Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- HIV Care Engagement
研究概览
简要总结
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 mental health care shows promise for integration into broader community health care services for people with chronic conditions, such as HIV. However, as CHWs are taking on more mental health care roles and community-based work, our team's preliminary research has demonstrated that high levels of stress and burnout are important considerations for successful implementation of these models.
详细描述
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 community-based care for people with chronic conditions, including HIV, with specific attention to both effectiveness and implementation of this model. Based on preliminary work demonstrating the need to better support CHWs' wellness and burnout as they take on more mental health roles, this trial will examine how to support CHWs themselves, including supporting their own well-being, self-care and boundaries through mindfulness, community- and nature-informed strategies. 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 a community-based CHW intervention ("Khanya-Ekhaya" or "Khanya at home") to support CHW's own stress and wellbeing when addressing mental health symptoms and HIV care engagement with clients. Our formative work pointed to the need to support CHWs in establishing boundaries, well-being practices, and attention to their own self-care when taking on this work. Through a series of workshops with CHWs and guided by qualitative analysis of Aim 1, we will adapt existing CHW trainings led by our team to support CHW wellness and self-care as they take on mental health roles in the community.
Aim 3 (Clinical Trial). To evaluate the implementation and preliminary effectiveness of a community-based intervention "Khanya-Ekhaya" to promote mental wellbeing and mental health for both CHWs and their patients. In a pilot Type 1 hybrid effectiveness-implementation trial, investigators will evaluate the effectiveness and implementation of the Khanya-Ekhaya CHW intervention, including evaluating nature-based intervention components and implementation strategies to support CHW well-being. This trial will demonstrate successful training of CHWs, reaching patients of interest, and collecting primary outcomes to inform future work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •must be a CHW who conducts home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site
排除标准
- •Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans
研究组 & 干预措施
Enhanced Treatment As Usual
This site will receive enhanced treatment as usual (ETAU)-a one-day training for all CHWs on mental health screening, psychoeducation on mental health in HIV and impact on HIV care outcomes, and available referral pathways, and encouraged to use these skills during their home visits.
Khanya-Ekhaya
The Khanya Ekhaya intervention includes an integration of several evidence-based treatment components, including problem solving therapy (PST), mindfulness, and behavioral activation (BA), previously tested and adapted for this context in clinic settings, as well as nature-informed cognitive-behavioral and mindfulness strategies to promote well-being. Aims 1-2 informed Khanya-Ekhaya adaptation.
干预措施: Khanya-Ekhaya (Behavioral)
结局指标
主要结局
HIV Care Engagement
时间窗: 3-month follow-up assessment
HIV care engagement is defined as the proportion of people with HIV (patients) receiving care after first CHW visit and monthly appointment attendance. Receipt of HIV care services will be assessed via medical records, including appointment attendance
Feasibility of Khanya Ekhaya
时间窗: 3-month follow-up assessment
Feasibility is defined as the suitability and practicability of Khanya Ekhaya intervention and implementation strategies. This will be measured via an adapted feasibility subscale of Applied Mental Health Research (AMHR) group implementation measure. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility
Acceptability of Khanya Ekhaya
时间窗: 3-month follow-up assessment
Acceptability of Khanya Ekhaya is defined as satisfaction, relevance, usefulness of CHW intervention and implementation strategies, measured via an adapted acceptability subscale of AMHR implementation measure. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability.
次要结局
- Fidelity of CHW delivery(3-month follow-up assessment)
- Fidelity of ETAU(3-month follow-up assessment)
- Mental health - depressive symptoms(3-month follow-up assessment)
- Mental health - alcohol use(3-month follow-up assessment)
- Fidelity(Weekly through 3-month follow-up assessment)
- CHW wellbeing(3-month follow-up assessment)
- Burnout(3-month follow-up assessment)