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

Not Applicable

Not yet recruiting

• Conditions: HIV Infections; Mental Health

• Registration Number: NCT07226323
• Lead Sponsor: Emory University

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?

Detailed Description

Men who have sex with men (MSM) in sub-Saharan Africa face very high HIV incidence and prevalence, with South Africa carrying the largest national burden and an estimated \~30% HIV prevalence among MSM. National policies in South Africa endorse universal test-and-treat and prioritize MSM for Pre-Exposure Prophylaxis (PrEP) and Anti-Retroviral Therapy (ART), but care cascade indicators and adherence outcomes for MSM lag behind national averages, indicating a need for differentiated, targeted service approaches.

Common mental health problems are prevalent among MSM and are strongly associated with poorer PrEP and ART adherence. Randomized and quasi-experimental trials in the region show that lay-delivered or nurse-delivered mental health interventions can reduce depression and improve ART adherence and viral suppression, while observational studies link poor mental health to lower PrEP adherence and limited trial evidence suggests integrated adherence interventions may improve biomarker outcomes.

The Friendship Bench (FB) model-an evidence-based, lay health worker-delivered problem-solving therapy program developed in Zimbabwe and adapted across low-resource settings-produces substantial reductions in depressive symptoms and can be delivered in person or digitally. FB's original form had limited effects on ART adherence, prompting calls to explicitly integrate adherence counseling; systematic adaptation is required to make FB effective for MSM by incorporating minority stress theory, addressing anti-MSM stigma and disclosure challenges, and adding explicit adherence skills training.

Aurum's POP INN clinics provide MSM-friendly services and peer support and have piloted FB-style coaching, revealing high rates of medication adherence challenges and moderate-to-severe depression among MSM. Pilot quantitative and qualitative data identify predictors of non-suppression and adherence problems-such as clinic location, transactional sex, missed doses, anxiety, and shorter ART duration-and show a clear preference among MSM for HIV status-neutral programming. Building on these findings, the proposed WeCare intervention aims to adapt Facebook into a status-neutral, minority-stress-informed package that integrates problem-solving therapy with explicit PrEP/ART adherence support, delivered by trained lay coaches, to improve mental health, medication adherence, viral suppression, stigma reduction, and community cohesion.

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-07
• Study First Submitted QC: 2025-11-07
• Last Update Submitted: 2025-11-07
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2025-12-01
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment : Modified version of the Session Evaluation Form (SEF) score	Baseline, Month 3, Month 6	13-item SEF measuring perceived feasibility, acceptability, and intervention utility.; Composite scores are calculated with higher scores indicating more perceived feasibility and acceptability.
Change in Client Satisfaction Survey (CSQ-8) score	Baseline, Month 3, Month 6	8-item CSQ assessing satisfaction with recruitment, retention, and intervention procedures, engagement data from the trial (e.g., completion of sessions).; Composite scores are calculated with higher scores indicating more satisfaction.
Mental health measures: Change in The Patient Health Questionnaire (PHQ-9) scores	Baseline, Month 3, Month 6	The Patient Health Questionnaire (PHQ-9) measures the frequency of depression symptoms within the past two weeks. The PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms
Change in Psychological stress: WHO Self-Reporting Questionnaire-20 (SRQ-20) score	Baseline, Month 3, Month 6	The WHO Self-Reporting Questionnaire-20 (SRQ-20) includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD) and have been found to detect probable mental health disorder with satisfactory accuracy
Change in ART adherence	Baseline, Month 3, Month 6	ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load \<200 copies/mL) in a blood sample
Change in PrEP adherence	Baseline, Month 3, Month 6	PrEP adherence will be defined as an intracellular Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch in a dried blood spot (DBS) sample. This concentration was found consistent with an average of ≥4 doses/week in the prior month in a directly observed study among men and women in the United States

Secondary Outcome Measures

Name	Time	Method
Self reported medication adherence	Baseline, Month 3, Month 6	Adherence outcomes will be based on self-report data, where participants will be asked, "How many days did you not take your PrEP in the past 30 days (0-30 days)
Status neutral composite adherence	Baseline, Month 3, Month 6	Based on Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch OR HIV-1 RNA viral load \<200 copies/ml

Trial Locations

Locations (1)

Aurum Institute; 🇿🇦 Johannesburg, South Africa