Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Enhanced Friendship Bench
- Conditions
- HIV
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 400
- Locations
- 5
- Primary Endpoint
- Change in Depressive Symptoms
- Status
- Recruiting
- Last Updated
- 3 days ago
Overview
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.
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.
Investigators
Eligibility Criteria
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 ≥
- •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.
Arms & Interventions
Enhanced Friendship Bench
Friendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum.
Intervention: Enhanced Friendship Bench
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.
Intervention: Enhanced usual care
Outcomes
Primary Outcomes
Change in Depressive Symptoms
Time Frame: 6 months post partum
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.
HIV Care Retention
Time Frame: 6 months post partum
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.
Secondary Outcomes
- 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)
- Infant Growth: weight-for-height(6 months post partum)