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

Not Applicable

Not yet recruiting

• Conditions: HIV; Depression; Depression, Postpartum

• Registration Number: NCT06702722
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-26
• Study Start: 2025-01
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Depressive Symptoms	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	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 Outcome Measures

Name	Time	Method
Change in Depressive Symptoms	6 months post partum	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.
Proportion of patients achieving depression remission	6 months post partum	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.
Proportion of patients achieving HIV viral suppression	12 months post partum	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.
Infant Growth: height-for-age	6 months post partum	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).
Infant Growth: weight-for-age	6 months post partum	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).
Infant Growth: weight-for-height	6 months post partum	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).

Trial Locations

Locations (5)

Likuni Mission Hosptial; 🇲🇼 Lilongwe, Malawi

Area 18 Health Center; 🇲🇼 Lilongwe, Malawi

Area 25 Health Center; 🇲🇼 Lilongwe, Malawi

Bwaila Hospital; 🇲🇼 Lilongwe, Malawi

Kawale Health Center; 🇲🇼 Lilongwe, Malawi