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

NCT07226323 | Not Yet Recruiting

• 3 other identifiers: STUDY000093395R34MH135806-022025P010078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

HIV Infections; Mental Health

Keywords

Men having sex with Men; Medication adherence; PrEP Adherence; ART Adherence

Outcome Measures

Primary Outcomes (6)

• Assessment : Modified version of the Session Evaluation Form (SEF) score

  13-item SEF measuring perceived feasibility, acceptability, and intervention utility. Composite scores are calculated with higher scores indicating more perceived feasibility and acceptability.

  Baseline, Month 3, Month 6

• Change in Client Satisfaction Survey (CSQ-8) score

  8-item CSQ assessing satisfaction with recruitment, retention, and intervention procedures, engagement data from the trial (e.g., completion of sessions). Composite scores are calculated with higher scores indicating more satisfaction.

  Baseline, Month 3, Month 6

• Mental health measures: Change in The Patient Health Questionnaire (PHQ-9) scores

  The Patient Health Questionnaire (PHQ-9) measures the frequency of depression symptoms within the past two weeks. The PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms

  Baseline, Month 3, Month 6

• Change in Psychological stress: WHO Self-Reporting Questionnaire-20 (SRQ-20) score

  The WHO Self-Reporting Questionnaire-20 (SRQ-20) includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD) and have been found to detect probable mental health disorder with satisfactory accuracy

  Baseline, Month 3, Month 6

• Change in ART adherence

  ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load \<200 copies/mL) in a blood sample

  Baseline, Month 3, Month 6

• Change in PrEP adherence

  PrEP adherence will be defined as an intracellular Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch in a dried blood spot (DBS) sample. This concentration was found consistent with an average of ≥4 doses/week in the prior month in a directly observed study among men and women in the United States

  Baseline, Month 3, Month 6

Secondary Outcomes (2)

• Self reported medication adherence

  Baseline, Month 3, Month 6

• Status neutral composite adherence

  Baseline, Month 3, Month 6

Study Arms (2)

Friendship Bench (FB) arm

EXPERIMENTAL

Behavioral: WeCare

Control Arm

OTHER

Behavioral: Standard of Care

Interventions

WeCare BEHAVIORAL

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.

Friendship Bench (FB) arm

Standard of Care BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Aurum Institute

Johannesburg, South Africa

Location

MeSH Terms

Conditions

HIV Infections; Psychological Well-Being; Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Don Operario, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Don Operario, PhD

CONTACT

404-727-0503; don.operario@emory.edu

Danielle Giovenco, PhD

CONTACT

404-727-3956; danielle.giovenco@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared following publication

Locations

ZA (1)