Clinical trial NCT06880172: Mental Health and Medication Adherence Among MSM in South Africa
Official title: Addressing Mental Health and Medication Adherence Among MSM in South Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Keywords: MSM
PrEP
ART
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Medication adherence (ART)
timeFrame: Baseline, Month 3, Month 6
measure: Medication adherence (PrEP)
timeFrame: Baseline, Month 3, Month 6
measure: Mental health status
timeFrame: Baseline, Month 3, Month 6
measure: Psychological stress
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: Status neutral composite adherence
timeFrame: Baseline, Month 3, Month 6
measure: Self Reported medication adherence
timeFrame: Baseline, Month 3, Month 6
measure: Persistence
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: The Aurum Institute
Study officials:
affiliation: The Aurum Institute, Johannesburg
name: Jacqueline Pienaar
role: PRINCIPAL_INVESTIGATOR
References: