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/37084104Actively Recruiting
Led by University of California, San Francisco · Updated on 2026-03-30
180
Participants Needed
1
Research Sites
13 weeks
Total Duration
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
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
Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Invest in Knowledge (IKI)
Zomba, Malawi
Actively Recruiting
J
James Mkandawire, MPH
A
Amy Conroy, Ph.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Angela M Bengtson, Teresa R Filipowicz, Steven Mphonda...
https://pubmed.ncbi.nlm.nih.gov/37084104Paul Ramchandani, Alan Stein, Jonathan Evans...
https://pubmed.ncbi.nlm.nih.gov/15978928Emily L Tuthill, Torsten B Neilands, Mallory O Johnson...
https://pubmed.ncbi.nlm.nih.gov/31273489Sarah F Coleman, Hildegarde Mukasakindi, Alexandra L Rose...
https://pubmed.ncbi.nlm.nih.gov/34642580Amy A Conroy, Rita M Butterfield, James Mkandawire...
https://pubmed.ncbi.nlm.nih.gov/42152436