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Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP/ART adherence skills-improves mental health and HIV medication adherence among men who have sex with men (MSM). It will also assess the safety, acceptability, and feasibility of delivering WeCare through trained lay coaches in community clinics. Main questions the trial aims to answer: * Does WeCare reduce symptoms of depression and anxiety among MSM? * Does WeCare improve PrEP and ART adherence and increase rates of viral suppression among participants on ART? * Is WeCare acceptable, feasible, and safe when delivered by lay coaches in POP INN clinics compared with usual care?

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• Male

• reports sexual intercourse with a man in the past 6 months

• reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months

• ability to communicate in English

• current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic.

• HIV positive participant only: unsuppressed HIV viral load (HIV-1 RNA viral load ≥200 copies/mL) in the sample collected in the past six months

• HIV negative participants only: Self-reported challenges adhering to daily oral PrEP (i.e miss 3 or more tablets per week)

• Moderate symptoms of depression during past 2 weeks (score on the PHQ-9 ≥10 and \<20)

• Ability to understand and provide informed consent.

Locations
Other Locations
South Africa
Aurum Institute
RECRUITING
Johannesburg
Contact Information
Primary
Don Operario, PhD
don.operario@emory.edu
404-727-0503
Backup
Danielle Giovenco, PhD
danielle.giovenco@emory.edu
404-727-3956
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Friendship Bench (FB) arm
Other: Control Arm
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Emory University

This content was sourced from clinicaltrials.gov