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

Recruiting now · Not applicable

Conditions studied: HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health, Depression During Pregnancy, PMTCT

In brief

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.

Key facts

Study ID

NCT06659315

Run by

University of California, San Francisco

People needed

180

Starts

2025-11-11

Expected to finish

2027-07-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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>

You may not qualify if…

• 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 is running

• Invest in Knowledge (IKI) — Zomba, Malawi (enrolling)

Full record on ClinicalTrials.gov

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