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Recruiting NCT06702722

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

Trial Parameters

Condition HIV
Sponsor University of North Carolina, Chapel Hill
Study Type INTERVENTIONAL
Phase N/A
Enrollment 400
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-02-26
Completion 2028-06
Interventions
Enhanced Friendship BenchEnhanced usual care

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.

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.

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