Khanya Ekhaya: A Home-Based Intervention

University of Maryland

Status: Not yet enrolling

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

Treatments: Behavioral: Khanya-Ekhaya

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06985641

EC017-8/2024

1R21TW012347-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Enhanced Treatment As Usual

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Khanya-Ekhaya