Developing and Testing a COVID-19 Vaccination Acceptance Intervention (CoVAcS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05027464|
Recruitment Status : Not yet recruiting
First Posted : August 30, 2021
Last Update Posted : August 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Vaccination||Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|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|
|Estimated Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||July 3, 2023|
|Estimated Study Completion Date :||September 30, 2023|
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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05027464
|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|
|United States, Arkansas|
|Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|
|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|
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA|
|San Francisco, California, United States, 94121|
|Contact: Rebecca Yu 415-221-4810 ext 3687 email@example.com|
|Contact: Gregory L Green, MPH BS (415) 221-4810 ext 2996 Gregory.Green@va.gov|
|Principal Investigator: Karen H Seal, MD MPH|
|Principal Investigator:||Karen H Seal, MD MPH||San Francisco VA Medical Center, San Francisco, CA|
|Principal Investigator:||Jeffrey M Pyne, MD||Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|