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A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination

Primary Purpose

Vaccine Hesitancy, COVID-19 Testing, Community Health Workers

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Worker led curriculum
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaccine Hesitancy focused on measuring COVID-19 vaccine hesitancy, COVID-19 testing, Community Health Workers, Safety-Net Patients

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not meeting the inclusion criteria listed above

Sites / Locations

  • Los Angeles Department of Public HealthRecruiting
  • Charles Drew University of Medicine and ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm - Standard Treatment (Group 1)

Intervention Arm - CHW-led curriculum (Group 2)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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"
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"

Full Information

First Posted
July 22, 2022
Last Updated
February 28, 2023
Sponsor
Charles Drew University of Medicine and Science
Collaborators
Los Angeles County Department of Public Health, National Library of Medicine (NLM)
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1. Study Identification

Unique Protocol Identification Number
NCT05473936
Brief Title
A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Drew University of Medicine and Science
Collaborators
Los Angeles County Department of Public Health, National Library of Medicine (NLM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Hesitancy, COVID-19 Testing, Community Health Workers
Keywords
COVID-19 vaccine hesitancy, COVID-19 testing, Community Health Workers, Safety-Net Patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm - Standard Treatment (Group 1)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Arm - CHW-led curriculum (Group 2)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker led curriculum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Project Survey: Phenx toolkit - Worry about COVID
Description
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.
Time Frame
Six weeks from start of project
Title
Project Survey: Phenx toolkit - Attitudes and Behavior
Description
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.
Time Frame
Six weeks from start of project
Title
Project Survey: Phenx toolkit - Perceived Coronavirus Threat
Description
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.
Time Frame
Six weeks from start of project
Secondary Outcome Measure Information:
Title
Project Survey: Phenx toolkit - Intent to participate in COVID testing and vaccination
Description
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.
Time Frame
Six weeks from start of project
Title
Pre and Post Program Survey: Medical Mistrust Scale
Description
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"
Time Frame
Six weeks from start of project
Title
Sherer, et al.'s General Self-Efficacy Scale
Description
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"
Time Frame
Six weeks from start of project

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Not meeting the inclusion criteria listed above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junko Nishitani, PhD
Phone
323-563-4966
Email
junkonishitani@cdrewu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheba George, PhD
Organizational Affiliation
Charles Drew University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Department of Public Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Daskivich, MD
Email
lpdaskivich@dhs.lacounty.gov
First Name & Middle Initial & Last Name & Degree
Lauren P Daskivich, MD
Facility Name
Charles Drew University of Medicine and Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheba George, PhD
Phone
323-249-5733
Email
denisseruiz@cdrewu.edu
First Name & Middle Initial & Last Name & Degree
Denisse A Ruiz, MPH
Phone
323-947-8045
Email
denisseruiz@cdrewu.edu
First Name & Middle Initial & Last Name & Degree
Omolola Ogunyemi, PhD
First Name & Middle Initial & Last Name & Degree
Sheba George, PhD
First Name & Middle Initial & Last Name & Degree
Lauren P Daskivich, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will become available at the end of study and will be uploaded to the RADxUP Data Hub, managed by Duke Coordinating Center
IPD Sharing Access Criteria
Only authorized RADxUP personnel will be able to access the IPD. The link below details how the COVID RADx Data Hub is a centralized, secure repository to store, search for and interrogate vast amounts of de-identified data related to COVID-19 testing and vaccination.
IPD Sharing URL
https://radx-up.org/research/cdes/

Learn more about this trial

A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination

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