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NCT06148584 | ACTIVE NOT RECRUITING | HIV Infections

Testing a Barbershop-based HIV Prevention Initiative Among Men
Sponsor:

HIV Prevention Trials Network

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.

Condition or disease

HIV Infections

Intervention/treatment

General, status-neutral HIV education

HIV self-test kits

Information about where to receive HIV prevention services

Barber-led peer support group education

Facility-based HIV risk reduction counseling

Facility-based HIV testing

Information about facility distributed HIV self-test kits

STI testing

Phase

NA

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 purposively selected to participate in the study and randomized 2:1 to provide the barbershop-based HIV prevention initiative (intervention) or the standard-of-care (control). Individual participants will be enrolled from the barbershops and receive intervention or control services based on their barbershop. The barbershop-based HIV prevention initiative will include barber provided status-neutral HIV education, HIV self-test kits, and information about where to receive HIV prevention services.

Study Type : INTERVENTIONAL
Estimated Enrollment : 250 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial
Actual Study Start Date : 2024-03-13
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • Persons who identify as a heterosexual male and meet all of the following criteria are eligible for inclusion in this study
    • 1. 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
    • 2. Able and willing to provide informed consent
    • 3. Behaviorally vulnerable to HIV, based on self-report of at least one of the following in the last three months
      • 1. Had condomless sex with a person of unknown HIV status or a person living with HIV
      • 2. Had more than one sexual partner
      • 4. HIV negative per Ugandan Ministry of Health guidelines and the Study-specific Procedures (SSP) Manual
      • 5. Is a regular customer at a participating barbershop as defined in the SSP Manual
      Exclusion Criteria
      • Persons who meet any of the following criteria will be excluded from this study
        • 1. Not planning to stay in the study catchment area in the next 12 months
        • 2. 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.
Testing a Barbershop-based HIV Prevention Initiative Among Men

Location Details

NCT06148584

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Uganda,

Mu-Jhun Research Collect

Kampala, Uganda,