RecruitingNot ApplicableNCT06702722

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


Sponsor

University of North Carolina, Chapel Hill

Enrollment

400 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combined mental health and HIV support program — delivering problem-solving therapy alongside help staying on HIV treatment — can improve both mental health and HIV outcomes for pregnant women living with HIV in Malawi who are also experiencing depression. **You may be eligible if...** - You are at least 18 years old and currently pregnant (34 weeks or less) - You are HIV-positive - You are taking or starting HIV medication (antiretroviral therapy) during this pregnancy - You are showing signs of depression based on a standard screening questionnaire **You may NOT be eligible if...** - You are at acute risk of suicide - You have another urgent health emergency requiring immediate care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEnhanced 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.

BEHAVIORALEnhanced 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.


Locations(5)

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

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NCT06702722


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