Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06659315

Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi

Led by University of California, San Francisco · Updated on 2026-03-30

180

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from sub-Saharan Africa (SSA) showing suboptimal adherence and persistent viremia among perinatal women. Perinatal depression (PD) is a major driver of women's poor adherence to PMTCT. Interventions that involve male partners to provide social and food/economic support could be a promising approach for addressing PD and PMTCT, yet few interventions have intervened with couples to improve systems of support, communication, and other dyadic processes. The investigators propose to develop and test a couple-based approach to intervene on the mother's perinatal depressive symptoms and to strengthen the relationship and support system for partners to work together around depression to improve PMTCT adherence. The study will take place in antenatal and HIV care settings in Zomba, Malawi. The specific aims are: (1) to develop a couple-based intervention to target perinatal depression (PD) based on an evidence-based approach using problem-solving therapy (PST), augmented with content on couple communication and problem-solving skills; and (2) to assess the feasibility and acceptability (F\&A) of the intervention via a pilot randomized controlled trial (RCT). Our short-term goal is the produce a couple-focused PST intervention that can be added to the global health toolkit for treating depression in perinatal women. Our long-term goal is to produce a high-impact and sustainable intervention leveraging the couple relationship that can be scaled-up to address depression, PMTCT adherence, and family health.

CONDITIONS

Official Title

Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be in a marriage or cohabitating union for at least 6 months
  • Have a woman in the couple who is in the second or third trimester of pregnancy and living with HIV
  • The woman must screen positive for depression with a score greater than 10 on the PHQ9
  • The woman must have disclosed her HIV status to her partner
Not Eligible

You will not qualify if you...

  • Fear for personal safety
  • Report incidents of severe intimate partner violence (IPV) in the past three months as measured by the WHO IPV scale

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Invest in Knowledge (IKI)

Zomba, Malawi

Actively Recruiting

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Research Team

J

James Mkandawire, MPH

CONTACT

A

Amy Conroy, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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