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

NCT06702722 | Recruiting DMC

• 2 other identifiers: 24-0690R01MH134660
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

HIV; Depression; Depression, Postpartum

Outcome Measures

Primary Outcomes (2)

• Change in Depressive Symptoms

  Depressive symptoms at baseline and 6 months post partum will be evaluated via the Edinburgh Postnatal Depression Scale (EPDS). This screening instrument is a 10-item self-rating questionnaire with scores ranging from 0-30. Higher scores identify women who may be experiencing symptoms of perinatal depression. The scale is designed for use during pregnancy as well as the postpartum period, making it a versatile tool in maternal health care. Change in EPDS scores will be considered the primary outcome because this measure is specific to a perinatal population. The change in depressive symptoms from baseline to 6 months postpartum will be calculated as Baseline EPDS total score minus the 6 month post partum EPDS total score.

  6 months post partum

• HIV Care Retention

  Retention in HIV care will be defined as ≥2 HIV visits that are at least 30 days apart in the first 6 months post-delivery; AND at least one visit in the first 90 days post-delivery and at least one visit in the second 90 days post-delivery. This definition is based on the minimum expected HIV care appointment schedule per Malawi HIV clinical guidelines. COVID-19 led to an enduring shift in ART prescribing patterns in Malawi, with many clinics moving from dispensing a 30-day ART supply to dispensing a 90-day supply in an effort to de-densify clinics. Consequently, two clinic visits in a 6-month period are typically sufficient to ensure continuous ART supply. While other retention measures such as the Missed or Kept Visit Proportion have high relevance in the US, they are less applicable in Malawian health care where missed visits are typically not recorded and only the dates of kept visits are noted in the medical record.

  6 months post partum

Secondary Outcomes (6)

• Change in Depressive Symptoms

  6 months post partum

• Proportion of patients achieving depression remission

  6 months post partum

• Proportion of patients achieving HIV viral suppression

  12 months post partum

• Infant Growth: height-for-age

  6 months post partum

• Infant Growth: weight-for-age

  6 months post partum

Study Arms (2)

Enhanced Friendship Bench

EXPERIMENTAL

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

Behavioral: Enhanced Friendship Bench

Enhanced usual care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced usual care

Interventions

Enhanced Friendship Bench BEHAVIORAL

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.

Enhanced Friendship Bench

Enhanced usual care BEHAVIORAL

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.

Enhanced usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Area 18 Health Center

Lilongwe, Malawi

NOT YET RECRUITING

Area 25 Health Center

Lilongwe, Malawi

RECRUITING

Bwaila Hospital

Lilongwe, Malawi

RECRUITING

Kawale Health Center

Lilongwe, Malawi

RECRUITING

Likuni Mission Hosptial

Lilongwe, Malawi

RECRUITING

MeSH Terms

Conditions

Depression; Depression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Brian Pence, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Pence, PhD, MPH

CONTACT

1-919-966-7446; bpence@unc.edu

Angela Bengtson, PhD, MA

CONTACT

angelabengtson@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm individually randomized controlled trial

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

MA (5)