Developing and Testing a COVID-19 Vaccination Acceptance Intervention

Completed · Not applicable

Conditions studied: COVID-19 Vaccination

In brief

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.

Key facts

Study ID

NCT05027464

Run by

VA Office of Research and Development

People needed

338718

Starts

2022-04-05

Expected to finish

2024-09-30

Last updated by the study team

2024-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria by Aim:
• Aim 1: Primary care clinic visit in VISN 16 or 21
• Aim 2: =1 visit(s) at a participating VISN 16 or 21 primary care clinic or CBOC after the start of the trial at their site, and at the time of recruitment, COVID-19 vaccination status is verified as one of the following:
• has not initiated COVID-19 vaccination
• has initiated one of the two mRNA vaccines and is outside the window for the second dose
• recently completed COVID-19 vaccination (has completed two doses of mRNA vaccination or has completed the single-dose Janssen/Johnson \& Johnson vaccine within the past 60 days)
• Aim 3: Implementation-focused Interviews with VISN 16 and 21 Staff and HCPs

You may not qualify if…

• Exclusion Criteria by Aim:
• Aim 1: Per VISN or VAMC leadership, the clinic or CBOC has extreme staffing shortages such that it would not be feasible or in the best interests of patient care to allow clinic or CBOC staff release time to participate in trainings or other meetings related to the trial
• Aim 2: Has initiated COVID-19 vaccination with one of the mRNA vaccines and is within the window to complete the second dose on schedule (< 42 days since dose 1)
• Serious allergic reaction or other contraindication to COVID-19 vaccination or other vaccines (e.g., flu vaccine)
• Currently in hospice care or < 6 months to live
• No consistent ability to be contacted by phone
• Participating in another COVID-19 trial or study (research study flag)
• Moderate to severe dementia as documented in the patient's VA medical record
• Increased suicide risk as indicated by behavioral health flag
• Aim 3: Staff or HCPs declines invitation to participate in the interview

Where it is running

• Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR — North Little Rock, Arkansas, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States

Full record on ClinicalTrials.gov

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