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

NCT ID: NCT04930965

Last Updated: 2024-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Covid19 Vaccine Refusal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Community health worker engagement

Intervention Type BEHAVIORAL

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

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Krousel-Wood, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

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Tulane University Medical Center

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OT2 HL158260

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2020-1600

Identifier Type: -

Identifier Source: org_study_id

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