Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
NCT ID: NCT07226323
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-31
2027-04-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Friendship Bench (FB) arm
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.
Control Arm
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Emory University
OTHER
Responsible Party
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Don Operario
Professor
Principal Investigators
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Don Operario, PhD
Role: PRINCIPAL_INVESTIGATOR
Rollins School of Public Health
Locations
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Aurum Institute
Johannesburg, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Eduard Sanders
Role: primary
Other Identifiers
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2025P010078
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00009339
Identifier Type: -
Identifier Source: org_study_id