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

Louisiana Community-Engagement Alliance Against COVID-19 Disparities (LA-CEAL): Impact of HALT COVID Ambassador Program on Likelihood to Vaccinate

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

Study Overview

• Status: Completed
• Conditions: Covid19; Vaccine Refusal
• Intervention / Treatment: Behavioral: Community health worker engagement

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 1 follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 2 follow-up
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	Month 1 follow-up
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	Month 2 follow-up

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Marie Krousel-Wood, MD, MSPH, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Community Health Worker
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-1600; OT2 HL158260 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No