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RECRUITING
NCT06702722
NA

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Official title: Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-02-26

Completion Date

2028-06

Last Updated

2025-03-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

Enhanced Friendship Bench

Friendship Bench problem-solving therapy involving 4 prenatal and 2 postnatal counseling sessions, enhanced for HIV care engagement with 2 social support building sessions and monthly home visits for ART delivery and counseling during the 3rd trimester and the first 3 months postpartum.

BEHAVIORAL

Enhanced usual care

Usual care for mental health in public facilities in Malawi includes options for basic supportive counseling by a primary provider or nurse, medication management by the primary provider (amitriptyline is the one antidepressant typically available at primary health centers and is rarely prescribed for depression), referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For the proposed study, usual care will be 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.

Locations (5)

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