COVER-ME: Developing and Evaluating community-based interventions to promote vaccine uptake in East London minority ethnicity (ME) populations; underserved migrants and persons with low income: protocol for a pilot randomised controlled trial

Introduction Under vaccination amongst underserved groups remains low due to existing disparities. This is particularly the case with post-pandemic COVID-19 vaccinations, and other vaccine-preventable diseases including measles, Mumps and Rubella (MMR) or influenza. Therefore, we aim to 1) to determine the feasibility and practicality of implementing a patient engagement tool (PET) and gain vital insights to plan a subsequent definitive randomised controlled trial (RCT) to evaluate the effectiveness of this tool for increasing uptake of COVID-19 and Flu vaccination; 2) and to define the appropriate level of support needed for health care providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 and Flu vaccinations. Methods and Analysis This is a randomised controlled feasibility study evaluating a co-designed PET, involving randomisation at individual and cluster level. For individual randomisation, patients will be individually randomised 1:1 to receive the intervention (PET) or routine care; whereas for cluster randomisation six GP practices will be randomised 1:1, and divided into two tranches at two separate time points. Both groups will receive training and activation of the software. Data will be analysed using statistical software R (4.0 or greater) or STATA (17 or greater). Baseline characteristics will be summarised and presented in groups based on an intention to treat (ITT) basis with categorical data; including demographics, socioeconomic variables, co-morbidities, and vaccination status. Ethics and Dissemination Ethical approval was granted Westminster Ethics Committee (ref: 316860). Our dissemination strategy targets three audiences: (1) Policy makers, public and health service managers and clinicians responsible for delivering vaccines and infection prevention services; (2) patients and public from underserved population groups (3) academics.