Randomized Controlled Trial of the Shauriana Intervention to Integrate PrEP, Sexual Health, and Mental Health Support for Gay, Bisexual, and Other Men Who Have Sex With Men in Kenya
Phase: NA
Conditions: HIV Prevention
Sponsor: University of Washington

 
 
 
Randomized Controlled Trial of the Shauriana Intervention to Integrate PrEP,  
Sexual Health, and Mental Health Support for Gay, Bisexual, and  
Other Men Who Have Sex With Men in Kenya 
 
NCT number: NCT04550221 
 
Document Date: March 2, 2021 

 
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Randomized Controlled Trial of the Shauriana Intervention 
to Integrate PrEP, Sexual Health, and Mental Health 
Support for Gay, Bisexual, and Other Men Who Have Sex 
with Men in Kenya 
March 2, 2021 
 

 
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Contents 
1. 
Title ...................................................................................................................................... 3 
2. 
Names of Investigators/Applicants ...................................................................................... 3 
3. 
Names and Addresses of Collaborating Institutions ............................................................ 3 
4. 
Names and Addresses of Sponsors and/or Funding Agencies ............................................. 3 
5. 
Project Abstract .................................................................................................................... 4 
6. 
Background .......................................................................................................................... 5 
7. 
Literature Review................................................................................................................. 5 
8. 
Previous Studies & Rationale .............................................................................................. 7 
9. 
Research Questions ............................................................................................................ 11 
10. 
Study Objectives/Aims ...................................................................................................... 12 
11. 
Description of the Study Areas/Regions, Design, Materials and Methods ........................ 12 
12. 
Ethical Considerations ....................................................................................................... 19 
13. 
Data Management & Statistical Analysis Plans: ............................................................... 26 
14. 
Laboratory Specimens and Biohazard Containment: ........................................................ 27 
15. 
Study Limitations/Possible Complications and How to Minimize Them: ........................ 27 
16. 
Timeline/Time Frame ........................................................................................................ 28 
17. 
References: ......................................................................................................................... 29 
18. 
Budgetary Estimates .......................................................................................................... 31 
19. 
Appendices ......................................................................................................................... 33 
 
 
 

 
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1. Title: Randomized Controlled Trial of the Shauriana Intervention to Integrate PrEP, Sexual 
Health, and Mental Health Support for Gay, Bisexual, and Other Men Who Have Sex with 
Men in Kenya 
 
2. Names of Investigators/Applicants: 
Role 
Name & Institution 
Research Ethics 
Training 
Principal Investigator 
Prof. Wilson Odero, M.D., Ph.D., Maseno 
University 
Yes 
Co-Principal 
Investigator 
Prof. Susan M. Graham, M.D., Ph.D., M.P.H., 
University of Washington 
Yes 
Co-Principal 
Investigator 
Prof. Gary W. Harper, Ph.D., M.P.H., 
University of Michigan 
Yes 
 
3. Names and Addresses of Collaborating Institutions: 
Maseno University 
Maseno University, P.O. Box Private Bag, 
Maseno, Kenya 
University of Washington 
4333 Brooklyn Ave NE, Seattle, WA 98195, 
United States 
University of Michigan School of Public 
Health 
1415 Washington Heights, Ann Arbor, MI 
48109, United States 
NYANZA Reproductive Health Society 
(NRHS) 
UNIM Research and Training Centre, Ondiek 
Avenue, P.O. Box 1764, Kisumu, Kenya 
Let Good Be Told In US NYARWEK 
Network 
Indusi Road, Off Nyerere Road, Tom Mboya 
Estate, P.O. Box 2897-4011 Kisumu, Kenya 
 
4. Names and Addresses of Sponsors and/or Funding Agencies: 
 
 
 
The National Institute of Mental Health (NIMH) 
6001 Executive Blvd. Room 8184, MSC 
9663, Bethesda, MD 20892 United States 

 
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5. Project Abstract: Gay, bisexual, and other men who have sex with men (GBMSM) are at 
high risk for HIV-1 acquisition, especially in rights-constrained settings such as Kenya, 
where men’s access to HIV prevention has been impeded by homophobia, stigma, and 
discrimination. Pre-exposure prophylaxis (PrEP) has the potential to greatly reduce HIV 
acquisition risk in this key population if accessible, sustainable PrEP programming with 
tailored, effective adherence support can be provided. To this end, close collaboration 
between PrEP program implementers and GBMSM-led community-based organizations is 
essential. We have recently completed a project to identify the multi-level barriers and 
facilitators that influence GBMSM’s ability to engage in the PrEP continuum of care through 
in-depth interviews with 20 peer navigators working to promote HIV testing and PrEP in the 
community and with 40 GBMSM with different PrEP experiences. Based on this work, we 
have adapted and enhanced a theory-based and culturally relevant PrEP support intervention 
that we named Shauriana (“we counsel each other”). The Shauriana intervention merges 
peer navigation and “integrated Next Step Counseling” (iNSC) to promote sexual health 
protection strategies, including PrEP uptake and adherence, among GBMSM in Kisumu. The 
present proposal aims to pilot the intervention among 10 participants for 3 months, and then 
to evaluate the Shauriana intervention for acceptability, feasibility, safety, and estimated 
effect on PrEP uptake and adherence, compared to standard of care, in a small randomized, 
controlled study with 60 participants followed for 6 months after enrollment. We anticipate 
that results of the proposed research will have high impact by ensuring GBMSM 
involvement in the scale-up of effective PrEP programming for this key population in Kenya 
and providing a peer-led PrEP support model for GBMSM and other vulnerable and 
marginalized populations in African settings.  
 
 

 
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6. Background:  
GBMSM in the Kenyan HIV Epidemic. While GBMSM received late recognition in 
the African HIV epidemic,1 numerous studies have since documented their elevated risk of HIV 
infection. The WHO and most countries in sub-Saharan Africa (sSA) now classify GBMSM as a 
“key population” at risk for HIV, and donor responses promote inclusion of GBMSM and their 
emerging organizations in HIV prevention programming.2 GBMSM in sSA have 2-4 times 
higher HIV prevalence than the general male population.1,3-6 In Kenya, HIV incidence among 
GBMSM north of Mombasa was estimated at 8.6 (95% confidence interval [CI] 6.7–11.0) per 
100 person-years of observation (pyo).7 Among male sex workers (MSW) in Nairobi, HIV 
incidence was 10.9 (95% CI 7.4 to 15.6) per 100 pyo.8 In contrast, the estimated HIV incidence 
in Kenya overall was 0.5 per 100 pyo in the 2012 Kenya AIDS Indicator Survey,9 highlighting 
the disparity in risk among GBMSM, especially among MSW. The Kenya National AIDS 
Strategic Plan has recognized the pivotal role that GBMSM play in the epidemic,10 since a 2009 
Modes of Transmission study estimated that 15% of new HIV infections were attributable to 
male-male sex.11 Concordantly, the Office of the U.S. Global AIDS Coordinator recently issued 
its “Technical Guidance on Combination HIV Prevention for Men Who Have Sex with Men,”12 
highlighting the urgent need to strengthen and expand prevention interventions for GBMSM 
globally. This considerable support provides an important opportunity to advance research to 
determine how HIV prevention services for GBMSM could best be structured, including in 
rights-constrained settings such as Kenya and other countries in sSA.  
In the past decade, numerous GBMSM-focused community organizations have been 
established in Kenya, especially in the Kisumu area. Umbrella organizations advocating for 
human rights and access to health care include the Gay and Lesbian Coalition of Kenya 
(GALCK) in Nairobi, and the NYARWEK (Nyanza, Rift Valley, and Western Kenya) lesbian, 
gay, bisexual, transgender and intersex (LGBTI) Network in Kisumu. NYARWEK advocates for 
23 registered organizations, including MAAYGO (Men Against AIDS Youth Group), and 
several un-registered organizations in western Kenya. Kenyan GBMSM organizations have also 
united to form G10, a national research advisory committee that published a roadmap for 
enhancing and sustaining meaningful research partnerships between the “sexual orientation 
gender identity and expression” (SOGIE) community, researchers and donors.13 In 2017, the 
Kenya MSM Health Research Consortium, of which co-Principal Investigators (co-PI) Graham 
and Harper are members, trained 27 LGBTI community members on research literacy and ethics; 
in addition, Dr. Harper trained 25 GBMSM on qualitative research and interviewing skills. 
7. Literature Review: 
PrEP Delivery to Kenyan GBMSM. The potential impact of daily PrEP with tenofovir-
emtricitabine (TDF-FTC) on high-risk populations was demonstrated in the 6-country iPrEx trial, 
which enrolled 2,499 GBMSM and transgender women, reporting a 44% reduction in HIV 
acquisition,14 with up to 90% effectiveness among participants who had measurable drug 
levels.15 Overall, PrEP studies have demonstrated effectiveness at reducing HIV infection risk 
for rectal exposure (relative risk [RR] 0.34, 95% CI: 0.15-0.80) and in men (RR 0.38, 95% CI 
0.20-0.60).16 Repeatedly, post-trial analyses have shown that PrEP efficacy depends on drug 
detection in serum or tissues.15,17 In the STRAND trial, in which doses were directly observed, 

 
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blood levels of tenofovir diphosphate (TFV-DP) achieved with daily dosing were estimated to 
provide 99% protection, while ≥4 doses per week were estimated to provide 96% protection.15 In 
2014, the WHO released a strong recommendation to include PrEP as an option in combination 
prevention packages oriented to GBMSM.18 In the same year, Kenya incorporated PrEP for key 
populations into its HIV Prevention Revolution Road Map.19 Soon afterwards, the Kenya 
Pharmacy and Poisons Board approved PrEP for HIV prevention,20 and Kenya officially adopted 
PrEP in early 2017 as part of combination HIV prevention for individuals at substantial ongoing 
risk, specifically including GBMSM.21 Kenya’s commitment to PrEP expansion presents an 
opportunity to conduct research on the effectiveness of this intervention in specific target groups 
such as GBMSM, as access is now a reality and there is a commitment from the Government of 
Kenya and several funders to support PrEP availability for this group for the foreseeable future. 
Experience is now accruing on PrEP use among Kenyan GBMSM. For example, one 
small Kenyan trial of intermittent PrEP enrolled 62 GBMSM and demonstrated high 
acceptability.22,23 Median adherence to daily PrEP using electronic monitoring was 80% in this 
study.24 Lower adherence was associated with travel, transactional sex, and longer follow-up; 
higher adherence was associated with assignment to daily dosing and higher income.24 A recent 
study in Nairobi and Kisumu found that 83% of enrolled GBMSM were willing to take daily 
PrEP, with higher willingness among bisexual and younger men.25 While men were motivated to 
stay HIV negative and protect their partners, a history of poor medication adherence, fear of side 
effects, and stigma were potential barriers to PrEP adherence.25 In early data from PrEP rollout 
among GBMSM on the Kenyan coast where Dr. Graham works with colleagues from the Kenya 
Medical Research Institute (KEMRI), 112 of 166 eligible men (69.6%) accepted PrEP at first 
offer and 11 of the 49 who did not initially accept PrEP (22.4%) accepted PrEP after a median of 
56 days (interquartile range, 32-83 days). In multivariable analysis, factors associated with early 
PrEP uptake included younger age (18-24 years) (adjusted prevalence ratio [aPR] 1.3, 95% CI 
1.1-1.6), self-reported receptive anal intercourse (aPR 1.5, 95% CI 1.0-2.1), payment for sex 
(aPR 1.3, 95% CI 1.1-1.7) and group sex (aPR 1.5, 95% CI 1.1-2.0) (Wahome, in preparation). 
These initial data on GBMSM interest in PrEP informed the Anza Mapema PrEP cohort 
that was conducted by our research team in Kisumu (described below), along with several 
programs offering PrEP to Key Populations including GBMSM. For example, LVCT Health has 
supported programmatic PrEP delivery at the Anza Mapema Clinic for over 420 HIV-negative 
GBMSM. A separate Gates-funded demonstration project “Bridge to Scale – Jilinde” provided 
PrEP to 20,000 adolescent women, fisher folk, female sex workers, injection drug users and 
GBMSM in 10 Kenyan counties, including Kisumu County, over 4 years, using the same supply 
chain currently used for ART provision. Such programs have increased demand and availability 
of PrEP for GBMSM in Kisumu. However, current PrEP programs for GBMSM in Kenya rely 
heavily on clinic-based support groups, peer outreach workers with limited training, and standard 
adherence counseling by HIV care providers who often are not GBMSM affirming. This 
approach too often results in discussions focused on assigning a regimen dose time and 
informing of need for high adherence, without patient-driven or tailored exploration of potential 
barriers and facilitators to optimal PrEP use. While standard PrEP programming may work for 
some, it is clear from our initial work that a tailored approach with more GBMSM input may be 
required to achieve optimal GBMSM engagement in HIV prevention. 

 
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8. Previous Studies & Rationale:  
Studies at the Coast, including the Shikamana intervention. In 2004, Dr. Graham 
established a pilot ART program providing treatment to cohort participants. Among 58 
participants taking ART from 2004-2006, 40% of GBMSM had <95% adherence, versus 28.6% 
of heterosexual men and 11.5% of women.26 Through a 3-year developmental project grant 
(R34-MH099946, Graham PI), Dr. Graham and the KEMRI team conducted qualitative research 
investigating facilitators and barriers to ART adherence among GBMSM living with HIV, and 
developed the Shikamana intervention to promote ART adherence.27,28  
Shikamana (Kiswahili for “form a bond or stick together”) uses motivational 
interviewing by counselors combined with peer support from HIV-positive GBMSM 
experienced in taking ART to promote ART adherence among GBMSM living with HIV. The 
intervention is based on a conceptual model situated in a socioecological framework 
incorporating factors on multiple levels that impact GBMSM access to and utilization of services 
(Figure 1, below). This model was based on qualitative work that demonstrated the relevance of 
basic concepts of an access-information-motivation-behavioral skills (access-IMB) model of 
ART adherence for this population. Our work demonstrated that this basic access-IMB model 
should be situated in a context in which stigma is a destructive influence that can be offset by 
contextual factors such as trust in providers and psychosocial support. In addition, resilience-
related concepts such as self-worth, social identity, disclosure of GBMSM status, connection to 
LGBTI organizations, homophobia management, goal-setting, and altruism were important 
factors influencing adherence.29 Our Shikamana intervention based on this work comprises the 
Figure 1: Shikamana  
Conceptual Model 

 
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following components: sensitivity training for clinicians and counselors, provider training in 
patient-centered care, counselor training in motivational interviewing, peer training in basic 
counseling and support methods, and mental health screening and support. A provider training 
manual includes counseling procedures, role-play exercises, case studies, and hypothetical 
problem scenarios. A peer training manual includes roles and responsibilities, didactic 
information, and role-playing exercises for skill building. Trainings were supplemented by 
periodic practice to reinforce skills. A detailed manuscript describing intervention development 
and pilot testing results has been published, along with the training manuals for peers and 
providers.27 
Shikamana results. A pilot randomized trial to determine acceptability, feasibility, 
safety, and initial effect size of the Shikamana intervention was recently completed. Sixty men 
enrolled, of whom 33 (55%) were assigned to standard care including adherence counseling per 
Kenyan guidelines and 27 (45%) to the intervention. Eight counselors and eight peers were 
trained to support the intervention; one peer dropped out. In exit interviews, all intervention 
participants reported finding the counseling acceptable, with several ART-experienced 
participants noting a difference from standard counseling and a few participants mentioning 
specific “next steps” they worked on. Three intervention participants withdrew from the peer 
component for various reasons; in all cases, discontinuation did not engender problems for 
participants or peers. For the 24 successful peer-participant pairings (89%), acceptability was 
high and feedback positive. No study-related adverse events occurred. Retention (85% in both 
arms) and visit attendance (median 7 in both arms) did not differ. Compared to SOC, 
intervention participants rated higher how well they took their ART (mean 4.80/6 vs. 4.41/6, 
p=0.002) and how often they took their ART as prescribed (mean 5.25/6 vs. 4.83/6, p=0.001). 
Plasma viral load suppression was 100% in the intervention and 76.9% in the standard care 
control at month 3 (p=0.025) and 90.5% in the intervention and 76.9% in the standard care 
control at month 6 (p=0.20). In GEE analysis adjusting for baseline suppression (<40 
copies/mL), men in the intervention had an increased odds of virologic suppression at 
months 3 and 6 (aOR, 5.7, 95% CI 1.1-30.7, p=0.04).28 This intervention also had a positive 
impact on depressive symptoms, which may have helped mediate its impact (Graff, in 
preparation). This work demonstrates our ability to develop a successful adherence intervention 
involving both peer and provider components and to engage with members of the GBMSM 
community to improve service delivery. While successful in this small trial, the impact of this 
approach on PrEP adherence is unknown. The change in focus from treatment to prevention may 
lead to different results; as such, careful adaptation of the Shikamana materials and evaluation 
of the acceptability, feasibility, and safety of the resulting intervention to promote PrEP 
adherence and sexual risk reduction is required. 
Studies among GBMSM in Kisumu. In 2010, NRHS completed a respondent-driven 
sampling study of GBMSM in Kisumu, in collaboration with NASCOP, Population Council, and 
University of Illinois at Chicago. From 11 original seeds, 415 men aged 18-62 years who 
reported oral or anal sex with another man in the last 6 months were recruited. HIV prevalence 
was 4.2% among 18-19 year-olds versus 28.9% among 25-29 year-olds, highlighting the need for 
prevention in young GBMSM. Factors associated with HIV infection were older age, herpes 
seropositivity, male sex clients, and unprotected sex with the most recent female partner,30 

 
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indicating that risk reduction for GBMSM must focus not only on same-sex behavior, but also on 
sex with female partners. Before and during this work, NRHS founded a support group for 
GBMSM, called Kisumu Initiative for Positive Empowerment (KIPE), which rapidly grew to 
≈200 active members. During 2011, KIPE provided HIV counseling and testing to 740 GBMSM 
in the greater Kisumu area, referring HIV-positive men to an ART clinic run by NRHS or an 
ART provider of their choice.  
This work formed the basis for the CDC-funded Anza Mapema (Kiswahili for “start 
early”) demonstration project (U01GH000762, Otieno PI, Graham and Bailey co-investigators), 
which aimed to: 1) find and test 700 GBMSM for HIV; 2) link and retain HIV-positive GBMSM 
in HIV care including ART; and 3) link and retain HIV-negative GBMSM in an HIV prevention 
program including quarterly HIV testing and counseling. Anza Mapema participants were 
followed for 12 months and benefitted from risk reduction counseling, condoms and lubricants, 
sexually transmitted infection (STI) screening and treatment, and post-exposure prophylaxis 
(PEP) as indicated, with ART for HIV-positive participants. In addition, social events such as 
theatre, movie nights, spiritual meetings, and “Coffee Wednesday” meetings to promote 
reduction in substance use were offered. Between 8/31/2015 and 9/17/2016, 713 men enrolled, 
the vast majority of whom (636, or 89%) were HIV-negative.31 Of note, 36% reported no 
transactional sex and 24% reported only occasional transactional sex, making this cohort more 
representative of GBMSM who are not sex workers than most Kenyan cohorts. Overall, 
retention is the Anza Mapema study was 83% at the month 12 visit. This retention is high 
given a young, mobile population with frequent travel in search of work. Twelve Anza Mapema 
participants seroconverted during follow-up (≈2.3 cases per 100 pyo). Among men reporting 
condomless anal intercourse (CAI) at baseline (29%), HIV incidence was ≈4.6 per 100 pyo. 
Overall, willingness to use PrEP was high (92.3%) and did not vary by risk behavior 
(unpublished data).  
Despite improved access to non-PrEP HIV prevention services in Anza Mapema, only 
interventions including PrEP are likely to bring HIV incidence below the reproductive threshold 
in this population. After the main study ended, the Anza Mapema PrEP cohort enrolled 167 men 
to receive PrEP services in line with current Kenyan recommendations for key populations,19 
enhanced by the social activities described above. This demonstration program, funded by 
Evidence for HIV Prevention in Southern Africa (EHPSA), aimed to provide evidence on PrEP 
adherence over 12 months of follow-up, and is cited as part of NASCOP’s Framework for the 
Implementation of Pre-Exposure Prophylaxis in Kenya.21 HIV-negative MSM ≥18 years were 
enrolled if they reported recent unprotected anal sex, ≥3 male sex partners, STI, transactional 
sex, or injection drug use. All participants were offered PrEP at baseline, with adherence 
counselling at each visit. Follow-up occurred at week 2; months 1, 2 and 3; then quarterly for 1 
year. Adherence was measured by visual analogue scale (VAS) and qualitative self-rating. Dried 
blood spots were collected at months 3 and 9 for TFV-DP testing. Generalized estimating 
equations (GEE) with robust variance were used to detect associations with (1) TFV-DP 
detection and (2) protective TFV-DP levels (≥700 fmol/punch, compatible with ≥4 weekly 
doses). 
DBS were provided at 275 visits by 161 participants. At baseline, median age was 26, 
46.6% reported unprotected anal sex, 86.5% reported >3 male partners, 9.8% reported a recent 

 
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STI, 66.3% reported transactional sex, and 5.5% reported injection drug use. Median VAS 
adherence was 98% (IQR 90%-100%), and men reported taking PrEP “most” or “all of the time” 
at 89% of visits. DBS results showed no detectable TFV-DP at 178 visits (64.7%), and protective 
TFV-DP levels at only 28 visits (10.2%). In GEE analysis, age, education, occupation, sex with 
female partners, injection drug use, depressive symptoms, social support, and time were 
associated with one or both outcomes in bivariable analysis. Only time was associated with TFV-
DP detection in multivariable analysis (adjusted odds ratio [aOR] 0.84, 95% confidence interval 
[CI] 0.78-0.90 per month). Increasing age (aOR 1.12, 95% CI 1.04-1.21), sex with a female 
partner in the past 3 months (aOR 3.98, 95% CI 1.33-11.9), and lower social support score (aOR 
0.97, 95% CI 0.95-0.99) were associated with protective TFV-DP levels in multivariable analysis 
(Graham, in preparation). 
Thus, the Anza Mapema PrEP sub-study demonstrated that uptake and adherence to 
PrEP among GBMSM was much lower than desired. Despite high reported adherence, drug 
levels were undetectable in most participants, and only 10% had protective levels. These results 
suggest that PrEP adherence is not aligned with risk among GBMSM in Kenya, and that tailored 
interventions to address PrEP adherence in this population are urgently needed. 
Strengthening HIV Prevention for Kenyan GBMSM. Optimizing comprehensive HIV 
prevention including PrEP delivery requires programs to reach a diversity of GBMSM, including 
men of different ages, backgrounds, sexual identities, degrees of outness, behaviors, and sex 
work status. Based on qualitative data about men’s concerns,23,25 GBMSM need skills for 
problem-solving, developing pill-taking routines, getting on-time refills, sustaining commitment 
to adhere, disclosing PrEP use, and combatting stigma.25 Tailored counseling and education on 
HIV transmission, use of condoms and lubricants, and STI risk is needed while delivering PrEP 
to GBMSM, to promote comprehensive sexual health.32 Many of the concerns raised by 
GBMSM in PrEP-oriented studies of barriers and facilitators are remarkably similar to those 
raised in the qualitative work used to design the Shikamana intervention to promote ART 
adherence,27,29,33 and are at least partly addressed in the Shikamana counselor and peer training 
materials.27 Our goal with the proposed work is to adapt the Shikamana intervention from its 
focus on HIV treatment and enhance and reinforce it for comprehensive HIV prevention 
including PrEP adherence and sexual risk reduction, through work in collaboration with our 
GBMSM community partners. Based on our experience with ART adherence promotion and 
preliminary work on PrEP scale-up, additional intervention components to foster resilience, 
address stigma, and promote healthy sexual identity development will likely strengthen the 
intervention and provide more benefit. By providing tailored, affirming support to GBMSM 
throughout the PrEP care continuum, the proposed research could increase the reach and 
optimize the impact of HIV prevention services for a high-risk, vulnerable population that has 
until recently been ignored.  
Recent qualitative work. In 2019, our team conducted a series of interviews with 20 
peers providing support to GBMSM, as well as 40 GBMSM in the Kisumu area who were 
purposively samples from the following groups: PrEP-experienced men currently taking PrEP, 
PrEP-experienced men who have stopped taking PrEP, PrEP-naïve men interested in taking 
PrEP, and PrEP-naïve men who have no interest in taking PrEP. This work, which was 
conducted as protocol MSU/DRPI/MUERC/00637/18, had the following aims: 

 
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Aim 1: To identify multi-level barriers and facilitators that influence GBMSM’s ability to 
engage in the PrEP continuum of care by examining socioecological factors that impact 
Kenyan GBMSM’s lives, including sexual and PrEP-related stigma, sexual health 
promotion, and resilience, through qualitative work with PrEP-experienced and PrEP-
naïve GBMSM and peers engaged in HIV testing/counseling or PrEP programming. 
Aim 2: Following steps 1-6 of the ADAPT-ITT model (assessment, decision-making, 
adaptation, production, expert review, and integration of feedback)34 in collaboration 
with our GBMSM community partners, to adapt and enhance a theory-based and 
culturally relevant PrEP support intervention that includes peer navigation and 
“integrated Next Step Counseling” to promote sexual health protection strategies, 
including PrEP uptake and adherence, among GBMSM in Kisumu. 
The project team has successfully conducted its Aim 1 qualitative work and has successfully 
used the ADAPT-ITT process to create a new intervention, called Shauriana (Kiswahili for “to 
consult one another”). The Shauriana Project team consists of a close collaboration between 
our research team and NYARWEK, a GBMSM-led community-based organization based in 
Kisumu. Trained GBM community members from NYARWEK conducted in-depth interviews 
with 20 peer educators and 40 community members with and without PrEP experience to 
identify multi-level barriers and facilitators that influence GBM’s ability to engage in the PrEP 
continuum of care. These interviews examined socioecological factors that impact Kenyan 
GBM’s lives, including sexual and PrEP-related stigma, sexual health promotion, and resilience. 
In addition, we held a community meeting with 51 representatives from GBM- and sexual 
minority-led organizations, to identify the barriers and facilities they have noticed in their work 
on HIV testing and counselling or PrEP programming in the Kisumu area. 
Feedback from the interviews and community meeting identified a number of barriers 
and facilitators influencing GBM’s PrEP engagement. Barriers to PrEP awareness included 
stigma and discrimination, mistrust and myths, and lack of tailored information. Barriers to 
uptake included fear of side effects, fear of disclosure, the perception that PrEP was only for sex 
workers and promiscuous individuals, poor ownership, and a feeling of “coercion” by programs 
perceived as only interested in numbers. Barriers to adherence included forgetting, side effects, 
pill burden, problems obtaining refills, negative interactions with providers or peers about PrEP, 
and challenges with substance use. Facilitators to engagement across the continuum included 
tailored information, feeling safer due to PrEP, support from partners and PrEP champions, 
theatre and drama with testimonials about personal experiences, community ownership and 
advocacy, and rapport with GBM-friendly providers and services. 
In summary, multiple barriers have limited GBM engagement in the PrEP care 
continuum, and there is poor community ownership of this intervention. Community-focused 
efforts and increased ownership are therefore key to improving PrEP engagement by GBM. 
These results are being used by the team to adapt and enhance a theory-based and culturally 
relevant PrEP support intervention to combat stigma and promote a more holistic approach to 
sexual health, including but not limited to PrEP uptake and adherence, among GBM in Kisumu. 
9. Research Questions: The current study’s research questions are as follows:  
1) Will the Shauriana intervention be acceptable, feasible, and safe? 

 
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2) What effect will this intervention have on PrEP uptake and adherence, compared to 
standard care? 
 
10. Study Objectives/Aims: 
Aim 1: To pilot the Shauriana intervention among 10 participants for 3 months, in order to 
ensure that intervention and study procedures are optimized. 
Aim 2: To determine the acceptability, feasibility, and safety of the Shauriana intervention and 
estimate initial effect size compared to standard care on PrEP uptake and adherence assessed by 
drug levels over 6 months in a pilot randomized controlled trial (RCT). 
 
11. Description of the Study Areas/Regions, Design, Materials and Methods: 
Study Sites. Sites engaged in research include the University of Washington, the University of 
Michigan, Nyanza Reproductive Health Society (NRHS), and the Nyanza, Rift Valley, and 
Western Kenya LGBTI Network (NYARWEK). Participant recruitment will occur through the 
NYARWEK Network. Enrollment, all study visits, and clinical care, including PrEP services 
provided according to the most recent Kenyan Ministry of Health guidelines, will take place in 
private rooms at the Anza Mapema Clinic. Intervention delivery will take place at NYARWEK, 
at private sites used by NYARWEK organizations, or at a meeting space agreed upon and 
deemed private and safe by both the participant and a Shauriana peer facilitator trained to 
deliver the intervention. In-person research team meetings to monitor the study will also be held 
in private rooms at the Anza Mapema Clinic, NYARWEK, or at private sites used by 
NYARWEK organizations. A description of each site’s facilities and other resources are 
included in “Appendix B: Facilities & Other Resources.” 
Study Population. The proposed Aim 1 pilot will include 10 adult HIV-negative GBMSM. The 
proposed Aim 2 intervention trial will include a population of 60 adult HIV-negative GBMSM, 
all of whom will be recruited in Kisumu, Kenya. The study team and peer facilitators trained to 
deliver the intervention will also participate in data collection, by providing feedback on 
intervention feasibility at routine study team meetings that will be minuted. 
Study Design. The Aim 1 work will be a prospective pilot of the intervention and of study 
procedures other than laboratory testing, in a small group of 10 men over a 3-month period, with 
visits at baseline, month 1, and month 3. During this pilot test, intervention and clinic visit 
procedures, including data collection tools, will be revised and improved as needed according to 
feedback on feasibility, comprehension, burden on participants, and acceptability among pilot 
participants. The Aim 2 work will be an RCT of the final Shauriana intervention, to test its 
acceptability, feasibility, and safety and estimate its initial effect size compared to standard care. 
The final phase of this study will consist of data analysis and dissemination activities. 
Recruitment. Subjects for the Aim 1 Pilot and the Aim 2 intervention trial will be recruited using 
existing NYARWEK peer networks, snowballing and venue-based referrals. All interested and 
potentially eligible subjects identified by the NYARWEK team will be given a business card of 

 
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the NYARWEK peer facilitator they were in contact with and referred to the Anza Mapema 
clinic for eligibility screening.  
Enrolment targets are presented in Table 1. If a participant tests positive for HIV infection at 
baseline or at any follow-up visit, he will be withdrawn from this study and undergo counselling 
and referral to the HIV clinic of his choice. Participants who withdraw before or test positive at 
the month 1 visit will be replaced; replacement participants in the RCT will undergo 
randomization and not necessarily be assigned to the arm to which the participant they replace 
was assigned. 
Table 1. Overview of Participant Enrolment 
Stage 
Pilot Test (Aim 1) 
Feasibility RCT (Aim 2) 
Purpose 
Standardization of intervention 
Initial testing of feasibility, tolerability, acceptability, and safety; 
estimate of effect size 
Group 
10 HIV-negative GBMSM 
participants 
60 HIV-negative GBMSM participants 
 
Eligibility Screening. A brief permission script will be used to confirm consent for screening. 
Basic sociodemographic data (age, sex), a brief risk behavior assessment, and reasons for 
screening out or failing to enroll will be noted. Men who are found to be ineligible will be 
referred by Anza Mapema staff to HIV prevention or care programming as indicated, including 
risk reduction counseling, condoms and lubricants, STI screening and treatment, programmatic 
PrEP if eligible and interested, and HIV care for men who self-report as HIV-positive. Men who 
are eligible will undergo an informed consent process as described in section 12 (Ethical 
Considerations). 
Inclusion criteria: Men recruited for each study aim must meet all of the following criteria: 
• Biologically male at birth and identifies as male, according to self-report  
• 18 to 35 years of age 
• Resident in the Kisumu area for ≥12 months 
• Reports anal intercourse with a man in the past 3 months 
• Not currently taking PrEP for HIV prevention in the past 3 months 
• Willing to provide complete locator information 
• Willing to undergo all study procedures, including HIV testing and counselling 
• Not currently participating in any HIV prevention or vaccine study 
• Planning to remain in the study area for at least 6 months 
For the pilot study only, men will be required to speak English, in order to expedite the study 
team’s analysis of feedback from these participants in preparation for the RCT. Of note, 
approximately 50%-60% of young MSM in Kisumu speak English. 
Exclusion criteria: Men who meet any of the following criteria will be excluded from this study: 
• Unable to understand the study purpose and procedures 
• Unwilling to adhere to study procedures 

 
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• Currently under the influence of alcohol or drugs 
• Prior diagnosis of HIV infection 
Men who screen out or decline enrolment will be reimbursed KSh 350 for transportation to the 
clinic. Locator information will be collected from all enrolled participants to ensure they can be 
traced in the event of a missed visit or lab result needing action. In addition, the Anza Mapema 
clinic provides the option for participants to use iris scanning rather than a study card with their 
ID number as a means of identification when they present to the clinic. This biometric 
identification method has been found to be more acceptable to the target population than 
fingerprint scanning, and helps avoid duplicate enrolments across studies. For study forms that 
include the recruitment script and eligibility screener and checklist please see “Appendix C: 
Eligibility Screener and Checklist.”  
 
Aim 1 Procedures: Piloting and Standardization of the Shauriana Intervention. The overall 
objective of this phase is to pilot test and standardize our empirically-based, targeted sexual 
health intervention for Kenyan GBMSM at risk for acquiring HIV. Objectives of the pilot test 
phase will be to a) assess acceptability of intervention components to the target population; b) 
test the adequacy of intervention materials and research instruments; and c) monitor fidelity of 
provider implementation. We will recruit 10 HIV-negative, PrEP-naïve GBMSM who are 
willing to undergo all intervention procedures at a scheduled roll-out date and provide detailed 
feedback after each intervention session. Recruitment will be achieved through outreach by the 
NYARWEK team, with screening and enrolment at the Anza Mapema clinic as described above.  
Clinic visits. The 10 field-test participants will undergo all study procedures at baseline, 
month 1, and month 3 at the Anza Mapema clinic as detailed below for the aim 2 work. The 
exception will be specimen collection and laboratory testing, which are currently not included as 
part of standard of care in Kenyan PrEP programs. Clinic visits will include HIV counselling and 
testing, screening for STI symptoms, and individual counselling about HIV prevention methods. 
Standard of care counselling for HIV prevention in Kenya includes general information about 
HIV transmission and discussions of risk reduction including condom use. PrEP counselling 
sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers. 
Our intervention will include this component as standard care at the Anza Mapema Clinic. After 
receipt of these services, pilot study participants will complete the detailed ACASI described 
below for Aim 2, allowing us to identify any technical problems with this data capture and the 
questions included. Each of the three clinic visits (baseline, month 1, and month 3) will take 
from 1.5 to 2 hours; participants will be reimbursed KSh 500 for each clinic visit.  
 
Intervention procedures. In addition to this standard of care, men in the pilot study will 
receive the Shauriana intervention, which is aimed at promoting sexual health and preventing 
HIV through a comprehensive prevention toolbox including PrEP. The intervention is adapted to 
respond to the particular needs of Kenyan GBMSM, as identified in the qualitative research 
conducted in as protocol MSU/DRPI/MUERC/00637/18. The components of this intervention 
are: four weekly in-person sessions with a trained peer intervention specialist; optional additional 
in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly 
group sessions at NYARWEK. The four in-person health education and coaching sessions will 
be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions 

 
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will focus on the following topics: sexual health basics (understanding how HIV and STIs are 
transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, 
characteristics of healthy relationships, communication skills), stress and coping (understanding 
mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and 
empowerment (understanding sexual orientation and gender identity, challenging stereotypes 
about GBMSM, making sexual choices).  
 
An overview of session content is included in “Appendix D: Shauriana Intervention 
Draft.” Peer facilitators will use a structured counselling format to help participants set specific 
goals, identify facilitators and barriers, and problem-solve to overcome barriers they anticipate or 
encounter. One-on-one sessions with peer facilitators will be structured as follows: 15 minutes 
introduction or review from previous week; 30 minutes didactic sharing of health information; 
45 minutes of integrated next step counselling (iNSC) related to the current topic and sexual 
health. Peer facilitators will document each module administration, which will also be 
digitally recorded, in order to monitor fidelity of intervention delivery. In addition, 
participants will be asked to provide both quantitative (i.e., scales) and qualitative (i.e., open-
ended questions) feedback on each intervention session delivered. Each session will take from 
1.5 to 2 hours; participants will be reimbursed KSh 500 for their time.  
 
A training manual is being designed for the six peer facilitators who will deliver the 
intervention. This manual will include the didactics and background information necessary to 
teach the peers the rationale and procedures of the intervention. Training components will be 
illustrated using role-play exercises, discussion of sample cases, and hypothetical problem 
scenarios. Peer training will be carried out over 3-4 days at least one week prior to the pilot test, 
and will include an overview of the study design, theoretical principles, and rationale, as well as 
step-by-step review of supporting manuals and handouts, practice role-playing exercises, and 
feedback. Practice sessions will be role-played until each intervention is adequately delivered, as 
assessed by the research team. We will hold weekly peer facilitator meetings to review study 
progress, guidelines, and issues that have arisen. Minutes of these meetings will be used to 
monitor the study and identify needs for revised training or procedures.  
Optional intervention components. Once participants have completed the four weekly 
sessions, peer facilitators will send regular messages to participants to check in with them. If 
participants choose, they may continue to meet with their peer facilitator for additional iNSC 
sessions by phone or in-person (this is an optional component of the intervention). Participants 
may also choose to attend group sessions focused on LGBTI mental health and wellbeing that 
will be held at NYARWEK (also an optional component of the intervention).  
 Exit interviews. On completion of each pilot participants’ 3 months of follow-up, an in-
depth exit interview will be conducted for feedback regarding intervention components and 
overall study experiences, including any social harms (i.e., inadvertent disclosure, breach of 
confidentiality) of participation. Participants will be reimbursed KSh 500 for the exit interview. 
The topic guide for the exit interviews is included in “Appendix E: Shauriana Exit Interview 
Guide.” 
Pilot data analysis. Data from the pilot study will be reviewed on a weekly basis and 
corrections to ACASI skip rules or other data programming problems will be made immediately. 
Feedback from participants after intervention sessions and notes taken during interviews will be 

 
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reviewed by the team and discussed at weekly meetings. At the conclusion of the pilot study, we 
will assess whether we need to revise the intervention based on pilot test findings. If this 
is the case, we will submit revisions to the ethical review board at Maseno University 
and to the human subjects research committee at the University of Washington for 
approval. 
Aim 2 Procedures: RCT of the Shauriana Intervention. Aim 2 work will use an RCT design to 
test the acceptability, feasibility, and safety of the Shauriana Intervention compared to standard 
care and estimate initial effect size. Acceptability will be assessed using Likert scales in 
participant ACASI questionnaires and qualitative exit interviews with participants in each study 
arm. Feasibility will be assessed at regular research team and peer facilitator meetings, which 
will be minuted. Safety will be assessed through careful monitoring of study participants to 
identify and report any adverse events. Information on perceived or experienced social harms 
and benefits will be collected by study staff at all clinic visits and assessed in greater depth in 
qualitative exit interviews. Additional trial outcomes that will be monitored and reported include 
screening and enrollment numbers, visit and intervention attendance, overall retention, and self-
reported PrEP uptake and adherence. At the end of the trial, urine samples will be tested for 
tenofovir (TFV) drug levels (see Laboratory details, below). Dried blood spots will also be 
collected and stored for future testing of TFV-DP and FTC-TP levels, should funding permit. 
Recruitment. The Shauriana Intervention pilot RCT will enroll 60 HIV-negative men (30 
in the intervention and 30 in SOC) and follow participants for 6 months. We will recruit 60 
participants over the course of 3 months; this target is realistic, given enrolment of over 160 men 
in the Anza Mapema PrEP cohort within a 2-month period. Potentially eligible participants will 
be recruited by NYARWEK, then referred to the Anza Mapema Clinic for screening and 
consenting, as described on pp. 11-12.  
Trial enrollment and randomization. Once consent has been given, participants will be 
randomized to a study arm. The process of randomization to one of two study arms will be 
explained carefully and reviewed as part of the informed consent process. Computer-generated 
randomization will be used to assign participants in a 1:1 ratio to the standard care or 
intervention group, in blocks of 4, to ensure that equal numbers are randomized across arms. 
Numbered envelopes indicating the assignment will be prepared in and sealed by the UW CFAR 
Biometrics Core; study staff will not be aware of an individual’s condition until the envelope is 
opened.  
Clinic visits. Consistent with the latest Kenyan guidelines, all trial field-test participants 
will undergo study procedures at baseline, month 1, month 3, and month 6 at the Anza Mapema 
clinic. As for the pilot study, clinic visits will include HIV counselling and testing, screening for 
STI symptoms, and individual counselling about HIV prevention methods, including standard of 
care counselling (information, risk reduction, and PrEP counselling). A standardized physical 
exam will be performed at each visit, and both blood and urine samples will be collected. For 
participants taking PrEP, medical history will also focus on PrEP side effects and seroconversion 
symptoms, and PrEP refills will be provided (monthly for the first 3 months then quarterly). 
After completing these procedures, RCT participants will complete a detailed ACASI described 
below. Each of the four clinic visits (baseline, month 1, month 3, and month 6) will take from 1.5 
to 2 hours; participants will be reimbursed KSh 500 for each clinic visit.  

 
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Standard care. All participants will receive standard care at the Anza Mapema Clinic, 
including standard counseling as described above; screening for depressive symptoms and 
substance use disorder; monthly Anza Mapema peer outreach for education and supply of 
condoms and lubricants; support group meetings; and social events as described above under 
“Previous Studies and Rationale.” Attendance at Anza Mapema support groups and social events 
by Shauriana study participants will be tracked, as will the content of these group and social 
events during the study period. To ensure fidelity of delivery for each arm, we will review study 
progress, procedures, and emergent issues at weekly study meetings. 
Clinical outcomes that will be tracked by the Anza Mapema Clinic using existing data 
collection instruments include visit attendance, attendance at clinic-sponsored support groups or 
social events, diagnosis and treatment of STI, HIV test results, PrEP refills, and PrEP-related 
adverse events and their management. Treatment will be provided for STI syndromes and acute 
illnesses as needed. All non-scheduled clinic visits will be documented. The study team (both 
clinic staff and intervention facilitators) will refer participants who need services beyond their 
capacity to mental health, substance use, advocacy, and/or legal services provided locally. All 
referrals will be documented. 
Men who discontinue PrEP will continue follow-up; PEP will be available for men 
reporting high-risk exposure while not taking PrEP. Men who seroconvert will be withdrawn 
from the study and linked to HIV care at Anza Mapema or at another HIV clinic of their choice. 
As described above under “Recruitment,” participants who withdraw before or test positive at the 
month 1 visit will be replaced; replacement participants in the RCT will undergo randomization 
and not necessarily be assigned to the arm to which the participant they replace was assigned. 
Intervention delivery. Participants assigned to the Shauriana intervention will be 
introduced to an assigned peer facilitator on the day of their enrolment visit, after which 
telephone, SMS, and/or WhatsApp contacts from peers will begin, with in-person meetings per 
the intervention schedule described above. For the RCT, the intervention has been expanded to 
include an initial introductory session where peer facilitators spend timing getting to know their 
assigned participants. Therefore, five core intervention sessions and an optional additional 
session will be delivered. All peer facilitator contacts with participants and all required and 
optional intervention sessions will be documented. RCT participants will be reimbursed 350 KSh 
for their transportation after receiving each of the five core Shauriana modules, as participants 
may need to travel to a safe space for intervention delivery to ensure privacy. 
 ACASI measures and data collection. Due to its enhanced privacy, ACASI will be the 
main method of data collection, in English, Dholuo, or Kiswahili. This method was successfully 
used in the Anza Mapema project. Because participants occasionally have difficulties using 
ACASI, a research assistant will be available to assist participants if needed. The Anza Mapema 
clinic has an ACASI in use that includes questions on sociodemographics, sexual history, risk 
behavior, intimate partner violence, depressive symptoms, alcohol and other substance use, 
trauma, HIV risk perception, and awareness and use of PrEP and post-exposure prophylaxis for 
HIV prevention. Data elements that have been added to the ACASI specifically for the 
Shauriana study are listed below in Table 2. Our selection of measures for the Shauriana 
ACASI has drawn from our conceptual model for the Shikamana intervention and from the 
qualitative and intervention development work completed in protocol 

 
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MSU/DRPI/MUERC/00637/18. The Shauriana ACASI will be updated after the Aim 1 pilot 
test, balancing the need for data collection with the need to ensure a reasonable ACASI length 
without undue burden on participants. The final ACASI questionnaire is included in “Appendix 
F: Shauriana ACASI.” 
Table 2. PrEP-oriented and Shauriana-Specific Data Elements for Collection by ACASI 
Data Element 
Content 
Method 
Frequency 
Primary Outcome Variables 
 
Acceptability 
5-point Likert scales evaluating acceptability of the 
Shauriana intervention components,35 exit interviews 
for detailed qualitative feedback 
ACASI, exit 
interviews 
Quarterly 
Feasibility 
Visit attendance, session delivery, documentation of 
peer contacts, minutes of research team meetings 
Clinic and 
intervention data, 
minutes 
Ongoing 
Safety 
Adverse events reported by participants or study 
staff; self-reported consequences of study 
participation in exit interviews 
Reports at clinic 
visits, exit 
interviews 
M1 then 
quarterly 
Secondary Outcome Variables 
PrEP uptake 
Two questions on past and ongoing PrEP use 
ACASI 
Quarterly 
PrEP adherence 
A series of self-report measures we have used in 
previous work. 
ACASI 
Quarterly 
PrEP refills 
Documented at Anza Mapema for each participant 
Clinic data 
Quarterly 
PrEP drug levels 
Urine TFV levels36 
DBS TFV-DP and FTC-TP levels (if funding 
permits) 
Laboratory 
Quarterly 
Potential Correlates of Retention and Adherence 
 
Risk perception 
A question on the participant’s self-assessment of his 
chance of getting HIV/AIDS 
ACASI 
Quarterly 
PrEP knowledge 
PrEP knowledge questions (based on relevant 
literature and completed qualitative research by the 
team) 
ACASI 
Quarterly 
Motivation/skills 
LifeWindows Information-Motivation-Behavioral 
Skills adherence questionnaire,37,38 adapted for PrEP 
use based on completed qualitative research by the 
team. 
ACASI 
Quarterly 
PrEP distrust 
PrEP-related distrust, skepticism, trust in providers, 
and ownership (championing) per Amico et al.43 
ACASI 
Quarterly 
Shared decision 
making 
Participant-reported sharing of decision-making 
related to PrEP; adapted from Barr et al.39,40 
ACASI 
Quarterly 
Social support and 
loneliness 
Multidimensional Scale of Perceived Social Support, 
a 12-item scale of perceived support from family, 
friends, others41 
ACASI 
Quarterly 
Self-esteem 
10-item Rosenberg self-esteem scale,42 previously 
used in this population43 
ACASI 
Quarterly 
Resilience 
Coping self-efficacy scale: 13-item version validated 
in HIV+ GBMSM with depressed mood44 
ACASI 
Quarterly 
Sexual 
identification 
27-item lesbian, gay, and bisexual identity scale 
(LGBIS),45 previously used in Kenya43 
ACASI 
Quarterly 
 
Laboratory testing. HIV testing at screening and follow-up visits will be performed with 
two rapid tests (Determine®, Abbott Laboratories, Abbott Park, IL, USA; and First Response®, 
Premier Medical Corporation, Kachigam, Nani Daman, India), in accordance with the latest 
Kenyan HIV testing guidelines. Dried blood spots will be collected per an existing SOP at the 

 
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Anza Mapema Clinic, and stored for analysis of PrEP drug levels (i.e., detection of TFV-DP and 
FTC-TP), should funding permit. Safety monitoring in the RCT will be done at a higher standard 
than is currently available in Kenya, where costs of lab testing have prohibited routine baseline 
testing and instead use an approach targeted based on signs or symptoms of kidney or liver 
disease. Serum will be tested at baseline for creatinine level using the Cobas Integra 400 Plus 
biochemistry analyzer (Roche, Germany), to document normal renal function prior to PrEP start. 
Baseline serum will also be tested for hepatitis B surface antigen (HBsAg) using SD Bioline 
HBsAg WB at the CDC-KEMRI laboratory in Kisumu; men who do not have chronic hepatitis B 
(i.e., those who are HBsAg negative) will be offered hepatitis B vaccination.  
Blood and urine aliquots from baseline, month 3, and month 6 will be stored at -80ºC in 
the NRHS laboratory in Kisumu. Urine samples will be shipped on dry ice for testing utilizing 
the liquid chromatography tandem mass spectrometry (LC-MS/MS) urine tenofovir (TFV) assay 
developed at Philadelphia FIGHT/Children’s Hospital of Philadelphia by Dr. Helen Koenig and 
colleagues, currently performed by Molecular Testing Labs in Vancouver, Washington, USA. 
This assay detects TFV with greater sensitivity than plasma-based measures, with a detection 
window within 7 days of the last TDF/FTC dose.36 In addition, dried blood spots will be shipped 
to Molecular Testing labs for TFV-DP and FTC-TP quantitation using LC-MS/MS to estimate 
the number of doses taken in the past 7 days.15 If any participant acquires HIV during the study, 
HIV-1 genotypic resistance testing will be conducted on stored samples at the CDC-KEMRI 
laboratory in Kisumu, to determine whether acquired virus is resistant to TDF or FTC.  
Exit interviews. At study completion or any visit on which a participant withdraws, an 
exit interview will be conducted regarding experiences, including any social harms of 
participation and feedback on standard care or the Shauriana intervention. Exit interviews will 
be conducted by the Shauriana Project Research Coordinator, who is based at NYARWEK, 
using a semi-structured exit interview guide. Notes will be taken and interviews will be recorded 
using a digital recorder. All participants who complete an exit interview will receive KSh 500 as 
reimbursement for their time and transport. The topic guide for the exit interviews is included in 
“Appendix E: Shauriana Exit Interview Guide.” 
Schedule of procedures. A table summarizing procedures for the Shauriana study is 
included in “Appendix G: Schedule of Procedures.” 
Power considerations. This project is designed to develop a novel intervention to promote 
PrEP adherence and sexual health among African GBMSM and to assess its acceptability, 
feasibility, and safety in a clinical trial setting. It is not designed or powered to determine the 
overall intervention effect nor the effects of individual components of the intervention. Data on 
PrEP drug levels and other secondary outcomes in each study arm will help to evaluate whether 
the intervention is at least as good as standard care and provide some insight into the promise of 
the intervention to inform larger-scale testing. See Section 13 for statistical analysis plans. 
 
12. Ethical Considerations: 
 
Human Subjects Involvement and Characteristics: The proposed research is non-
exempt human subjects research. Prisoners and children under 18 years of age will not be 
included. Precautions will be taken as below regarding potential subjects with low literacy. All 
procedures will be conducted in accordance with 45 CFR Part 46. Protocols will be approved by 

 
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the Human Subjects Research Committees (HSRC) at the University of Washington (UW) and 
by the Maseno University Ethics and Research Committee (MUERC) in Kisumu, Kenya. During 
both research stages (pilot test and RCT), we will actively solicit feedback from GBMSM 
participants, as well as from the study team (clinic staff and peer facilitators) regarding the 
feasibility of the intervention components. In addition, we will hold ongoing discussions with the 
Anza Mapema Community Advisory Board, within the NYARWEK member network, and with 
our ethical review boards to ensure the relevance and ethical conduct of the research.  
 
The proposed Aim 1 study will include a population of 10 adult HIV-negative GBMSM 
recruited in Kisumu, Kenya. The proposed Aim 2 study will include a population of 60 adult 
HIV-negative GBMSM recruited in Kisumu, Kenya. To be eligible for the Shauriana 
intervention pilot or trial, men must be biologically male at birth and male-identifying, 18 to 35 
years of age, resident in the Kisumu area for ≥12 months, report anal intercourse with a man in 
the past 3 months, and be willing to provide complete locator information and undergo all study 
procedures, including HIV testing and counseling (HTC). In addition, men should not be 
currently participating in any HIV prevention or vaccine study and be planning to remain in the 
study area for at least 6 months. Men will be excluded if they are unable to understand the study 
purpose and procedures or unwilling to adhere to study procedures or currently under the 
influence of alcohol or drugs (assessed by clinic staff during screening) or have a prior diagnosis 
of HIV infection. 
Clinical management of PrEP, including PrEP eligibility and exclusion criteria, will be 
strictly according to Kenyan Ministry of Health (MoH) guidelines, which closely follow World 
Health Organization guidelines. While current management is detailed in the study protocol, 
procedures will be updated if Kenyan MoH guidelines change. PrEP will be supplied by the 
Kenya National AIDS and STI Control Programme (NASCOP). Syndromic treatment for STI 
and for minor injuries or illness will be managed at the study clinic free of charge. 
Eligible men who consent to pilot study participation will all receive the Shauriana 
intervention. Pilot study participants will be followed for 3 months total, attending visits as 
detailed in the protocol. At each clinic visit, participants will be given 500 Kenyan shillings 
(Ksh, about $5) to reimburse them for their time and transport expenses. After delivery of each 
of four intervention modules, feedback on the intervention materials will be elicited and 
participants will be reimbursed 500 KSh for their time and transport expenses. Men who test 
positive for HIV during the study will be withdrawn from the pilot study and referred to care at 
the comprehensive care clinic of their choice, either at the Anza Mapema Clinic run by the 
Nyanza Reproductive Health Society (NRHS) or at any of several other clinics providing HIV 
care and treatment in the greater Kisumu area. All non-scheduled contacts with study staff will 
be documented. At month 3 or at the time of withdrawal for any reason (e.g., a move from the 
study area), a semi-structured exit interview will be conducted regarding experiences, including 
any social harms of study participation. Permission will be requested for digital recording of the 
pilot test intervention sessions and the semi-structured exit interviews during the consenting 
process, and confirmed at the time of the interview. Men will be reimbursed KSh 500 for 
completing their exit interview. 
Eligible men who consent to RCT participation will be randomized to receive either 
standard PrEP counseling and support following Kenyan MoH guidelines or standard care plus 

 
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the Shauriana intervention. RCT participants will be followed for 6 months total, attending 
visits as detailed in the protocol. At each clinic visit, participants will be given 500 Kenyan 
shillings (about $5) to reimburse them for their time and transport expenses. RCT participants 
will be reimbursed 350 KSh for their transportation after receiving each of the four core 
Shauriana modules, as participants may need to travel to a safe space for intervention delivery 
to ensure privacy. 
Men who test positive for HIV during the study will be withdrawn from the trial and 
referred to care at the comprehensive care clinic of their choice, either at the Anza Mapema 
Clinic run by the Nyanza Reproductive Health Society (NRHS) or at any of several other clinics 
providing HIV care and treatment in the greater Kisumu area. All non-scheduled contacts with 
study staff will be documented. At month 6 or at the time of withdrawal for any reason (e.g., a 
move from the study area), a semi-structured exit interview will be conducted regarding 
experiences, including any social harms of study participation. Permission will be requested for 
digital recording of the semi-structured exit interviews during the consenting process, and 
confirmed at the time of the interview. Men will be reimbursed KSh 500 for completing their 
exit interview. 
Research Material Obtained from Participants: At study visits, detailed audio 
computer-assisted self-interview (ACASI) data collected will include sociodemographic 
background; sexual risk behavior; experience of stigma, discrimination and violence; depression; 
alcohol and drug use; current physical symptoms; and HIV and PrEP knowledge. Before each 
PrEP dispensation/refill, data on PrEP status and adherence will also be recorded by ACASI. 
Names will be included only on a registration form containing information to be used in locating 
the participant in case of need (e.g., laboratory results requiring follow-up, tracing after a missed 
visit); this registration form will also be used to prevent duplicate enrolments. Names will not be 
included in routine data collection forms or in the computer database. Names of sexual contacts 
will not be collected. 
Collection of specimens is for study purposes (e.g., monitoring of outcomes), but results 
will also be used to provide appropriate clinical care (e.g., PrEP safety monitoring, HIV care 
referral if indicated). HIV testing using a finger-prick blood sample will be conducted at all study 
visits, regardless of PrEP uptake or adherence. This testing will be conducted following current 
Kenyan MoH guidelines. Safety monitoring in the RCT will be done at a higher standard than is 
currently available in Kenya, where costs of lab testing have prohibited routine baseline testing 
and instead use an approach targeted based on signs or symptoms of kidney or liver disease. 
Serum will be tested at baseline for creatinine level using the Cobas Integra 400 Plus 
biochemistry analyzer (Roche, Germany), to document normal renal function prior to PrEP start. 
Baseline serum will also be tested for HBsAg using SD Bioline HBsAg WB at the CDC-KEMRI 
laboratory in Kisumu; men who do not have chronic hepatitis B (i.e., HBsAg positive) will be 
offered hepatitis B vaccination. 
Urine and dried blood spots will be collected and stored for assessment of PrEP drug 
levels at baseline, month 3, and month 6. Blood draws at the baseline, month 3, and month 6 
visits will have a maximum volume of 15 mL, with up to 10 mL for required for laboratory 
testing and 5 mL to store for assessment of genotypic drug resistance for any participant who 
acquired HIV during the study. Consent will be obtained prior to all specimen collection.  

 
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Recruitment of Subjects and Consent Procedures: Subjects will be recruited by the 
NYARWEK team using existing peer networks, snowballing and venue-based referrals. All 
interested subjects will be referred to the Anza Mapema clinic for study eligibility screening, for 
which a brief screening consent will be used (Appendix C). If an individual is found to be 
eligible, he will undergo the informed consent process outlined below. Men who are found to be 
ineligible will be referred to HIV prevention or care programming as indicated, including risk 
reduction counseling, condoms and lubricants, STI screening and treatment, programmatic PrEP 
if eligible and interested, and HIV care for men who test positive. These men will receive KSh 
350 for their time and transport to the clinic for the screening process. 
Trained Anza Mapema study staff, fluent in Dholuo, English and Kiswahili, will offer 
participation to the ongoing study component (i.e., pilot study or RCT participation) using a 
consent specific to that study component. Each informed consent document will describe the 
purpose of the specific component of the study described, the procedures to be followed, and the 
risks and benefits of participation. During the consent process, staff will explain the study 
procedures, with emphasis on features that differ from routine programmatic services, 
highlighting the risks and benefits of study participation. Consent documents will be available in 
Dholuo, English and Kiswahili. If an individual is illiterate, all procedures, risks and benefits will 
be explained and the individual will be given the option of having a friend or family member or a 
trained consultant who is not a member of the research staff to be present to further explain the 
study.  
Written informed consent will be obtained from all participants; persons incapable of 
providing informed consent are excluded. Potential participants who would like to take 
additional time to consider their enrolment will be encouraged to do so. Participants will be able 
to opt in or out of optional elements of study participation before signing the consent; these 
include: iris scanning as biometric identification, text messages as reminders of study visits, 
digital recording of intervention sessions (pilot test only) and exit interviews (pilot test and 
RCT). Staff will emphasize that participation is voluntary, and that participants can refuse to 
answer any question or undergo any procedure or can discontinue participation at any time 
without penalty. Participants will be informed of the procedures for ensuring confidentiality, 
including use of unique non-personally identifying ID numbers instead of names on research 
materials, and the maintenance of data in encrypted computer databases and locked filing 
cabinets in locked rooms. Enrolled participants will be provided with a signed and dated copy of 
the informed consent document before they leave the study site. 
Risks to Human Subjects: The potential risks of study participation can be divided into 
risks specifically related to the study and, for those participants who initiate and adhere to PrEP, 
risks inherent in taking prophylactic antiretroviral medications. The risks associated with taking 
PrEP are not truly risks associated with the research, since any man who takes PrEP is exposed 
to these potential complications and inconveniences, regardless of study participation. However, 
we list them here to be comprehensive. 
Risks and Inconveniences Related to Participation 
• There is a small risk of loss of privacy or confidentiality for participants related to study 
visits, exit interviews, or contacts by staff, peers, or field workers. This study will include 
questionnaires and counselling on sensitive topics including sexual risk behavior.  

 
23 | P a g e  
 
      
• Participants may also experience psychological discomfort during discussion and 
disclosure about stigma, mental health symptoms, and substance use.  
• Participants may experience stigma or discrimination if stigmatized sexual risk behavior 
(e.g., male-male sex) is revealed. 
• Potential inconveniences include: 
o Intensive monitoring during study follow-up, and 
o Collection of blood and urine specimens (RCT only). 
Risks and Inconveniences Inherent to Use of PrEP 
Medical risks associated with PrEP will be no different in this trial than they would be if 
PrEP were started in a non-research setting according to standard care in Kenya. TDF/FTC or 
TDF/3TC, the drugs used for PrEP in Kenya, may cause side effects including headache, 
nausea, diarrhea, vomiting, rash, depression and mild, painless darkening of the skin on their 
palms and/or soles of feet. Most medication-related adverse effects are mild to moderate, 
resolve within weeks, and do not require discontinuation of therapy. Rarely, severe side 
effects including hepatitis and renal failure can occur, and may be life threatening. There is a 
small risk that men with chronic hepatitis B infection but no evidence of liver disease 
constituting a medical exclusion at baseline could experience a hepatitis flare upon 
discontinuation of PrEP. Because reports to date indicate that this risk is minimal, the 
Kenyan PrEP guidelines do not exclude these men from PrEP programming. There is a small 
risk that a participant could acquire an HIV-1 strain with antiretroviral resistance, if 
adherence to PrEP is suboptimal. Other potential risks and inconveniences related to PrEP 
use include the need for regular HIV testing, collection of blood for safety monitoring, and 
loss of privacy related to the need for chronic medication. Participants who experience 
persistent or serious adverse effects of PrEP will be advised to stop this medication and focus 
on behavioral risk reduction instead. Participants who are diagnosed with HIV infection 
during PrEP monitoring will receive supportive counseling and referral for HIV care. 
Adequacy of Protection from Risks: Every effort will be made to minimize the risks 
associated with study participation. Experienced research staff will counsel participants prior to 
enrolment, so that they are aware of the risks described above. We will have strict guidelines and 
procedures in order to minimize the potential for emotional distress due to questions asked in the 
ACASI, intervention sessions or participant interviews. Participants will be told during the 
informed consent procedures that some of the questions asked may cause discomfort or distress. 
Participants will be assured of their right to refuse to answer any questions they do not wish to 
answer. Participants will be assured of their right to leave an intervention session or end an 
interview prior to completion. To minimize the risk of discomfort, assessments, intervention 
sessions, and interviews will be conducted in private areas. If during the course of an computer-
assisted interview, intervention session, or interview, the participant demonstrates or articulates 
signs of distress, the research staff will be trained to immediately stop the activity taking place. 
Referral to mental health and other support services will be available onsite or through referrals 
to local community providers. Research staff members will receive initial and ongoing training 
in: ethics and confidentiality; study protocols; emergency procedures; mandated reporting 
procedures; general interviewing skills and data management. We have in place an emergency 
procedure protocol if the participant reveals information that would require immediate action 
(e.g., suicidal intent). Drs. Harper and Simoni, both licensed mental health professionals, will be 

 
24 | P a g e  
 
      
notified immediately of such events and provide support as needed to the study team for triage 
and management pending successful referral. 
The risk for loss of privacy will be minimized by strict confidentiality procedures. 
Identifying information collected for tracing purposes will be kept in an encrypted contact 
information file on a password-protected laptop computer with an encrypted hard drive. A master 
electronic file including the linkage of names to numbers (used to identify participants who 
return without a numbered study card) will be encrypted and retained on a single computer at 
NRHS in a secure location. This master file will be checked each day for duplicates. Consents 
will be stored in a separate area in a locked file cabinet. All personal identifying information will 
be destroyed immediately after the study is completed. In addition, privacy will be protected by 
ensuring that computer-assisted interviews and examinations take place in private rooms. 
Recordings from pilot test intervention sessions and participant interviews will be transcribed 
and stored on a password-protected personal computer. Interviews conducted in Swahili or 
Dholuo will be simultaneously translated into English and transcribed, with back-translation and 
verification by a different person to ensure accuracy. Participants will not be identified by name 
in the interview transcripts, rather by study ID. We will also protect privacy by developing 
individualized procedures for study-related contacts in collaboration with each participant. 
NRHS study staff and peer outreach workers already have 2-10 years of experience maintaining 
confidentiality and privacy with GBMSM in Kisumu, and are either from the GBMSM 
community or face social challenges due to secondary stigma. The NYARWEK research team, 
including all peer facilitators, similarly have all been trained in human subjects research 
protections and privacy protections. All newly hired staff and peers will undergo rigorous 
training on the protection of confidentiality and particular need for discretion in working with 
this population, whether in the clinic or community.  
All study procedures will be conducted according to detailed standard operating 
procedures that emphasize participant protections and the voluntary nature of participation. All 
HIV testing will be accompanied by pre- and post-test counselling, in accordance with the latest 
Kenyan national guidelines. In addition, experienced research staff will oversee all computer-
assisted interviews and perform examinations and blood collection. Appropriate clinical and 
laboratory monitoring will minimize the risk of severe adverse events related to PrEP during 
clinic follow-up. Participants will be assured that their clinical care will not be affected by their 
participation status in any component of the study, nor by their responses in questionnaires. 
Participants will be informed that they have the right to withdraw or refuse an examination or 
sample collection at any point. All study staff and GBMSM community members involved in 
research procedures will be required to undergo training in Human Subjects protection 
certification and in Good Clinical Practice (GCP), and all laboratory staff will be required to 
undergo periodic training in Good Clinical Laboratory Practice (GCLP).  
The District Commissioner, Officer Commanding Police Division, the County Health 
Director and the District Medical Officer of Health are aware of our GBMSM research activities, 
and they support non-discrimination based on sexual orientation. While homosexuality is illegal 
in Kenya, there are strong passages in the constitution protecting human rights, and judicial, 
police and health authorities have chosen to emphasize human rights as protecting LGBT, 
including in Kisumu County. This does not mean, however, that there are no risks to disclosure 

 
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of same-sex sexual behavior, and this study will do everything possible to maintain 
confidentiality and anonymity of study participants. We have an established community advisory 
board (CAB) at Anza Mapema to advise us on risks to participants related to study procedures 
and to assist in monitoring social and psychological harm resulting from study participation. This 
CAB is currently composed of Mr. Onyango (Executive Director, NYARWEK), an additional 
GBMSM community representative, a lawyer with experience in defending GBMSM in the 
courts, a religious leader, and the Kisumu District AIDS and STI Control Officer (DASCO).  
All participating men will receive a comprehensive package of services, including HIV 
testing and risk reduction counseling, condoms and lubricants, and screening and treatment for 
syndromic STI, regardless of whether they initiate and continue PrEP. For men who initiate and 
continue PrEP, appropriate clinical and laboratory monitoring will minimize the risk of severe 
adverse events. Men in the standard care and intervention arms will receive regular PrEP 
adherence support, according to detailed procedures for each study arm. There will be no charge 
to participants for the medications or services provided. Men may withdraw from the study at 
any time. For any man who withdraws from the study, we will ask him to complete a withdrawal 
survey regarding his reason for withdrawal, any care and referral needs, and intent to establish 
care elsewhere. Men who withdraw will also be invited to participate in an exit interview, if 
willing. Of note, PrEP is available in a non-research (program) context at several sites in Kisumu 
including the Anza Mapema Clinic, should men be eligible for and interested in PrEP but not 
want to participate in this research study. 
Potential Benefits to the Subjects and Others: Benefits of study participation include the 
following: 
1. All study participants may benefit in terms of access to risk reduction counseling, 
periodic STI screening and HIV testing, and PrEP programming. 
2. For study participants who initiate and adhere to PrEP during follow-up, there is the 
potential to avoid HIV acquisition while working to reduce behavioral risks. 
3. Pilot study participants and those assigned to the Shauriana intervention group in the 
randomized trial may benefit from a GBMSM-affirming, tailored approach to PrEP 
provision with activities to promote resilience, decrease stigma, and improve sexual 
health. 
4. All participants will contribute to a study that will evaluate ways of increasing access to 
HIV prevention services tailored to the needs of Kenyan GBMSM. 
Potential Benefits to Others 
1. From the perspective of the population from which participants be recruited, this study 
offers the potential for GBMSM to benefit from the testing and evaluation of a GBMSM-
affirming, tailored approach to HIV prevention.  
2. This study has the potential to reduce HIV transmission in the Kisumu area by reducing 
HIV transmission in a key population that is estimated to account for ≈15% of new HIV 
infections in Kenya. 
The proposed work will help us to adapt and enhance a promising intervention for this at-risk 
population. Given the low likelihood of significant risks to participants, the risks seem 
reasonable in relation to anticipated benefits. 

 
26 | P a g e  
 
      
Importance of the Knowledge to be Gained: Results of this study will be applicable to 
the development and scale-up of HIV prevention programs for GBMSM in Kenya and other East 
African countries, and could serve as a model for peer-led approaches to HIV prevention for 
vulnerable and marginalized populations. In addition to the general applicability of the results, 
this project will help to develop capacity in Kenya to scale-up PrEP for this target population and 
to promote GBMSM leadership and input into research and programs. 
Trial Registration: The trial will be registered with ClinicalTrials.gov upon ethical 
approval of a final protocol. 
 
Consent Form: For participant screening materials and consent form, see “Appendix C: 
Eligibility Screener and Checklist,” “Appendix H: Pilot Study Consent,” and “Appendix I: RCT 
Consent.” 
 
Other Institutional Ethics Reviews Received: The IRB at University of Washington has 
approved this research protocol, along with the screener and two consents. Documentation is 
attached with this application. 
13. Data Management & Statistical Analysis Plans: 
 
Data Management Plan: Recruitment, consenting, and data collection will be monitored 
carefully to ensure the confidentiality and safety of participants, as detailed in our Human 
Subjects statement. 
Statistical Analysis Plan: Data analysis will include both quantitative and qualitative 
components. 
Qualitative analyses. Clinic staff and intervention team feedback from meetings will be 
monitored in real time, to identify any problems needing correction, and then analyzed at the end 
of the study, to assess feasibility of the intervention, should scale-up for a larger trial seem 
warranted. Pilot study feedback and pilot/RCT exit interviews will be analyzed to evaluate men’s 
views regarding the acceptability and overall value of the intervention vs. standard care. In 
addition, we will review exit interview transcripts to identify best practices for engaging and 
retaining GBMSM in the Shauriana intervention and for optimizing adherence to a daily PrEP 
regimen and uptake of other HIV prevention services. Notes and tapes from exit interviews will 
be translated and transcribed into English, then reviewed to identify and code salient themes. 
NVivo software will be used to facilitate qualitative analysis.  
Primary quantitative analyses. Acceptability of intervention procedures will be assessed 
by comparing month 3 and month 6 Likert scale scores for the acceptability of study 
participation across study arms, using Mann-Whitney U tests. Likert scale scores for Shauriana 
intervention components will be summarized using medians, interquartile ranges, and ranges for 
intervention participants. Social harms and benefits reported by participants in each arm will be 
tallied and described in report form. 
Secondary quantitative analyses. Participant characteristics in the two study arms will be 
presented using counts and percentages for categorical variables and means and standard 
deviations or medians and inter-quartile ranges (IQR) for continuous variables. Descriptive 
statistics will be used to evaluate distributions of the measures assessed at each time-point. To 
determine validity of the scales used, item scores will be evaluated using Cronbach’s alpha and 
factor analysis, then compared to published scale psychometrics in African populations if 
possible. The temporal stability of scales will also be investigated to ensure reliability. These 

 
27 | P a g e  
 
      
approaches will help assess the utility of the instruments used for future analyses and research in 
HIV-negative Kenyan GBMSM.  
Given the preliminary nature of this work and the small sample size dictated by time and 
budget limitations, secondary analyses will focus on obtaining estimates of Table 2 secondary 
outcomes (PrEP uptake, adherence, refills, and drug levels) in each group and characteristics 
associated with these outcomes, for use in design of a larger study. Retention will be compared 
across study arms using uncorrected Chi square tests in an intent-to-treat analysis. Rates and 
patterns of self-reported PrEP adherence (defined as taking 4 or more doses per week) will be 
examined, and assessment methods will be compared using bivariate analyses (e.g., Spearman 
correlation coefficients for continuous variables). Sociodemographic and other potential 
cofactors will be evaluated for associations with adherence measures and other outcomes (e.g., 
urine TFV levels, dried blood spot TFV-DP) using Wilcoxon rank sum or independent-sample t 
tests, Spearman or Pearson correlations, and chi-square tests as appropriate. Multivariable 
analyses will adjust for sociodemographic and other potential cofactors. Parsimonious model 
testing will explore potential intervention efficacy. 
14. Laboratory Specimens and Biohazard Containment: 
Laboratory Specimens: The following specimens will be collected for the tests to be 
conducted for the randomized trial:  
• Blood (15 milliliters) for creatinine and hepatitis B surface antigen testing at baseline 
and dried blood spots plus storage at baseline, month 3, and month 6 
• Urine (10 milliliters) for PrEP drug level testing 
Research staff will adhere to standards of good clinical laboratory practice, and local SOPs for 
specimen management, including proper collection, processing, labeling, and transport of 
specimens to the CDC-KEMRI laboratory for testing or the UNIM Research and Training Centre 
for storage. 
Biohazard Containment: Transmission of HIV and other blood borne pathogens can 
occur through contact with contaminated needles, blood, and blood products. Appropriate blood 
and secretion precautions will be employed by all personnel in the collection of clinical samples 
and the shipping and handling of all clinical samples and isolates for this study, as currently 
recommended by the World Health Organization and the Kenyan Ministry of Health. After all 
requisite permissions are obtained, urine and dried blood spot samples will be shipped to Dr. 
Graham at the University of Washington and then forwarded to Molecular Testing Labs in 
Vancouver, Washington, USA, for PrEP drug level testing. All specimens will be shipped using 
packaging that meets requirements specified by the International Air Transport Association 
Dangerous Good Regulations for UN 3373, Biological Substance, Category B, and Packing 
Instruction 650. In addition, all infectious specimens will be transported in accordance with 
United States regulations (42 CFR 72). 
15. Study Limitations/Possible Complications and How to Minimize Them: 
This proposal includes an ambitious research plan and timeline, based on the urgency of the 
problem addressed. We acknowledge several potential complications: 
1. Research involving GBMSM in Kenya can be sensitive, and a good relationship with the 
key stakeholders (e.g., Ministry of Health, police, media) will be critical to ensure safety. 
While male-male sex is illegal in Kenya, the Kenyan courts recently ruled against forced 

 
28 | P a g e  
 
      
anal examinations at police stations. We have safely conducted multiple studies with 
GBMSM participants in Kenya since 2005, and have taken measures in Kisumu to ensure 
we have assistance should any problems arise (e.g., the Anza Mapema CAB has 
successfully resolved sensitive situations through dialogue). In addition, security is a 
pillar of NYARWEK’s work, and includes GBMSM sensitivity training for local police 
and judiciary. We also have the endorsement of the Kisumu County Ministry of Health 
for the proposed work, and confer with County Health officials periodically and when 
issues arise. 
2. We do not anticipate that recruiting and retaining participants for the Aim 1 pilot and the 
Aim 2 trial will be difficult. The >600 HIV-negative participants recruited and high 
retention achieved in Anza Mapema, support from GBMSM partners, and a strong 
community outreach program suggests recruitment of 60 GBMSM participants not 
currently taking PrEP will not be challenging.  
3. Because we will conduct the intervention trial in a single community with overlap in 
social and sexual networks, there could be contamination of arms, with participants in the 
standard care arm receiving some intervention components. We will address this risk by 
locating all intervention procedures outside the Anza Mapema Clinic, monitoring 
standard care at the Anza Mapema Clinic, and strict adherence to trial protocols. We had 
success with such monitoring in the Shikamana trial, in which audits of recorded 
counseling sessions found minimal contamination of standard vs. intervention 
approaches. Manipulation checks will also be included in exit surveys to identify 
potential crossover contamination. 
4. We also acknowledge that there may be differences in attention due to increased peer 
contact or counseling efforts in the intervention arm. We will monitor data on Anza 
Mapema Clinic visits (planned study visits and interim visits), Anza Mapema social 
activities, and all Shauriana intervention contacts with participants, to assess differences 
in attention across study arms. 
5. Finally, the HIV prevention landscape is constantly changing and injectable PrEP may be 
on the horizon. Even if injectable PrEP replaces oral PrEP and reduces the burden on 
participants to adhere to daily therapy, GBMSM in Kenya and other rights-constrained 
settings will continue to face stigma and discrimination that may affect uptake and 
maintenance of HIV prevention. Hence, a holistic approach to sexual health such as that 
provided by the Shauriana intervention would still be pertinent and needed. 
 
16. Timeline/Time Frame:  
Aims 1 and 2 of the project (pilot phase and trial of the Shauriana intervention) will occur over 
an 18-month period, from the time all ethical approvals are in place. Piloting will take place in 
months 1-5 of the proposed work, after training of the peer facilitators and of the Anza Mapema 
Clinic staff on the research protocol. Recruitment for the RCT would take place over months 6-
12, with 6-month follow-up for each enrolled participant. As work progresses, we will present 
abstracts at international and national conferences and submit manuscripts to top-tier journals 
with an audience inside and outside of Africa. 

 
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17. References: 
1. 
Smith AD, Tapsoba P, Peshu N, Sanders EJ, Jaffe HW. Men who have sex with men and 
HIV/AIDS in sub-Saharan Africa. Lancet 2009;374:416-22. 
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Beyrer C, Sullivan PS, Sanchez J, et al. A call to action for comprehensive HIV services 
for men who have sex with men. Lancet 2012;380:424-38. 
3. 
Baral S, Sifakis F, Cleghorn F, Beyrer C. Elevated risk for HIV infection among men who 
have sex with men in low- and middle-income countries 2000-2006: a systematic review. 
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4. 
Cáceres CF, Konda K, Segura ER, Lyerla R. Epidemiology of male same-sex behaviour 
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Wade AS, Kane CT, Diallo PA, et al. HIV infection and sexually transmitted infections 
among men who have sex with men in Senegal. AIDS 2005;19:2133-40. 
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Sanders EJ, Graham SM, Okuku HS, et al. HIV-1 infection in high risk men who have sex 
with men in Mombasa, Kenya. AIDS 2007;21:2513-20. 
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Sanders EJ, Okuku HS, Smith AD, et al. High HIV-1 incidence, correlates of HIV-1 
acquisition, and high viral loads following seroconversion among MSM. AIDS 
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8. 
McKinnon LR, Gakii G, Juno JA, et al. High HIV risk in a cohort of male sex workers 
from Nairobi, Kenya. Sex Transm Infect 2014;90:237-42. 
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National AIDS and STI Control Programme. Kenya AIDS Indicator Survey 2012: Final 
Report. Nairobi, Kenya: Ministry of Health; 2014. 
10. Government of Kenya. Kenya National AIDS Strategic Plan III: 2009/10 – 2012/13. 
Nairobi, Kenya: Ministry of Health; 2013. 
11. National AIDS Control Council. Kenya: HIV Prevention Response and Modes of 
Transmission Analysis. Nairobi, Kenya: Ministry of Health; 2009. 
12. The US President’s Emergency Plan for AIDS Relief. Technical Guidance on Combination 
HIV Prevention. Washington, DC: PEPFAR; 2011.  
13. National SOGIE Research Advisory Committee. G10 Research Engagement: A 3 Year 
Roadmap for Action for Sexual Orientation Gender Identity and Expression (SOGIE) 
Engagement in Research (2016/17 -2018/2019). Nairobi, Kenya: International AIDS 
Vaccine Initiative; 2016. 
14. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV 
prevention in men who have sex with men. N Engl J Med 2010;363:2587-99. 
15. Anderson PL, Glidden DV, Liu A, et al. Emtricitabine-tenofovir concentrations and pre-
exposure prophylaxis efficacy in men who have sex with men. Sci Transl Med 
2012;4:151ra25. 
16. World Health Organization. Guideline on when to start antiretroviral therapy and on pre-
exposure prophylaxis for HIV. Geneva, Switzerland: WHO Press; 2015. 
17. Donnell D, Baeten JM, Bumpus NN, et al. HIV protective efficacy and correlates of 
tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. J Acquir 
Immune Defic Syndr 2014;66:340-8. 
18. World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, 
treatment and care for key populations. Geneva, Switzerland: WHO Press; 2014. 
19. National AIDS Control Council. Kenya HIV Prevention Revolution Road Map: Countdown 
to 2013. Nairobi, Kenya: Ministry of Health; 2014. 

 
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20. PrEP Watch: Country Updates. Accessed August 29, 2017, at 
http://www.prepwatch.org/advocacy/country-updates/#kenya. 
21. National AIDS & STI Control Programme (NASCOP), Ministry of Health. Framework for 
the Implementation of Pre-exposure Prophylaxis of HIV in Kenya. Nairobi, Kenya: 
NASCOP; 2017. 
22. Mutua G, Sanders E, Mugo P, et al. Safety and adherence to intermittent pre-exposure 
prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex 
workers. PLoS One 2012;7:e33103. 
23. Van der Elst EM, Mbogua J, Operario D, et al. High acceptability of HIV pre-exposure 
prophylaxis but challenges in adherence and use: qualitative insights from a phase I trial of 
intermittent and daily PrEP in at-risk populations in Kenya. AIDS Behav 2013;17:2162-72. 
24. Mugo PM, Sanders EJ, Mutua G, et al. Understanding adherence to daily and intermittent 
regimens of oral HIV pre-exposure prophylaxis among men who have sex with men in 
Kenya. AIDS Behav 2015;19:794-801. 
25. Karuga RN, Njenga SN, Mulwa R, et al. "How I wish this thing was initiated 100 years 
ago!" Willingness to take daily oral pre-exposure prophylaxis among men who have sex 
with men in Kenya. PLoS One 2016;11:e0151716. 
26. Graham SM, Mugo P, Gichuru E, et al. Adherence to antiretroviral therapy and clinical 
outcomes among young adults reporting high-risk sexual behavior, including men who 
have sex with men, in coastal Kenya. AIDS Behav 2013;17:1255-65. 
27. Graham SM, Micheni M, Kombo B, et al. Development and pilot testing of an intervention 
to promote care engagement and adherence among HIV-positive Kenyan MSM. AIDS 
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28. Graham SM, Micheni M, Chirro O, et al. A randomized controlled trial of the Shikamana 
intervention to promote antiretroviral therapy adherence among gay, bisexual, and other 
men who have sex with men in Kenya: Feasibility, acceptability, safety and initial effect 
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29. Graham SM, Micheni M, Secor A, et al. HIV care engagement and ART adherence among 
Kenyan gay, bisexual, and other men who have sex with men: a multi-level model 
informed by qualitative research. AIDS Care 2018;30:S97-S105. 
30. Plenty A, Bailey RC, Geibel S. Men's Health Study: preliminary findings of a respondent-
driven sampling study of MSM in Kisumu. University of Nairobi Annual Collaborative 
Meeting; Nairobi, Kenya: January 23-27, 2012. 
31. Kunzweiler CP, Bailey RC, Okall DO, Graham SM, Mehta SD, Otieno FO. Factors 
associated with prevalent HIV infection among Kenyan MSM: The Anza Mapema Study. J 
Acquir Immune Defic Syndr 2017;76:241-249. 
32. Geibel S. Same-sex sexual behavior of men in Kenya: Implications for HIV prevention, 
programs, and policy. Facts Views Vis Obgyn 2012;4:285-94. 
33. Micheni M, Kombo BK, Secor A, et al. Health provider views on improving antiretroviral 
therapy adherence among men who have sex with men in coastal Kenya. AIDS Patient 
Care STDS 2017;31:113-21. 
34. Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting 
evidence-based HIV Interventions. J Acquir Immune Defic Syndr 2008;47 Suppl 1:S40-6. 
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36. Koenig HC, Mounzer K, Daughtridge GW, et al. Urine assay for tenofovir to monitor 
adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure 
prophylaxis. HIV Med 2017;18:412-8. 
37. Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills 
model of adherence to antiretroviral therapy. Health Psychol 2006;25:462-73. 
38. Fisher JD, Amico KR, Fisher WA, et al. Computer-based intervention in HIV clinical care 
setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav 
2011;15:1635-46. 
39. Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric 
properties of CollaboRATE: a fast and frugal patient-reported measure of the shared 
decision-making process. J Med Internet Res 2014;16:e2. 
40. Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. Correction: the 
psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the 
shared decision-making process. J Med Internet Res 2015;17:e32. 
41. Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics 
of the Multidimensional Scale of Perceived Social Support. J Pers Assess 1990;55:610-7. 
42. Rosenberg M. Society and the adolescent self-image. Princeton, New Jersey: Princeton 
University Press; 1965. 
43. Harper GW, Wade RM, Onyango DP, et al. Resilience among gay/bisexual young men in 
Western Kenya: psychosocial and sexual health outcomes. AIDS 2015;29 Suppl 3:S261-9. 
44. Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and 
reliability study of the coping self-efficacy scale. Br J Health Psychol 2006;11:421-37. 
45. Mohr JJ, Kendra MS. Revision and extension of a multidimensional measure of sexual 
minority identity: the Lesbian, Gay, and Bisexual Identity Scale. J Couns Psychol 
2011;58:234-45. 
 
18. Budgetary Estimates 
Budget, Year 1 
Budget Category 
Amount in USD 
Personnel 
$54,215 
Research Travel (US to Kenya) 
$15,000 
Supplies  
$20,000 
Nyanza Reproductive Health Society Subcontract (includes NRHS 
personnel, NYARWEK personnel, travel, supplies, clinic and 
community costs, and other study expenses) 
$85,784 
 
Budget Justification 
The provided budget sufficiently covers the expenses required to conduct the proposed research. 
This budget includes salary support for investigators and other personnel at Maseno University 
(PI Dr. Wilson Odero), the University of Washington (Co-PI Dr. Susan Graham, adherence 
expert Dr. Jane Simoni, grants administrator Yvonne Zhang, and biostatistician Sarah Holte), the 
University of Michigan (Co-PI Dr. Gary Harper, counseling expert Dr. K. Rivet Amico, and 
research manager Laura Jadwin-Cakmak), Nyanza Reproductive Health Society (Research 

 
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Director Dr. Fredrick Otieno and other staff), and Nyanza Rift Valley LGBTI Network 
(NYARWEK; Daniel Onyango). The budget also includes international travel funds for Drs. 
Graham, Harper, Amico, and Ms. Jadwin-Cakmak to travel from the U.S. to Kenya for study 
activities. Finally, the budget includes a subcontract to NRHS that includes salary support for 
personnel, travel, supplies, clinic and community costs, and other study expenses. 
 
 

 
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19. Appendices 
 
Appendix A: Investigator Biosketches / CVs 
 
Appendix B: Facilities & Other Resources  
 
Appendix C: Eligibility Screener and Checklist 
 
Appendix D: Shauriana Intervention Draft 
 
Appendix E: Shauriana Exit Interview Guide 
 
Appendix F: Shauriana ACASI 
 
Appendix G: Schedule of Procedures 
 
Appendix H: Pilot Study Consent 
• English 
• Dholuo 
• Kiswahili 
 
Appendix I: RCT Consent 
• English 
• Dholuo 
• Kiswahili 
Appendix J: University of Washington IRB Approval Letter 
Appendix K: Ethics Certificates 
 
 
 
 

SHAURIANA TRIAL CONSENT 
 
Shauriana Project MUERC Application 
 
Version 2.0, March 2, 2021 
PARTICIPANT INFORMATION & CONSENT FORM 
The Shauriana Program: A Community Participatory Approach to Integrating PrEP,  
Sexual Health, and Mental Health Services for  
Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya 
 
Investigators:  
Susan Graham, MD, MPH, PhD, Associate Professor in Medicine, University of Washington, 
email: grahamsm@uw.edu 
Gary Harper, PhD, MPH, Professor of Health Behavior & Health Education, University of 
Michigan School of Public Health, email: gwharper@umich.edu  
Fredrick Otieno, DCMS, MPH, PhD, Nyanza Reproductive Health Society (NRHS); 
telephone: +254 57 2023903 (Kisumu); fax: +254 57 2024647; email: 
fotieno@nrhskenya.org 
Wilson Odero, MD, MSc, PhD, Dean of School of Medicine, Professor of Public Health, 
Maseno University, phone: +41 057-351622; email: wodero@gmail.com 
Study Location: Kisumu, Kenya 
Study Sponsor: National Institutes of Mental Health (NIMH), USA 
 
Why am I being asked to participate? 
You are invited to be a part of a research study. Gay, bisexual, and other men who have sex 
with men (GBMSM) are at higher risk of HIV infection compared to other men. To prevent 
new HIV infections among GBMSM and their partners, it is important to ensure that 
GBMSM are connected to HIV prevention and services and given the option to start pre-
exposure prophylaxis (PrEP). PrEP is a medication that can reduce HIV risk by over 90% if it 
is taken as prescribed. It is also important that HIV prevention services, including counselling 
related to PrEP use, be culturally appropriate and meet the needs of GBMSM in Kenya.  
The objective of this study is to test a tailored sexual health program called “Shauriana” that 
has been developed specifically by and for Kenyan GBMSM. Shauriana aims to help men 
improve their sexual health and reduce their risk of HIV acquisition using available tools. We 
are conducting a study to determine the feasibility (can we do this?), acceptability (will 
GBMSM like this?), and safety (will this be safe for GBMSM?) of the Shauriana program. 
We are recruiting 60 HIV-negative GBMSM for this study, and will randomly assign 30 men 
to the Shauriana program and 30 men to standard care at the Anza Mapema clinic in 
Kisumu. 
We are asking your permission for you to participate in this study. 
What will happen during the study? 
This study will last for 6 months from the time you enrol. You will be asked to attend three 
additional clinic visits after today’s visit: at months 1, 3, and 6 after enrolment. If you enrol in 
the study, we will reimburse you KSh 500 for time and travel expenses related to each 
scheduled study visit, beginning with today’s visit.  
 

SHAURIANA TRIAL CONSENT 
 
Shauriana Project MUERC Application 
 
Version 2.0, March 2, 2021 
If you are randomly assigned to the Shauriana program, you will be introduced to a trained 
peer facilitator. You will meet with this peer at agreed-upon safe spaces in the community 
weekly during the first several weeks of the study (5 weekly sessions). You will be 
reimbursed KSh 350 after completing each of the 5 Shauriana sessions with the facilitator.  
 
At the end of the study, we will ask for your feedback in an in-person exit interview. You will 
be reimbursed KSh 500 after completing the exit interview. 
 
If you participate, you will be informed of any changes made to the study after you enrol or 
any new information that becomes available pertinent to HIV prevention or PrEP that may 
affect your health or study participation. 
 
Procedures at Scheduled Clinic Visits 
At each clinic visit, you will receive standard HIV prevention care at the Anza Mapema 
clinic, including HIV testing and counselling, screening for symptoms of sexually transmitted 
infections, and counselling about HIV prevention methods. If you test positive for HIV 
infection, you will be counselled and referred to the HIV clinic of your choice and withdrawn 
from this study. 
 
You will be offered condoms, lubricants (when available) and PrEP free of charge. At each 
visit, the clinic counsellor and other providers will talk with you about: how PrEP works and 
why it might be right for you, your pill-taking practices, potential barriers and facilitators to 
your adherence, problem management skills, and strategies for remembering pills. 
 
At the baseline visit, we will collect your contact information so that we can reach you in 
case of a missed visit or a laboratory test that needs follow-up. At baseline, month 3, and 
month 6, you will undergo blood collection (5 mL, ≈1 teaspoon) and urine collection (4 
ounces in a collection cup). These samples will be used for PrEP monitoring and safety. In 
addition, we will test your blood at baseline to see if you may benefit from hepatitis B 
vaccination. 
 
At each clinic visit, you will undergo a computer-based questionnaire, in which you will be 
asked questions about your general health, sexual behaviour, substance use, mood, social 
support, and medication-taking. This computer-based questionnaire will take approximately 1 
hour to complete. 
 
Shauriana Program Procedures 
If you are randomly assigned to the Shauriana program today, we will introduce you to the 
Shauriana facilitator who will work with you. This facilitator is a peer from the GBMSM 
community who has helped to develop the Shauriana program and received training in 
counselling and sexual health. You will meet with the facilitator once a week for the first 
month. After each session, we will get your feedback on how it went and whether you felt it 
was helpful. 
After you have completed the 5 weeks of weekly intervention sessions, you will have the 
option to meet in person with the peer facilitator once a month for the last two months of the 
study if you like (this is optional), and you can contact him as many times as the two of you 
agree upon by phone or SMS.  You will also be invited to attend an optional group session on 
mental health at NYARWEK, our community partner for the Shauriana program. There will 

SHAURIANA TRIAL CONSENT 
 
Shauriana Project MUERC Application 
 
Version 2.0, March 2, 2021 
be no reimbursement for these optional components of the interview, but we encourage you 
to participate if you find these programs offerings helpful. 
 
Exit Interviews 
After completing the study or if you need to withdraw before completing the study, you will 
be interviewed about how your study participation went, and asked to provide any feedback 
you have about the clinic procedures. If you were assigned to the Shauriana program, we 
will also ask for your feedback on the program and how it was delivered. With your 
permission, we will record this interview. 
 
Iris Scan 
To help the Anza Mapema clinic keep track of who is enrolled in this and other ongoing 
studies, we will ask you to look into a binocular. This machine will scan your iris in less than 
2 seconds. This is a painless exercise and will not cause eye damage. The scan will translate 
into a unique identification number that will be added to your study ID card, and will be 
accessible only to the Anza Mapema clinic staff. At each subsequent clinic visit, an iris scan 
will be done at the reception desk to ensure that we identify you as a Shauriana study 
participant. 
 
SMS Reminder Messages 
If you would like, we can send you reminder messages for your scheduled clinic 
appointments one day in advance. If you do not want to receive such messages, please let us 
know either now or at any time in the future. 
 
After the Study 
After the research study ends, you may continue to receive care at the Anza Mapema clinic or 
can transfer to any other GBMSM-friendly clinic or program in the Kisumu area. In case 
there will be another research study for which you are eligible, you will be informed of this 
and requested for consent to enrol. 
 
The information and/or specimens that we obtain from you for this study might be used for 
future studies. We may remove anything that might identify you from the information and 
specimens. If we do so, that information and specimens may then be used for future research 
studies or given to another investigator without getting additional permission from you. It is 
also possible that in the future we may want to use or share study information that might 
identify you. If we do, a review board will decide whether or not we need to get additional 
permission from you. 
 
What are the potential risks and discomforts? 
There is a small risk of loss of privacy or confidentiality related to study visits or contacts by 
research staff or peer facilitators. We take this risk seriously, and have protocols in place 
protect participants' confidential data, including HIV status and MSM behavior. Our priority 
for every participant is their well-being. Drawing blood may cause pain, and a bruise may 
form where the needle enters the vein. When blood is collected, there is a minimal risk of 
infection at the site – if this occurs, you will receive treatment at the clinic. Questionnaires 
and counselling may be stressful for some people. Each of the four clinic visits (baseline, 
month 1, month 3, and month 6) will take from 1.5 to 2 hours of your time. Each Shauriana 
session (5 weekly sessions over the first 5 weeks) will take from 1.5 to 2 hours of your time. 
 

SHAURIANA TRIAL CONSENT 
 
Shauriana Project MUERC Application 
 
Version 2.0, March 2, 2021 
To protect against these potential risks and discomforts: 
Our research team members, including the peer facilitator, will all treat your information as 
private and confidential. An independent committee will monitor this research continuously 
to ensure participant’s safety and rights are respected at all times. If for any reason the 
research team thinks you would benefit from leaving this study, they will recommend this 
and ensure that you receive care outside the study. 
 
Are there benefits to taking part in this study? 
By participating in this research, you may learn more about your own barriers and facilitators 
to sexual health including HIV prevention, and may as a result start to use PrEP or increase 
your PrEP adherence. However, it is also possible that you will have no direct personal 
benefit and will only contribute to an increase in knowledge about sexual health for GBMSM 
in the community. You will also help us learn about factors that help and hinder sexual health 
for GBMSM in Kisumu.  
 
What will happen if I refuse to participate?  
All participation in research is voluntary. You are free to decide if you want to take part or 
not. If you do agree you can change your mind at any time. In addition, you may refuse to 
answer questions or provide samples at any time. If you would not like to participate, this will 
not affect your relationship with or services received at Anza Mapema or NYARWEK 
network organizations. If you withdraw from the research project after enrolling, we will ask 
you to complete an exit interview regarding your reason for withdrawal, care and referral 
needs. 
 
What about privacy and confidentiality? 
All our research records are stored securely in locked cabinets and password-protected 
computers.  Your information will be kept in your study file and be marked with your study ID 
number. To protect your confidentiality, your name will not appear anywhere in this file. Your 
signed consent and the information you provide at registration will be locked separately from 
your file. If we do need to contact you, your confidentiality will be strictly protected by our 
staff.  
 
Audio recordings of interviews will be stored securely in locked cabinets and on password 
protected computers. The audio files will be destroyed after completion of the research and 
expiration of the records retention period required by our funder.  
When the study ends and the records retention period has expired, we will destroy the evidence 
that links your name with your study ID number. We will not publish or discuss in public 
anything that could identify you. We plan to publish results of this study, but we will not 
include any information that would identify you. No personal information about you will be 
given to any person or agency without your written permission. 
There are some reasons why people other than the researchers may need to see information 
you provided as part of the study.  This includes organizations responsible for making sure 
the research is done safely and properly, including the ethics review boards at Maseno 
University and/or the University of Washington. Because this study explores sensitive topics, 
if you tell us something that makes us believe that you or others have been or may be 
physically harmed, we may report that information to the appropriate agencies to make sure 
everyone is safe. 
 

SHAURIANA TRIAL CONSENT 
 
Shauriana Project MUERC Application 
 
Version 2.0, March 2, 2021 
What will happen to my samples? 
Blood samples will be tested locally for hepatitis B exposure and kidney function at baseline. 
Any remaining blood and all urine collected will be stored for analysis of PrEP drug levels at 
the end of the study. These samples will be sent to two different laboratories in the United 
States (one for the blood and one for the urine) that specialize in the detection and 
quantification of PrEP metabolites in blood and urine. 
 
Will I receive any compensation for helping with this study? 
After you complete each clinic visit, you will receive 500 KSh to thank you for your time and 
participation. Reimbursement for all clinic visits will total 2,000 KSh: 500 KSh today if you 
complete the enrolment visit, 500 KSh after the month 1 visit, 500 KSh after the month 3 
visit, and 500 KSh after the month 6 visit. If you are assigned to the intervention, you will 
receive 350 KSh after completing each of the 5 Shauriana program sessions with your 
assigned peer facilitator. All participants, regardless of whether they are assigned to the 
intervention, will receive 500 KSh after the exit interview. 
 
What are my rights as a research subject? 
If you have any concerns or questions about your rights as a study participant, please contact:  
 The Secretary, Maseno University Ethics Review Committee 
Private Bag, Maseno 
Telephone numbers: 057 -51622, 0722203411, 0721543976, 0733230878 
Email address: muerc-secretariate@maseno.ac.ke; muerc-secretariate@gmail.com 
You may also contact the University of Washington’s Human Subjects Division (HSD) at +1-
206-543-0098 or e-mail HSD at hsdinfo@uw.edu.   
 
Who should I contact if I have questions?  
If you have any questions concerning the study or your role as a participant or if you wish to 
report a research-related injury or harm, please contact the following person: 
 Fredrick O. Otieno, Research Director, Nyanza Reproductive Health Society (NRHS); 
telephone: +254 57 2023903 (Kisumu); 0721-759867 (cell phone) 
Remember: Your participation in this research is voluntary. If you decide to participate, you 
are free to withdraw at any time. 
You will be given a copy of this form for your information and to keep for your records. 
This research is supported by the United States National Institute of Mental Health. A 
description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time. 
 
 

SHAURIANA TRIAL CONSENT 
 
Shauriana Project MUERC Application 
 
Version 2.0, March 2, 2021 
Statement of Consent 
I have read this participant information and consent form. I have had the chance to discuss 
this research study with a study assistant. I have had my questions answered by him or her in 
language that I understand. The risks and benefits have been explained to me. I understand 
that I will be given a copy of this consent form after signing it. I understand that my 
participation in this study is voluntary and that I may choose to withdraw at any time. I freely 
agree to participate in this research study. 
I understand that all efforts will be made to keep information regarding my personal identity 
confidential. I authorize the inspection of records that relate to this study by the Maseno 
University and University of Washington ethics boards, and/or their funding agencies for 
quality assurance purposes. 
By verbally consenting to participate in this study, I have not given up any of the legal 
rights that I have as a participant in a research study. 
 
I agree to participate in this research study as it has been explained to me  
Yes 
No 
I agree for my 6-month exit interview to be audio recorded  
 
 
Yes 
No 
I agree to scanning of the eye (iris scan) when I attend clinic visits  
 
Yes 
No 
I agree to receive text reminders for clinic visits 
 
 
 
 
Yes 
No 
I agree for my blood and urine samples to be stored for future testing 
 
Yes 
No 
I agree for my blood and urine samples to be shipped for further study  
either elsewhere in Kenya or overseas 
 
 
 
 
 
Yes 
No 
 
Participant Name Printed: ____________________________________________________  
Participant Signature: ________________________________ Date___________________ 
 
I, the undersigned, have fully explained the relevant details of this research study to the 
participant named above and believe that the participant has understood and has knowingly 
given his consent. 
Staff Signature: ____________________________________ Date ___________________ 
Staff Name Printed: ________________________________________________________  
Witness Signature, if necessary: ________________________ Date __________________ 
THE PARTICIPANT SHOULD NOW BE GIVEN A SIGNED COPY TO KEEP