Clinical trial NCT06659315: Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
Official title: Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Perinatal Mental Health
Depression During Pregnancy
PMTCT
Keywords: Perinatal depression
Couples
Problem-solving
PMTCT
ART adherence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Invest in Knowledge Initiative (IKI) - Zomba, Malawi
First posted: 2024-10-26
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples will be randomized 1:1 to intervention or control arm
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Participation in the intervention
timeFrame: following the intervention period, an average of 5 months
measure: Retention
timeFrame: through study completion, an average of 11 months
measure: Intervention fidelity
timeFrame: following the intervention period, an average of 5 months
measure: Acceptability
timeFrame: Assessed at the 3-month post-partum follow-up
Secondary outcomes:
measure: Perinatal depression
timeFrame: 3 months post partum
measure: Perinatal depression
timeFrame: 6 months post-partum
measure: Perinatal viral suppression
timeFrame: 6 months post-partum
measure: Perinatal adherence to ART
timeFrame: 3 months post-partum
measure: Perinatal adherence to ART
timeFrame: 6 months post-partum
measure: Adherence to infant prophylaxis
timeFrame: 3 months post-partum
measure: Infant HIV testing
timeFrame: 3 months post-partum
measure: Breast feeding
timeFrame: 3 months post-partum
measure: Breast feeding
timeFrame: 6 months post-partum.
Other outcomes:
Locations:
city: Zomba
country: Malawi
facility: Invest in Knowledge (IKI)
Study officials:
affiliation: University of California, San Francisco
name: Amy Conroy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ramchandani P, Stein A, Evans J, O'Connor TG; ALSPAC study team. Paternal depression in the postnatal period and child development: a prospective population study. Lancet. 2005 Jun 25-Jul 1;365(9478):2201-5. doi: 10.1016/S0140-6736(05)66778-5.
citation: Tuthill EL, Neilands TB, Johnson MO, Sauceda J, Mkandawire J, Conroy AA. A Dyadic Investigation of Relationship Dynamics and Depressive Symptoms in HIV-Affected Couples in Malawi. AIDS Behav. 2019 Dec;23(12):3435-3443. doi: 10.1007/s10461-019-02583-9.
citation: Coleman SF, Mukasakindi H, Rose AL, Galea JT, Nyirandagijimana B, Hakizimana J, Bienvenue R, Kundu P, Uwimana E, Uwamwezi A, Contreras C, Rodriguez-Cuevas FG, Maza J, Ruderman T, Connolly E, Chalamanda M, Kayira W, Kazoole K, Kelly KK, Wilson JH, Houde AA, Magill EB, Raviola GJ, Smith SL. Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi. Intervention (Amstelveen). 2021 Jan-Jun;19(1):58-66. Epub 2021 Mar 31.