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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659315 on ClinicalTrials.gov