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NCT07226323Recruiting

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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?

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
7 Nov 2025
Start date
1 Dec 2025
Primary completion date
31 Jul 2027
Lead sponsor
Emory University
Diseases
HIV
NCT number
NCT07226323

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Dec 2025 to the primary completion date, 31 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presently engaged in mental health therapy.

Other

  • Participated in qualitative phase of WeCare study (AUR2-18-419) or open-pilot (present study).
  • Refuses audio recording of the in-person or online individual counselling session

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aurum Institute
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.