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Studies

Interventional Active not recruiting

NCT06985641 on ClinicalTrials.gov

Khanya Ekhaya: A Home-Based Intervention

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

  • Sponsor: University of Maryland, College Park
  • Collaborators: Medical Research Council, South Africa, Fogarty International Center of the National Institute of Health, Curtin University
  • Enrollment: 119 (Estimated)
  • Study start: 2026-08-17 (Actual)
  • Primary completion: 2026-11-23 (Estimated)
  • Study completion: 2026-11-23 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Behavioral: Khanya-Ekhaya

Primary Outcome Measures

  • Feasibility of Khanya Ekhaya (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 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
  • Acceptability of Khanya Ekhaya (3-month follow-up assessment)
    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.

Countries

South Africa

Locations and Investigators

  • South African Medical Research Council - Delft Office, Cape Town, South Africa

Study Officials