Mental HealthNCT06985641
Khanya Ekhaya: A Home-Based Intervention
A study testing Khanya-Ekhaya in people with Mental Health and Community Health Workers, run by University of Maryland, College Park at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Community Health Workers, Training
- What is being tested?
- Khanya-Ekhaya
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Aug 2026to 23 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- must be a CHW who conducts home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site
Who cannot join
- -Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Medical Research Council - Delft Office
Cape Town, Western Cape, 7580
About this study
Official title: Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation 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 mental health care shows promise for integration into broader community health care services for people with chronic conditions, such as HIV. However, as CHWs are taking on more mental health care roles and community-based work, our team's preliminary research has demonstrated that high levels of stress and burnout are important considerations for successful implementation of these models.
Read the 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 community-based care for people with chronic conditions, including HIV, with specific attention to both effectiveness and implementation of this model. Based on preliminary work demonstrating the need to better support CHWs' wellness and burnout as they take on more mental health roles, this trial will examine how to support CHWs themselves, including supporting their own well-being, self-care and boundaries through mindfulness, community- and nature-informed strategies. 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 a community-based CHW intervention ("Khanya-Ekhaya" or "Khanya at home") to support CHW's own stress and wellbeing when addressing mental health symptoms and HIV care engagement with clients. Our formative work pointed to the need to support CHWs in establishing boundaries, well-being practices, and attention to their own self-care when taking on this work. Through a series of workshops with CHWs and guided by qualitative analysis of Aim 1, we will adapt existing CHW trainings led by our team to support CHW wellness and self-care as they take on mental health roles in the community.
Aim 3 (Clinical Trial). To evaluate the implementation and preliminary effectiveness of a community-based intervention "Khanya-Ekhaya" to promote mental wellbeing and mental health for both CHWs and their patients. In a pilot Type 1 hybrid effectiveness-implementation trial, investigators will evaluate the effectiveness and implementation of the Khanya-Ekhaya CHW intervention, including evaluating nature-based intervention components and implementation strategies to support CHW well-being. This trial will demonstrate successful training of CHWs, reaching patients of interest, and collecting primary outcomes to inform future work.
- Conditions
- Mental Health, Community Health Workers, Training, Global Health, Burnout, Well-being
- Being tested
- Khanya-Ekhaya
- Keywords
- Community Health Workers, Health Personnel, Global Health, Health Care Seeking Behavior, Attitude of Health Personnel, Burnout, Well-being, Nature-informed therapy
- Medical subject headings
- Psychological Well-Being, Burnout, Psychological, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khanya-EkhayaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 problem solving therapy (PST), mindfulness, and behavioral activation (BA), previously tested and adapted for this context in clinic settings, as well as nature-informed cognitive-behavioral and mindfulness strategies to promote well-being. Aims 1-2 informed Khanya-Ekhaya adaptation. Receives: Behavioral: Khanya-Ekhaya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Khanya Ekhaya
Feasibility is defined as the suitability and practicability of Khanya Ekhaya intervention and implementation strategies. This will be measured via an adapted feasibility subscale of Applied Mental Health Research (AMHR) group implementation measure. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility
Measured: 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 an adapted acceptability subscale of AMHR implementation measure. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability.
Measured: 3-month follow-up assessment
Secondary outcomes (3)
Fidelity
Fidelity will be measured using a self-reported checklist. We will assess the perceived fidelity of main components of the Khanya-Ekhaya training through a self-reported log of delivery of main components, including use of self-care and wellness skills learned in the training, as well as of time spent in nature and location of activities.
Measured: Weekly through 3-month follow-up assessment
CHW wellbeing
To assess CHW wellbeing, we will use the 7-item Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS). Total scores are summed across all items and range from 1 to 5. Higher scores indicate greater mental wellbeing.
Measured: 3-month follow-up assessment
Burnout
To assess burnout, we will use the 16-item Maslach Burnout Inventory-General Survey (MBI-GS). Total scores are averaged across all items and range from 0 to 6. Higher scores indicate greater levels of burnout.
Measured: 3-month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start17 Aug 2026
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, Fogarty International Center of the National Institute of Health, Curtin University
- Responsible party
- Sponsor
- Investigators
- Jessica F Magidson, PhD, Principal investigator, University of Maryland, College ParkTara Carney, PhD, Principal investigator, Medical Research Council, South AfricaBronwyn Myers, PhD, Principal investigator, Curtin University; South African Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985641
- Sponsor's protocol ID
- EC017-8/2024
- Other IDs
- 1R21TW012347-01A1
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation Trial
- ClinicalTrials.gov ID
- NCT06985641
- Acronym / sponsor ID
- EC017-8/2024
- Conditions
- Mental Health, Community Health Workers, Training, Global Health, Burnout, Well-being
- Keywords
- Community Health Workers, Health Personnel, Global Health, Health Care Seeking Behavior, Attitude of Health Personnel, Burnout, Well-being, Nature-informed therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, Fogarty International Center of the National Institute of Health, Curtin University
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mental health care shows promise for integration into broader community health care services for people with chronic conditions, such as HIV. However, as CHWs are taking on more mental health care roles and community-based work, our team's preliminary research has demonstrated that high levels of stress and burnout are important considerations for successful implementation of these models.
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 community-based care for people with chronic conditions, including HIV, with specific attention to both effectiveness and implementation of this model. Based on preliminary work demonstrating the need to better support CHWs' wellness and burnout as they take on more mental health roles, this trial will examine how to support CHWs themselves, including supporting their own well-being, self-care and boundaries through mindfulness, community- and nature-informed strategies. 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 a community-based CHW intervention ("Khanya-Ekhaya" or "Khanya at home") to support CHW's own stress and wellbeing when addressing mental health symptoms and HIV care engagement with clients. Our formative work pointed to the need to support CHWs in establishing boundaries, well-being practices, and attention to their own self-care when taking on this work. Through a series of workshops with CHWs and guided by qualitative analysis of Aim 1, we will adapt existing CHW trainings led by our team to support CHW wellness and self-care as they take on mental health roles in the community.
Aim 3 (Clinical Trial). To evaluate the implementation and preliminary effectiveness of a community-based intervention "Khanya-Ekhaya" to promote mental wellbeing and mental health for both CHWs and their patients. In a pilot Type 1 hybrid effectiveness-implementation trial, investigators will evaluate the effectiveness and implementation of the Khanya-Ekhaya CHW intervention, including evaluating nature-based intervention components and implementation strategies to support CHW well-being. This trial will demonstrate successful training of CHWs, reaching patients of interest, and collecting primary outcomes to inform future work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Khanya-EkhayaThe Khanya Ekhaya intervention includes an integration of several evidence-based treatment components, including problem solving therapy (PST), mindfulness, and behavioral activation (BA), previously tested and adapted for this context in clinic settings, as well as nature-informed cognitive-behavioral and mindfulness strategies to promote well-being. Aims 1-2 informed Khanya-Ekhaya adaptation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old
- must be a CHW who conducts home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site
Key exclusion criteria (1 listed)
- -Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Khanya-EkhayaThe 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. | Behavioural | Khanya-Ekhaya |
Primary outcome
Feasibility of Khanya Ekhaya
Time frame: 3-month follow-up assessment
Feasibility is defined as the suitability and practicability of Khanya Ekhaya intervention and implementation strategies. This will be measured via an adapted feasibility subscale of Applied Mental Health Research (AMHR) group implementation measure. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility
Acceptability of Khanya Ekhaya
Time frame: 3-month follow-up assessment
Acceptability of Khanya Ekhaya is defined as satisfaction, relevance, usefulness of CHW intervention and implementation strategies, measured via an adapted acceptability subscale of AMHR implementation measure. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability.
3 secondary outcomes
Fidelity
Time frame: Weekly through 3-month follow-up assessment
CHW wellbeing
Time frame: 3-month follow-up assessment
Burnout
Time frame: 3-month follow-up assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica F Magidson, PhD principal investigator
University of Maryland, College Park
Tara Carney, PhD principal investigator
Medical Research Council, South Africa
Bronwyn Myers, PhD principal investigator
Curtin University; South African Medical Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Khanya-Ekhaya in people with Mental Health and Community Health Workers, run by University of Maryland, College Park at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Khanya Ekhaya (time frame: 3-month follow-up assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.