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Motivational Interviewing

Vaccine Acceptance Intervention for COVID-19 (CoVAcS Trial)

N/A
Waitlist Available
Led By Jeffrey M Pyne, MD BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
has not initiated COVID-19 vaccination
Be older than 18 years old
Must not have
No consistent ability to be contacted by phone
Staff or HCPs declines invitation to participate in the interview
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing a method to increase vaccine hesitancy and lack of access to the COVID-19 vaccine among Veterans.

Who is the study for?
This trial is for unvaccinated U.S. Veterans in VISNs 16 and 21, including those hesitant or with limited vaccine access. Eligible participants have visited a primary care clinic after the trial started and are not in another COVID-19 study, at high suicide risk, severely demented, allergic to vaccines, in hospice care or unable to be contacted by phone.Check my eligibility
What is being tested?
The study aims to increase COVID-19 vaccination rates among Veterans through a Vaccine Acceptance Intervention using Motivational Interviewing plus Implementation Facilitation. It targets those who haven't started or completed their vaccination due to hesitancy or access issues.See study design
What are the potential side effects?
Since this intervention involves motivational interviewing rather than medication or vaccines directly administered as part of the trial, there are no direct medical side effects associated with it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not started receiving the COVID-19 vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot be reliably contacted by phone.
Select...
I am a staff member or healthcare provider who has chosen not to participate in the interview.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
COVID-19 Vaccination Status
Secondary outcome measures
Qualitative Interview with purposive subset of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination
Qualitative Interviews with VA staff and Healthcare Providers
Seasonal Influenza Vaccination Status
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
The VAMC Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAMC site. In addition, each CBOC and clinic affiliated with a VAMC in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAMC, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional.
Group II: Usual Care ArmActive Control1 Intervention
A VAMC assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,749 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
74 Previous Clinical Trials
15,719 Total Patients Enrolled
VA Bedford Healthcare SystemUNKNOWN

Media Library

Moving to COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) Clinical Trial Eligibility Overview. Trial Name: NCT05027464 — N/A
COVID-19 Vaccination Research Study Groups: Intervention Arm, Usual Care Arm
COVID-19 Vaccination Clinical Trial 2023: Moving to COVID-19 Vaccine Acceptance Intervention Highlights & Side Effects. Trial Name: NCT05027464 — N/A
Moving to COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027464 — N/A
~71 spots leftby Jul 2025
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