The Shauriana Intervention for GBMSM in Kenya

Not Applicable

Completed

• Conditions: HIV Prevention
• Interventions: Behavioral: Shauriana

• Registration Number: NCT04550221
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-08-30
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Study Start: 2021-05-10
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Results First Submitted: 2023-05-15
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Results First Posted: 2023-09-22
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Shauriana	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.
Standard care	Shauriana	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anza Mapema Clinic; 🇰🇪 Kisumu, Kenya