N/A
Completed N=63
The Shauriana Intervention for GBMSM in Kenya
Source: ClinicalTrials.gov NCT04550221 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Completion of Exit Interview — 28 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion of Exit Interview |
28 | — |
| PRIMARY Intervention Feasibility |
11; 0; 18; 0 | — |
| PRIMARY Intervention Safety |
0; 0; 29; 31 | — |
| SECONDARY PrEP Uptake |
16; 14; 12; 15; 1; 2 | — |
| SECONDARY PrEP Adherence |
0; 0; 0; 1; 5; 7 | — |
| SECONDARY PrEP Drug Levels |
3; 7; 23; 23; 3; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04550221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.