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

Not Applicable

Completed

• Conditions: Covid19; Vaccine Refusal
• Interventions: Behavioral: Community health worker engagement

• Registration Number: NCT04930965
• Lead Sponsor: Tulane University

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.

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-18
• Study Start: 2021-10-05
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-28
• Status Verified: 2023-12
• Results First Submitted: 2023-12-20
• Results First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Results First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Community health worker engagement	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

Tulane University Medical Center; 🇺🇸 New Orleans, Louisiana, United States