Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation.

Background: COVID-19 has resulted in significant disability and loss of life. COVID-19 vaccines effectively prevent severe illness, hospitalization, and death. Nevertheless, many people remain hesitant to accept vaccination. Veterans perceive healthcare providers (HCP) and staff as trusted vaccine information sources and thereby are well suited to initiate vaccine discussions. The overall objective of this study is to implement and test a virtual COVID-19 Vaccine Acceptance Intervention (VAI) training that is informed by motivational interviewing (MI) techniques.

Methods: The VAI training is being delivered to VA HCPs and staff within a Hybrid Type 2 pragmatic implementation-effectiveness trial using Implementation Facilitation as the implementation strategy. The implementation team includes external facilitators paired with VA Healthcare System (VAHCS)-level internal facilitators. The trial has three aims: 1) Examine the effectiveness of the VAI versus usual care on unvaccinated veterans' vaccination rates in a one-year cluster randomized controlled trial, with randomization at the level of VAHCS. 2) Determine factors associated with veterans' decisions to accept or decline primary COVID-19 vaccination, and better understand how these factors influence vaccination decisions, through survey and qualitative data; and 3) Use qualitative interviews with HCPs and staff from clinics with high and low vaccination rates to learn what was helpful and not helpful about the VAI and implementation strategies.

Conclusion: This is the first multisite randomized controlled trial to test an MI-informed vaccine acceptance intervention to improve COVID-19 vaccine acceptance. Information gained can be used to inform healthcare systems' approaches to improve future vaccination and other public health campaigns.

Clinicaltrials: gov Identifier: NCT05027464.