Testing a Barbershop-based HIV Prevention Initiative Among Men

NCT06148584 | Completed DMC

• 2 other identifiers: HPTN 111UM1AI068619-17
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; HIV Prevention; Barbershop; Uganda; Kalangala District; Heterosexual Men; HIV Education; HIV Self-test Kits; Peer Support; HIV Testing; HIV Risk Reduction Counseling; STI Testing

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

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

  Week 26 and Week 52

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

  Week 26 and Week 52

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

  Week 26 and Week 52

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

  Week 26 and Week 52

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

  Week 26 and Week 52

Study Arms (2)

Intervention Barbershops Group

EXPERIMENTAL

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; Diagnostic Test: HIV self-test kits; Other: Information about where to receive HIV prevention services; Behavioral: Barber-led peer support group education

Control Barbershops Group

ACTIVE COMPARATOR

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; Diagnostic Test: Facility-based HIV testing; Other: Information about facility distributed HIV self-test kits; Diagnostic Test: STI testing

Interventions

General, status-neutral HIV education BEHAVIORAL

General, status-neutral HIV education

Intervention Barbershops Group

HIV self-test kits DIAGNOSTIC_TEST

HIV self-test kits

Intervention Barbershops Group

Information about where to receive HIV prevention services OTHER

Information about where to receive HIV prevention services

Intervention Barbershops Group

Barber-led peer support group education BEHAVIORAL

Barber-led peer support group education

Intervention Barbershops Group

Facility-based HIV risk reduction counseling BEHAVIORAL

Facility-based HIV risk reduction counseling

Control Barbershops Group

Facility-based HIV testing DIAGNOSTIC_TEST

Facility-based HIV testing

Control Barbershops Group

Information about facility distributed HIV self-test kits OTHER

Information about facility distributed HIV self-test kits

Control Barbershops Group

STI testing DIAGNOSTIC_TEST

STI testing

Control Barbershops Group

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

Kampala, Uganda

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 28, 2023
• Study Start: March 13, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)