Testing a Barbershop-based HIV Prevention Initiative Among Men

HIV Infections Clinical Trial

— TRIM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06148584
• Other study ID #: HPTN 111
• Secondary ID: UM1AI068619-17
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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
• 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

Locations

Country	Name	City	State
Uganda	MU-JHU Research Collaboration (MUJHU CARE LTD) CRS	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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