COVER-ME: developing and evaluating community-based interventions to promote vaccine uptake for COVID-19 and influenza in East London minority ethnicity (ME) and underserved individuals - protocol for a pilot randomised controlled trial
COVER-ME: developing and evaluating community-based interventions to promote vaccine uptake for COVID-19 and influenza in East London minority ethnicity (ME) and underserved individuals - protocol for a pilot randomised controlled trial
Blog Article
Introduction Under-vaccination among underserved groups remains low due to existing disparities.This is particularly the case with postpandemic COVID-19 vaccinations and other vaccine-preventable diseases, including measles, mumps, rubella or influenza.Therefore, we aim to (1) determine the feasibility and practicality of implementing a patient engagement tool (PET) and gain vital insights to plan a subsequent definitive randomised controlled Bowl Adapter trial (RCT) to evaluate the effectiveness of this tool for increasing uptake of COVID-19 and influenza vaccinations and (2) define the appropriate level of support needed for healthcare providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 and influenza vaccinations.
Methods and analysis This is a randomised controlled feasibility study evaluating a co-designed PET, involving randomisation at individual and cluster levels.For individual randomisation, patients will be individually randomised 1:1 to receive the intervention (PET) or routine care; whereas for cluster randomisation, six GP (General Practitioner) practices will be randomised 1:1 and divided into two tranches at two separate time points.Both groups will receive training and software activation.
Data will be analysed using statistical software R (V.4.0 or greater) or STATA (V.
17 or greater).Baseline characteristics will be summarised and presented in groups based on an intention-to-treat basis with categorical data, Course a pied - Homme - Vetements - Manteau - Impermeable including demographics, socioeconomic variables, comorbidities and vaccination status.Ethics and dissemination Ethical approval was granted by the 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 and (3) academics.Trial registration number ClinicalTrials.gov (NCT05866237).