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

Sponsor
Tulane University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04930965
Collaborator
National Institutes of Health (NIH) (NIH)
100
Enrollment
1
Location
2
Arms
5.8
Anticipated Duration (Months)
17.2
Patients Per Site Per Month

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Community health worker engagement
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Louisiana Community-Engagement Alliance Against COVID-19 Disparities (LA-CEAL): Impact of HALT COVID Ambassador Program on Likelihood to Vaccinate
Actual Study Start Date :
Oct 5, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Intervention

Behavioral: Community health worker engagement
3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour

No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

  1. Difference in proportion of participants "likely to vaccinate" between study arms at Month 1 [Month 1 follow-up]

    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

  1. Difference in proportion of participants "likely to vaccinate" between study arms at Month 2 [Month 2 follow-up]

    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.

  2. Difference in proportion of participants who have received >=1 dose of vaccine between study arms at Month 1 [Month 1 follow-up]

    Receipt of vaccination will be measured by self-report

  3. Difference in proportion of participants who have received >=1 dose of vaccine between study arms at Month 2 [Month 2 follow-up]

    Receipt of vaccination will be measured by self-report

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Tulane University Medical CenterNew OrleansLouisianaUnited States70112

Sponsors and Collaborators

  • Tulane University
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Marie Krousel-Wood, MD, MSPH, Tulane University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tulane University
ClinicalTrials.gov Identifier:
NCT04930965
Other Study ID Numbers:
  • 2020-1600
  • OT2 HL158260
First Posted:
Jun 18, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tulane University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021