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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Khanya-Ekhaya
BehavioralThe 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
Trial outcomes
Primary outcomes
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).
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).
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
Secondary outcomes
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.
Fidelity of ETAU
Fidelity to ETAU will be assessed via documentation of screening and referrals.
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
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.
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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