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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
=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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CoVAcS Trial 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.
CoVAcS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not started receiving the COVID-19 vaccine.
Select...
I have visited a VISN 16 or 21 clinic and my COVID-19 vaccination status is verified.
CoVAcS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreCoVAcS 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
1,609 Previous Clinical Trials
3,306,373 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
72 Previous Clinical Trials
14,690 Total Patients Enrolled
VA Bedford Healthcare SystemUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious memory and thinking problem as shown in your medical records.I have not started receiving the COVID-19 vaccine.You are currently receiving end-of-life care or have less than 6 months to live.I cannot be reliably contacted by phone.You had a severe allergic reaction or other reason that prevents you from getting a COVID-19 vaccine or other vaccines.I am a staff member or healthcare provider who has chosen not to participate in the interview.This criterion refers to interviews with staff and healthcare professionals in specific Veterans Integrated Service Network (VISN) regions, 16 and 21, focusing on the implementation of certain practices or protocols.I have visited a VISN 16 or 21 clinic and my COVID-19 vaccination status is verified.You have been flagged for having an increased risk of suicide based on your behavior and mental health.I have started my COVID-19 mRNA vaccine and am due for my second dose within 42 days.This criterion refers to conducting interviews with staff and healthcare providers in certain regions.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Usual Care Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been inducted into this research endeavor?
"Indeed, according to clinicaltrials.gov the trial is still looking for participants. Initially shared on April 5th 2022 and most recently amended a week later on April 14th, it requires 2500 study members from two distinct medical facilities."
Answered by AI
Are there still openings to join this research endeavor?
"Affirmative, clinicaltrials.gov states that this research initiative is in the process of enrolling participants. The trial was initially publicized on April 5th 2022 and has had recent modifications as of April 14th 2022. 2500 individuals are being sought at two locations for participation."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
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