Recruiting
Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi
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.
ClinicalTrials.gov IDNCT06702722
PhaseNA
Enrollment400
SponsorUniversity of North Carolina, Chapel Hill
Age18 Years
SexFEMALE
Conditions studied
HIV, Depression, Depression, Postpartum
About this study
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.
Interventions
- Behavioral: Enhanced 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.
- Behavioral: Enhanced 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.
Primary outcomes
- Change in Depressive Symptoms (6 months post partum)
- HIV Care Retention (6 months post partum)
Eligibility information
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.
Study locations
- Area 18 Health Center, Lilongwe, Malawi
- Area 25 Health Center, Lilongwe, Malawi
- Bwaila Hospital, Lilongwe, Malawi
- Kawale Health Center, Lilongwe, Malawi
- Likuni Mission Hosptial, Lilongwe, Malawi
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.