CompletedNot Applicable

Mental Health and Medication Adherence Among MSM in South Africa

South Africa12 participantsStarted 2025-05-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Medication adherence (ART)

Timeframe: Baseline, Month 3, Month 6

Medication adherence (PrEP)

Timeframe: Baseline, Month 3, Month 6

Mental health status

Timeframe: Baseline, Month 3, Month 6

Psychological stress

Timeframe: Baseline, Month 3, Month 6

Trial details

NCT IDNCT06880172

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-22

View on ClinicalTrials.gov More HIV trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.