Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Presenting for antenatal care at one of our 5 recruitment sites
• ≥ 18 years of age
• ≤ 34 weeks gestation
• HIV-positive, based on medical records
• Initiating, re-initiating, or on established ART during index pregnancy
• Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression
Locations
Other Locations
Malawi
Area 18 Health Center
NOT_YET_RECRUITING
Lilongwe
Area 25 Health Center
RECRUITING
Lilongwe
Bwaila Hospital
RECRUITING
Lilongwe
Kawale Health Center
RECRUITING
Lilongwe
Likuni Mission Hosptial
RECRUITING
Lilongwe
Contact Information
Primary
Brian Pence, PhD, MPH
bpence@unc.edu
1-919-966-7446
Backup
Angela Bengtson, PhD, MA
angelabengtson@emory.edu
Time Frame
Start Date: 2025-02-26
Estimated Completion Date: 2028-06
Participants
Target number of participants: 400
Treatments
Experimental: Enhanced Friendship Bench
Friendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum.
Active_comparator: Enhanced usual care
Continue with usual outpatient care, enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of North Carolina, Chapel Hill