tetano
Editor, Senior Moderator
BMJ Open
. 2025 Mar 18;15(3):e092568.
doi: 10.1136/bmjopen-2024-092568. 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
Tahreem Chaudhry[SUP] 1 [/SUP], Patricia Tum[SUP] 2 [/SUP], Hui Zhen Tam[SUP] 2 [/SUP], Adam Brentnall[SUP] 2 [/SUP], Hector Smethurst[SUP] 2 [/SUP], Karina Kielmann[SUP] 3 [/SUP], Heinke Kunst[SUP] 4 [/SUP], Sally Hargreaves[SUP] 5 [/SUP], Colin N J Campbell[SUP] 6 [/SUP], Chris Griffiths[SUP] 2 [/SUP], Dominik Zenner[SUP] 2 [/SUP]
Affiliations
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).
Keywords: COVID-19; Health Equity; Health Services; Infection control; Vaccination.
. 2025 Mar 18;15(3):e092568.
doi: 10.1136/bmjopen-2024-092568. 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
Tahreem Chaudhry[SUP] 1 [/SUP], Patricia Tum[SUP] 2 [/SUP], Hui Zhen Tam[SUP] 2 [/SUP], Adam Brentnall[SUP] 2 [/SUP], Hector Smethurst[SUP] 2 [/SUP], Karina Kielmann[SUP] 3 [/SUP], Heinke Kunst[SUP] 4 [/SUP], Sally Hargreaves[SUP] 5 [/SUP], Colin N J Campbell[SUP] 6 [/SUP], Chris Griffiths[SUP] 2 [/SUP], Dominik Zenner[SUP] 2 [/SUP]
Affiliations
- PMID: 40107676
- DOI: 10.1136/bmjopen-2024-092568
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).
Keywords: COVID-19; Health Equity; Health Services; Infection control; Vaccination.