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Could a combined therapy boost HIV care in south africa?

NCT ID NCT06152003

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 3 times

Summary

This study aims to develop and pilot a program for people with HIV in South Africa who also face depression, trauma, and food insecurity. Researchers will first explore how these problems interact, then create a treatment called CBT-SA that combines therapy, nutrition support, and case management. The pilot will test whether 60 participants find the program acceptable and feasible, with a focus on improving HIV medication adherence.

What this could mean

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

Active substance
Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA) combined with nutritional counseling, food parcels, case management, and linkage to care
What this could lead to
If successful, this could point toward a practical treatment package that improves both mental health and HIV medication adherence in underserved communities.
What could go wrong
This is a very early pilot study with only 60 participants, so results may not apply broadly. The intervention is complex and may be difficult to deliver consistently.

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.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Patient receiving HIV care in Khayelitsha (confirmed by medical record) 2. Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data) 3. Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following: * Clinically significant depressive symptoms (CES-D ≥ 16) * Clinically significant post-traumatic stress symptoms (SPAN ≥ 5) 4. 18 years of age or older Exclusion Criteria: 1. Unable or unwilling to provide informed consent 2. In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling 3. Current untreated or undertreated serious mental health issue that would interfere with participation

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Conditions

The condition(s) this trial relates to.

Depression HIV infectious disease post-traumatic stress disorder

As listed by the trial registrant

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

HIV infections

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

  • University of Cape Town

    Cape Town, Western Cape, South Africa

More trials for these conditions

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