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Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.
In our R34 pilot trial, the Enhanced Friendship Bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in HIV care. The goal of this proposal is to evaluate the effectiveness of the Enhanced Friendship Bench in a fully powered randomized control trial to improve perinatal depression, HIV care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Area 18 Health Center
Lilongwe, Malawi
Area 25 Health Center
Lilongwe, Malawi
Bwaila Hospital
Lilongwe, Malawi
Kawale Health Center
Lilongwe, Malawi
Likuni Mission Hosptial
Lilongwe, Malawi
Start Date
February 26, 2025
Primary Completion Date
June 1, 2028
Completion Date
June 1, 2028
Last Updated
March 25, 2025
400
ESTIMATED participants
Enhanced Friendship Bench
BEHAVIORAL
Enhanced usual care
BEHAVIORAL
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT01875588
NCT07071623
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07360600