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Active, not recruiting

NCT Number: NCT06985641

Khanya Ekhaya: A Home-Based Intervention

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mental Health Behavior Behavioral Symptoms Burnout Burnout, Psychological Community Health Workers Global Health Health Behavior Natured-informed Therapy Patient Acceptance of Health Care Personal Satisfaction Psychological Well-Being Stress, Psychological Training Treatment Adherence and Compliance Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South African Medical Research Council - Delft Office

Cape Town, Western Cape, 7580, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans

Treatment and study plan

Khanya-Ekhaya

Behavioral

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 sessions of CHW home visits based on formative work with ongoing supervision and support for CHWs.

Primary outcomes

  1. Feasibility of Khanya Ekhaya

    Time frame: 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

  2. Acceptability of Khanya Ekhaya

    Time frame: 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.

Secondary outcomes

  1. Fidelity

    Time frame: Weekly through 3-month follow-up assessment

    Fidelity will be measured using a self-reported checklist. We will assess the perceived fidelity of main components of the Khanya-Ekhaya training through a self-reported log of delivery of main components, including use of self-care and wellness skills learned in the training, as well as of time spent in nature and location of activities.

  2. CHW wellbeing

    Time frame: 3-month follow-up assessment

    To assess CHW wellbeing, we will use the 7-item Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS). Total scores are summed across all items and range from 1 to 5. Higher scores indicate greater mental wellbeing.

  3. Burnout

    Time frame: 3-month follow-up assessment

    To assess burnout, we will use the 16-item Maslach Burnout Inventory-General Survey (MBI-GS). Total scores are averaged across all items and range from 0 to 6. Higher scores indicate greater levels of burnout.

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • Curtin University
  • Fogarty International Center of the National Institute of Health
  • Medical Research Council, South Africa

Registry information

Official study title

Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2025
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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