A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination
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
2 other identifiers
interventional
66
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
October 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMarch 2, 2023
February 1, 2023
5 months
July 22, 2022
February 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Six weeks from start of project
Secondary Outcomes (3)
Project Survey: Phenx toolkit - Intent to participate in COVID testing and vaccination
Six weeks from start of project
Pre and Post Program Survey: Medical Mistrust Scale
Six weeks from start of project
Sherer, et al.'s General Self-Efficacy Scale
Six weeks from start of project
Study Arms (2)
Control Arm - Standard Treatment (Group 1)
NO INTERVENTIONThe 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)
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Los Angeles Department of Public Health
Los Angeles, California, 90012, United States
Charles Drew University of Medicine and Science
Los Angeles, California, 90059, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheba George, PhD
Charles Drew University of Medicine and Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2022
First Posted
July 26, 2022
Study Start
October 11, 2022
Primary Completion
March 1, 2023
Study Completion
May 1, 2023
Last Updated
March 2, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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
- 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.
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.