RecruitingNot ApplicableNCT07226323

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


Sponsor

Emory University

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria3

  • Presently engaged in mental health therapy.
  • 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

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Interventions

BEHAVIORALWeCare

The intervention is an adapted Friendship Bench (FB) for MSM in South Africa that integrates counseling on HIV medication adherence and the mental health-adherence relationship. The intervention includes up to 4 individual sessions and up to 4 group sessions; individual sessions may be delivered in person or online (Inuka-style), while all group sessions are in person.

BEHAVIORALStandard of Care

The control group will receive enhanced standard care at POP INN Wellness Clinic: psychoeducation for all PrEP/ART enrollees, free medication, access to ongoing support groups, and referrals provided by the clinic.


Locations(1)

Aurum Institute

Johannesburg, South Africa

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NCT07226323


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