Testing a Barbershop-based HIV Prevention Initiative Among Men

NCT ID: NCT06148584

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Barbershops Group

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.

Group Type EXPERIMENTAL

General, status-neutral HIV education

Intervention Type BEHAVIORAL

General, status-neutral HIV education

HIV self-test kits

Intervention Type DIAGNOSTIC_TEST

HIV self-test kits

Information about where to receive HIV prevention services

Intervention Type OTHER

Information about where to receive HIV prevention services

Barber-led peer support group education

Intervention Type BEHAVIORAL

Barber-led peer support group education

Control Barbershops Group

Participants recruited from control barbershops will receive standard-of-care HIV prevention services which include facility-based HIV risk reduction counseling and testing and providing information about facility distributed HIV self-test kits.

Group Type ACTIVE_COMPARATOR

Facility-based HIV risk reduction counseling

Intervention Type BEHAVIORAL

Facility-based HIV risk reduction counseling

Facility-based HIV testing

Intervention Type DIAGNOSTIC_TEST

Facility-based HIV testing

Information about facility distributed HIV self-test kits

Intervention Type OTHER

Information about facility distributed HIV self-test kits

STI testing

Intervention Type DIAGNOSTIC_TEST

STI testing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

General, status-neutral HIV education

General, status-neutral HIV education

Intervention Type BEHAVIORAL

HIV self-test kits

HIV self-test kits

Intervention Type DIAGNOSTIC_TEST

Information about where to receive HIV prevention services

Information about where to receive HIV prevention services

Intervention Type OTHER

Barber-led peer support group education

Barber-led peer support group education

Intervention Type BEHAVIORAL

Facility-based HIV risk reduction counseling

Facility-based HIV risk reduction counseling

Intervention Type BEHAVIORAL

Facility-based HIV testing

Facility-based HIV testing

Intervention Type DIAGNOSTIC_TEST

Information about facility distributed HIV self-test kits

Information about facility distributed HIV self-test kits

Intervention Type OTHER

STI testing

STI testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

HIV Prevention Trials Network

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zubair Lukyamuzi, MBChB, MPH

Role: STUDY_CHAIR

Makerere University, Johns Hopkins University Collaboration (MU-JHU)

Brenda Gati Mirembe, MBChB, MscEpi

Role: STUDY_CHAIR

Makerere University, Johns Hopkins University Collaboration (MU-JHU)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

Kampala, , Uganda

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Uganda

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UM1AI068619-17

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HPTN 111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Test-to-PrEP Study
NCT06927856 RECRUITING NA