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Impact of LA-CEAL HALT COVID-19 Ambassador Program on Likelihood to Vaccinate

Primary Purpose

Covid19, Vaccine Refusal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community health worker engagement
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Community Health Worker

Eligibility Criteria

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

Inclusion Criteria:

  • Unlikely to vaccinate in next month
  • Age >=18 years
  • Self-identification as Black or African American
  • Ability to understand and speak English
  • Willingness to engage with HALT COVID Ambassador via in-person or virtual sessions exploring questions and concerns about vaccines

Exclusion Criteria:

  • Unable or unwilling to give informed consent

Sites / Locations

  • Tulane University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Difference in proportion of participants "likely to vaccinate" between study arms at Month 1
Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., "On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?"), with "likely to vaccinate" defined as a score of 5-7.

Secondary Outcome Measures

Difference in proportion of participants "likely to vaccinate" between study arms at Month 2
Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., "On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?"), with "likely to vaccinate" defined as a score of 5-7.
Difference in proportion of participants who have received >=1 dose of vaccine between study arms at Month 1
Receipt of vaccination will be measured by self-report
Difference in proportion of participants who have received >=1 dose of vaccine between study arms at Month 2
Receipt of vaccination will be measured by self-report

Full Information

First Posted
June 16, 2021
Last Updated
April 5, 2023
Sponsor
Tulane University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04930965
Brief Title
Impact of LA-CEAL HALT COVID-19 Ambassador Program on Likelihood to Vaccinate
Official Title
Louisiana Community-Engagement Alliance Against COVID-19 Disparities (LA-CEAL): Impact of HALT COVID Ambassador Program on Likelihood to Vaccinate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University
Collaborators
National Institutes of Health (NIH)

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to assess the effectiveness of the HALT COVID Ambassador educational outreach program on increasing likelihood to vaccinate against COVID-19
Detailed Description
Investigators will use a randomized controlled trial to test the effectiveness of HALT COVID educational outreach by HALT COVID Ambassadors. HALT COVID Ambassadors will receive training to answer common vaccine questions & address misconceptions; conduct motivational interviewing; and implement basic behavioral economics and related strategies to remove barriers to vaccination. A random sample of FQHC patients will be identified in EHR data downloads of adult patients seen in the last year and contacted by telephone to gain consent and assess eligibility. A total of 100 individuals will be enrolled into the trial and randomized to intervention (engagement with the HALT COVID Ambassador over a 1 month period via in-person or virtual sessions exploring their own questions and concerns about vaccines) or usual care (no extra engagement). Baseline, 1-month, and 2-month follow-up surveys will assess for vaccine likelihood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vaccine Refusal
Keywords
Community Health Worker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Community health worker engagement
Intervention Description
3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour
Primary Outcome Measure Information:
Title
Difference in proportion of participants "likely to vaccinate" between study arms at Month 1
Description
Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., "On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?"), with "likely to vaccinate" defined as a score of 5-7.
Time Frame
Month 1 follow-up
Secondary Outcome Measure Information:
Title
Difference in proportion of participants "likely to vaccinate" between study arms at Month 2
Description
Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., "On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?"), with "likely to vaccinate" defined as a score of 5-7.
Time Frame
Month 2 follow-up
Title
Difference in proportion of participants who have received >=1 dose of vaccine between study arms at Month 1
Description
Receipt of vaccination will be measured by self-report
Time Frame
Month 1 follow-up
Title
Difference in proportion of participants who have received >=1 dose of vaccine between study arms at Month 2
Description
Receipt of vaccination will be measured by self-report
Time Frame
Month 2 follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Unlikely to vaccinate in next month Age >=18 years Self-identification as Black or African American Ability to understand and speak English Willingness to engage with HALT COVID Ambassador via in-person or virtual sessions exploring questions and concerns about vaccines Exclusion Criteria: Unable or unwilling to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Krousel-Wood, MD, MSPH
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of LA-CEAL HALT COVID-19 Ambassador Program on Likelihood to Vaccinate

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