The Shauriana Intervention for GBMSM in Kenya

Study Overview
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Brief Summary
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The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.

Detailed Description
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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. Based on preliminary qualitative work, this theory-based and culturally relevant PrEP support intervention is called Shauriana (Kiswahili for 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. 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.

Official Title
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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

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: Shauriana


Participation Criteria
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Eligibility Criteria
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Inclusion 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 randomized controlled trial (RCT). Of note, approximately 50%-60% of young MSM in Kisumu speak English. Exclusion Criteria: Unable to understand the study purpose and procedures Unwilling to adhere to study procedures Currently under the influence of alcohol or drugs Prior diagnosis of HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study with 10 intervention participants followed by randomized controlled trial with 60 participants assigned to the intervention or to standard care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. 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. | Behavioral: Shauriana<br>* 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. 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 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).<br>|
| Active Comparator: Standard care<br>Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers. | Behavioral: Shauriana<br>* 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. 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 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Exit Interview | All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview | Month 6 | 
| Intervention Feasibility | Intervention session attendance | Month 6 | 
| Intervention Safety | Adverse events reported by participants | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Uptake | Ongoing PrEP use (yes or no) assessed by ACASI | Month 1, Month 3, and Month 6 | 
| PrEP Adherence | In the last 30 days, how good a job did you do at taking your PrEP daily? | Month 1, Month 3, and Month 6 | 
| PrEP Drug Levels | Tenofovir levels measured in dried blood spots | Month 3 and Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preexposure prophylaxis, sexual health, mental health, behavioral intervention