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

Chaudhry, T; Tum, P; Tam, HZ; Brentnall, A; Smethurst, H; Kielmann, K; Kunst, H; Hargreaves, S; Campbell, CNJ; Griffiths, C; Zenner, D

COVID-19 Collection

Journal article

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

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)

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Chaudhry, T., Tum, P., Tam, H. Z., Brentnall, A., Smethurst, H., Kielmann, K., Kunst, H., Hargreaves, S., Campbell, C. N. J., 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.

MLA Style

Chaudhry, T, et al. “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, vol. 15, no. 3, 2025, pp. e092568–e092568.

Chicago Style

Chaudhry, T, P Tum, HZ Tam, et al. 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.
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