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New hope for HIV-positive moms: counseling tackles depression and boosts care

NCT ID NCT06702722

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a program called Enhanced Friendship Bench that combines problem-solving therapy with HIV support for pregnant women in Malawi who have HIV and depression. About 400 women will take part to see if the program reduces depression symptoms and helps them stay in HIV care. The goal is to improve both mental health and HIV outcomes for mothers and their babies.

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 400 people

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

Started

Feb 2025

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

Female participants only

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: * Presenting for antenatal care at one of our 5 recruitment sites * ≥ 18 years of age * ≤ 34 weeks gestation * HIV-positive, based on medical records * Initiating, re-initiating, or on established ART during index pregnancy * Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression Exclusion Criteria: * Suicidal ideation evaluated as acute risk. * Other health concerns requiring emergent response.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder HIV infectious disease perinatal asphyxia postpartum depression

As listed by the trial registrant

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

Depression Depression, postpartum HIV

How to take part

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

  1. The places running it

    5 sites. 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

  • Area 18 Health Center

    NOT_YET_RECRUITING

    Lilongwe, Malawi

  • Area 25 Health Center

    RECRUITING

    Lilongwe, Malawi

  • Bwaila Hospital

    RECRUITING

    Lilongwe, Malawi

  • Kawale Health Center

    RECRUITING

    Lilongwe, Malawi

  • Likuni Mission Hosptial

    RECRUITING

    Lilongwe, Malawi

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