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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930965
• Other study ID #: 2020-1600
• Secondary ID: OT2 HL158260
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2023
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Vaccine Refusal

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

Locations

Country	Name	City	State
United States	Tulane University Medical Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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