Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
NCT06659315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2026-03-30
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.
Conditions
- HIV Antiretroviral Therapy (ART) Adherence
- Perinatal Mental Health
- Depression During Pregnancy
- PMTCT
Interventions
- BEHAVIORAL
-
Couples Problem Solving Therapy
A couples-based problem solving program to deal with depression, PMTCT adherence, and couple communication.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
Invest in Knowledge Initiative (IKI) - Zomba, Malawi
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Amy Conroy, Ph.D. · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-11
- Primary Completion
- 2027-03-31
- Completion
- 2027-07-01
Countries
- Malawi
Study Locations
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