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Completed

NCT Number: NCT06148584

Testing a Barbershop-based HIV Prevention Initiative Among Men

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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.

Treatment and study plan

General, status-neutral HIV education

Behavioral

General, status-neutral HIV education

HIV self-test kits

Diagnostic Test

HIV self-test kits

Information about where to receive HIV prevention services

Other

Information about where to receive HIV prevention services

Barber-led peer support group education

Behavioral

Barber-led peer support group education

Facility-based HIV risk reduction counseling

Behavioral

Facility-based HIV risk reduction counseling

Facility-based HIV testing

Diagnostic Test

Facility-based HIV testing

Information about facility distributed HIV self-test kits

Other

Information about facility distributed HIV self-test kits

STI testing

Diagnostic Test

STI testing

Primary outcomes

  1. To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative

    Time frame: Week 26 and Week 52

    Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Participant responses from surveys at Week 26 and Week 52 about acceptability of the intervention

  2. To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative

    Time frame: Week 13, Week 26, Week 39, Week 52, Week 65

    Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Barber responses from surveys about feasibility and acceptability of intervention

  3. To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative

    Time frame: Week 26 and Week 52

    Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Recruitment rates during enrollment and retention in study and barbershop activities at Week 26 and Week 52

  4. To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative

    Time frame: Week 13, Week 26, Week 39, Week 52, Week 65

    Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Frequency of barber-participant interactions

  5. To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative

    Time frame: Week 13, Week 26, Week 39, Week 52, Week 65

    Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Proportion of barber-participant interactions that include delivery of the intervention

Secondary outcomes

  1. To compare completion of self-initiated HIV testing between intervention and control groups

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Self-report of HIV test conducted during the study follow-up

  2. To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported risk behaviors at Week 26 and Week 52, including condom use

  3. To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported risk behaviors at Week 26 and Week 52, including number of total sexual partners

  4. To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported risk behaviors at Week 26 and Week 52, including number of new sexual partners

  5. To compare interest in or use of HIV prevention services between intervention and control groups

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Voluntary medical male circumcision (VMMC) during the study

  6. To compare interest in or use of HIV prevention services between intervention and control groups

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported access to PEP care or use of PEP

  7. To compare interest in or use of HIV prevention services between intervention and control groups

    Time frame: Week 26 and Week 52

    Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported access to PrEP care or use of any PrEP method during the study

  8. To assess the preliminary interest in Long-Acting PrEP (LAPrEP) among all participants

    Time frame: Week 52

    Consistent with this secondary study objective, the following endpoints will be assessed: Self-reported interest in LAPrEP at Week 52

Sponsors and collaborators

Lead sponsor

HIV Prevention Trials Network

Network

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Feasibility and Acceptability of a Barbershop Based HIV Prevention Initiative Among Heterosexual Men in Kalangala Islands, Uganda: A Cluster Randomized Trial

Acronym: TRIM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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