NCT07226323 Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
| NCT ID | NCT07226323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-12-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Don Operario, PhD
PRINCIPAL INVESTIGATOR
Rollins School of Public Health
Frequently Asked Questions
Who can join the NCT07226323 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07226323 currently recruiting?
Yes, NCT07226323 is actively recruiting participants. Contact the research team at don.operario@emory.edu for enrollment information.
Where is the NCT07226323 trial being conducted?
This trial is being conducted at Johannesburg, South Africa.
Who is sponsoring the NCT07226323 clinical trial?
NCT07226323 is sponsored by Emory University. The principal investigator is Don Operario, PhD at Rollins School of Public Health. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.