Khanya Ekhaya: A Home-Based Intervention

NCT06985641 | Not Yet 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 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.

Conditions

HIV; HIV Antiretroviral Therapy (ART) Adherence; Mental Health; Substance Use Disorders; Stigma; Community Health Workers; Training; Global Health; Mental Health Recovery; Substance Use Recovery

Keywords

Community Health Workers; Health Personnel; Global Health; Substance Use Recovery; Mental Health Recovery; HIV; Health Care Seeking Behavior; Treatment Adherence and Compliance; Attitude of Health Personnel; Substance Use Stigma; Mental health Stigma; Substance Use Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

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 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

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• Medical Research Council, South Africa: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Curtin University: 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; Substance-Related Disorders; Social Stigma; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders; Social Behavior; 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

Central Study Contacts

Jessica F Magidson, PhD

CONTACT

301-405-5095; jmagidso@umd.edu

Abigail C Hines, MPH

CONTACT

ahines01@umd.edu

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: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

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)