{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T07:24:31Z","timestamp":1771658671717,"version":"3.50.1"},"reference-count":4,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"unspecified","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015652","name":"Barts Charity","doi-asserted-by":"publisher","award":["G-002331"],"award-info":[{"award-number":["G-002331"]}],"id":[{"id":"10.13039\/100015652","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,2,5]]},"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>ClinicalTrials.gov (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05866237\">NCT05866237<\/jats:ext-link>).<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2024-092568","type":"journal-article","created":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T08:10:05Z","timestamp":1742544605000},"page":"e092568","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["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"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct05866237","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5245-3007","authenticated-orcid":false,"given":"Tahreem","family":"Chaudhry","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Tum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8542-1749","authenticated-orcid":false,"given":"Hui Zhen","family":"Tam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Brentnall","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hector","family":"Smethurst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karina","family":"Kielmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heinke","family":"Kunst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sally","family":"Hargreaves","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colin N J","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7935-8694","authenticated-orcid":false,"given":"Chris","family":"Griffiths","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dominik","family":"Zenner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,3,18]]},"reference":[{"key":"2025040100165628000_15.3.e092568.1","unstructured":"World Health Organization . COVID-19 cases | WHO COVID-19 dashboard, 2024. Available: https:\/\/data.who.int\/dashboards\/covid19\/cases?n=c"},{"key":"2025040100165628000_15.3.e092568.2","doi-asserted-by":"crossref","unstructured":"Robertson E . Predictors of COVID-19 vaccine hesitancy in the UK Household Longitudinal Study. Brain, Behavior, and Immunity, 2021. Available: https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0889159121001100?via%3Dihub","DOI":"10.1016\/j.bbi.2021.03.008"},{"key":"2025040100165628000_15.3.e092568.3","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1003826","article-title":"Vaccination uptake amongst older adults from minority ethnic backgrounds: A systematic review","volume":"18","author":"Bhanu","year":"2021","journal-title":"PLoS Med"},{"key":"2025040100165628000_15.3.e092568.4","doi-asserted-by":"crossref","DOI":"10.3390\/ijerph15102065","article-title":"Interventions to Improve Vaccination Uptake and Cost Effectiveness of Vaccination Strategies in Newly Arrived Migrants in the EU\/EEA: A Systematic Review","volume":"15","author":"Hui","year":"2018","journal-title":"Int J Environ Res Public Health"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-092568","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T12:09:16Z","timestamp":1743509356000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-092568"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3]]},"references-count":4,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2025,3,18]]},"published-print":{"date-parts":[[2025,3]]}},"alternative-id":["10.1136\/bmjopen-2024-092568"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-092568","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3]]}}}