Couples support program for depression and HIV adherence in pregnant women in Malawi
Tests couples problem solving therapy for depression in women with HIV during pregnancy.
Plain-language title generated from the registry record
Registry title: Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
Key facts
- Where
- Zomba, MalawiSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for couples in Malawi in which the woman is pregnant, living with HIV and has signs of depression. It tests a couples therapy to help with depression and HIV medicine use.
- Age
- 18 years or older
- Sex
- All sexes; one member of the couple must be a pregnant woman
- Disease stage
- A woman in the second or third trimester of pregnancy, living with HIV, who screens positive for depression (above 10 on the PHQ9).
- Biomarker or test result
- HIV positive woman with a depression screening score above 10 on the PHQ9.
Main reasons for not taking part
- Fear that their safety would be at risk
- Severe intimate partner violence in the past three months
- Couple married or living together for less than 6 months
- HIV status not shared with the partner
Read by machine on 9 November 2026.
Where in Malawi
- Invest in Knowledge (IKI)Zomba, MalawiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of California, San Francisco
- Trial code
- NCT06659315
- Record updated
- 30 March 2026
- Original description
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.Read full original descriptionShow less
Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach
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.
Inclusion: 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: 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.