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

NCT07226323 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-10

No results posted yet for this study

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?

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Don Operario, PhD · Rollins School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226323 on ClinicalTrials.gov