RecruitingNot ApplicableNCT06702722

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

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial


Sponsor

University of North Carolina, Chapel Hill

Enrollment

400 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria2

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

Interventions

BEHAVIORALEnhanced Friendship Bench

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.

BEHAVIORALEnhanced usual care

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.


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

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NCT06702722


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