NCT06702722Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 26 Feb 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- HIV
- NCT number
- NCT06702722
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 26 Feb 2025 to the primary completion date, Jun 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Suicidal ideation evaluated as acute risk.
- Other health concerns requiring emergent response.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Area 25 Health Center Coordinator of this site? Confirm its status | Lilongwe | Malawi | Recruiting |
| Likuni Mission Hosptial Coordinator of this site? Confirm its status | Lilongwe | Malawi | Recruiting |
| Bwaila Hospital Coordinator of this site? Confirm its status | Lilongwe | Malawi | Recruiting |
| Area 18 Health Center Coordinator of this site? Confirm its status | Lilongwe | Malawi | Not yet recruiting |
| Kawale Health Center Coordinator of this site? Confirm its status | Lilongwe | Malawi | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.