Couples problem-solving support for pregnant women with HIV and depression in Malawi
Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach
This project will try couples problem-solving therapy to reduce depression and help pregnant women with HIV stick with their PMTCT treatment and care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Zomba) |
| Trial ID | NCT06659315 on ClinicalTrials.gov |
What this trial studies
The team will develop and test a problem-solving therapy delivered to pregnant women living with HIV and their male partners in Zomba, Malawi, aiming to reduce perinatal depressive symptoms and strengthen partner support. Enrollment targets couples where the woman is in her second or third trimester, screens positive for depression (PHQ-9 >10), has disclosed her HIV status, and has been cohabiting with her partner for at least six months. Sessions will focus on improving communication, joint problem solving around economic and caregiving stressors, and specific behaviors that support adherence to ART, infant prophylaxis, testing, and exclusive breastfeeding. Key outcomes include changes in maternal depression scores, maternal viral suppression/PMTCT adherence measures, and retention in care during the early postpartum period.
Who should consider this trial
Good fit: Women living with HIV in their second or third trimester who screen positive for depression (PHQ-9 >10), have disclosed their HIV status to a cohabiting partner of at least six months, and whose partner is willing to participate are the ideal candidates.
Not a fit: Women who are not in stable cohabiting relationships, have recent severe intimate partner violence or safety concerns, decline partner involvement, or have severe psychiatric conditions may not benefit from this couples-based approach.
Why it matters
Potential benefit: If successful, the intervention could lower maternal depression, improve adherence to ART and PMTCT practices, and reduce mother-to-child HIV transmission.
How similar studies have performed: Problem-solving therapy and partner-involvement interventions have shown benefit for depression and treatment adherence in some settings, but couple-based PST specifically targeting PMTCT in sub-Saharan Africa remains largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zomba
- Invest in Knowledge (IKI) — Zomba, Malawi (Recruiting)
Study contacts
- Principal investigator: Amy Conroy, Ph.D. — University of California, San Francisco
- Study coordinator: James Mkandawire, MPH
- Email: James3mkandawire@gmail.com
- Phone: +265(0) 999412756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.