Mental Health and Medication Adherence Among MSM in South Africa

Not Applicable

Not yet recruiting

• Conditions: HIV

• Registration Number: NCT06880172
• Lead Sponsor: Emory University

Brief Summary

The goal of this behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa.

Detailed Description

Men who have sex with men (MSM) are at an increased risk of HIV infection and transmission, and MSM with depression or anxiety may have adherence to medication challenges. Development of an integrated mental health and adherence support intervention for MSM can be an effective strategy to improve both psychological outcomes and care continuum outcomes including adherence to Pre-Exposure prophylaxis (PrEP) and Anti Retroviral Therapy (ART).

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-09
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Cis-gender male
• 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

• Presently engaged in mental health therapy.
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication adherence (ART)	Baseline, Month 3, Month 6	ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load \<200 copies/mL) in the blood sample
Medication adherence (PrEP)	Baseline, Month 3, Month 6	PrEP adherence is defined as an intracellular TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample
Mental health status	Baseline, Month 3, Month 6	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.
Psychological stress	Baseline, Month 3, Month 6	The WHO Self-Reporting Questionnaire-20 (SRQ-20) will be used that includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD).

Secondary Outcome Measures

Name	Time	Method
Persistence	Baseline, 3 months, 6 months	Defined as time to first PrEP discontinuation, based on a PrEP clinical hold, elective PrEP stop, or missed prescription refill as indicated by pharmacy data
Status neutral composite adherence	Baseline, Month 3, Month 6	This is based on TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample OR HIV-1 RNA viral load \<200 copies/mL)
Self Reported medication adherence	Baseline, Month 3, Month 6	participants will be asked, "How many days did you not take your PrEP \[ART\] in the past 30 days (0-30 days)

Trial Locations

Locations (1)

The Aurum Institute; 🇿🇦 Johannesburg, South Africa