Khanya Ekhaya: A Home-Based Intervention

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Training; Substance Use Disorders; Mental Health; Community Health Workers; Stigma; Global Health; HIV Antiretroviral Therapy (ART) Adherence; Mental Health Recovery; Substance Use Recovery
• Intervention / Treatment: Behavioral: Khanya-Ekhaya

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 119
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica F Magidson, PhD; Phone Number: 301-405-5095; Email: jmagidso@umd.edu
• Study Contact Backup: Name: Abigail C Hines, MPH; Email: ahines01@umd.edu

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7580
      • South African Medical Research Council - Delft Office
      • Contact: Kim Johnson, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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 sessions of CHW home visits based on formative work with ongoing supervision and support for CHWs.	Behavioral: 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 sessions of CHW home visits based on formative work with ongoing supervision and support for CHWs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Khanya Ekhaya	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).	3-month follow-up assessment
Acceptability of Khanya Ekhaya	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-month follow-up assessment
HIV Care Engagement	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	3-month follow-up assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity of CHW delivery	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.	3-month follow-up assessment
Fidelity of ETAU	Fidelity to ETAU will be assessed via documentation of screening and referrals.	3-month follow-up assessment
Mental health - depressive symptoms	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	3-month follow-up assessment
Mental health - alcohol use	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.	3-month follow-up assessment

Collaborators and Investigators

• Sponsor: University of Maryland, College Park
• Collaborators: Fogarty International Center of the National Institute of Health; Medical Research Council, South Africa; Curtin University
• Investigators: Principal Investigator: Jessica F Magidson, PhD, University of Maryland, College Park; Principal Investigator: Tara Carney, PhD, Medical Research Council, South Africa; Principal Investigator: Bronwyn Myers, PhD, Curtin University; South African Medical Research Council

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Global Health; Community Health Workers; Substance Use Disorders; Health Personnel; Treatment Adherence and Compliance; Attitude of Health Personnel; Substance Use Stigma; Health Care Seeking Behavior; Mental Health Recovery; Substance Use Recovery; Mental health Stigma
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: EC017-8/2024; 1R21TW012347-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will provide de-identified transcripts, codebooks, and quantitative data from this project to interested individuals (with appropriate training and approvals) upon completion of each study aim. These data will be provided in digital format with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.
• IPD Sharing Time Frame: Data will be available following completion of each study aim (i.e., after publication of the main outcome paper).
• IPD Sharing Access Criteria: Data will be released directly by the investigators to interested individuals providing evidence of their institution's IRB approval for planned analyses of the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No