Clinical trial NCT06985641: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: Fogarty International Center of the National Institute of Health
name: Curtin University
First posted: 2025-05-22
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: 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 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.

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 conditions, including HIV. Investigators will use an existing cadre of CHWs conducting home visits, highlighting the potential for sustainability.

Aim 1: To explore barriers and facilitators to implementing a home-based, CHW-delivered intervention for mental health concerns (depression, anxiety, harmful alcohol use) "Khanya-Ekhaya". Guided by the Consolidated Framework for Implementation Research (CFIR), investigators will accomplish this aim by conducting individual semi-structured interviews with CHWs and other key stakeholders, including CHW supervisors, policymakers, and organizational leaders and patients with mental health problems. Key domains of the interviews include: (a) appropriateness of providing integrated home-based care for mental health among people newly initiating or re-initiating HIV services after ≥3 months; (b) barriers and facilitators to implementing a CHW-delivered intervention for mental health and HIV care engagement in patients' homes, including how to promote feasibility within CHWs' existing roles; (c) training and supervision needs of CHWs, including how to manage risk and support referrals; and (d) adapting existing evidence-based intervention components developed by the research team (problem solving, motivational interviewing, behavioral activation, mindfulness) for CHW home-delivery.

Aim 2: To adapt with patients and CHWs a home-based, intervention to improve mental health symptoms and HIV outcomes "Khanya-Ekhaya". Investigators will adapt a home-based CHW intervention ("Khanya-Ekhaya" or "Khanya at home") to address mental health symptoms and improve HIV care engagement based on our formative clinic-based work and training CHWs in reducing mental health stigma refined based on Aim 1 feedback. Adapting the intervention components from clinic-based delivery to CHW home-based delivery will be heavily guided by qualitative analysis in Aim 1.

Aim 3 (Clinical Trial). To evaluate the implementation and preliminary effectiveness of a home-based CHW intervention "Khanya-Ekhaya" to reduce mental health symptoms and improve engagement in HIV care. In a pilot Type 1 hybrid effectiveness-implementation trial, investigators will evaluate the effectiveness and implementation of the Khanya-Ekhaya home-delivered CHW intervention. This trial will demonstrate successful training of CHWs, reaching patients of interest, and collecting primary outcomes to inform future work.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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

Primary outcomes:
measure: Feasibility of Khanya Ekhaya
timeFrame: 3-month follow-up assessment
measure: Acceptability of Khanya Ekhaya
timeFrame: 3-month follow-up assessment
measure: HIV Care Engagement
timeFrame: 3-month follow-up assessment
Secondary outcomes:
measure: Fidelity of CHW delivery
timeFrame: 3-month follow-up assessment
measure: Fidelity of ETAU
timeFrame: 3-month follow-up assessment
measure: Mental health - depressive symptoms
timeFrame: 3-month follow-up assessment
measure: Mental health - alcohol use
timeFrame: 3-month follow-up assessment
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council - Delft Office
state: Western Cape
Study officials:
affiliation: University of Maryland, College Park
name: Jessica F Magidson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Council, South Africa
name: Tara Carney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Curtin University; South African Medical Research Council
name: Bronwyn Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: