NCT06659315 Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
| NCT ID | NCT06659315 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | HIV Antiretroviral Therapy (ART) Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-11-11 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Amy Conroy, Ph.D.
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06659315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Antiretroviral Therapy (ART) Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06659315 currently recruiting?
Yes, NCT06659315 is actively recruiting participants. Contact the research team at James3mkandawire@gmail.com for enrollment information.
Where is the NCT06659315 trial being conducted?
This trial is being conducted at Zomba, Malawi.
Who is sponsoring the NCT06659315 clinical trial?
NCT06659315 is sponsored by University of California, San Francisco. The principal investigator is Amy Conroy, Ph.D. at University of California, San Francisco. The trial plans to enroll 180 participants.
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