Mental Health and Medication Adherence Among MSM in South Africa
NCT ID: NCT06880172
Last Updated: 2025-03-17
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
2025-09-30
2026-09-30
Brief Summary
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Detailed Description
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The team proposes developing an intervention approach that responds to the unique social contexts of South African MSM living with or at risk for HIV, and that addresses the relationship between mental health and adherence to HIV prevention medication (daily PrEP) and ART. This intervention approach, WeCare, will adapt an evidence-based program entitled Friendship Bench (i.e., FB) - an empirically supported mental health program using problem-solving therapy (developed/validated in southern Africa) - to incorporate mental health and medication adherence concerns for MSM.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Condition
The intervention involves four weekly individual sessions followed by four weekly group support sessions, focusing on themes from the individual sessions. Services will be provided by peer wellness coaches from the MSM community, who will undergo an intensive two-week training with role-play and feedback, followed by weekly supervision. All testing and treatment services are provided free through Aurum.
WeCare
Individual level: Problem identification, Linking Mental health and minority stress, medication adherence, developing an action plan, complementing the plan, and follow-up.
Group level: Social support and self acceptance in MSM, coping with stigma and minority stress, support for medication adherence
Control Condition
The control group (Phase 3) will receive enhanced standard care which includes access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, enrollment in their standard drop-in Mpowerment support groups, as well as referrals to mental health services on request
Standard of Care
Access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, and enrollment in their standard drop-in. Mpowerment support groups, as well as referrals to mental health services on request
Interventions
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WeCare
Individual level: Problem identification, Linking Mental health and minority stress, medication adherence, developing an action plan, complementing the plan, and follow-up.
Group level: Social support and self acceptance in MSM, coping with stigma and minority stress, support for medication adherence
Standard of Care
Access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, and enrollment in their standard drop-in. Mpowerment support groups, as well as referrals to mental health services on request
Eligibility Criteria
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Inclusion Criteria
* Reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
* Current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic
* Self-reported challenges adhering to daily ART (HIV-positive participants) or PrEP (HIV-negative participants)
* Interested in participating in a group discussion to discuss common mental health problems and medication adherence challenges
* Ability to understand and provide informed consent.
Exclusion Criteria
* Participated as an intervention participant in a pilot mental health study (AUR6-8-403)
* Refuses audio recording of the focus group discussion
* Those who score over 20 on the PHQ-9 (i.e., indicating severe depression)
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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Jacqueline Pienaar
Role: PRINCIPAL_INVESTIGATOR
The Aurum Institute, Johannesburg
Locations
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The Aurum Institute
Johannesburg, Johannesburg, South Africa
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00007894
Identifier Type: -
Identifier Source: org_study_id
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