Skip to main content
OpenTrials
Not Yet 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 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

HIV Behavior Chemically-Induced Disorders Community Health Workers Global Health HIV Antiretroviral Therapy (ART) Adherence Health Behavior Mental Disorders Mental Health Mental Health Recovery Patient Acceptance of Health Care Personal Satisfaction Psychological Well-Being Social Behavior Social Stigma Stigma Substance Use Disorders Substance Use Recovery Substance-Related Disorders Training Treatment Adherence and Compliance

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

Location contact

Kim Johnson, MA

CONTACT

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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

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 (1) 14-item feasibility subscale of Applied Mental Health Research (AMHR) group implementation measure (scored 0-3).

  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 a 15-item acceptability subscale of AMHR implementation measure (scored 0-3).

  3. HIV Care Engagement

    Time frame: 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

Secondary outcomes

  1. Fidelity of CHW delivery

    Time frame: 3-month follow-up assessment

    Fidelity monitoring of delivery of intervention components and competence will be assessed using the (ENhancing Assessment of Common Therapeutic factors) ENACT scale for the Khanya-Ekhaya group.

  2. Fidelity of ETAU

    Time frame: 3-month follow-up assessment

    Fidelity to ETAU will be assessed via documentation of screening and referrals.

  3. Mental health - depressive symptoms

    Time frame: 3-month follow-up assessment

    Mental health symptoms will be assessed among patients using routine mental health screening data extracted from patients' medical records using the Patient Health Questionnaire-2 (PHQ-2) to measure depressive symptoms

  4. Mental health - alcohol use

    Time frame: 3-month follow-up assessment

    Mental health symptoms will be assessed among patients using routine mental health screening data extracted from patients' medical records using the Alcohol Use Disorders Identification Test (AUDIT-C) to measure alcohol use.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail C Hines, MPH

CONTACT

[email protected]

Jessica F Magidson, PhD

CONTACT

[email protected]

301-405-5095

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

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.