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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
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.
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.
Area 18 Health Center
Lilongwe, Malawi
NOT_YET_RECRUITINGArea 25 Health Center
Lilongwe, Malawi
RECRUITINGBwaila Hospital
Lilongwe, Malawi
RECRUITINGChange 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.
Time frame: 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.
Time frame: 6 months post partum
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.
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Kawale Health Center
Lilongwe, Malawi
RECRUITINGLikuni Mission Hosptial
Lilongwe, Malawi
RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 months post partum