Mental Health and Medication Adherence Among MSM in South Africa

NCT06880172 | Completed

• 2 other identifiers: STUDY00007894R34MH135806
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

MSM; PrEP; ART

Outcome Measures

Primary Outcomes (4)

• Medication adherence (ART)

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

  Baseline, Month 3, Month 6

• Medication adherence (PrEP)

  PrEP adherence is defined as an intracellular TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample

  Baseline, Month 3, Month 6

• Mental health status

  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

• Psychological stress

  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).

  Baseline, Month 3, Month 6

Secondary Outcomes (3)

• Status neutral composite adherence

  Baseline, Month 3, Month 6

• Self Reported medication adherence

  Baseline, Month 3, Month 6

• Persistence

  Baseline, 3 months, 6 months

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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.

Behavioral: WeCare

Control Condition

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

Interventions

WeCare BEHAVIORAL

Individual level: Problem identification, Linking Mental health and minority stress, medication adherence, developing an action plan, complementing the plan, and follow-up. Group level: Social support and self acceptance in MSM, coping with stigma and minority stress, support for medication adherence

Intervention Condition

Standard of Care BEHAVIORAL

Access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, and enrollment in their standard drop-in. Mpowerment support groups, as well as referrals to mental health services on request

Control Condition

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cis-gender male (assigned male at birth and identify as male)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

The Aurum Institute

Johannesburg, 2194, South Africa

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jacqueline Pienaar

  The Aurum Institute, Johannesburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: May 26, 2025
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication (anticipated June 2026)
• Access Criteria: Proposals should be directed to don.operario@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website

Locations

ZA (1)