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NCT06702722 | NOT YET RECRUITING | HIV

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

Condition or disease

HIV

Depression

Depression, Postpartum

Intervention/treatment

Enhanced Friendship Bench

Enhanced usual care

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2028-06
Estimated Study Completion Date : 2028-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

Location Details

NCT06702722

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Malawi,

Area 18 Health Center

Lilongwe, Malawi,

Not yet recruiting

Malawi,

Area 25 Health Center

Lilongwe, Malawi,

Not yet recruiting

Malawi,

Bwaila Hospital

Lilongwe, Malawi,

Not yet recruiting

Malawi,

Kawale Health Center

Lilongwe, Malawi,

Not yet recruiting

Malawi,

Likuni Mission Hospital

Lilongwe, Malawi,