Clinical trial NCT06702722: Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi
Official title: Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Depression
Depression, Postpartum
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm individually randomized controlled trial
Primary purpose: TREATMENT

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.

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 ≥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.

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: 6 months post partum
measure: HIV Care Retention
timeFrame: 6 months post partum
Secondary outcomes:
measure: Change in Depressive Symptoms
timeFrame: 6 months post partum
measure: Proportion of patients achieving depression remission
timeFrame: 6 months post partum
measure: Proportion of patients achieving HIV viral suppression
timeFrame: 12 months post partum
measure: Infant Growth: height-for-age
timeFrame: 6 months post partum
measure: Infant Growth: weight-for-age
timeFrame: 6 months post partum
measure: Infant Growth: weight-for-height
timeFrame: 6 months post partum
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Area 18 Health Center
city: Lilongwe
country: Malawi
facility: Area 25 Health Center
city: Lilongwe
country: Malawi
facility: Bwaila Hospital
city: Lilongwe
country: Malawi
facility: Kawale Health Center
city: Lilongwe
country: Malawi
facility: Likuni Mission Hosptial
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pence, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: