NCT06702722 Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi
| NCT ID | NCT06702722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-02-26 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Brian Pence, PhD, MPH
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06702722 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06702722 currently recruiting?
Yes, NCT06702722 is actively recruiting participants. Contact the research team at bpence@unc.edu for enrollment information.
Where is the NCT06702722 trial being conducted?
This trial is being conducted at Lilongwe, Malawi, Lilongwe, Malawi, Lilongwe, Malawi, Lilongwe, Malawi and 1 additional location.
Who is sponsoring the NCT06702722 clinical trial?
NCT06702722 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Brian Pence, PhD, MPH at University of North Carolina, Chapel Hill. The trial plans to enroll 400 participants.
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