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.
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>
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.
Parallel
Couples Problem Solving Therapy
BehavioralA couples-based problem solving program to deal with depression, PMTCT adherence, and couple communication.
Participation in the intervention
Proportion of couples who attend 75% and 100% of sessions.
Retention
Proportion of couples who complete the study follow-up surveys at 3 months post-partum and 6 months post-partum
Intervention fidelity
Study managers will listen to audio recordings of the intervention sessions and complete checklists to assess whether or not each session component was completed.
Acceptability
Proportion of couples who report satisfaction with the intervention and proportion who would recommend the intervention to friends and neighbors
Perinatal depression
Using the Center for Epidemiologic Studies Depression Scale (CES-D scale), which is validated for people living with HIV in SSA. Scores range from 0 to 60 with higher scores indicating more depression symptomatology.
Perinatal depression
Using the Center for Epidemiologic Studies Depression Scale (CES-D scale), which is validated for people living with HIV in SSA. Scores range from 0 to 60 with higher scores indicating more depression symptomatology.
Perinatal viral suppression
This is a component of PMTCT. The lab at Zomba Central Hospital will use plasma samples to measure viral load.
Perinatal adherence to ART
This is a component of PMTCT. Using the Visual Analog Scale (VAS), women will report the proportion of prescribed ART doses taken during pregnancy and postpartum. Adherence will be defined as taking 100% of the prescribed medication during each time period.
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University of California, San Francisco
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Invest in Knowledge Initiative (IKI) - Zomba, Malawi
Collaborator