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New counseling program aims to boost mental health and HIV drug adherence in south african men

NCT ID NCT07226323

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a program called WeCare, which combines problem-solving therapy with support for taking HIV medication. It is designed for men who have sex with men (MSM) in South Africa. The study will enroll 60 participants to see if the program reduces depression and anxiety, improves medication adherence, and is acceptable and safe when delivered by trained lay coaches in community clinics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WeCare (adapted Friendship Bench counseling program)
What this could lead to
If it works, this could point toward a low-cost, community-based way to improve mental health and HIV medication adherence among men who have sex with men.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply broadly. It tests feasibility and acceptability, not yet proven effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male * reports sexual intercourse with a man in the past 6 months * reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months * ability to communicate in English * current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic. * HIV positive participant only: unsuppressed HIV viral load (HIV-1 RNA viral load ≥200 copies/mL) in the sample collected in the past six months * HIV negative participants only: Self-reported challenges adhering to daily oral PrEP (i.e miss 3 or more tablets per week) * Moderate symptoms of depression during past 2 weeks (score on the PHQ-9 ≥10 and \<20) * Ability to understand and provide informed consent. Exclusion Criteria: * Presently engaged in mental health therapy. * Participated in qualitative phase of WeCare study (AUR2-18-419) or open-pilot (present study). * Refuses audio recording of the in-person or online individual counselling session

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Conditions

The condition(s) this trial relates to.

depressive disorder HIV infectious disease Medication Adherence Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections Mental health

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aurum Institute

    RECRUITING

    Johannesburg, South Africa

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