Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21TW012347-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
| Fogarty International Center of the National Institute of Health | NIH |
| Curtin University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Treatment As Usual | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3-month follow-up assessment |
| 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). | 3-month follow-up assessment |
| 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 | 3-month follow-up assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-month follow-up assessment |
| Fidelity of ETAU |
Not provided
Inclusion Criteria:
CHWs:
PATIENTS:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica F Magidson, PhD | Contact | 301-405-5095 | jmagidso@umd.edu | |
| Abigail C Hines, MPH | Contact | ahines01@umd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jessica F Magidson, PhD | University of Maryland, College Park | Principal Investigator |
| Tara Carney, PhD | Medical Research Council, South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council - Delft Office | Cape Town | Western Cape | 7580 | South Africa |
Investigators will provide de-identified transcripts, codebooks, and quantitative data from this project to interested individuals (with appropriate training and approvals) upon completion of each study aim. These data will be provided in digital format with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.
Data will be available following completion of each study aim (i.e., after publication of the main outcome paper).
Data will be released directly by the investigators to interested individuals providing evidence of their institution's IRB approval for planned analyses of the data.
Not provided
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D019966 | Substance-Related Disorders |
| D057545 | Social Stigma |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
Fidelity to ETAU will be assessed via documentation of screening and referrals. |
| 3-month follow-up assessment |
| 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 | 3-month follow-up assessment |
| 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. | 3-month follow-up assessment |
| Bronwyn Myers, PhD |
| Curtin University; South African Medical Research Council |
| Principal Investigator |
| D012919 |
| Social Behavior |
| D015438 | Health Behavior |