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

University of North Carolina (UNC)

Status: Enrolling

Conditions: HIV; Depression, Postpartum; Depression

Treatments: Behavioral: Enhanced Friendship Bench; Behavioral: Enhanced usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06702722

R01MH134660 (U.S. NIH Grant/Contract)

24-0690

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Suicidal ideation evaluated as acute risk.
• Other health concerns requiring emergent response.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Enhanced Friendship Bench

Experimental group

Description:

Friendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum.

Treatment:

Behavioral: Enhanced Friendship Bench

Enhanced usual care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced usual care