Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

Официальное название

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial

Обзор

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.

Подробное описание

In our R34 pilot trial, the Enhanced Friendship Bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in HIV care. The goal of this proposal is to evaluate the effectiveness of the Enhanced Friendship Bench in a fully powered randomized control trial to improve perinatal depression, HIV care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.

Вмешательства

• Поведенческое 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.
• Поведенческое 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 ca

Первичные конечные точки

• Change in Depressive Symptoms [Срок оценки: 6 months post partum]
• HIV Care Retention [Срок оценки: 6 months post partum]

Вторичные конечные точки (6)

• Change in Depressive Symptoms [Срок оценки: 6 months post partum]
• Proportion of patients achieving depression remission [Срок оценки: 6 months post partum]
• Proportion of patients achieving HIV viral suppression [Срок оценки: 12 months post partum]
• Infant Growth: height-for-age [Срок оценки: 6 months post partum]
• Infant Growth: weight-for-age [Срок оценки: 6 months post partum]
• Infant Growth: weight-for-height [Срок оценки: 6 months post partum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Suicidal ideation evaluated as acute risk.
• Other health concerns requiring emergent response.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Malawi · 5 центров

• Area 18 Health Center — Lilongwe
• Area 25 Health Center — Lilongwe
• Bwaila Hospital — Lilongwe
• Kawale Health Center — Lilongwe
• Likuni Mission Hosptial — Lilongwe

Идентификаторы

NCT: NCT06702722 · 24-0690 · R01MH134660

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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