Status:
COMPLETED
Testing a Barbershop-based HIV Prevention Initiative Among Men
Lead Sponsor:
HIV Prevention Trials Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
MALE
16+ years
Phase:
NA
Brief Summary
To test community-based approaches to engage heterosexual men at risk for HIV and specifically to assess the feasibility and acceptability of a barbershop based HIV prevention program.
Detailed Description
HPTN 111/TRIM is a cluster randomized study to assess the feasibility and acceptability of a barbershop-based HIV prevention program. Eighteen barbershops in Kalangala District, Uganda will be purposi...
Eligibility Criteria
Inclusion
- Persons who identify as a heterosexual male and meet all of the following criteria are eligible for inclusion in this study:
- Age ≥ 16 years
- a. Any participants 16-17 years old will be enrolled following the Uganda National Council for Science and Technology (UNCST) guidelines for mature and emancipated minors
- Able and willing to provide informed consent
- Behaviorally vulnerable to HIV, based on self-report of at least one of the following in the last three months:
- Had condomless sex with a person of unknown HIV status or a person living with HIV
- Had more than one sexual partner
- HIV negative per Ugandan Ministry of Health guidelines and the Study-specific Procedures (SSP) Manual
- Is a regular customer at a participating barbershop as defined in the SSP Manual
Exclusion
- Persons who meet any of the following criteria will be excluded from this study:
- Not planning to stay in the study catchment area in the next 12 months
- Any other condition that in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- Participants who report sex with other men will not be excluded from this study so long as they meet the inclusion and exclusion criteria listed above.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06148584
Start Date
March 13 2024
End Date
June 30 2025
Last Update
October 1 2025
Active Locations (1)
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1
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda