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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Couples problem-solving support for pregnant women with HIV and depression in Malawi

Official title: Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach

Run by University of California, San Francisco · NCT06659315 · Data updated 2026-11-12

This project will try couples problem-solving therapy to reduce depression and help pregnant women with HIV stick with their PMTCT treatment and care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment180 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (Zomba)
StatusRecruiting
StartedNovember 11, 2025
Main results expectedMarch 31, 2027
Study endsJuly 1, 2027
Registry record updatedMarch 30, 2026
Trial IDNCT06659315 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women living with HIV in their second or third trimester who screen positive for depression (PHQ-9 >10), have disclosed their HIV status to a cohabiting partner of at least six months, and whose partner is willing to participate are the ideal candidates.

Probably not a fit

Women who are not in stable cohabiting relationships, have recent severe intimate partner violence or safety concerns, decline partner involvement, or have severe psychiatric conditions may not benefit from this couples-based approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The team will develop and test a problem-solving therapy delivered to pregnant women living with HIV and their male partners in Zomba, Malawi, aiming to reduce perinatal depressive symptoms and strengthen partner support. Enrollment targets couples where the woman is in her second or third trimester, screens positive for depression (PHQ-9 >10), has disclosed her HIV status, and has been cohabiting with her partner for at least six months. Sessions will focus on improving communication, joint problem solving around economic and caregiving stressors, and specific behaviors that support adherence to ART, infant prophylaxis, testing, and exclusive breastfeeding. Key outcomes include changes in maternal depression scores, maternal viral suppression/PMTCT adherence measures, and retention in care during the early postpartum period.

Why it matters

Potential benefit: If successful, the intervention could lower maternal depression, improve adherence to ART and PMTCT practices, and reduce mother-to-child HIV transmission.

How similar studies have gone: Problem-solving therapy and partner-involvement interventions have shown benefit for depression and treatment adherence in some settings, but couple-based PST specifically targeting PMTCT in sub-Saharan Africa remains largely untested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Invest in Knowledge (IKI)
    Zomba, Malawi     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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HIV Antiretroviral Therapy (ART) Adherence 7Perinatal Mental Health 8Depression During Pregnancy 2PMTCT 2University of California, San Francisco 3127
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.