Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06659315

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

Led by University of California, San Francisco · Updated on 2026-03-30

180

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach to help women living with HIV who are experiencing depression during pregnancy and after childbirth in Malawi. The study focuses on improving adherence to prevention of mother-to-child transmission (PMTCT) of HIV, which involves taking antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding. Depression during this period often leads to poor adherence and ongoing HIV presence in mothers. This trial aims to develop and test a couple-based intervention that strengthens partner support, communication, and problem-solving skills to address depression and improve PMTCT adherence. The study compares two groups: one receiving standard care, including regular HIV and perinatal care with referrals for depression services, and the other receiving a couples-based intervention adapted from the World Health Organization's Problem Management Plus (PM+) program. This intervention consists of five sessions covering stress management, problem-solving, behavioral activation, and skills to enhance social support and couple communication. Special emphasis is placed on addressing food insecurity, a major issue for participants, by helping couples brainstorm solutions related to nutrition and access to food. Participants will engage in the intervention over about five months, with follow-up continuing for roughly eleven months to assess participation, retention, intervention quality, and acceptability. Researchers will measure changes in depression symptoms, viral suppression, adherence to antiretroviral therapy and infant prophylaxis, infant HIV testing, and breastfeeding practices at three and six months postpartum. The study takes place within antenatal and HIV care settings, offering a comprehensive evaluation of this novel couple-based support approach.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 5 months

Participants in the couple-based intervention attend sessions focused on problem-solving, stress management, behavioral activation, and improving couple communication to support perinatal depression and adherence to PMTCT.

5 sessions with the couple

Follow-up

Duration - Up to 6 months post-partum

Participants are followed up postpartum to assess perinatal depression, adherence to ART and infant prophylaxis, infant HIV testing, and breastfeeding practices.

Follow-up visits at 3 months and 6 months post-partum

Trial Site Locations

Total: 1 location

1

Invest in Knowledge (IKI)

Zomba, Malawi

Actively Recruiting

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Research Team

J

James Mkandawire, MPH

A

Amy Conroy, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

Angela M Bengtson, Teresa R Filipowicz, Steven Mphonda...

https://pubmed.ncbi.nlm.nih.gov/37084104

A Dyadic Investigation of Relationship Dynamics and Depressive Symptoms in HIV-Affected Couples in Malawi.

Emily L Tuthill, Torsten B Neilands, Mallory O Johnson...

https://pubmed.ncbi.nlm.nih.gov/31273489

Adapting Problem Management Plus for Implementation: Lessons Learned from Public Sector Settings Across Rwanda, Peru, Mexico and Malawi.

Sarah F Coleman, Hildegarde Mukasakindi, Alexandra L Rose...

https://pubmed.ncbi.nlm.nih.gov/34642580

Couples problem-solving therapy for perinatal women living with HIV and male partners in Malawi: a study protocol for a pilot trial of Mphatso.

Amy A Conroy, Rita M Butterfield, James Mkandawire...

https://pubmed.ncbi.nlm.nih.gov/42152436