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

Sponsor
Charles Drew University of Medicine and Science (Other)
Overall Status
Recruiting
CT.gov ID
NCT05473936
Collaborator
Los Angeles County Department of Public Health (Other), National Library of Medicine (NLM) (NIH)
142
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71
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Community Health Worker led curriculum
N/A

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 142 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

Study Type:
Interventional
Anticipated Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Arm - Standard Treatment (Group 1)

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.

Experimental: Intervention Arm - CHW-led curriculum (Group 2)

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Measure three key measures: trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination [Six weeks from start of project]

    Pre- and post- surveys will measure participants' intentions of getting vaccinated and tested for COVID-19.

Secondary Outcome Measures

  1. Increase health literacy regarding COVID-19 testing and vaccination [Six weeks from start of project]

    Pre- and post- surveys will measure changes in worry about COVID-19, knowledge, attitudes, behaviors, social support, perceived COVID-19 threat, and sources of information about COVID-19.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Los Angeles Department of Public Health Los Angeles California United States 90012
2 Charles Drew University of Medicine and Science Los Angeles California United States 90059

Sponsors and Collaborators

  • Charles Drew University of Medicine and Science
  • Los Angeles County Department of Public Health
  • National Library of Medicine (NLM)

Investigators

  • Principal Investigator: Sheba George, PhD, Charles Drew University of Medicine and Science

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT05473936
Other Study ID Numbers:
  • 1838914-2
  • 3R01LM012309-04S2
First Posted:
Jul 26, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Charles Drew University of Medicine and Science
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022