NCT06659315Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 11 Nov 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT06659315
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 11 Nov 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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\>
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Invest in Knowledge (IKI) Coordinator of this site? Confirm its status | Zomba | Malawi | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.