Participatory development and initial pilot run of the Shauriana program to integrate sexual health and mental health support for young gay and bisexual men and other men who have sex with men in Kenya

Gay and bisexual men and other men who have sex with men (GBMSM) in sub-Saharan Africa, and in Kenya specifically, are inequitably impacted by HIV [1, 2, 3, 4, 5]. Prevalence among GBMSM is estimated to be at least 4 times higher than the general adult population in Kenya [6]. Same-sex sexual behavior and orientation are highly stigmatized and remain criminalized in Kenya [7, 8, 9], and this pervasive and systemic homophobia exposes young GBMSM to high rates of poverty, violence, HIV, depressive symptoms, and substance misuse [7, 10, 11, 12]. These multiple, synergistic obstacles continue to place young Kenyan GBMSM at high risk for HIV.

Daily pre-exposure prophylaxis (PrEP) with tenofovir-emtricitabine (TDF-FTC) for HIV prevention among GBMSM was demonstrated in the 6-country iPrEx trial in 2010 [13], and the World Health Organization released a strong recommendation to include PrEP as an option in combination prevention packages oriented to GBMSM 2 years later [14]. Kenya officially adopted PrEP in early 2017 as part of combination HIV prevention for individuals at substantial ongoing risk, specifically including GBMSM [15]. Unfortunately, results of subsequent studies focused on PrEP uptake, adherence, and retention among Kenyan GBMSM have so far been disappointing. Though studies have indicated relatively high PrEP uptake among GBMSM in Kenya (70%–83% of those eligible) [16, 17, 18], PrEP adherence and continuation have been low, with fewer than 15% of participants reporting PrEP use having protective TFV-DP levels, despite high self-reported adherence [18, 19, 20, 21, 22]. These findings make it clear that in order to effectively achieve goals set forward by both Kenyan and international frameworks (e.g., UNAIDS 95-95-95 targets) [6, 23], access to biomedical HIV prevention options is not enough. Rather, programs that include biomedical HIV prevention may need to include highly tailored, holistic wrap-around support that meets the comprehensive needs of GBMSM, including mental health and well-being in addition to HIV and STI prevention.

Though GBMSM make up an estimated 15% of people living with HIV in Kenya [24], to date there have been no published research on the development and evaluation of primary HIV prevention interventions designed for and tested with young GBMSM in Kenya. The current study set out to do just this—to use participatory methods to develop and then conduct small randomized controlled trial (RCT) of a peer-led primary HIV prevention program that included a holistic focus on overall sexual health (i.e., HIV and STI prevention methods including but not limited to PrEP) and mental health and well-being in ways that were relevant to the everyday lives and experiences of Kenyan GBMSM. Kenyan GBMSM-identified members of the research team selected “Shauriana” as the program name (which in Swahili means “we counsel each other”) to highlight the fact that the program is for GBMSM in Kisumu and led by GBMSM in Kisumu. This article presents the participatory development and initial pilot run of the Shauriana program, a theory-based and culturally relevant program that combines peer health education and “integrated Next Step Counseling” (iNSC) [25, 26] to promote sexual and mental health and well-being. The Methods and Results sections of this article focus on describing the program development process and presenting the methods and results of an initial pilot run of the program with 10 participants to gain initial feedback on materials and procedures before implementing an RCT. In addition, lessons learned from our community engagement and sexual health-affirming research methods are presented.

The Shauriana Project consists of a close collaboration between our research team and GBMSM-led community-based organizations (CBOs) based in Kisumu, Kenya. At the onset of the study, we worked with these CBOs to identify young GBMSM who had experience conducting peer outreach and were interested in helping with the formative qualitative research and program development, some of whom had prior experience collaborating on research studies with members of the research team (Gary W. Harper and Laura Jadwin-Cakmak). We identified 6 local GBMSM team members through this process, and this group became the Shauriana Project Development Team (SPDT), led by a peer who was hired as the project coordinator (Elijah Ochieng). In 2019, the SPDT conducted a series of interviews with 20 peers providing support to GBMSM, as well as 40 GBMSM not living with HIV in the Kisumu area, purposively sampled based on PrEP experience and interest. These interviews examined socioecological factors impacting Kenyan GBMSM’s lives, including sexual and PrEP-related stigma, sexual health promotion, and resilience [27, 28]. As interviews concluded, we held a community charrette [29], an interactive community engagement strategy, with 51 representatives from GBMSM- and other LGBTI-led organizations to discuss the barriers and facilitators they have noticed in their work on HIV testing and counseling (HTC) and/or PrEP programming in the Kisumu area. This work coincided with the availability of the results from testing of dried blood spots (DBS) for TFV-DP after a small cohort study of GBMSM offered PrEP, which showed very low levels in most participants. Feedback from the community charrette helped identify a number of barriers and facilitators influencing GBMSM’s PrEP engagement and adherence and overall sexual health [22]. These formative qualitative research findings, along with conversations with the SPDT, emphasized the importance of not narrowly focusing the intervention on PrEP uptake and adherence but instead holistically addressing sexual health alongside topics related to mental health.

Shikamana [30], an antiretroviral therapy (ART) adherence support intervention for Kenyan GBMSM living with HIV, served as the basis of the Shauriana program that is the topic of the present study. In Shikamana, participants received a modified version of Next Step Counseling focused on ART adherence from trained providers at monthly clinic visits, as well as peer support from local GBMSM who were also living with HIV. The core research team, working in close collaboration with the SPDT, used community input from the qualitative phase to adapt and enhance the Shikamana program to be appropriate for primary prevention of HIV and to address needs related to mental health and well-being among GBMSM community members in Kisumu, Kenya. Following the ADAPT-ITT model [31], we first assessed the material from the Shikamana program for suitability and used findings from the qualitative interviews to guide decisions about what to keep and what to add. In addition to the focus on primary prevention, major adaptations from the Shikamana program included: a greater role for GBMSM peers, who received intensive training and supervision and facilitated the program’s weekly sessions; incorporating structured sexual and mental health education topics and addressing 2 health-related topics/goals in each session using iNSC.

We then produced program materials, including a facilitator guide, participant booklet that included visuals and key messages for each session, and data collection tools to obtain feedback from participants. These materials were reviewed by the SPDT and other community members including those serving on a community advisory board (our topical experts), with iterative integration of feedback. This collaborative work included discussion of the theoretical foundations for the program, which included the situated-Information Motivation Behavioral Skills Model of Care Initiation and Maintenance [32], as well as the Minority Stress Model developed by Meyer [33], which posits that stress and coping processes determine key health-related outcomes in GBMSM individuals. In addition, we incorporated elements of Empowerment Theory [34, 35, 36] in order to focus on strengths-based and resilience processes that would help men take ownership of their overall sexual health and support their engagement in HIV prevention strategies. A key priority for our adapted program was to use iNSC [26, 37] to integrate positively framed sexual health promotion discussions alongside discussions about other session topics related to mental health and well-being. iNSC is a process for having a nonjudgmental conversation about a participant’s experiences related to an aspect of their health and well-being to understand their individual needs, desires, and context. In an iNSC discussion, the facilitator avoids telling the participant what they must or should do and draws on the participant’s strengths and resources, while using probing, questions and reflections and motivational interviewing strategies [38], in order to move the conversation through a series of steps to help them identify their “next step” toward an improved situation.

For the pilot run, the Shauriana program included 4 weekly one-on-one sessions with a trained peer facilitator, with approximately 15 min of introduction or review from previous week; 30 min of didactic sharing of structured health information with accompanying visual aids (see Shauriana Participant Booklet S1); and 45 min of iNSC related to the current session topic and sexual health. Session topics included sexual health basics, relationships, stress and coping, and healthy sexuality and empowerment. Peer facilitators used the iNSC principles and structured format to help participants identify their needs, set specific goals, identify facilitators and barriers, and problem-solve to overcome barriers they anticipated or encountered; they also sent regular messages to participants to check in about progress toward their goals. Participants had the option to schedule an additional review session with their peer facilitator by phone or in person. While implementing the program, peer facilitators received clinical supervision through weekly meetings and frequent check-ins through WhatsApp.

The overall goal of the pilot run was to obtain feedback on the intervention and study procedures (with the exception of laboratory testing) with a small group of 10 participants over a 3-month period. Specific objectives were to (1) get feedback on intervention components from the focus population, (2) pilot intervention materials and research instruments, and (3) monitor fidelity of facilitator implementation. Pilot run findings informed revisions and improvements made to the intervention and procedures before implementing a small RCT of the final Shauriana intervention to test its acceptability, feasibility, and safety and estimate its initial effect size compared to standard care. The Institutional Review Boards of the participating U.S. academic institutions, as well as the Ethics Review Committee of our local Kenyan academic partner, approved all study procedures.

Five members of the SPDT were selected to be peer facilitators for both the pilot run of the intervention and the RCT. A comprehensive training manual was designed for the peer facilitators, which included information about the situated information-motivation-behavioral skills model, communication and counseling skills, and information on motivational interviewing principles and iNSC, the rationale and procedures of the intervention, and the didactic and background information that peer facilitators would share with participants. Training components were illustrated using role-play exercises, discussion of sample cases, and hypothetical problem scenarios. Prior to the pilot run, peer facilitators received 10 days of in-person training, which included an overview of the study design, theoretical principles, and rationale; a step-by-step review of supporting manuals and handouts; training in basic communication and counseling skills, as well as on iNSC principles and discussion format; and practice through role-playing exercises and feedback. Peer facilitators then recorded additional practice sessions and received individualized iNSC coaching virtually from the Project Director (Laura Jadwin-Cakmak) until each intervention session was satisfactorily delivered, as assessed by the core research team. We held weekly peer facilitator meetings during the pilot run to review study progress, guidelines, and issues that arose. Minutes of these meetings were used to monitor the study and identify needs for revised training or procedures.

A convenience sample of 10 GBMSM who were not living with HIV were recruited for the pilot run. Inclusion criteria were as follows: (1) assigned male at birth and identifies as a man; (2) 18–35 years of age inclusive; (3) resident in the Kisumu area for ≥12 months; (4) self-reported anal intercourse with a man in the past 3 months; (5) not taking PrEP for HIV prevention in the past 3 months; (6) willing to provide complete locator information; (7) willing to undergo all study procedures, including HTC; (8) not currently participating in any other HIV prevention or vaccine study; and (9) planning to remain in the study area for at least 6 months. For the pilot run only, we required that participants speak English in order to expedite the analysis of feedback from these participants in preparation for the RCT. Of note, approximately 50%–60% of young GBMSM in Kisumu speak English, therefore this requirement was feasible. Men were excluded if they were unable to understand the study purpose and procedures, unwilling to adhere to study procedures, currently under the influence of alcohol or drugs, or had a prior diagnosis of HIV infection. The research team and peer facilitators also provided implementation feasibility data by documenting study activities and through routine research team meetings documented through detailed meeting minutes.

Participants were recruited using the existing peer networks of our CBO partners and SPDT members and venue-based referrals. All interested and potentially eligible participants identified through this outreach were given a study business card and referred to the study clinic, known in the community to be GBMSM-friendly, for eligibility screening.

After obtaining consent to screen, a member of the research team collected basic sociodemographic data and conducted a brief risk behavior assessment to determine eligibility, and then provided an overview of the study and read through the consent form, which was available in English, Swahili, and Dholuo, with the participant and answered any questions. Written informed consent was obtained from individuals who were eligible and willing to participate. Research team members documented reasons for screening out or failing to enroll. Those found to be ineligible were referred by research team members to HIV prevention or care programming as indicated. Locator information was collected from all enrolled participants to ensure they could be traced in the event of a missed visit.

Pilot run participants had study visits at baseline, month 1, and month 3 at the research clinic. Clinic procedures were provided according to the standard of care in Kenya and included HIV counseling and testing, screening for STI symptoms, and individual counseling about HIV prevention methods, including general information about HIV transmission; discussions of risk reduction, including condom use; and PrEP knowledge, adherence tips, and adherence strategies. Participants were offered PrEP during clinic visits but were not required to receive or take the medication. After receipt of these services, participants completed an audio computer self-interview (ACASI) with demographic, behavioral, and psychosocial measures to be used in the future small RCT to identify any technical problems with this data capture or the questions included. Each of the 3 clinic visits took from 1.5 to 2 h; participants were provided a transportation reimbursement of KSh 500 (about $3.44 USD) for each clinic visit.

In addition to this standard clinic-based care, participants received the Shauriana program. Participants were introduced to their assigned peer facilitator on the day of their baseline visit, at which time they scheduled their first of 4 weekly sessions. Facilitators documented and audio-recorded each session to monitor fidelity of intervention delivery. They later received feedback from the research team on each session. Additionally, participants were asked to complete a short session evaluation form to provide brief feedback after each intervention session. Each session took from 1.5 to 2 h; participants were reimbursed an additional KSh 500 as a transportation reimbursement per completed session.

Upon completion of their 3-month follow-up, an SPDT member (who was not their intervention facilitator) conducted an in-depth exit interview with each participant. Both during the consent process and again at the start of the interview, we emphasized to participants that the purpose of the pilot run was to receive their honest feedback so that we could make improvements to the study procedures and intervention materials. The interview guide included questions about why they decided to participate, experiences at the clinic for study visits, feedback on the intervention format and content, experiences with peer facilitators, personal perspectives on the intervention, any barriers to participation, and any negative experiences they had due to study participation (i.e., inadvertent disclosure, breach of confidentiality). Interviews were audio-recorded and the interviewer took debriefing notes for rapid assessment. Participants were reimbursed KSh 500 for the exit interview. Feedback from participants after intervention sessions and notes taken during interviews were reviewed by the research team and discussed at weekly meetings, with adjustments to study procedures and refresher training as needed.

Descriptive statistics were used to characterize participant baseline data, visit attendance, and retention. The Project Director (Laura Jadwin-Cakmak) listened and re-listened to the audio recordings of the exit interviews to identify themes in the data, and then manually transcribed relevant sections of the interviews to capture quotations that were good illustrations of the themes, compiling and grouping them according to the interview guide [39, 40]. The initial level of analysis focused on categorical codes to identify themes within participant feedback related to: program content and format, challenges and barriers to participation, recommendations to improve, program impact, and whether participants would recommend Shauriana to others. Subsequently, an additional level of interpretive analysis was conducted to identify elements of the program that were key to participants’ positive experience with the program, wherein the analyst reviewed the codes utilized in the first level of analysis with this lens to identify commonalities between participants. These findings were triangulated using several data sources, including interviews conducted during the exploratory phase of the study, notes from discussions with SPDT members during the intervention development process, and notes from discussions during weekly supervision meetings during the pilot run. As these pilot data were rapidly analyzed to inform the finalization of intervention procedures and materials before beginning an RCT, study IDs were not linked to interview data, so study IDs or pseudonyms and demographic information are not provided for representative quotes. We engaged in member checking by presenting the results to the peer facilitators and interviewers, who provided feedback and confirmation of the analytic findings [41].

A total of 10 GBMSM aged 22–35 years (mean 25 years) were enrolled in the pilot run of the intervention; 50% were bisexual, 10% were gay, and 40% described their sexual orientation as “MSM” (Table 1). The majority of participants (90%) attended all 4 core one-on-one sessions; 1 participant attended only the first 2 sessions before moving out of the country. On average, participants attended 1 session per week (average of 8 days between sessions; minimum of 3 days, maximum of 22 days). Only 1 participant (10%) attended an additional optional session. On the brief quantitative evaluation form completed at the end of each session, participants indicated high acceptability of all sessions; all participants indicated that they “strongly agreed” or “agreed” with each question (e.g., “I learned a lot from this session.” “This session helped me think about my health in a new way.” and “I would recommend this session to others.”). The majority of participants (90%) completed their 1-month and 3-month study visits (and corresponding ACASI), except the participant who moved out of the country. All 10 participants completed an exit interview, either in person (90%) or by phone (10%).

In the initial level of analysis of the exit interviews, which employed a more a priori, categorical approach, we identified feedback from participants within 5 major categories: feedback on program content and format, challenges/barriers to participation, recommendations to improve the program, program impact, and recommending Shauriana to others. Participants shared that they liked the one-on-one format of the program, were either satisfied with the number of core sessions or wanted more sessions, liked meeting weekly, and were satisfied with the location where sessions were provided. They provided positive feedback on program topics and materials, including that the topics included were useful and relevant, that they were supported in understanding new information, and that the participant booklet was helpful. Participants demonstrated good recall of the health education topics covered in each core session and enthusiastically endorsed the iNSC portion of sessions. Specifically, participants described how the iNSC approach used by facilitators, which supports autonomy and seeks to balance power between facilitator and participant, made them feel heard and understood, which allowed them to open up, learn, and receive needed referrals. They also described how the iNSC structure, which guided participants to identify their own needs and help them identify a “next step” they could take to meet those needs, helped them create a plan to take action and be prepared to deal with potential barriers. Finally, participants shared how the process of setting goals at the end of each iNSC conversation, as well as having facilitators check in with them about those goals at the start of the next session, motivated them to make positive changes.

No participant in the pilot run reported having adverse or negative experiences due to their participation in the program, nor did they report experiencing major barriers to participation. Challenges experienced included those related to: joining a new program (apprehension about what to expect, that new ideas sometimes required additional explanation from facilitators), scheduling (unpredictable personal schedules, poor communication about scheduling changes, clinic visit wait time, and clinic distance from home), and privacy (one participant’s session was interrupted). Recommendations to improve the program centered on the desire to connect with others during the program by adding group sessions and/or completing sessions with their partner(s). To ensure accessibility and expand program reach, participants reinforced the need to continue providing transport reimbursement (i.e., incentive) to them and recommended we make the Shauriana program available to other communities beyond GBMSM, such as lesbian, bisexual, and queer (LBQ) women.

When asked about program impact, participants reported 3 primary areas of improvement: HIV-related knowledge and skills, interactions with partners, and practices that support mental health. With regard to HIV-related knowledge and skills, participants described learning accurate information about HIV transmission and methods of prevention, learning accurate information and dispelling misinformation about PrEP, reducing the perceived stigma surrounding PrEP use, increasing motivation to engage in HIV prevention, and improving PrEP adherence skills. With regard to interactions with partners, participants described improving honest communication with partners about their relationship and sexual health, reducing their number of sexual partners, and attending clinic for HIV prevention services with a partner. With regard to practices that support mental health, participants described how they engaged in healthier ways to cope with stress and engaged in critical personal reflection that stimulated a desire to learn new information and skills. Pilot participants unanimously said that they would recommend the program to others.

In the second level of analysis, which employed a more interpretive approach, we identified 4 elements as key to participants’ positive experience of the Shauriana program, including: (1) taking a holistic approach by focusing on issues affecting GBMSM’s lives, (2) being peer-led by young GBMSM, (3) maintaining privacy and confidentiality, and (4) maintaining autonomy and choice while providing one-on-one guidance by using iNSC. In addition to focusing on HIV prevention and sexual health more broadly, the Shauriana intervention (1) took a holistic approach by focusing on issues affecting GBMSM’s lives, including topics relevant to mental health and well-being. Participants shared that Shauriana’s broader focus, which included topics related to stigma, stress and coping, relationships, and sexuality, in addition to HIV prevention strategies, contributed to their overall well-being and gave them skills to navigate life challenges that might otherwise stop them from effectively engaging in sexual health promotion strategies. Sharing information about these important life topics related to their mental health, thinking about whether their coping strategies promoted or hurt their health, and providing information about healthy communication skills, and addressing aspects of sexual identity that are often stigmatized or not discussed among GBMSM seemed to make participants feel understood. Giving participants the opportunity to set goals in these areas of their lives and a space to talk through challenges with a peer gave them the chance to take action using this new information. The fact that Shauriana was (2) peer-led by young GBMSM from the community made participants feel accepted and more comfortable sharing personal, honest information. They appreciated that facilitators connected with them on a personal level, shared about their own similar experiences, and would talk with participants when they saw them out in community settings. Another element identified as foundational to the success of the program was (3) maintaining privacy and confidentiality. Facilitators gained participants’ trust by explaining how information would be kept confidential and by finding safe, private locations within the clinic compound to hold sessions. In the specific instance when a participant’s session was interrupted, this made him uncomfortable attending later sessions, further reinforcing the importance of maintaining privacy and confidentiality. Finally, by (4) maintaining autonomy and choice while providing one-on-one guidance using iNSC, facilitators and participants were able to have open discussions that allowed participants to express themselves, feel listened to, explore new ideas, and talk through any challenges they experienced without feeling pressured into any particular strategies or changes. See Table 2 for representative quotes.

In response to participant feedback that they initially felt apprehensive about what to expect from a new program, as well as feedback from the facilitators that they needed more time to build rapport at the beginning of the program, we added an introduction session to familiarize participants with Shauriana’s goals and what to expect, as well as an activity designed to help the facilitator get to know the participant and build rapport. This increased the number of core sessions from 4 to 5. See Table 3 for an overview of the final Shauriana program sessions and structure. Participants also suggested adding group sessions to the program; originally, we did plan to include optional group sessions focused on mental health, though due to the COVID-19 pandemic we were unable to offer group sessions during this pilot run or the subsequent RCT.

Logistically, we attended to feedback about scheduling challenges by coordinating with the clinic to reduce study visit wait times by scheduling Shauriana study visits only on days when no other study appointments were occurring. With facilitators, we also emphasized the importance of being on time for scheduled sessions and clear, advance communication with participants if scheduling changes were needed. Refresher training with peer facilitators before the RCT also reinforced the importance of protecting participants’ privacy and ensuring they were not interrupted during sessions.

Developed in partnership with local GBMSM leaders, the Shauriana program is a peer-delivered behavioral HIV prevention intervention for young GBMSM in Kenya that takes a holistic approach to address both sexual health and mental health and well-being, based on the situated IMB model of antiretroviral adherence [42], the Minority Stress Model [33], and Empowerment Theory [34, 35, 36]. Through weekly one-on-one sessions, participants learn about HIV and STI prevention strategies and other relevant topics such as mental health, stigma, adaptive coping, and healthy relationships. Peer facilitators use iNSC [25, 26] to support participants in identifying their needs and to set achievable goals related to HIV/STI prevention methods, including PrEP uptake and adherence, and goals that will support their mental health and well-being in a way that respects participants’ autonomy.

Participants reported the Shauriana program content was highly relevant to their lives, and their feedback provided initial indications of the acceptability and feasibility of Shauriana. Pilot participants and facilitators gave input that allowed the team to refine the program content, materials, and study procedures for the RCT. Most (90%) participants attended all sessions and clinic visits, and all participants provided feedback in exit interviews; intervention facilitators and clinic staff reported that study procedures were realistic and doable. Based on participant and facilitator feedback, an additional introductory session was added to the intervention, to enable the Shauriana peer facilitator and the intervention participant to get to know one another better, resulting in 5 core intervention sessions (Table 3). This refined Shauriana intervention is being tested in a small, unblinded RCT for acceptability, feasibility, and safety.

Throughout our participatory program development process—including exploratory in-depth interviews [27, 28], the community charrette [22], conversations with the SPDT while developing content and materials, and conversations with SPDT members who served as intervention facilitators during the pilot—we learned a number of lessons about what local young GBMSM felt was most needed in HIV prevention programs. One such “lesson learned” was how community involvement throughout all stages of development facilitated community ownership and engagement. We also learned that having the program developed with and led by local young GBMSM enhanced community members’ trust in the program and willingness to engage with the study and program content. They were more comfortable disclosing their personal experiences, thoughts, and feelings with individuals who shared their identities, so long as privacy and confidentiality were upheld and peer facilitators were well-trained and professional. Additionally, we learned that many GBMSM’s experiences with HIV risk reduction counseling and/or PrEP counseling was didactic and prescriptive, where a clinician or counselor gave a client-specific HIV prevention behaviors that he was expected to follow, without allowing the client to explore whether and how those behaviors fit in with his day-to-day life and needs. Lastly, we learned that GBMSM community members desired programming that did not solely focus on HIV risk reduction or sexual health but that also addressed mental health, stigma, and other issues that they were dealing with in their day-to-day lives. These lessons learned were confirmed with findings from the pilot exit interviews, from which we identified 4 similar key program elements that contributed to the participants’ positive experience of and engagement with the intervention (Figure 1). We believe that integration of these elements into not only the Shauriana program but also other HIV- and health-related programming for GBMSM in Kenya will contribute to the acceptability and success of these programs.

We hope that the Shauriana program will allow GBMSM to identify the strategies that are right for them so that they can prevent HIV, take charge of their overall sexual health, and improve their well-being through improved coping and communication skills. While much of the feedback from pilot run participants and intervention facilitators provided our team with initial indications of acceptability and feasibility, a few participants did report challenges, including apprehension about joining a new program, requiring an additional explanation of content in the sessions, scheduling challenges, and privacy concerns. To address these challenges, we made changes to the materials and procedures and provided refresher training to facilitators as described above; in future trials, we will need to assess whether these changes sufficiently address participants’ concerns in these areas. Additionally, the small sample size of 10 participants is a significant limitation. Though we believe this to be an appropriate sample size for an initial pilot run, we acknowledge that the evidence collected during the evaluation was limited. However, the feedback permitted us to make needed adjustments to materials and procedures, and our qualitative findings regarding lessons learned about key elements for program engagement were triangulated with information gathered during the initial formative phase of the parent study and conversations with intervention facilitators. The small sample size and nature of an initial pilot run may also have allowed intervention facilitators to dedicate a greater amount of time to participants during program delivery than will be feasible during scale-up. We will attempt to address and/or evaluate these limitations due to the pilot run nature of the current study in future trials.

There has been no previously published research on the development or evaluation of primary HIV prevention interventions designed for GBMSM in Kenya [24]. HTC services and standard counseling for patients taking PrEP tend to be didactic and prescriptive in their approach and are primarily provided by health-care providers, with whom patients experience a power differential and potentially stigmatizing interactions [43, 44]. The inequitable impact of HIV among GBMSM [4–5] and the documented challenges among GBMSM in achieving protective levels of adherence to PrEP [18, 22] make it clear that additional approaches to HIV prevention that provide psychosocial support are needed [45]. 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 the uptake and maintenance of HIV prevention [46, 47]. Hence, a holistic approach to sexual health that addresses overall well-being, such as that provided by the Shauriana intervention, would still be pertinent and needed [48]. Although results of the intervention trial are pending, our work on the Shauriana intervention has made clear to us that community engagement and collaborative approaches to intervention development with the community are important ways to incorporate lived experiences, address pertinent barriers and tap into important facilitators, and increase the relevance of intervention content by taking into account the whole person rather than focusing solely on their HIV risk.

Informed consent for data sharing was not obtained due to the very small sample and risk of identification.

The supplemental files for this article can be found as follows:

Shauriana Participant Booklet S1.

We would like to thank the men who participated in all aspects of the Shauriana program development, including a community charrette, in-depth interviews, and pilot run of the program. Special thanks go to research assistants Hyuri McDowell and Kendall Lauber, our Community Advisory Board, and the GBMSM community organizations who supported our work. We also thank the staff at the Anza Mapema clinic for supporting study visits and participants’ needs outside of the study.

This work was supported by the National Institutes of Mental Health (grant number R34 MH118950). SMG was also supported by the University of Washington/Fred Hutch Center for AIDS Research, an NIH-funded program under award number AI027757, which is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, NIDDK, and by the University of Washington Behavioral Research Center for HIV (P30 MH123248).

All authors declare no competing interests.

LJ-C: Conceptualization, methodology, project administration, supervision, thematic analysis, writing—original draft; GWH: Funding acquisition, conceptualization, methodology, supervision, writing—review and editing; EO: Methodology, investigation, data curation, writing—review and editing; KRA: Conceptualization, methodology, writing—review and editing; TA: Methodology, investigation, writing—review and editing; FO: Methodology, investigation, writing—review and editing; EG: Methodology, investigation, writing—review and editing; KO: Methodology, investigation, writing—review and editing; DOO: Project administration, supervision, investigation, data curation, writing—review and editing; FOO: Funding acquisition, project administration, supervision, methodology, investigation, data curation, writing—review and editing; WO: Supervision, investigation, writing—review and editing; SMG: Funding acquisition, conceptualization, methodology, formal analyses, writing—original draft.

The Shauriana study was approved by Maseno University’s Ethical Review Committee (MSU/DRPI/MUERC/849/20) and the University of Washington Human Subjects Division (STUDY00009441), with concurrence from the University of Michigan Human Research Protection Program. All participants provided written informed consent.

Registered on ClinicalTrials.gov on September 16, 2020 (NCT04550221).

How to cite this article: Jadwin-Cakmak L, Harper GW, Ochieng E, Amico KR, Aloo T, Okutah F, Gumbe E, Olango K, Okall DO, Otieno FO, Odero W, Graham SM. Participatory development and initial pilot run of the Shauriana program to integrate sexual health and mental health support for young gay and bisexual men and other men who have sex with men in Kenya. Adv Glob Health. 2025;4(1). https://doi.org/10.1525/agh.2025.2442813

Editor-in-Chief: Craig R. Cohen, University of California San Francisco, CA, USA

Senior Editor: Andres G. Lescano, Cayetano University, Lima, Peru

Section: Improving Health and Well-Being