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Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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\>

Locations
Other Locations
Malawi
Invest in Knowledge (IKI)
RECRUITING
Zomba
Contact Information
Primary
James Mkandawire, MPH
James3mkandawire@gmail.com
+265(0) 999412756
Backup
Amy Conroy, Ph.D.
amy.conroy@ucsf.edu
1 303 522 9439
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 216
Treatments
No_intervention: Enhanced Usual Care
Standard of care, e.g., regular HIV care, regular perinatal care, referrals to services for depression
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Invest in Knowledge Initiative (IKI) - Zomba, Malawi, National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov