An interventional study of Couples Problem Solving Therapy in HIV Antiretroviral Therapy (ART) Adherence, Perinatal Mental Health and Depression During Pregnancy, sponsored by University of California, San Francisco. Recruiting at 1 site in Malawi. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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.
Although prevention of mother-to-child transmission of HIV (PMTCT) services are widely available, 140,000 infants contracted HIV in 2021 and the majority were in sub-Saharan Africa (SSA). Urgent attention is needed to address poor engagement in PMTCT care with more than half of mothers disengaged from care by six months postpartum. Perinatal depression (PD) is a robust predictor of poor engagement in HIV care and suboptimal PMTCT adherence-defined as adherence to antiretroviral therapy (ART), infant prophylaxis and testing, and exclusive breastfeeding. Few PD interventions have been developed to address PMTCT in SSA and none have involved male partners, who are often major sources of financial and emotional support. Nor have interventions targeted the couple dynamics that can influence the mother's experience of PD and ability to access PMTCT. This project aims to fill this gap by developing and evaluating a problem-solving therapy (PST) intervention with perinatal women and their male partners to reduce PD symptoms and improve adherence to PMTCT in Malawi.
Pregnancy and postpartum are challenging times for couples with the stress of a new child, rising food expenses and nutritional demands, potential for couple conflict with new stressors, and less opportunity for connection and intimacy-all of which are amplified in the presence of PD. Among perinatal women with HIV in Kenya, investigators found that women's mental health and adherence to PMTCT was worsened by intimate partner violence (IPV) but positively affected by social support from partners, including food support during pregnancy and the breastfeeding period. In Malawi, investigators found that women in higher functioning relationships (e.g., better intimacy, communication) reported lower levels of depression, whereas women who reported IPV had higher rates of depression. Together, this suggests that dyadic processes such as support, conflict, and communication are central for women's experience of depression and for PMTCT. However, most PD interventions have focused on women alone rather than the dyad, which may explain why half of women treated for PD have reoccurring symptoms.
In this study, the investigators propose a couple-based intervention to strengthen couple relationships and support for partners to work together around depression, food insecurity, and PMTCT. Because food insecurity was the most significant problem for women with PD in the formative work, the investigators believe interventions will be most effective if couples can also engage in problem-solving around nutrition, meal preparation, and access to food.
The investigators propose to build on the World Health Organization (WHO) Problem Management Plus (PM+) intervention, which is based on problem-solving therapy (PST) and is effective at reducing depressive symptoms with individuals. PM+ has been adapted for the Malawi context and is currently undergoing an implementation evaluation. The investigators will adapt PM+ for couples with the goal of engaging partners to provide social support for PD, helping women brainstorm and solve problems around PD, food insecurity, and PMTCT adherence, and improving couple communication skills to help couples talk constructively about depression, nutrition and other needs, relationship challenges, and adherence to PMTCT.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 180 is above the median of 81 across 7,063 interventional studies indexed under Depression.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care, e.g., regular HIV care, regular perinatal care, referrals to services for depression
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.
Behavioral: Couples Problem Solving Therapy
A 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.
Time frame: following the intervention period, an average of 5 months
Retention
Proportion of couples who complete the study follow-up surveys at 3 months post-partum and 6 months post-partum
Time frame: through study completion, an average of 11 months
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.
Time frame: following the intervention period, an average of 5 months
Acceptability
Proportion of couples who report satisfaction with the intervention and proportion who would recommend the intervention to friends and neighbors
Time frame: Assessed at the 3-month post-partum follow-up
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.
Time frame: 3 months post partum
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.
Time frame: 6 months post-partum
Perinatal viral suppression
This is a component of PMTCT. The lab at Zomba Central Hospital will use plasma samples to measure viral load.
Time frame: 6 months post-partum
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.
Time frame: 3 months post-partum
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.
Time frame: 6 months post-partum
Adherence to infant prophylaxis
This is a component of PMTCT. Women will be asked if they ingested Nevirapine (NVP) during labor and delivery (yes or no). Using the Visual Analog Scale (VAS), women will estimate adherence to NVP prophylaxis for the infant postpartum. Higher scores indicated better adherence.
Time frame: 3 months post-partum
Infant HIV testing
This is a component of PMTCT. Women will self-report whether they tested their infant for HIV after 8 weeks and the result of test (to be confirmed with medical records).
Time frame: 3 months post-partum
Breast feeding
This is a component of adherence to PMTCT. Women will be asked, "Are you currently exclusively breastfeeding your baby?"
Time frame: 3 months post-partum
Breast feeding
This is a component of adherence to PMTCT. Women will be asked, "Are you currently exclusively breastfeeding your baby?"
Time frame: 6 months post-partum.
Plan to share: Yes — The dataset will include self-reported demographic and behavioral data from surveys and laboratory data from blood specimens. Individual-participant level or IPD data will be shared. The data will be made in a de-identified format. In addition to the IPD dataset, the researcher will share the data dictionary and final protocol with amendments. Identifiable data will be de-identified prior to repository submission. All participant-level data will be preserved and shared through deposition in the NIMH Data Archive (NDA), a controlled access public repository.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: All collection data will be shared automatically two years after the grant end date specified on the first Notice of Award. Any subject-level data and the associated analyzed data used in a journal publication will be shared at the time of publication, even if the publication occurs before the two-year automatic share date.
Access criteria: The data will be made available for sharing with the general research community via the NDA website. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NDA data by submitting a data access request in accordance with applicable NDA policies. Data requests will be reviewed and granted by an NDA Data Access Committee. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
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