Testing a Barbershop-based HIV Prevention Initiative Among Men (TRIM)

HIV Prevention Trials Network

Status

Completed

Conditions

HIV Infections

Treatments

Behavioral: Facility-based HIV risk reduction counseling

Diagnostic Test: HIV self-test kits

Behavioral: Barber-led peer support group education

Diagnostic Test: STI testing

Other: Information about where to receive HIV prevention services

Other: Information about facility distributed HIV self-test kits

Behavioral: General, status-neutral HIV education

Diagnostic Test: Facility-based HIV testing

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT06148584

HPTN 111

UM1AI068619-17 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 patients

Sex

Male

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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:
1. Had condomless sex with a person of unknown HIV status or a person living with HIV
2. 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 criteria

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Intervention Barbershops Group

Experimental group

Description:

Participants recruited from intervention barbershops will receive the barbershop-based HIV prevention initiative. The trained barber will provide the following services during regular haircut services: general, status-neutral HIV education, HIV self-test kits, and information about where to receive HIV prevention services. The barber will also lead peer support group education every two months for clients enrolled in the study.

Treatment: