Khanya Ekhaya: A Home-Based Intervention

NCT06985641 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-05-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medical Research Council, South Africa

    collaborator OTHER
  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • Curtin University

    collaborator OTHER
  • University of Maryland, College Park

    lead OTHER

Principal Investigators

  • Jessica F Magidson, PhD · University of Maryland, College Park

  • Tara Carney, PhD · Medical Research Council, South Africa

  • Bronwyn Myers, PhD · Curtin University; South African Medical Research Council

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-04-01
Completion
2026-06-15

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06985641 on ClinicalTrials.gov