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New depression care model shows promise in Malawi's HIV clinics

NCT ID NCT04777006

Disease control Sponsor: RAND 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a stepped care model for depression in 14 HIV clinics in Malawi. 487 adults with moderate to severe depression received group counseling and, if needed, antidepressant medication. The goal was to see if this approach could reduce depression symptoms and improve overall health. The study also looked at whether the program was cost-effective for use in low-resource settings.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

487 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2025

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: * Attendance at integrated chronic care centers (IC3) in Neno District, Malawi * Adult, age 18 or older Exclusion Criteria: * Psychosis, or indication of other Axis I psychiatric illness

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

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

Depressive disorder

Contacts and locations

Locations

  • Partners In Health

    Neno, Neno District, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.