Mental Health and Medication Adherence Among MSM in South Africa

Emory University

Status: Not yet enrolling

Conditions: HIV

Treatments: Behavioral: Standard of Care; Behavioral: WeCare

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06880172

R34MH135806 (U.S. NIH Grant/Contract)

STUDY00007894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention Condition

Experimental group

Description:

The intervention involves four weekly individual sessions followed by four weekly group support sessions, focusing on themes from the individual sessions. Services will be provided by peer wellness coaches from the MSM community, who will undergo an intensive two-week training with role-play and feedback, followed by weekly supervision. All testing and treatment services are provided free through Aurum.

Treatment:

Behavioral: WeCare

Control Condition

Active Comparator group

Description:

The control group (Phase 3) will receive enhanced standard care which includes access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, enrollment in their standard drop-in Mpowerment support groups, as well as referrals to mental health services on request

Treatment:

Behavioral: Standard of Care