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Can couples counseling help pregnant women with HIV stay healthy and beat depression?

NCT ID NCT06659315

Disease control Sponsor: University of California, San Francisco 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a couple-based problem-solving therapy for pregnant women living with HIV who also have depression. The goal is to improve their mental health and help them stick to their HIV medication, which prevents passing the virus to their baby. The trial will enroll 180 couples in Malawi to see if the approach is feasible and acceptable.

What this could mean

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

Active substance
Couples Problem Solving Therapy (behavioral intervention)
What this could lead to
If successful, this could provide a practical, scalable way to improve both mental health and HIV medication adherence in pregnant women, reducing mother-to-child transmission of HIV.
What could go wrong
This is a small, early-stage feasibility study (180 couples) in one region of Malawi, so results may not apply broadly. The intervention is behavioral and depends on partner participation, which may be challenging.

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 180 people

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

Started

Nov 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

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: * In a marriage or cohabitating union for at least 6 months. * One member of the couple is a woman in the second or third trimester of pregnancy who is living with HIV and screens positive for depression (\>10 on the PHQ9). * Have revealed their HIV status to their partner if living with HIV\> Exclusion Criteria: * Fear their safety would be at risk. * Report incidents of severe intimate partner violence (IPV) in the past three months using the WHO IPV measure.

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Conditions

The condition(s) this trial relates to.

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 during pregnancy HIV antiretroviral therapy (ART) adherence Perinatal mental health PMTCT

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

  • Invest in Knowledge (IKI)

    RECRUITING

    Zomba, Malawi

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