Khanya Ekhaya: A Home-Based Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, College Park

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years old

must conduct home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site

at least 18 years old

seen by a CHW after newly initiating or re-initiating ART in the past three months

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Khanya-Ekhaya

    Behavioral

    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 groups

119 Participants
are divided into 2 treatment groups
Group A: Enhanced Treatment As UsualNo intervention 0 interventions
Group B: Khanya-EkhayaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Khanya Ekhaya

Feasibility is defined as the suitability and practicability of Khanya Ekhaya intervention and implementation strategies. This will be measured via (1) 14-item feasibility subscale of Applied Mental Health Research (AMHR) group implementation measure (scored 0-3).

Time frame
3-month follow-up assessment
2

Acceptability of Khanya Ekhaya

Acceptability of Khanya Ekhaya is defined as satisfaction, relevance, usefulness of CHW intervention and implementation strategies, measured via a 15-item acceptability subscale of AMHR implementation measure (scored 0-3).

Time frame
3-month follow-up assessment
3

HIV Care Engagement

HIV care engagement is defined as the proportion of people with HIV (patients) receiving care after first CHW visit and monthly appointment attendance. Receipt of HIV care services will be assessed via medical records, including appointment attendance

Time frame
3-month follow-up assessment

Secondary outcomes

1

Fidelity of CHW delivery

Fidelity monitoring of delivery of intervention components and competence will be assessed using the (ENhancing Assessment of Common Therapeutic factors) ENACT scale for the Khanya-Ekhaya group.

Time frame
3-month follow-up assessment
2

Fidelity of ETAU

Fidelity to ETAU will be assessed via documentation of screening and referrals.

Time frame
3-month follow-up assessment
3

Mental health - depressive symptoms

Mental health symptoms will be assessed among patients using routine mental health screening data extracted from patients' medical records using the Patient Health Questionnaire-2 (PHQ-2) to measure depressive symptoms

Time frame
3-month follow-up assessment
4

Mental health - alcohol use

Mental health symptoms will be assessed among patients using routine mental health screening data extracted from patients' medical records using the Alcohol Use Disorders Identification Test (AUDIT-C) to measure alcohol use.

Time frame
3-month follow-up assessment

Other outcomes

Sponsors and contacts

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University of Maryland, College Park

Lead sponsor

Medical Research Council, South Africa

Collaborator

Fogarty International Center of the National Institute of Health

Collaborator

Curtin University

Collaborator

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