Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi

NCT06659315 | Recruiting DMC

• 2 other identifiers: 23-40685R34MH134725
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Antiretroviral Therapy (ART) Adherence; Perinatal Mental Health; Depression During Pregnancy; PMTCT

Keywords

Perinatal depression; Couples; Problem-solving; PMTCT; ART adherence

Outcome Measures

Primary Outcomes (4)

• Participation in the intervention

  Proportion of couples who attend 75% and 100% of sessions.

  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

  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.

  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

  Assessed at the 3-month post-partum follow-up

Secondary Outcomes (9)

• Perinatal depression

  3 months post partum

• Perinatal depression

  6 months post-partum

• Perinatal viral suppression

  6 months post-partum

• Perinatal adherence to ART

  3 months post-partum

• Perinatal adherence to ART

  6 months post-partum

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

Standard of care, e.g., regular HIV care, regular perinatal care, referrals to services for depression

Couple-based problem solving

EXPERIMENTAL

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

Interventions

Couples Problem Solving Therapy BEHAVIORAL

A couples-based problem solving program to deal with depression, PMTCT adherence, and couple communication.

Couple-based problem solving

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\>

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator
• Invest in Knowledge Initiative (IKI) - Zomba, Malawi: collaborator

Study Sites (1)

Invest in Knowledge (IKI)

Zomba, Malawi

RECRUITING

Related Publications (4)

• Bengtson AM, Filipowicz TR, Mphonda S, Udedi M, Kulisewa K, Meltzer-Brody S, Gaynes BN, Go VF, Chibanda D, Verhey R, Hosseinipour MC, Pence BW. An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial. AIDS Behav. 2023 Nov;27(11):3559-3570. doi: 10.1007/s10461-023-04070-8. Epub 2023 Apr 21.

  PMID: 37084104 BACKGROUND

• 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.

  PMID: 15978928 BACKGROUND

• 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.

  PMID: 31273489 BACKGROUND

• 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.

  PMID: 34642580 BACKGROUND

Study Officials

• Amy Conroy, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Mkandawire, MPH

CONTACT

+265(0) 999412756; James3mkandawire@gmail.com

Amy Conroy, Ph.D.

CONTACT

1 303 522 9439; amy.conroy@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Couples will be randomized 1:1 to intervention or control arm

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 26, 2024
• Study Start: November 11, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

MA (1)