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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: General, status-neutral HIV education; Diagnostic test: HIV self-test kits; Other: Information about where to receive HIV prevention services; Behavioral: Barber-led peer support group education; Behavioral: Facility-based HIV risk reduction counseling; Diagnostic test: Facility-based HIV testing; Other: Information about facility distributed HIV self-test kits; Diagnostic test: STI testing

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
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin Scoville, MPH; Phone Number: 202-464-3750; Email: cscoville@fhi360.org
• Study Contact Backup: Name: Michelle Robinson; Phone Number: 919-321-3585; Email: mrobinson@fhi360.org

Study Locations

• Uganda
  • Kampala, Uganda
    • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: General, status-neutral HIV education; General, status-neutral HIV education; Diagnostic test: HIV self-test kits; HIV self-test kits; Other: Information about where to receive HIV prevention services; Information about where to receive HIV prevention services; Behavioral: Barber-led peer support group education; Barber-led peer support group education
Active Comparator: 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.	Behavioral: Facility-based HIV risk reduction counseling; Facility-based HIV risk reduction counseling; Diagnostic test: Facility-based HIV testing; Facility-based HIV testing; Other: Information about facility distributed HIV self-test kits; Information about facility distributed HIV self-test kits; Diagnostic test: STI testing; STI testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative	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	Week 26 and Week 52
To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative	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	Week 13, Week 26, Week 39, Week 52, Week 65
To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative	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	Week 26 and Week 52
To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative	Consistent with this primary study objective, the following endpoint will be assessed from participants in the intervention group: Frequency of barber-participant interactions	Week 13, Week 26, Week 39, Week 52, Week 65
To evaluate the feasibility and acceptability of a barbershop based HIV prevention initiative	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	Week 13, Week 26, Week 39, Week 52, Week 65

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare completion of self-initiated HIV testing between intervention and control groups	Consistent with this secondary study objective, the following endpoint will be assessed: Self-report of HIV test conducted between enrollment and study visit at Week 26, and between the Week 26 and Week 52 study visits	Week 26 and Week 52
To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition	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	Week 26 and Week 52
To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition	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	Week 26 and Week 52
To evaluate the preliminary effectiveness of the intervention on change in risk behaviors associated with HIV acquisition	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	Week 26 and Week 52
To compare interest in or use of HIV prevention services between intervention and control groups	Consistent with this secondary study objective, the following endpoint will be assessed: Voluntary medical male circumcision (VMMC) during the study	Week 26 and Week 52
To compare interest in or use of HIV prevention services between intervention and control groups	Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported referral to PEP care or use of PEP	Week 26 and Week 52
To compare interest in or use of HIV prevention services between intervention and control groups	Consistent with this secondary study objective, the following endpoint will be assessed: Self-reported referral to PrEP care or use of any PrEP method during the study	Week 26 and Week 52

Collaborators and Investigators

• Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
• Investigators: Study Chair: Zubair Lukyamuzi, MBChB, MPH, Makerere University, Johns Hopkins University Collaboration (MU-JHU); Study Chair: Brenda Gati Mirembe, MBChB, MscEpi, Makerere University, Johns Hopkins University Collaboration (MU-JHU)

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HIV; HIV Prevention; Uganda; HIV Testing; Peer Support; STI Testing; Barbershop; Kalangala District; Heterosexual Men; HIV Education; HIV Self-test Kits; HIV Risk Reduction Counseling
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: HPTN 111; UM1AI068619-17 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No