The Shauriana Intervention for GBMSM in Kenya

Not Applicable

Completed

Conditions: HIV Prevention

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.

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.

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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 Uptake	Month 1, Month 3, and Month 6	Ongoing PrEP use (yes or no) assessed by ACASI
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?