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

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое WeCare
  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.
• Поведенческое Standard 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.

Первичные конечные точки

• Assessment : Modified version of the Session Evaluation Form (SEF) score [Срок оценки: Baseline, Month 3, Month 6]
• Change in Client Satisfaction Survey (CSQ-8) score [Срок оценки: Baseline, Month 3, Month 6]
• Mental health measures: Change in The Patient Health Questionnaire (PHQ-9) scores [Срок оценки: Baseline, Month 3, Month 6]
• Change in Psychological stress: WHO Self-Reporting Questionnaire-20 (SRQ-20) score [Срок оценки: Baseline, Month 3, Month 6]
• Change in ART adherence [Срок оценки: Baseline, Month 3, Month 6]
• Change in PrEP adherence [Срок оценки: Baseline, Month 3, Month 6]

Вторичные конечные точки (2)

• Self reported medication adherence [Срок оценки: Baseline, Month 3, Month 6]
• Status neutral composite adherence [Срок оценки: Baseline, Month 3, Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

ЮАР · 1 центр

• Aurum Institute — Johannesburg

Идентификаторы

NCT: NCT07226323 · STUDY00009339 · 5R34MH135806-02 · 2025P010078

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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