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Completed

NCT Number: NCT04930965

Impact of LA-CEAL HALT COVID-19 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

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Key information

Conditions

Covid19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Refusal Vaccine Refusal Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Health Worker engagement

Behavioral

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

Primary outcomes

  1. Difference in Proportion of Participants "Likely to Vaccinate" Between Study Arms at Month 1

    Time frame: 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 outcomes

  1. Difference in Proportion of Participants "Likely to Vaccinate" Between Study Arms at Month 2

    Time frame: 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

    Time frame: 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

    Time frame: Month 2 follow-up

    Receipt of vaccination will be measured by self-report

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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