Khanya Ekhaya: A Home-Based Intervention

NCT06985641 | Active Not Recruiting

• 2 other identifiers: EC017-8/20241R21TW012347-01A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health; Community Health Workers; Training; Global Health; Burnout; Well-being; Natured-informed Therapy

Keywords

Community Health Workers; Health Personnel; Global Health; Health Care Seeking Behavior; Attitude of Health Personnel; Burnout; Well-being; Nature-informed therapy

Outcome Measures

Primary Outcomes (2)

• Feasibility of Khanya Ekhaya

  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

  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 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.

  3-month follow-up assessment

Secondary Outcomes (3)

• Fidelity

  Weekly through 3-month follow-up assessment

• CHW wellbeing

  3-month follow-up assessment

• Burnout

  3-month follow-up assessment

Study Arms (2)

Enhanced Treatment As Usual

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Khanya-Ekhaya

Interventions

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.

Khanya-Ekhaya

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• Medical Research Council, South Africa: collaborator
• Curtin University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

South African Medical Research Council - Delft Office

Cape Town, Western Cape, 7580, South Africa

Location

MeSH Terms

Conditions

Psychological Well-Being; Burnout, Psychological; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Stress, Psychological; Behavioral Symptoms; Treatment Adherence and Compliance; Health Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention will be delivered in Aim 3 (clinical trial). This study uses a parallel design. Two existing teams of healthcare workers will be randomized 1:1 at the team level to receive the Khanya-Ekhaya training or to continue their patient care as usual.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 22, 2025
• Study Start: August 17, 2026
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available following completion of each study aim (i.e., after publication of the main outcome paper).
• 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.

Locations

ZA (1)