Chaudhry, T;
Tum, P;
Tam, HZ;
Brentnall, A;
Smethurst, H;
Kielmann, K;
Kunst, H;
Hargreaves, S;
Campbell, CNJ;
Griffiths, C;
et al.
Chaudhry, T; Tum, P; Tam, HZ; Brentnall, A; Smethurst, H; Kielmann, K; Kunst, H; Hargreaves, S; Campbell, CNJ; Griffiths, C; Zenner, D
(2025)
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.
BMJ OPEN, 15 (3).
e092568-e092568.
ISSN 2044-6055
https://doi.org/10.1136/bmjopen-2024-092568
SGUL Authors: Hargreaves, Sally
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Abstract
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 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, 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).
Item Type: | Article | ||||||
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Additional Information: | © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. | ||||||
Keywords: | COVID-19, Health Services, Health Equity, Infection control, Vaccination | ||||||
SGUL Research Institute / Research Centre: | Academic Structure > Infection and Immunity Research Institute (INII) | ||||||
Journal or Publication Title: | BMJ OPEN | ||||||
ISSN: | 2044-6055 | ||||||
Language: | en | ||||||
Publisher License: | Creative Commons: Attribution-Noncommercial 4.0 | ||||||
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URI: | https://openaccess.sgul.ac.uk/id/eprint/117394 | ||||||
Publisher's version: | https://doi.org/10.1136/bmjopen-2024-092568 |
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