TY - JOUR
T1 - 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
AU - Chaudhry, T
AU - Tum, P
AU - Tam, HZ
AU - Brentnall, A
AU - Smethurst, H
AU - Kielmann, K
AU - Kunst, H
AU - Hargreaves, S
AU - Campbell, CNJ
AU - Griffiths, C
AU - Zenner, D
N1 - FTX; DOAJ; (CC BY-NC)
© 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.
PY - 2025/3/18
Y1 - 2025/3/18
N2 - 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).
AB - 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).
KW - COVID-19
KW - Health Equity
KW - Health Services
KW - Infection control
KW - Vaccination
KW - Minority Groups
KW - Humans
KW - Patient Participation
KW - Vulnerable Populations
KW - Feasibility Studies
KW - Randomized Controlled Trials as Topic
KW - Ethnicity
KW - Influenza Vaccines/administration & dosage
KW - Pilot Projects
KW - Vaccination/statistics & numerical data
KW - London
KW - COVID-19/prevention & control
KW - Influenza, Human/prevention & control
KW - COVID-19 Vaccines/administration & dosage
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=itm_wosliteitg&SrcAuth=WosAPI&KeyUT=WOS:001449179500001&DestLinkType=FullRecord&DestApp=WOS_CPL
U2 - 10.1136/bmjopen-2024-092568
DO - 10.1136/bmjopen-2024-092568
M3 - A1: Web of Science-article
C2 - 40107676
SN - 2044-6055
VL - 15
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e092568
ER -