Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Amon… (NCT07226323) | Clinical Trial Compass
RecruitingNot Applicable
Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
South Africa60 participantsStarted 2025-12-01
Plain-language 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?
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment : Modified version of the Session Evaluation Form (SEF) score
Timeframe: Baseline, Month 3, Month 6
2
Change in Client Satisfaction Survey (CSQ-8) score
Timeframe: Baseline, Month 3, Month 6
3
Mental health measures: Change in The Patient Health Questionnaire (PHQ-9) scores
Timeframe: Baseline, Month 3, Month 6
4
Change in Psychological stress: WHO Self-Reporting Questionnaire-20 (SRQ-20) score