Developing and Testing a COVID-19 Vaccination Acceptance Intervention (CoVAcS)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Vaccination
• Intervention / Treatment: Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention

Detailed Description

For Aim 1, the investigators will conduct a one-year cluster randomized controlled trial of a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC). Usual Care will consist of all national and local initiatives to promote COVID-19 vaccine acceptance in Veterans such as vaccine mandates, mobile clinics, outreach calls, etc. The Implementation Facilitation team will include a VISN-level external facilitator, VAMC-level internal facilitators, and clinic-level site champions to support PACT staff, Coaches and Peers in implementing the Vaccine Acceptance Intervention with unvaccinated Veterans as well as in lowering barriers to vaccine access at intervention sites. For Aim 2, the investigators will identify a diverse sample of 450 Veterans across VAMCs in VISNs 16 and 21, who have had primary care visits at Intervention and Usual Care sites, and who have either recently received (N=360) or have not received (N=90) COVID-19 vaccination. The investigators will over sample recently vaccinated Veterans to describe the impact of the Vaccine Acceptance Intervention on Veterans' decisions to accept COVID-19 vaccination in addition to over-sampling women, ethnic/racial minorities, rural and younger Veterans, and those with mental health conditions. Follow-up qualitative interviews will be conducted in a subsample to better understand factors related to recent vaccine acceptance and persistent vaccine hesitancy. Finally, for Aim 3, the investigators will conduct process and summative interviews with VA staff and providers from VAMC sites in VISNs 16 and 21 with high and low vaccination rates) to learn which implementation strategies were most and least effective.

• Study Type: Interventional
• Enrollment (Actual): 338718
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72114-1706
      • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  • California
    • San Francisco, California, United States, 94121-1563
      • San Francisco VA Medical Center, San Francisco, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	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.
No Intervention: Usual Care Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of Any Dose COVID-19 Vaccination	A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Series Completion of COVID-19 Vaccination	A greater proportion of previously unvaccinated Veterans in the intervention arm will complete the primary series for COVID-19 vaccination compared to usual care	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Booster Vaccination	Receipt of booster requires the Veteran needs to have completed the primary series of the COVID-19 vaccination.	1 Year
Receipt of Flu Vaccine	Receipt of Flu Vaccine during study period.	1 Year

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Minneapolis Veterans Affairs Medical Center; Central Arkansas Veterans Healthcare System; Edith Nourse Rogers Memorial Veterans Hospital
• Investigators: Principal Investigator: Jeffrey M Pyne, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR; Principal Investigator: Karen H Seal, MD MPH, San Francisco VA Medical Center, San Francisco, CA; Principal Investigator: Jennifer K Manuel, PhD, San Francisco VA Medical Center, San Francisco, CA

Publications and helpful links

General Publications

• Pyne JM, Seal KH, Manuel JK, DeRonne B, Oliver KA, Bertenthal D, Esserman D, Purcell N, Petrakis BA, Elwy AR. Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation. Contemp Clin Trials. 2023 Oct;133:107325. doi: 10.1016/j.cct.2023.107325. Epub 2023 Aug 29.
• Seal KH, Bertenthal D, Manuel JK, Pyne JM. Association of Demographic, Clinical, and Social Determinants of Health With COVID-19 Vaccination Booster Dose Completion Among US Veterans. JAMA Netw Open. 2022 Jul 1;5(7):e2222635. doi: 10.1001/jamanetworkopen.2022.22635.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Motivational Interviewing; COVID-19 Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: SDR 21-141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No