Khanya Ekhaya: A Home-Based Intervention
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Khanya-Ekhaya.
- Кому может быть актуально
- Состояния в реестре: HIV, HIV Antiretroviral Therapy (ART) Adherence, Mental Health, Substance Use Disorders. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- ЮАР
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation Trial
Обзор
Mental health conditions, such as depression, anxiety, and harmful alcohol use are prevalent among people with chronic diseases, including HIV, and contribute to poor engagement in care. There is a need to address untreated mental health problems. Community health workers (CHWs) are frontline workers who play a central role in supporting vulnerable individuals to stay in care, including seeking people living with HIV who are newly initiating antiretroviral therapy (ART) or re-initiating after a period of care disengagement. CHW-delivered interventions are promising for improving engagement and retention in care. Yet, these programs rarely address mental health -a significant barrier to chronic disease care engagement and treatment. An approach that moves beyond providing care in the clinic setting is needed. Community-delivered home-based mental health care has been shown to be feasible and acceptable and shows promise for integration into broader community health care services for people with chronic conditions, such as HIV.
Подробное описание
The overall aim of this 3-phase study (the third phase being the clinical trial) is to develop a feasible mental health intervention for CHW delivery during home-based care for people with chronic conditions, including HIV. Investigators will use an existing cadre of CHWs conducting home visits, highlighting the potential for sustainability.
Aim 1: To explore barriers and facilitators to implementing a home-based, CHW-delivered intervention for mental health concerns (depression, anxiety, harmful alcohol use) "Khanya-Ekhaya". Guided by the Consolidated Framework for Implementation Research (CFIR), investigators will accomplish this aim by conducting individual semi-structured interviews with CHWs and other key stakeholders, including CHW supervisors, policymakers, and organizational leaders and patients with mental health problems. Key domains of the interviews include: (a) appropriateness of providing integrated home-based care for mental health among people newly initiating or re-initiating HIV services after ≥3 months; (b) barriers and facilitators to implementing a CHW-delivered intervention for mental health and HIV care engagement in patients' homes, including how to promote feasibility within CHWs' existing roles; (c) training and supervision needs of CHWs, including how to manage risk and support referrals; and (d) adapting existing evidence-based intervention components developed by the research team (problem solving, motivational interviewing, behavioral activation, mindfulness) for CHW home-delivery.
Aim 2: To adapt with patients and CHWs a home-based, intervention to improve mental health symptoms and HIV outcomes "Khanya-Ekhaya". Investigators will adapt a home-based CHW intervention ("Khanya-Ekhaya" or "Khanya at home") to address mental health symptoms and improve HIV care engagement based on our formative clinic-based work and training CHWs in reducing mental health stigma refined based on Aim 1 feedback. Adapting the intervention components from clinic-based delivery to CHW home-based delivery will be heavily guided by qualitative analysis in Aim 1.
Aim 3 (Clinical Trial). To evaluate the implementation and preliminary effectiveness of a home-based CHW intervention "Khanya-Ekhaya" to reduce mental health symptoms and improve engagement in HIV care. In a pilot Type 1 hybrid effectiveness-implementation trial, investigators will evaluate the effectiveness and implementation of the Khanya-Ekhaya home-delivered CHW intervention. This trial will demonstrate successful training of CHWs, reaching patients of interest, and collecting primary outcomes to inform future work.
Вмешательства
- Поведенческое Khanya-Ekhaya
The Khanya Ekhaya intervention includes an integration of several evidence-based treatment components, including motivational interviewing (MI), problem solving therapy (PST), and behavioral activation (BA), previously tested and adapted for this context in clinic settings, as well as cognitive-behavioral and mindfulness strategies that target rumination and negative thinking patterns. Aims 1-2 will inform Khanya-Ekhaya adaptation, including intervention length, but it is likely to include 3-6 s
Первичные конечные точки
- Feasibility of Khanya Ekhaya [Срок оценки: 3-month follow-up assessment]
- Acceptability of Khanya Ekhaya [Срок оценки: 3-month follow-up assessment]
- HIV Care Engagement [Срок оценки: 3-month follow-up assessment]
Вторичные конечные точки (4)
- Fidelity of CHW delivery [Срок оценки: 3-month follow-up assessment]
- Fidelity of ETAU [Срок оценки: 3-month follow-up assessment]
- Mental health - depressive symptoms [Срок оценки: 3-month follow-up assessment]
- Mental health - alcohol use [Срок оценки: 3-month follow-up assessment]
Критерии участия
Критерии включения
CHWs:
- at least 18 years old
- must conduct home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site
PATIENTS:
- at least 18 years old
- seen by a CHW after newly initiating or re-initiating ART in the past three months
- screen positive for depressive symptoms or harmful alcohol use
Критерии исключения
CHWs:
-Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans
PATIENTS:
-Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans
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
- Открытое
- Основная цель
- Лечение
Центры проведения
ЮАР · 1 центр
- South African Medical Research Council - Delft Office — Cape Town
Идентификаторы
NCT: NCT06985641 · EC017-8/2024 · 1R21TW012347-01A1