RecruitingNot ApplicableNCT06659315

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

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


Sponsor

University of California, San Francisco

Enrollment

180 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a couples-based counseling intervention in Malawi to help pregnant women living with HIV who are also experiencing depression. The program aims to improve both mental health and the prevention of passing HIV to their babies. **You may be eligible if...** - You are a pregnant woman in your second or third trimester living with HIV - You have screened positive for depression (PHQ-9 score above 10) - You are in a marriage or cohabiting relationship of at least 6 months - You have already shared your HIV status with your partner **You may NOT be eligible if...** - You are afraid for your safety if you participate - You have experienced severe intimate partner violence in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCouples Problem Solving Therapy

A couples-based problem solving program to deal with depression, PMTCT adherence, and couple communication.


Locations(1)

Invest in Knowledge (IKI)

Zomba, Malawi

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NCT06659315


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