Developing and Testing a COVID-19 Vaccination Acceptance Intervention

NCT05027464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338718

Last updated 2024-11-08

Study results available
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Summary

The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Nevertheless, according to VA data sources, only 56% of all U.S. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation.

Conditions

  • COVID-19 Vaccination

Interventions

BEHAVIORAL

Moving to COVID-19 Vaccine Acceptance Intervention

The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.

Sponsors & Collaborators

  • Edith Nourse Rogers Memorial Veterans Hospital

    collaborator FED
  • Central Arkansas Veterans Healthcare System

    collaborator FED
  • Minneapolis Veterans Affairs Medical Center

    collaborator FED
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Karen H Seal, MD MPH · San Francisco VA Medical Center, San Francisco, CA

  • Jeffrey M Pyne, MD · Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  • Jennifer K Manuel, PhD · San Francisco VA Medical Center, San Francisco, CA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2023-08-30
Completion
2024-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027464 on ClinicalTrials.gov