Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorEmory University
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
WeCare
BehavioralThe 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
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Friendship Bench (FB) armExperimental treatment 1 intervention
Group B: Control ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Month 3, Month 62
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.
Time frame
Baseline, Month 3, Month 63
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
Time frame
Baseline, Month 3, Month 64
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
Time frame
Baseline, Month 3, Month 6Secondary outcomes
1
Self reported medication adherence
Adherence outcomes will be based on self-report data, where participants will be asked, "How many days did you not take your PrEP in the past 30 days (0-30 days)
Time frame
Baseline, Month 3, Month 62
Status neutral composite adherence
Based on Tenofovir Diphosphate (TFV-DP) concentration ≥700 fmol/punch OR HIV-1 RNA viral load \<200 copies/ml
Time frame
Baseline, Month 3, Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov