Status:

NOT_YET_RECRUITING

Khanya Ekhaya: A Home-Based Intervention

Lead Sponsor:

University of Maryland, College Park

Collaborating Sponsors:

Medical Research Council, South Africa

Fogarty International Center of the National Institute of Health

Conditions:

HIV

HIV Antiretroviral Therapy (ART) Adherence

Eligibility:

All Genders

18+ years

Phase:

NA

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 ne...

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 con...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 15 2026

Estimated Enrollment :

119 Patients enrolled

Trial Details

Trial ID

NCT06985641

Start Date

September 1 2025

End Date

June 15 2026

Last Update

May 22 2025

Active Locations (1)

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1

South African Medical Research Council - Delft Office

Cape Town, Western Cape, South Africa, 7580