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

Vaccine Hesitancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473936
• Other study ID #: 1838914-5
• Secondary ID: 3R01LM012309-04S
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: May 2023

Study information

• Verified date: February 2023
• Source: Charles Drew University of Medicine and Science
• Contact: Junko Nishitani, PhD
• Phone: 323-563-4966
• Email: junkonishitani[@]cdrewu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: May 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community Health Workers
• COVID-19
• COVID-19 Testing
• Vaccine Hesitancy

Intervention

Behavioral:
• Community Health Worker led curriculum
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.

Locations

Country	Name	City	State
United States	Charles Drew University of Medicine and Science	Los Angeles	California
United States	Los Angeles Department of Public Health	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	Los Angeles County Department of Public Health, National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Six weeks from start of project
Secondary	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"	Six weeks from start of project
Secondary	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"	Six weeks from start of project