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

Emory University

Status

Not yet enrolling

Conditions

HIV Infections

Mental Health

Treatments

Behavioral: WeCare

Behavioral: Standard of Care

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07226323

STUDY00009339

5R34MH135806-02 (U.S. NIH Grant/Contract)

2025P010078 (Other Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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