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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-11

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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Although prevention of mother-to-child transmission of HIV (PMTCT) services are widely available, 140,000 infants contracted HIV in 2021 and the majority were in sub-Saharan Africa (SSA). Urgent attention is needed to address poor engagement in PMTCT care with more than half of mothers disengaged from care by six months postpartum. Perinatal depression (PD) is a robust predictor of poor engagement in HIV care and suboptimal PMTCT adherence-defined as adherence to antiretroviral therapy (ART), infant prophylaxis and testing, and exclusive breastfeeding. Few PD interventions have been developed to address PMTCT in SSA and none have involved male partners, who are often major sources of financial and emotional support. Nor have interventions targeted the couple dynamics that can influence the mother's experience of PD and ability to access PMTCT. This project aims to fill this gap by developing and evaluating a problem-solving therapy (PST) intervention with perinatal women and their male partners to reduce PD symptoms and improve adherence to PMTCT in Malawi.

Pregnancy and postpartum are challenging times for couples with the stress of a new child, rising food expenses and nutritional demands, potential for couple conflict with new stressors, and less opportunity for connection and intimacy-all of which are amplified in the presence of PD. Among perinatal women with HIV in Kenya, investigators found that women's mental health and adherence to PMTCT was worsened by intimate partner violence (IPV) but positively affected by social support from partners, including food support during pregnancy and the breastfeeding period. In Malawi, investigators found that women in higher functioning relationships (e.g., better intimacy, communication) reported lower levels of depression, whereas women who reported IPV had higher rates of depression. Together, this suggests that dyadic processes such as support, conflict, and communication are central for women's experience of depression and for PMTCT. However, most PD interventions have focused on women alone rather than the dyad, which may explain why half of women treated for PD have reoccurring symptoms.

In this study, the investigators propose a couple-based intervention to strengthen couple relationships and support for partners to work together around depression, food insecurity, and PMTCT. Because food insecurity was the most significant problem for women with PD in the formative work, the investigators believe interventions will be most effective if couples can also engage in problem-solving around nutrition, meal preparation, and access to food.

The investigators propose to build on the World Health Organization (WHO) Problem Management Plus (PM+) intervention, which is based on problem-solving therapy (PST) and is effective at reducing depressive symptoms with individuals. PM+ has been adapted for the Malawi context and is currently undergoing an implementation evaluation. The investigators will adapt PM+ for couples with the goal of engaging partners to provide social support for PD, helping women brainstorm and solve problems around PD, food insecurity, and PMTCT adherence, and improving couple communication skills to help couples talk constructively about depression, nutrition and other needs, relationship challenges, and adherence to PMTCT.

Conditions

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HIV Antiretroviral Therapy (ART) Adherence Perinatal Mental Health Depression During Pregnancy PMTCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Couples will be randomized 1:1 to intervention or control arm

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enhanced Usual Care

Standard of care, e.g., regular HIV care, regular perinatal care, referrals to services for depression

Group Type NO_INTERVENTION

No interventions assigned to this group

Couple-based problem solving

A couples-based intervention to support perinatal women who are experience symptoms of depression. We will adapt the WHO Problem Management Plus manual for this study. There are 5 sessions that deal with stress management, problem-solving, behavioral activation, and skills to strengthen social support. The final session will be modified to enhance couple communication skills. Because many of our participants will be dealing with food scarcity, we will develop a priori strategies to help couple brainstorm dealing with this issue.

Group Type EXPERIMENTAL

Couples Problem Solving Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Couples Problem Solving Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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\>

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No