Improving mental health and HIV care for pregnant women 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
Run by University of North Carolina, Chapel Hill · NCT06702722 · Data updated 2026-11-12
This study is testing a new support program to see if it can help pregnant women living with HIV in Malawi feel better mentally, engage more with their HIV care, and improve their baby's health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 5 sites (Lilongwe and 4 other locations) |
| Status | Recruiting |
| Started | February 26, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT06702722 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 years and older, HIV-positive, and experiencing elevated depressive symptoms.
✕Probably not a fit
Patients with acute suicidal ideation or other urgent health concerns may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the Enhanced Friendship Bench intervention aimed at improving perinatal depression, HIV care engagement, and infant health outcomes among pregnant women living with HIV in Malawi. It builds on previous pilot findings that demonstrated the intervention's feasibility and preliminary effectiveness. The study will be conducted as a fully powered randomized control trial, assessing various mediators and moderators to understand the mechanisms of action and collecting implementation measures to facilitate the translation of findings into practice.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance mental health and HIV care engagement for pregnant women, leading to better health outcomes for both mothers and infants.
How similar studies have gone: Previous studies have shown promising results with similar interventions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Area 25 Health Center
Lilongwe, Malawi Recruiting -
Bwaila Hospital
Lilongwe, Malawi Recruiting -
Kawale Health Center
Lilongwe, Malawi Recruiting -
Likuni Mission Hosptial
Lilongwe, Malawi Recruiting -
Area 18 Health Center
Lilongwe, Malawi Not yet recruiting
Study contacts
- Principal investigator: Brian Pence, PhD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Brian Pence, PhD, MPH
- Email: bpence@unc.edu
- Phone: 1-919-966-7446
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.