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

• ClinicalTrials.gov Identifier: NCT05027464
• Recruitment Status: Recruiting
• First Posted: August 30, 2021
• Last Update Posted: April 22, 2022
• Sponsor: VA Office of Research and Development
• Collaborator: Edith Nourse Rogers Memorial Veterans Hospital
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
COVID-19 Vaccination	Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One-year cluster randomized parallel group trial, stratified by VISN, using covariate constrained randomization (e.g., rural/urban clinics, facility size). Specifically, the investigators will compare a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC), with the intervention directed at VAMC clinic and CBOC PACT staff members.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The study PIs and co-investigators, other research staff (except for the study statistician, see below), qualitative interviewers and participating VA staff will be unblinded because they are involved in delivering the intervention or, in the case of the qualitative researchers, will be tasked with interviewing study stakeholders about the intervention or implementation strategies. In contrast, the study evaluators, study statistician, and Veterans will be blinded to study arm assignment. Evaluators will conduct the study survey in Veterans, and while they will be aware of COVID-19 vaccination status, they will not be apprised of study arm. In addition, unless Veterans are unintentionally informed, Veterans will not know to which arm their VAMC has been randomized. Blinding of the study statistician conducting the outcomes analyses, survey evaluators, and the Veteran participants is important to protect the internal validity of study findings.
• Primary Purpose: Health Services Research
• Official Title: Developing and Testing a COVID-19 Vaccination Acceptance Intervention
• Actual Study Start Date: April 5, 2022
• Estimated Primary Completion Date: July 3, 2023
• Estimated Study Completion Date: September 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. COVID-19 Vaccination Status [ Time Frame: 1 year ]
   A greater proportion of previously unvaccinated Veterans in the intervention group will receive COVID-19 vaccination compared to usual care.

Secondary Outcome Measures :

1. Seasonal Influenza Vaccination Status [ Time Frame: 1 year ]
   A greater proportion of Veterans in the intervention arm will receive the seasonal flu vaccination compared to usual care
2. Survey of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination [ Time Frame: 18 months ]
   The survey will examine predictors of COVID-19 vaccine acceptance and are organized according to the World Health Organization Behavioral and Social Drivers of Vaccination (BeSD) framework. The survey includes questions from Centers for Disease Control and multiple VA surveys.
3. Qualitative Interview with purposive subset of Veterans from Intervention and Usual Care who did and did not receive COVID-19 vaccination [ Time Frame: 18 months ]
   In purposive subset of Veterans, the investigators will conduct deeper-dive qualitative interviews to explore with Veterans' HCPs influence their decisions to accept COVID-19 vaccination and which factors (e.g., trust in VA HCPs, correct information about vaccines, prior experiences with VA healthcare, risk perception, perceived lack of time/access, and/or discrimination) are most influential in Veterans' decision-making regarding COVID-19 vaccination.
4. Qualitative Interviews with VA staff and Healthcare Providers [ Time Frame: 18 months ]
   Conduct mid-trial and end-of-trial qualitative interviews with VISN 16 and 21 study stakeholders, (i.e., a purposive sample of VA staff and HCPs from sites with high and low vaccination rates) to learn which aspects of the Vaccine Acceptance Intervention and which implementation strategies were helpful (or not) in improving Veteran vaccine acceptance and access.
5. Secondary Analysis of VA National Data [ Time Frame: 1 year ]
   The investigators will utilize the VA Corporate Data Warehouse (CDW) and other VA administrative data (e.g., VA Shared COVID-19 Data Resource), to assess other independent predictors of vaccine acceptance, including sociodemographic factors, clinical diagnoses, and health services utilization.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Yasmin Jolly; (415) 221-4810 ext 24852; Yasmin.Jolly@va.gov

Contact: Nicole McCamish, MA; (415) 221-4810 ext 4284; Nicole.McCamish@va.gov

Locations

United States, Arkansas

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR; Not yet recruiting

North Little Rock, Arkansas, United States, 72114-1706

Contact: Yasmin Jolly 415-221-4810 ext 24852 Yasmin.Jolly@va.gov

Principal Investigator: Jeffrey M Pyne, MD BA

United States, California

San Francisco VA Medical Center, San Francisco, CA; Recruiting

San Francisco, California, United States, 94121

Contact: Yasmin Jolly 415-221-4810 ext 24852 Yasmin.Jolly@va.gov

Contact: Nicole McCamish, MA (415) 221-4810 ext 4284 Nicole.McCamish@va.gov

Principal Investigator: Karen H Seal, MD MPH

Sponsors and Collaborators

VA Office of Research and Development

Edith Nourse Rogers Memorial Veterans Hospital

Investigators

• Principal Investigator: Karen H Seal, MD MPH; San Francisco VA Medical Center, San Francisco, CA
• Principal Investigator: Jeffrey M Pyne, MD BA; Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT05027464
• Other Study ID Numbers: SDR 21-141
• First Posted: August 30, 2021
• Last Update Posted: April 22, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

COVID-19 Vaccine; Motivational Interviewing

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases