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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Depression, Postpartum; HIV
• Intervention / Treatment: Behavioral: Enhanced Friendship Bench; Behavioral: Enhanced usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Pence, PhD, MPH; Phone Number: 1-919-966-7446; Email: bpence@unc.edu
• Study Contact Backup: Name: Angela Bengtson, PhD, MA; Email: angelabengtson@emory.edu

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Recruiting
    • Area 25 Health Center
    • Contact: Steve Mphonda; Phone Number: 265-1755056; Email: smphonda@unclilongwe.org
  • Lilongwe, Malawi
    • Recruiting
    • Bwaila Hospital
    • Contact: Steve Mphonda; Phone Number: 265-1755056; Email: smphonda@unclilongwe.org
  • Lilongwe, Malawi
    • Not yet recruiting
    • Area 18 Health Center
    • Contact: Steve Mphonda; Phone Number: 265-1755056; Email: smphonda@unclilongwe.org
  • Lilongwe, Malawi
    • Recruiting
    • Kawale Health Center
    • Contact: Steve Mphonda; Phone Number: 265-1755056; Email: smphonda@unclilongwe.org
  • Lilongwe, Malawi
    • Recruiting
    • Likuni Mission Hosptial
    • Contact: Steve Mphonda; Phone Number: 265-1755056; Email: smphonda@unclilongwe.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Friendship Bench; Friendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms	Depressive symptoms will be measured at baseline and 6 months post partum using the Patient Health Questionnaire-9 (PHQ-9) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27 where higher scores indicate greater self-reported depression. The change in depressive symptom scores from baseline to 6 months postpartum is calculated as baseline PHQ-9 score minus the 6 month post partum PHQ-9 score.	6 months post partum
Proportion of patients achieving depression remission	Depression remission will be defined as the proportion of patients who achieve depression remission at 6 months post partum. Depressive symptoms will be measured at 6 months post partum using the Patient Health Questionnaire-9 (PHQ-9) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27 where higher scores indicate greater self-reported depression. Depression remission is defined as achievement of no or minimal depressive symptoms as defined by the widely used definition of a PHQ-9 score <5 at 6 months follow-up.	6 months post partum
Proportion of patients achieving HIV viral suppression	A secondary outcome for maternal HIV care engagement will be the proportion of patients with viral load suppression at 12 months. Viral load suppression will be defined as HIV RNA level <1000 copies/mL, the standard definition in Malawian medical care based on dried blood spot thresholds.	12 months post partum
Infant Growth: height-for-age	A secondary outcome for infant health will be infant growth at 6 months, defined as WHO z-score of height-for-age. This refers to a standardized score calculated using a child's measured height, weight, and age compared to the reference population established by the World Health Organization (WHO).	6 months post partum
Infant Growth: weight-for-age	A secondary outcome for infant health will be infant growth at 6 months, defined as WHO z-score of weight-for-age. This refers to a standardized score calculated using a child's measured height, weight, and age compared to the reference population established by the World Health Organization (WHO).	6 months post partum
Infant Growth: weight-for-height	A secondary outcome for infant health will be infant growth at 6 months, defined as WHO z-score of weight-for-height. This refers to a standardized score calculated using a child's measured height, weight, and age compared to the reference population established by the World Health Organization (WHO).	6 months post partum

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Brian Pence, PhD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depressive Disorder; Behavior; Depression; Depression, Postpartum
• Other Study ID Numbers: 24-0690; R01MH134660 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).

Deidentified data will also be posted to the NIMH Data Archive pursuant to the requirements of that site.

• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No