Vaccine HesitancyNCT05473936
A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination
A study testing Community Health Worker led curriculum in people with Vaccine Hesitancy and COVID-19 Testing, run by Charles Drew University of Medicine and Science at 2 sites in United States.
Trial summary
The objective of this study is to compare the results of a COVID-19 specific curriculum led by LACDHS Community Health Workers (CHWs) from these same communities of safety-net patients to effectively increase COVID-19 testing and vaccination for individual patients, and to facilitate needed healthcare in a timely… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, COVID-19 Testing, Community Health Workers
- What is being tested?
- Community Health Worker led curriculum
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Oct 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 16 years and older
- Self-identify as African American or Latinx
- English Speaking
- Receives primary or specialty care treatment at an LACDHS facility
- Has either not completed lab orders for COVID-19 testing and/or vaccination at an LACDHS facility
- Have reliable internet access
Who cannot join
- Not meeting the inclusion criteria listed above
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Los Angeles Department of Public Health
Los Angeles, California, 90012
Lauren Daskivich, MD, lpdaskivich@dhs.lacounty.gov
Lauren P Daskivich, MD
- Recruiting
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
Sheba George, PhD, 323-249-5733, denisseruiz@cdrewu.edu
Denisse A Ruiz, MPH, 323-947-8045, denisseruiz@cdrewu.edu
About this study
Official title: A Community Health Worker Intervention to Identify and Decrease Barriers to Pre-Procedural COVID 19 Testing Among Los Angeles County Department of Health Safety-Net Patients
The objective of this study is to compare the results of a COVID-19 specific curriculum led by LACDHS Community Health Workers (CHWs) from these same communities of safety-net patients to effectively increase COVID-19 testing and vaccination for individual patients, and to facilitate needed healthcare in a timely manner for the safety net health system, and to develop a sustained public health presence in these communities to build trust and preparedness for critical COVID-19 related future needs.
Read the detailed description
This study represents the third aim of a grant with three aims. The study used unsupervised machine learning and qualitative interviews to develop a CHW intervention for this aim. The aim will compare and evaluate a Community Health Worker-led curriculum aimed to identify and address barriers to COVID-19 testing and vaccination among LACDHS safety-net patients.
For the study, the investigators will recruit 66 eligible safety-net patients for a COVID-19 specific curriculum, provided by Community Health Workers at Los Angeles County Department of Health Services. The study will take place remotely over the course of 6-weeks. Utilizing a randomized control design among African American and Latinx safety net patients, will assess the effect of the CHW hypothesis-driven intervention on trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination.
The remote CHW intervention that the study participants will participate in and be compensated for is a pilot program intended to provide additional CHW training. Monthly calls from LACDHS to remind them of COVID-19 vaccination are standard of care for all empaneled LACDHS patients.
- Being tested
- Community Health Worker led curriculum
- Keywords
- COVID-19 vaccine hesitancy, COVID-19 testing, Community Health Workers, Safety-Net Patients
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker led curriculumBehavioural
The intervention arm will consist of a CHW-based health educational program via Zoom, where participants will be provided with information about COVID-19, COVID-19 resources and services in Los Angeles County, and engagement with Los Angeles County Department of Health Services CHWs who will lead the curriculum and be available to answer questions of the intervention arm patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm - Standard Treatment (Group 1) | No intervention | The standard care for the control arm will be: the LACDHS Vaccine Hesitancy Outreach Group calling patients once every month to remind patients of the need to be vaccinated and tested if needed. During the duration of the six weeks, the study participants will be exposed to the call from the LACDHS Vaccine Hesitancy Outreach Group. Participants will receive two phone calls six-weeks apart, where they will complete a pre-survey in the first phone call, and 2 surveys (post-survey and CDE survey) in the second phone call. The survey will measure their trust in medical institutions, rate their self-efficacy, and intention, knowledge, and perceptions on COVID-19 testing and vaccination. |
| Intervention Arm - CHW-led curriculum (Group 2) | Experimental | Participants assigned to the intervention group will complete the same activities as Group 1 and be asked to participate in the virtual intervention, consisting of six-weekly group classes via Zoom, and six-weekly personalized teleconsultations (via phone call or Zoom) at a suitable time for both participants and CHWs. Study participants will receive 6 linguistically and ethnically concordant weekly two-hour group classes and personalized teleconsultations led by CHWs. The total time commitment for Group 2 will be a maximum of 20 hours (6 two-hour group classes, + 6 one hour personal session, + 2 half hour phone calls), over the next 6 weeks. Receives: Behavioral: Community Health Worker led curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project Survey: Phenx toolkit - Worry about COVID
In a 4-point Likert scale, we will ask questions about their worry and concern about getting infected with COVID from "extremely concerned, somewhat concerned, neutral, not concerned" Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination. Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
Measured: Six weeks from start of project
Project Survey: Phenx toolkit - Attitudes and Behavior
In a 5 point Likert scale, questions will ask about attitudes, and behaviors regarding COVID, from "very likely, somewhat likely, neutral, somewhat unlikely, and very unlikely" Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination. Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
Measured: Six weeks from start of project
Project Survey: Phenx toolkit - Perceived Coronavirus Threat
In a 4-point Likert scale, we will ask questions about their perceived Coronavirus threat "extremely concerned, somewhat concerned, neutral, not concerned" Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination. Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
Measured: Six weeks from start of project
Secondary outcomes (3)
Project Survey: Phenx toolkit - Intent to participate in COVID testing and vaccination
assessed by a single declarative item using a four-point scale (very likely, somewhat likely, somewhat not likely, very not likely). Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
Measured: Six weeks from start of project
Pre and Post Program Survey: Medical Mistrust Scale
Trust will be measured using 8 adapted items from the Medical Mistrust scale, with a list of statements asking about general feelins about the healthcare systems, answers will be "strongly disagree, disagree, neutral, agree, strongly agree"
Measured: Six weeks from start of project
Sherer, et al.'s General Self-Efficacy Scale
It contains 17 items that are rated on a 5-point Likert-type scale ranging from agree strongly to disagree strongly and are intended to assess a "general set of expectations that the individual carries into new situations"
Measured: Six weeks from start of project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start11 Oct 2022
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Sheba George, PhD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473936
- Sponsor's protocol ID
- 1838914-5
- Other IDs
- 3R01LM012309-04S2
- Status last verified
- Feb 2023
- First submitted
- 22 Jul 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study falls is managed through the RADxUP program and such it is required for supplement grant projects to share their data dictionaries to the RADx Data Hub.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Health Worker Intervention to Identify and Decrease Barriers to Pre-Procedural COVID 19 Testing Among Los Angeles County Department of Health Safety-Net Patients
- ClinicalTrials.gov ID
- NCT05473936
- Acronym / sponsor ID
- 1838914-5
- Keywords
- COVID-19 vaccine hesitancy, COVID-19 testing, Community Health Workers, Safety-Net Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, National Library of Medicine (NLM)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 26 Jul 2022 (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.
The objective of this study is to compare the results of a COVID-19 specific curriculum led by LACDHS Community Health Workers (CHWs) from these same communities of safety-net patients to effectively increase COVID-19 testing and vaccination for individual patients, and to facilitate needed healthcare in a timely manner for the safety net health system, and to develop a sustained public health presence in these communities to build trust and preparedness for critical COVID-19 related future needs.
Detailed description
This study represents the third aim of a grant with three aims. The study used unsupervised machine learning and qualitative interviews to develop a CHW intervention for this aim. The aim will compare and evaluate a Community Health Worker-led curriculum aimed to identify and address barriers to COVID-19 testing and vaccination among LACDHS safety-net patients.
For the study, the investigators will recruit 66 eligible safety-net patients for a COVID-19 specific curriculum, provided by Community Health Workers at Los Angeles County Department of Health Services. The study will take place remotely over the course of 6-weeks. Utilizing a randomized control design among African American and Latinx safety net patients, will assess the effect of the CHW hypothesis-driven intervention on trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination.
The remote CHW intervention that the study participants will participate in and be compensated for is a pilot program intended to provide additional CHW training. Monthly calls from LACDHS to remind them of COVID-19 vaccination are standard of care for all empaneled LACDHS patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm - Standard Treatment (Group 1) | No intervention | –The standard care for the control arm will be: the LACDHS Vaccine Hesitancy Outreach Group calling patients once every month to remind patients of the need to be vaccinated and tested if needed. During the duration of the six weeks, the study participants will be exposed to the call from the LACDHS Vaccine Hesitancy Outreach Group. Participants will receive two phone calls six-weeks apart, where they will complete a pre-survey in the first phone call, and 2 surveys (post-survey and CDE survey) in the second phone call. The survey will measure their trust in medical institutions, rate their self-efficacy, and intention, knowledge, and perceptions on COVID-19 testing and vaccination. |
| Intervention Arm - CHW-led curriculum (Group 2) | Experimental | Behavioral: Community Health Worker led curriculumParticipants assigned to the intervention group will complete the same activities as Group 1 and be asked to participate in the virtual intervention, consisting of six-weekly group classes via Zoom, and six-weekly personalized teleconsultations (via phone call or Zoom) at a suitable time for both participants and CHWs. Study participants will receive 6 linguistically and ethnically concordant weekly two-hour group classes and personalized teleconsultations led by CHWs. The total time commitment for Group 2 will be a maximum of 20 hours (6 two-hour group classes, + 6 one hour personal session, + 2 half hour phone calls), over the next 6 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 16 years and older
- Self-identify as African American or Latinx
- English Speaking
- Receives primary or specialty care treatment at an LACDHS facility
- Has either not completed lab orders for COVID-19 testing and/or vaccination at an LACDHS facility
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria listed above
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 |
|---|---|---|
| Community Health Worker led curriculumThe intervention arm will consist of a CHW-based health educational program via Zoom, where participants will be provided with information about COVID-19, COVID-19 resources and services in Los Angeles County, and engagement with Los Angeles County Department of Health Services CHWs who will lead the curriculum and be available to answer questions of the intervention arm patients. | Behavioural | Intervention Arm - CHW-led curriculum (Group 2) |
Primary outcome
Project Survey: Phenx toolkit - Worry about COVID
Time frame: Six weeks from start of project
In a 4-point Likert scale, we will ask questions about their worry and concern about getting infected with COVID from "extremely concerned, somewhat concerned, neutral, not concerned" Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination. Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
Project Survey: Phenx toolkit - Attitudes and Behavior
Time frame: Six weeks from start of project
In a 5 point Likert scale, questions will ask about attitudes, and behaviors regarding COVID, from "very likely, somewhat likely, neutral, somewhat unlikely, and very unlikely" Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination. Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
Project Survey: Phenx toolkit - Perceived Coronavirus Threat
Time frame: Six weeks from start of project
In a 4-point Likert scale, we will ask questions about their perceived Coronavirus threat "extremely concerned, somewhat concerned, neutral, not concerned" Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination. Consolidated pre- and post- surveys (Name: Project Survey) will measure participants' intentions of getting vaccinated and tested for COVID-19.
3 secondary outcomes
Project Survey: Phenx toolkit - Intent to participate in COVID testing and vaccination
Time frame: Six weeks from start of project
Pre and Post Program Survey: Medical Mistrust Scale
Time frame: Six weeks from start of project
Sherer, et al.'s General Self-Efficacy Scale
Time frame: Six weeks from start of project
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes. The study falls is managed through the RADxUP program and such it is required for supplement grant projects to share their data dictionaries to the RADx Data Hub.
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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.
Sheba George, PhD principal investigator
Charles Drew University of Medicine and Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker led curriculum in people with Vaccine Hesitancy and COVID-19 Testing, run by Charles Drew University of Medicine and Science at 2 sites in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junko Nishitani, PhD (323-563-4966, junkonishitani@cdrewu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Project Survey: Phenx toolkit - Worry about COVID (time frame: Six weeks from start of project). The study lists 3 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 2 Mar 2023.