased preferences. Our experience implementing 
small economic incentive interventions in Kenya and Uganda has also demonstrated that such 
interventions are acceptable to both communities and ethical review boards. 
In addition, we will ensure that our training session for network-central promoters, including messaging to 
participants promoting confirmatory testing or linkage to care or to prevention, includes a component on 
the importance of maintaining privacy and confidentiality and the rights of all individuals to choose 
whether, when, how, and to whom to disclose their HIV status. Our prior experience in Kenya 
implementing interventions among HIV-infected adults who are receiving ART, and on the nature and 
pathways of stigma and stigma reduction, shows that the risk of stigma and inadvertent disclosure can be 
minimized. As a result, we expect the risk of inadvertent disclosure of HIV status because of study 
participant to be very rare. 
Behavioral and social network research. In this study, we will be conducting survey questionnaires and in-
depth semi-structured interviews among adult men only (ages 18 and older)      working in fishing or      
fishing-related occupations. Aim 1 begins with a BMU census/registry verification and updating at 
participating beach landing sites to identify and enumerate the population of men registered as working in 
the fishing industry currently registered as working at the beach-landing site.  This will involve collection of 
non-sensitive data including residency, confirmed occupation in fishing, and age. The baseline survey for 
Aim 1 will include questions about participants’ perceived personal risk and perceived severity of HIV 
infection; self-reported sexual behavior, as well as marital and partnership status, sero-concordant or 
discordant couple status; prior HIV testing history; knowledge, attitudes, beliefs, and self-efficacy related 
to HIV care and prevention behaviors (specifically, usage of PrEP or ART); socio-demographic 
characteristics; and members of close social networks.  
Under Aim 1, the 3-month follow up surveys will be used to assess HIVST experiences and to verify self-
test usage, and to measure the sexual and health behaviors of men who do and do not accept self-tests or 
vouchers. Qualitative key informant interviews with a small sample of network promoters will include 
questions about men’s experiences offering self-tests to the men in their close social networks 
(intervention group) or offering vouchers to exchange for self-tests at local clinics (comparison group). 

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Under Aim 2, A small sample of respondents will be selected for recruitment for in depth interviews that 
explore in greater depth, the dimensions of ART and PrEP decision-making including perceptions of risk 
and severity of HIV disease, beliefs about efficacy of ART and PrEP, and other factors in the individuals’ 
lives (occupational mobility, relationship context and dynamics, community norms and dynamics, and 
perceptions of local health care services) that influence the decision whether or not to self-refer for 
confirmatory testing and enrollment in ART, or PrEP eligibility screening and uptake.  
Under Aim 3, qualitative in-depth interviews will explore factors that affect participants’ motivations and 
ability to stay engaged in HIV care and prevention programs. 
As with all collection of data on sensitive topics, there is a risk of emotional discomfort that may 
accompany disclosure of potentially stigmatized behaviors. To minimize this risk, we will use the 
procedures we have previously used in several studies in the setting that we have conducted that involved 
collection of sensitive information; these are described in the sections that follow.  
3.2 KNOWN POTENTIAL BENEFITS  
The proposed benefits to the participants are two-fold. First, we will provide free HIV self-testing kits to 
fishermen, allowing them to test themselves regularly and offer tests to their friends. This will help them 
make informed sexual decisions, thereby protecting them from HIV acquisition or helping them to avoid 
transmitting HIV to their sexual partners. The study may give rise to increased identification of HIV-
infected men in fishing communities in Siaya, Kenya, and their increased engagement in HIV care and 
treatment, thereby reducing the overall number of HIV transmissions to women. The linkage of HIV-
negative men to PrEP will also have individual and community-level benefits to both men and women.   
Importance of the knowledge to be gained. The risks faced by men 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 – particularly Lake Victoria fishermen, who generally have lower uptake of 
HIV care and prevention services, and poorer health outcomes – it is vital to find effective new strategies 
that can be used to promote testing and identify HIV-infected men who are 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 men 
to other men in their close social networks as a strategy to improve men’s testing uptake. And, it will 
examine whether a social network based approach, when combined with low-cost incentives, can be 
useful for improving linkage to care and prevention among men. Finally, this study will determine whether 
these novel interventions, combined, can be useful for reaching populations of men who are especially 
hard to engage in fixed-location, fixed calendar-based programs and interventions. 
3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Trained study team members will obtain written informed consent from all participants. The study team 
members will find a private place; carefully explain the nature and purpose of the study to each potential 

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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, 
Dholuo or Luyha (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. 
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. Participants will be given 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.  
Training and referral process for requests for HIV self-tests by non-eligible persons: community members 
with requests may approach Network-central promoters for HIV self-tests. In our training of network of 
network-central promoters and community sensitization and preparation, we will explain the purpose of 
the study carefully to ensure that promoters and members of communities understand that not all people 
in the community will receive HIV self-tests through the promoters. We will instruct the promoters to 
refer anyone interested in HIV testing to the nearest venue (the standard of care), and will distribute 
multiple copies of a list of the nearby testing venues to each promoter, including sites distributing free HIV 
self-tests. Promoters will receive coaching on how to explain that they were given a limited number of 
self-tests that were pre-assigned to specific individuals. In our experience with secondary distribution of 
HIV self-tests, we have found that the distribution of kits does not tend to be a public activity. We do not 
anticipate, based on other studies, that it will be common for men to approach with numerous requests 
for tests, but will have contingencies and messaging in place to handle these situations should they occur. 
Minimizing probability of adverse reactions to test results and ensuring receipt of appropriate services: To 
ensure correct usage of self-tests 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 (see Appendix 1 for materials we have prepared). These instruction materials have 
been developed by us and used in several HIVST studies (including studies that other teams are 
conducting in eastern and southern Africa). They were well received by women and their sexual partners. 
In addition, the network-central promoter training will include messaging and informational materials 
including clear information on the importance of seeking confirmatory HIV testing for those who obtain an 
HIV-positive test result (which is recommended by the WHO and the Kenyan Ministry of Health) – and a 
list VCT clinics in the area where free confirmatory is available. In addition, training and informational 
materials will emphasize the importance of screening for PrEP, in the case of an HIV-negative test result, 
and information will be provided on clinics in the area where free HIV care, treatment, and PrEP are 
available. We will also establish a support telephone line (hotline) that study participants 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, or prevention services. 

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Minimizing discomfort during blood draws or urine collection: to ensure that the participants are 
comfortable and do not experience discomfort or pain related to blood draws or urine collection, only 
trained staff and phlebotomists will conduct blood draws- these will be the same trained staff who usually 
draw blood for routine care. The same will be done for urine collection in a private and protected space. 
Minimizing potential emotional discomfort related to collection of sensitive data in survey and qualitative 
research. Study surveys will be administered in a private area so that participants can answer questions 
freely. For survey questionnaires, interviewers will record responses into a pre-programmed data 
collection software “interface” using portable tablets. In-depth interviews will be conducted by trained 
qualitative interviewers and recorded using a digital recording device. For both types of data collection, 
interviewers who are native speakers of languages of the research participants (in most instances, Dholuo, 
or Luyha), and will receive in-depth training on research ethics and methods for collection of sensitive 
information. We will use the same approach to training and oversight that we have successfully used for 
the collection of data on sexual behavior in the same setting, which is designed to create rapport and 
emotional comfort, and involves assurances of human subjects protections for participants, which include 
emphasizing the right to skip over questions that the participant does not want to answer, and the right to 
end an interview at any time, and use of the ‘relationship history calendar’ method with enables the 
collection of data on sexual behavior in a manner that contextualizes collection of sensitive sexual 
behavior data and minimizes a need to ask direct questions that are potentially stigmatizing (e.g. numbers 
of sexual partners within given time periods.) These assurances are discussed by interviewers not only 
during the process of obtaining informed consent; they are also repeated again, as needed, during the 
data collection process. No individually identifiable private information will be collected or recorded by 
interviewers, in either qualitative or quantitative data collection.  
Maintaining confidentiality, confirming identity and obtained informed consent over phone-based data 
collection. In response to COVID-19, UCSF CHR, the regulatory body for research at UCSF, has indicated 
that all research studies that were previously approved and endeavoring to “change visits that are not 
essential to the health and/or well-being of participants from in-person visits to remote/virtual visits”, are 
in fact making changes that do not increase risks to subjects, and therefore do not require prior IRB 
approval. Instead, UCSF asks studies to submit these changes at the time of the next scheduled 
modification or continuing review, and to note-to-file in the interim (https://irb.ucsf.edu/irb-covid-19-
faqs-resources). KEMRI, the regulatory body for research in Kenya and our study sites, has encouraged 
research studies to utilize phone-based methods where possible, and is requesting that all studies submit 
modifications detailing the changes in the data collection format. This amendment to adjust to a potential 
need to conduct phone-based rather than in person data collection to respond to the COVID-19 epidemic, 
is being included as a modification to both UCSF and KEMRI IRBs, in order to ensure that study progress is 
not delayed. To ensure confidentiality we will draft and institute SOPs to confirm key information in beach 
management registers (BMU) - official data sources at the beach sites. We will ask potential participants 
key questions to confirm/verify identity. To ensure privacy, we will only conduct interviews when 
convenient for participants. We have also drafted a detailed verbal consent form, which includes 
additional sections to confirm and document participant’s comprehension of the activities. These 

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measures will allow us to ensure that only intended participants take part in the survey, and are informed 
and have provided consent.   
 
Data Security: Precautions will be taken to avoid any risks of data being inadvertently shared. We will 
make strong efforts to ensure the maintenance of privacy, confidentiality, and security of all study data 
that are obtained. We will develop 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 tablets used for data collection will be encrypted and password protected. They will be 
autonomously monitored so that the tablet can be wiped clean in the case of a tablet going missing. All 
electronic study data will be stored on a secure server with access limited only to authorized staff. All 
computers and servers will be encrypted and password-protected with limited access. Daily backup of the 
data will be done by a designated study staff onto a secure server at UCSF. 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 MPIs, Coordinator and IRDO Regulatory 
Research Officer. At the end of the study, data will be kept for up to 5 years for electronic version and up 
to 2 years for paper forms, including consent forms. 
Institutional Review Board approval: Approval from the University of California San Francisco institutional 
review board, and the Kenya Medical Research Institute institutional review boards will be obtained prior 
to initiation of any study activities. 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.  
3.4  DATA SAFETY AND MONITORING PLAN 
This research presents minimal risk to participants- the duration of study follow-up is relatively short, 
interventions have previously been deployed (incentives) and testing technology (HIVST) is now WHO pre-
qualified and in Kenya’s HIV testing guidelines. Given the level of risk posed in this study, we have 
proposed in the sections to follow, a close monitoring and evaluation plan to assess the nature and 
frequency of adverse events. These steps will ensure that the study is being implemented as designed, 
following the strictest guidelines to protect participants’ confidentiality and minimize physical, 
psychological, and social risks due to study participation. We believe these rigorous procedures will ensure 
the protection of the research participants. 
Data and Safety Monitoring Plan 

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This study will employ three levels of data and participant safety monitoring including:  
1. Event reporting 
2. US and host country Institutional Review Board (IRB) review,  
3. Data Safety Monitoring Board (DSMB) Review. 
 
1. Event reporting: Participants will be encouraged to report serious adverse events to study team 
members through a hotline, and the study will also routinely inquire about the occurrence of such 
events. Events will be reported immediately to the UCSF and KEMRI IRBs. Study team members will be 
trained to complete descriptions of adverse events that will then be sent electronically to both the US 
and Kenyan site PIs. Thus, adverse events will be monitored at three levels; by the Principal 
Investigators, by the UCSF IRB, and by the KEMRI IRB. Of course, efforts will be taken to minimize the 
potential for adverse events. Research staff training will stress ensuring confidentiality and the study 
team will perform avoidance of negative events, and quality assurance/quality control (QA/QC) 
regularly to ensure adherence to proper enrollment procedures. Two types of reports will be made 
involving the conduct of the study. (1) Adverse Events Reports will be made using standard forms 
available from the relevant IRBs for adverse events associated with the study procedures or subject 
participation. We expect the risk of such events to be very low. (2) Incident Reports will also be made 
of any incidents involving the conduct of the study (e.g., enrolling a participant who did not meet 
eligibility). These reports will be made in the form of a letter or memo to the Chairs of the relevant 
IRBs signed by the Principal Investigators and shared with the DSMB as detailed in the sections below. 
 
We will provide participants with cards containing information on how to contact the local study team 
to report such events as breach of confidentiality, disruption of families, acts of discrimination, and 
physical harm. We will ask participants to return to the research site or otherwise contact research 
team members in order to make such reports as well as receive referrals to mitigate potential harm. 
Cards will not include identifying information about the study or references to IPV or HIV, so that the 
cards will not have the potential to jeopardize the confidentiality of participants. We will also establish 
links to social service organizations or provide referral information to participants who are in need of 
appropriate IPV services 
 
2. Institutional Review Boards: Institutional Review Boards (IRB) in both the United States and in the 
host country Kenya will be responsible for the review of the study protocol, relevant background 
information, the informed consent documents, proposed plans for informing participants about the 
trial, and any other procedures associated with the trial. The IRBs will be responsible for evaluating 
the trial to determine, among other things, whether "[r]isks to subjects are minimized" and "[r]isks to 
subjects are reasonable in relation to anticipated benefits" (21 CFR 56.111(a)) and to determine 
whether risks to subjects are minimized by "using procedures which are consistent with sound 
research design" (21 CFR 56.111(a)(1)(i)).  The IRBs will also be responsible for considering information 
arising from the trial that may bear on the continued acceptability of the trial at the study site(s) it 
oversees (see 21 CFR 56.103). The IRBs will be reported to annually by the study and PIs and will 
include communications from the DSMB as they occur. In addition, occurrences of Severe Adverse 
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3. Data Safety Monitoring Board (DSMB): Overall, the level of risk to study subjects participating in the 
study is low and no investigational or study drugs are being provided or evaluated. The primary 
criteria supporting the use of a Data Safety Monitoring Board (DSMB) for this study is its classification 
as a Phase-III clinical trial per the US DHHS Guidance for Clinical Trial Sponsors on the Establishment of 
Clinical Trial Data Monitoring Committees (March 2006, OMB Control No. 0910-0581 Expiration Date: 
10/31/2021).  
 
A Data Safety and Monitoring Board (DSMB) will be convened to provide oversight of the trial. The 
role of the DSMB will be to review a) study enrollment, b) fidelity to the intervention, and c) 
unexpected problems that might arise during the study. The study team will convene the DSMB 
consisting of 3-4 members whose expertise cover the following areas: 1) the specific disease(s) under 
study, 2) biostatistics, 3) ethics/patient advocacy, and 4) clinical trials. Membership will consist of 
persons completely independent of the investigators who have no financial, scientific, or other conflict 
of interest with the trial.  A written DSMB Charter containing these responsibilities will be drafted and 
signed by all DSMB members and the trial leadership (including the PIs).  
 
Timing of DSMB Meetings: The DSMB will meet prior to commencement of study implementation, as 
needed during the implementation period (with a meeting taking  place at least once every 12 
months), and at end of the study for review of data and findings. At the annual meeting, the study 
Statistician and Principal Investigator will present summaries of the trial progress: enrollment, 
intervention fidelity and any unexpected problems. Following its meetings, the DSMB will present its 
recommendations in writing to continue or modify the trial to the NIH and the study Principal 
Investigator. 
Responsibilities of DSMB:  
These may include: 
• 
Review the research protocol, informed consent documents and plans for data safety and 
monitoring; 
• 
Evaluate the progress of the project, including periodic assessments of data quality and timeliness, 
recruitment, accrual and retention, participant risk versus benefit, and other factors that can affect 
study outcome; 
• 
Review study performance, make recommendations and assist in the resolution of problems 
reported by the PI; 
• 
Make recommendations to protect the safety of the study participants; 
• 
Make recommendations concerning continuation, termination or other modifications of the trial 
based on the observed beneficial or adverse effects of the treatment under study; 
• 
Ensure the confidentiality of the study data and the results of monitoring; and, 
• 
Review any problems with study conduct, enrollment, sample size, and/or data collection. 
 
Monitoring for Unanticipated Problems: In the unlikely event that a serious adverse event (SAE) is 
considered possibly, probably or definitely related to the study, or in the event of unexpected 

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incidents or protocol violations, reporting to University of California-San Francisco CHR and Kenya 
Medical Research Institute SERU IRBs will be reported as outlined in the protocol. Suspected events 
will be reviewed by study investigators prior to submission to the IRB. 
Data Safety Monitoring Reports: A report to the DSMB will be prepared annually. Interim reports will 
describe enrollment, intervention fidelity and unanticipated problems.   
DSMB Membership and Affiliation: We will constitute a DSMB for the study that includes specialists 
from Kenya and the US – including clinicians, scientists, and other relevant specialists who have HIV 
prevention research expertise in  sub-Saharan Africa. The DSMB membership will be reviewed and 
approved by NIMH. Invitations to be part of the study DSMB will be issued when the study 
implementation is in progress and confirmed DSMB members and their CVs will then be sent to NIMH. 
DSMB members will have no direct involvement with the study investigators or intervention. Each 
DSMB member will sign a Conflict of Interest Statement which includes current affiliations, if any, with 
pharmaceutical and biotechnology companies (e.g., stockholder, consultant), and any other 
relationship that could be perceived as a conflict of interest related to the study and / or associated 
with commercial interests pertinent to study objectives 
 
Confidentiality and Conflicts of Interest: All materials, discussions and proceedings of the DSMB are 
completely confidential. Members and other participants in DSMB meetings are expected to maintain 
confidentiality.  The DSMB will routinely assess potential conflicts of interest of DMC members and 
provide disclosure to all DMC members of any potential conflicts that are not thought to impede 
objectivity and thus would not preclude service on the DMC. 
3.5  ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
Minimizing probability of adverse reactions to test results and ensuring receipt of appropriate services: To 
ensure correct usage of self-tests 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 (see Appendix 1 for materials we have prepared). These instruction materials have 
been developed by us and used in several HIVST studies (including studies that other teams are 
conducting in eastern and southern Africa). They were well received by women and their sexual partners. 
In addition, the network-central promoter training will include messaging and informational materials 
including clear information on the importance of seeking confirmatory HIV testing for those who obtain an 
HIV-positive test result (which is recommended by the WHO and the Kenyan Ministry of Health) – and a 
list VCT clinics in the area where free confirmatory is available. In addition, training and informational 
materials will emphasize the importance of screening for PrEP, in the case of an HIV-negative test result, 
and information will be provided on clinics in the area where free HIV care and treatment and PrEP are 
available. We will also establish a support telephone line (hotline) that study participants 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, or prevention services. 

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3.6  DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems (UPs) as defined by the Office for Human 
Research Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved 
research protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized 
3.7  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report unanticipated problems to the reviewing Institutional Review Board (IRB) and 
study sponsor. The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP 
 
UPs that are serious adverse events (SAEs) or protocol violations will be reported to the IRBs within 7-10 
working days of the investigator becoming aware of the event (see section 10.1.10 for individual IRB 
reporting timelines). 
3.8  REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
Participants will be informed of any UP that changes the study’s risk/benefit ratio and/or requires 
modification to the informed consent.  The nature of the UP will determine how and when participants 
will be notified. 
 
4 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
4.1  INFORMED CONSENT PROCESS 
 
Informed consent will be obtained for the Owete RCT participants and for participants of the qualitative 
focus groups and in-depth interviews to better understand mechanisms of the intervention action. Verbal 

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as well written consent forms will be utilized. Study team members will find a private place; 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. 
4.1.1 
CONSENT/ASSENT  
  
The following informed consent form (ICF) materials will be used in the main study: 
● Phone study contact script (verbal) 
● Eligibility screening consent (verbal) 
● Census and screening form (written) 
● Social network survey consent (written) 
● Survey, HIVST, qualitative, medical record release, viral load, urine assay, and future contact 
consent form (written)      
● Follow up survey, qualitative, medical record release, viral load, urine assay and future contact 
consent form (written) 
● Promoter consent form (2 versions- control and intervention) (written) 
● Photo consent forms 
 
These consents are included as attachments to the protocol. 
4.1.2 
CONSENT PROCEDURES AND DOCUMENTATION 
 
All consent forms will be translated into the local language and back translated into English to ensure 
correct use of language. Consent forms will be read aloud to participants by trained staff. The informed 
consent will describe the purpose of the study, all the procedures involved, and the risks and benefits of 
participation. Interviewers will ask participants to summarize the study and explain the reasons why they 
want to participate. Either a signature or a thumbprint (for those who cannot read) will be acceptable to 
confirm informed consent for participation in the study, in the case of written consent forms. 
 
The process and timing of obtaining informed consent for study participation is detailed below:   
 
1. Prior to the study start, we will conduct a pilot survey and qualitative interviews with potentially 
eligible men listed in the BMU census registry in the pilot site. If interested, study staff will 
administer a verbal script for informed consent, to screen men’s potential eligibility to be in the 
pilot (the same screener used for the main study).  Both the phone introduction and eligibility 
forms are verbal and included as attachments. The screening will be documented using a census 
and screening form, also attached. Following eligibility screening, written informed consent will be 

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obtained to enroll up to n=200 eligible men to participate in the pilot survey, using the pilot 
informed consent form. Some or all of these interviews may also be conducted over the phone, in 
response to the restrictions placed by the COVID-19 response efforts. For phone based data 
collection, we will include the phone data collection screening verbal script, a verbal consent for 
screening, and a verbal consent to participate-all of which are included as amendments to this 
protocol. 
The in-person pilot activities will use the following forms (and their local-language versions): 
a. English phone screening script  
b. English census and screening form 
c. English verbal script for informed consent for study screening 
d. English written consent for pilot  
 
The phone pilot activities will use the following forms (and their local-language versions): 
a. English pilot phone screening script  
b. English pilot screening form 
c. English verbal script for informed consent for study screening 
d. English verbal phone consent for study pilot  
2. At study start, study team members will use a screening script, to introduce the study for 
potentially eligible men listed in the BMU census registry in the study sites. If interested, study 
staff will administer a verbal script for informed consent, to screen men’s potential eligibility to be 
in the study.  Both the phone introduction script and consent are verbal and included as 
attachments. The screening will be documented using a census and screening form, also attached. 
This will allow us to conduct these activities remotely, allowing for COVID-19 precautions. 
3. After eligibility screening, written informed consent for the social network survey will be 
administered to up to n=1000 men to participate in the social network mapping process. 
4. Within the first quarter of the study start, the network data will be analyzed and the sub-group of 
up to n=90 men who are socially connected, network central men will be selected for recruitment 
as promoters. Study staff will then obtain written informed consent from up to n=45 men in the 
intervention arm using the Informed Consent for Intervention Promoters and from up to n=45 
men in the control arm using the Informed Consent for Control Promoters. This procedure will 
include consent to participate in trainings, to distribute information, HIVSTs (for intervention) and 
vouchers to peers in their networks, and to be contacted by study team members for follow up 
activities during the study period. 
5. After the social networks are mapped, and clusters randomized to control or intervention, and 
promoters consented, written informed consent will be obtained to enroll up to n=>=1000 eligible 
men to participate in the study, using the  survey, HIVST, qualitative, medical record release, viral 
load, urine assay, and future contact consent form. Potential participants will be presented and 
explained a consent form to participate in the baseline survey, 3 month follow up survey, 
qualitative interviews or focus group discussions if selected, contact for future research, as well as 
consent to use an HIVST. Further, this consent will ask for release of test dates, appointment 
dates, and medication information as well as other medical records. It will include permission for 
the use of the urine assay to test for PrEP adherence, if applicable and for those who are 

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subsequently identified as HIV-positive and enrolled in care, venous blood draws for viral load 
measurements during study scheduled visits. If verbally authorized, the viral load results may also 
be released to their provider to guide their care.      
6. For men who receive a self-test and incentive voucher from a promoter (intervention) or a 
voucher for referral to the facility (control) but who were not part of the social network survey or 
the baseline survey consent procedures, we will consent them anew, following screening 
procedures similar to the baseline survey and study enrollment (men, >=18 yrs., working in fishing 
related industries), and consent for the  3 month follow up survey, qualitative interviews or focus 
group discussions if selected, contact for future research. Further, this consent will ask for release 
of test dates, appointment dates, and medication information as well as other medical records. It 
will include permission for the use of the urine assay to test for PrEP adherence, if applicable, and 
for those who are subsequently identified as HIV-positive and enrolled in care, venous blood 
draws for viral load measurements. 
4.2  STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Notification documenting the reason for study suspension or termination will be provided to study 
participants, the funding agency, and regulatory authorities. 
 
4.3  CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the sponsor. This confidentiality is extended to the data being collected as part of this study. Data that 
could be used to identify a specific study participant will be held in strict confidence within the research 
team. No personally-identifiable information from the study will be released to any unauthorized third 
party without prior written approval of the sponsor/funding agency. All research activities will be 
conducted in as private a setting as possible. However, elements such as the baseline survey, may be 
conducted in areas where other individuals are present. Our study will do everything possible to ensure 
privacy in this case. The study participant’s contact information will be securely stored at each clinical site 
for internal use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB, institutional policies, or sponsor/funding 
agency requirements. 
 
Data Security 
All information will be recorded using study identification numbers, rather than participant names, and 
stored securely in locked offices at a study data center. All study computers will be password encrypted 
and kept in locked offices. 
 
Risk of HIV Status Disclosure 

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Given the sensitive and private nature of the HIV-status of participants of the RCT, extra measures will be 
put in place to ensure maintenance of privacy, confidentiality and security of the data obtained.   
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be made 
available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms 
used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, 
and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be 
implemented, as appropriate. 
 
4.4  FUTURE USE OF STORED SPECIMENS AND DATA  
There is no planned use of specimens. Plans for data use are described in detail under section 13.8. 
4.5  KEY ROLES AND STUDY GOVERNANCE 
Protocol Co-Chair 
Protocol Co-Chair 
Protocol Co-Chair 
Carol Camlin, PhD, MPH 
Principal Investigator: University 
of California, San Francisco 
Principal Investigator, University 
of California, San Francisco 
Address:  ANSIRH Program, 1330 
Broadway, Suite 1100, Oakland, 
CA 94612 
Phone Number: +1-510-986-8981 
Email: carol.camlin@ucsf.edu 
 
Harsha Thirumurthy, PhD 
Principal Investigator, University of 
Pennsylvania 
Address:  423 Guardian Drive, 1111 
Blockley Hall, Philadelphia, PA 19104-
4884, U.S.A 
Phone Number:  +1-215-746-0410 
Email: 
hthirumu@pennmedicine.upenn.edu   
 
Zachary Kwena, PhD, MA 
Site Principal Investigator, 
Kenya Medical Research 
Institute 
Address:  Box 54840, 
Kisumu, Kenya 
Phone Number: +254-
733-617503 
Email:  zkwena@kemri-
ucsf.org  
 
 
4.6  SAFETY OVERSIGHT 
 
Safety oversight in this minimal risk study will be led by the study investigators and by adherence to the 
quality management plan (QMP) described in section 12.1.9 
 
4.7  QUALITY ASSURANCE AND QUALITY CONTROL 
 
Each clinical site will perform internal quality management of study conduct, data collection, 
documentation and completion. All sites will follow a common quality management plan. 
 
Quality control (QC) procedures will be implemented as follows: 
 
a. Informed Consent Review 

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Study staff will review both the documentation of the consenting process as well as all the 
completed consent documents.  This review will evaluate compliance with GCP, accuracy, and 
completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed and retraining done as appropriate. 
 
b. Data 
Data will be captured on source documents or entered directly onto electronic CRFs. To ensure 
accuracy study staff will compare a representative sample of source data against the database, 
targeting key data points in that review.  Reports based on recent data will be made available to 
study staff and investigators. 
 
c. Intervention Fidelity 
Consistent delivery of the study interventions will be monitored throughout the study. Procedures 
for ensuring fidelity of intervention delivery will be detailed in subsequent protocol amendments. 
 
d. Protocol Deviations 
The study team will review protocol deviations on an ongoing basis and will implement corrective 
actions when the quantity or nature of deviations are deemed to be at a level of concern. As 
required, the investigators will provide direct access to all trial related sites, documents, and 
regulatory records for the purpose of monitoring and auditing by local regulatory authorities. 
 
4.8  DATA COLLECTION AND MANAGEMENT  
 
The UCSF-based study director will oversee quantitative and qualitative activities for this study while data 
acquisition in Kenya will be managed in collaboration with Impact Research and Development 
Organization (IRDO) and the in-country study data manager. A UCSF-based data manager will oversee the 
work of the Kenya-based data manager and provide support. 
 
Data Storage 
i. Provision for database management: Data from the tablets will be uploaded weekly to a UCSF-based 
server. All records will be kept on password protected tablet computers at KEMRI and UCSF. All participant 
record forms will be kept in individual files in a secured filing cabinet in an access-limited room at the 
health facility. Participant names and addresses will be stripped from the database prior to analysis.   
ii. Description of devices to be used for storage: Data collected for this study will be entered into handheld 
computer tablets operating RedCap system. The database will be protected by a separate password on 
password-protected tablets.   
 
In order to ensure data security and integrity, the following measures will be implemented: 
● All members of the study team will be educated in the study protocol prior to the onset of the 
study.  

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● Detailed Standard Operating Procedures (SOPs) will be written for all project activities and be 
provided to relevant team members.  
● Team members will be thoroughly trained on the SOPs.  
● Where applicable, team members will receive additional training on the use of tablet computers.  
● All data transcribed from paper will be double data entered or verified.  
● All electronic data will be backed up regularly.  
● All data will be transferred to the main secure server. This sever is backed up on a daily basis and a 
monthly backup is stored off-site and on the cloud. 
● All computers, including the tablets, will be password protected.  
● All computers, including tablets, will be locked in a secure room each night.  
● Any Log Books and CRF’s will be locked in a secure room each night. 
 
4.9  STUDY RECORDS RETENTION  
Data archives will be kept for periods based upon the terms of the agreement between the funding 
organization UCSF and IRDO. Datasets that are required to be retained for periods as prescribed by law 
will also be kept following the respective durations as set in the enacted laws of Kenya.  In general, study 
data will be kept electronically for a period of at least 5 years post completing of the study.  Data will 
remain on the password secured study servers.  After 5 years from the close of the study, all paper records 
will be destroyed and the electronic records will be removed from the server, but retained on Archival, 
password-protected cloud servers.  
4.10PROTOCOL DEVIATIONS 
 
It will be the responsibility of the site investigators and staff to use continuous vigilance to identify 
deviations or violations and report violations that meet the IRB definition of reportable events.  Protocol 
violations that occur at UCSF will be reported to the UCSF CHR IRB within 10 working days of the PI’s 
awareness.  Protocol violations that occur on-site will be reported to the KEMRI IRB within 7 working days.  
SOPs will describe the process for communicating with study coordinators and investigators and the event 
reporting procedures. 
 
4.11PUBLICATION AND DATA SHARING POLICY  
 
The results will be shared with the study site staff; NASCOP and other stakeholders in relevant forums. 
The results will also be presented at local and international meetings and conferences where other 
researchers and policymakers are present, particularly those working on HIV prevention and treatment. 
Our conclusions regarding the implications for health services planning, and our policy recommendations 
based on the findings, will be shared with representatives of the Government of Kenya including Ministry 
of Health officials at the national and Siaya County level, as well as the National AIDS Control Program of 
the Government of Kenya (NASCOP). We will prepare manuscripts containing our quantitative and 
qualitative results and submit them to peer-reviewed journals for publication and wider dissemination. In 

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addition, findings will be shared with study participants in year 5, through communications in local 
community dissemination meetings in the study sites, as well as via circulation of press releases to local 
media. Local community dissemination meetings will be advertised through local leadership structures 
(including Beach Management Units) and printed notices at the study sites.  
 
No individual identities will be used in any reports or publications resulting from the study. The 
researchers will publish results of the study in accordance with NIMH, UCSF, IRDO, and KEMRI policies and 
procedures. 
 
4.12CONFLICT OF INTEREST 
 
Any actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, or 
any aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict 
of interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial. The study leadership in conjunction with the NICHD 
has established policies and procedures for all study group members to disclose all conflicts of interest 
and will establish a mechanism for the management of all reported dualities of interest. 
 
4.13ABBREVIATIONS AND SPECIAL TERMS 
 
ART 
Antiretroviral Treatment 
BMU  
Beach Management Unit 
CHR 
Committee on Human Research (UCSF) 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
eCRF 
Electronic Case Report Forms 
FGD 
Focus Group Discussion 
GCP 
Good Clinical Practice 
HIV 
Human Immunodeficiency Virus 
HTS 
HIV Testing Services 
ICF 
Informed Consent Form 
ICH 
International Council on Harmonization  
IDI 
In-depth interviews 
IRDO 
Impact Research and Development Organization 
IRB 
Institutional Review Board 
KEMRI 
Kenya Medical Research Institute 
LTFU 
Lost to Follow-Up 
NASCO
P 
National AIDS and STI Control Programme 
NCT 
National Clinical Trial 
NIMH 
National Institute of Mental Health (NIH) 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 

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PI 
Principal Investigator 
PrEP 
Pre-Exposure Prophylaxis 
QA 
Quality Assurance 
QC 
Quality Control 
QMP 
Quality Management Plan 
RCT 
Randomized Controlled Trial 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
SSA 
Sub-Saharan Africa 
UCSF 
University of California, San Francisco 
UPenn 
University of Pennsylvania 
UP 
Unanticipated Problem 
US 
United States 
VL 
HIV Viral Load 
 
 

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6 
APPENDICES 
6.1 DATA COLLECTION INSTRUMENTS AND TOOLS 
These attachments are included as a part of the protocol submission. 
6.1.1 
BMU DATA ABSTRACTION FORM 
6.1.2 
PILOT SURVEY 
6.1.3 
PILOT QUALITATIVE INTERVIEW GUIDE 
6.1.4 
BASELINE SOCIAL NETWORK SURVEY 
6.1.5 
BASELINE SURVEY      
6.1.6 
3-MONTH FOLLOW UP SURVEY (THREE VERSIONS) 
6.1.7 
PROMOTER TRAINING CURRICULUM AND ASSESSMENT TOOLS 
6.1.8 
BASELINE QUALITATIVE IN-DEPTH TOOLS (COMBINED IDI, KII, FGD GUIDES) 
6.1.9 
3 MONTH FOLLOW UP QUALITATIVE IN-DEPTH TOOLS (COMBINED IDI, KII, AND FGD GUIDES) 
6.1.10 6 MONTH FOLLOW UP QUALITATIVE IN-DEPTH TOOLS (COMBINED IDI, KII, AND FGD GUIDES)  
6.1.11 6 and 12 MONTH ADHERENCE ASSESSMENT  

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6.2 INFORMED CONSENT FORMS AND SCREENING FORMS 
These consent and screening form attachments are included as a part of the protocol submission. 
6.2.1 
PHONE ELIGIBILITY SCREENING SCRIPT (VERBAL) 
6.2.2 
ELIGIBILITY SCREENING CONSENT FORM (VERBAL) 
6.2.3 
CENSUS AND SCREENING FORM (WRITTEN) 
6.2.4 
SOCIAL NETOWRK CONSENT (WRITTEN) 
6.2.5 
SURVEY, HIVST, QUALITATIVE, MEDICAL RECORD RELEASE, VIRAL LOAD, URINE ASSAY, AND FUTURE 
CONTACT CONSENT (WRITTEN) 
6.2.6 
FOLLOW UP SURVEY, HIVST, QUALITATIVE, MEDICAL RECORD RELEASE, VIRAL LOAD, URINE ASSAY, 
AND FUTURE CONTACT CONSENT (WRITTEN) 
6.2.7 
PHOTO/MEDIA CONSENT (WRITTEN) 
6.2.8 
PROMOTER CONSENT (WRITTEN)-2 VERSIONS (INTERVENTION AND CONTROL) 
6.3  OTHER STUDY TOOLS 
 
These attachments are also included as additional study tools/resources. 
STUDY CONTACT CARD