{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T07:05:36Z","timestamp":1775631936174,"version":"3.50.1"},"reference-count":40,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,2]],"date-time":"2025-07-02T00:00:00Z","timestamp":1751414400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007602","name":"Programme Grants for Applied Research","doi-asserted-by":"publisher","award":["154310"],"award-info":[{"award-number":["154310"]}],"id":[{"id":"10.13039\/501100007602","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Non-pharmaceutical interventions were used widely in care homes for older people during the COVID-19 pandemic, but there have been few randomised trials to support policy decisions. We aimed to evaluate the effect of biweekly asymptomatic staff testing with support funding for sick pay and agency staffing on the clinical outcomes of residents.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>We conducted a cluster randomised unblinded superiority trial, aiming to recruit up to 280 residential and\/or nursing homes in England providing care to adults aged &gt;65 years. Homes were randomised 1:1 to the control arm, which followed national testing policy (comprising symptomatic plus outbreak testing at trial initiation) or intervention (additional twice weekly asymptomatic staff testing for SARS-CoV-2, staff sick pay and agency backfill). Outcomes were evaluated using health data from routine national datasets in combination with aggregate data from participating homes. The primary outcome was the incidence of COVID-19-related hospital admissions in residents.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>The trial was conducted from January to August 2023, with 41 care homes randomised to intervention and 40 randomised to control included in the analysis. The trial was stopped early as it was not adequately powered for the primary outcome due to site recruitment and primary outcome events being substantially lower than expected. There was no significant difference in the primary outcome of resident COVID-linked hospital admission incidence between intervention and control arms (22.7\/1000 person-years vs 15.0\/1000 person-years, incidence rate ratio 1.19, 95%CI 0.55\u20132.58, P\u2009=\u20090.66; incidence rate difference 4.0, 95%CI \u221214.3 to 22.2). Trial set up took less than three months. Most trial outcomes were derived from routinely collected data. Recorded uptake of staff testing in the intervention arm was low (mean per home each week 14.4%).<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>This trial was not well-powered to evaluate the impact of the intervention on the primary outcome, and recorded uptake of staff testing was low. However, our pre-existing care home network underpinned by linked routinely collected data provides a model for more agile interventional studies in the care home setting.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>ClinicalTrials.gov registration<\/jats:title>\n<jats:p>NCT05639205.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0324908","type":"journal-article","created":{"date-parts":[[2025,7,2]],"date-time":"2025-07-02T17:28:47Z","timestamp":1751477327000},"page":"e0324908","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["VIVALDI-CT shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8705-3281","authenticated-orcid":true,"given":"Oliver","family":"Stirrup","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4335-5269","authenticated-orcid":true,"given":"James","family":"Blackstone","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iona","family":"Cullen-Stephenson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Fenner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalie","family":"Adams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth","family":"Leiser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Krutikov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Borscha","family":"Azmi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick","family":"Freemantle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Gordon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martyn","family":"Regan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Knapp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2392-6271","authenticated-orcid":true,"given":"Lara","family":"Gosc\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Henderson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Hopkins","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arpana","family":"Verma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jackie","family":"Cassell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1398-5841","authenticated-orcid":true,"given":"Dorina","family":"Cadar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Fowler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Copas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Flowers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Shallcross","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,7,2]]},"reference":[{"issue":"3","key":"pone.0324908.ref001","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1007\/s10654-022-00861-w","article-title":"COVID-19 prevalence and mortality in longer-term care facilities","volume":"37","author":"AT Levin","year":"2022","journal-title":"European Journal of Epidemiology"},{"issue":"1","key":"pone.0324908.ref002","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1186\/s12877-023-04300-7","article-title":"The impact of protective measures against COVID-19 on the wellbeing of residents in nursing homes and their relatives: a rapid review","volume":"23","author":"P Schneider","year":"2023","journal-title":"BMC Geriatr"},{"key":"pone.0324908.ref003","volume-title":"Technical report on the COVID-19 pandemic in the UK \u2018Chapter 8.2: care homes\u2019","author":"UK Department of Health and Social Care","year":"2023"},{"issue":"2","key":"pone.0324908.ref004","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1017\/S1041610221002799","article-title":"\u201cBecause if I don\u2019t hold his hand then I might as well not be there\u201d: Experiences of Dutch and UK care home visiting during the COVID-19 pandemic","volume":"35","author":"C Giebel","year":"2023","journal-title":"Int Psychogeriatr"},{"issue":"2","key":"pone.0324908.ref005","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2021-053563","article-title":"What factors have influenced quality of life in people with dementia and their family carers during the COVID-19 pandemic: a qualitative study","volume":"12","author":"S Daley","year":"2022","journal-title":"BMJ Open"},{"key":"pone.0324908.ref006","volume-title":"Office for National Statistics: Older people living in care homes in 2021 and changes since 2011","author":"A Storey","year":"2023"},{"issue":"3","key":"pone.0324908.ref007","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1093\/ageing\/aft158","article-title":"The provision of care for residents dying in U.K. nursing care homes","volume":"43","author":"J Kinley","year":"2014","journal-title":"Age Ageing"},{"key":"pone.0324908.ref008","volume-title":"Guidelines for PHE health protection teams on the management of outbreaks of influenza-like illness (ILI) in care homes","author":"Public Health England","year":"2020"},{"key":"pone.0324908.ref009","volume-title":"Guidelines for the management of norovirus outbreaks in acute and community health and social care settings","author":"Public Health England","year":"2012"},{"key":"pone.0324908.ref010","author":"UK Health Security Agency","year":"2024"},{"key":"pone.0324908.ref011","author":"UK Department of Health and Social Care","year":"n.d"},{"issue":"7","key":"pone.0324908.ref012","article-title":"Duration of vaccine effectiveness against SARS-CoV-2 infection, hospitalisation, and death in residents and staff of long-term care facilities in England (VIVALDI): a prospective cohort study","volume":"3","author":"M Shrotri","year":"2022","journal-title":"Lancet Healthy Longev"},{"issue":"1","key":"pone.0324908.ref013","doi-asserted-by":"crossref","first-page":"7475","DOI":"10.1038\/s41598-024-57817-1","article-title":"Faster detection of asymptomatic COVID-19 cases among care home staff in England through the combination of SARS-CoV-2 testing technologies","volume":"14","author":"F Ryan","year":"2024","journal-title":"Sci Rep"},{"issue":"9","key":"pone.0324908.ref014","article-title":"Non-pharmacological measures implemented in the setting of long-term care facilities to prevent SARS-CoV-2 infections and their consequences: a rapid review","volume":"9","author":"JM Stratil","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"issue":"1","key":"pone.0324908.ref015","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1111\/irv.12203","article-title":"Influenza outbreak control practices and the effectiveness of interventions in long-term care facilities: a systematic review","volume":"8","author":"K Rainwater-Lovett","year":"2014","journal-title":"Influenza Other Respir Viruses"},{"issue":"12","key":"pone.0324908.ref016","doi-asserted-by":"crossref","first-page":"1101","DOI":"10.1056\/NEJMoa2210063","article-title":"Covid-19 Surveillance Testing and Resident Outcomes in Nursing Homes","volume":"388","author":"BE McGarry","year":"2023","journal-title":"New England Journal of Medicine"},{"key":"pone.0324908.ref017","volume-title":"Evaluation of the national COVID-19 testing programme in England between October 2020 and March 2022","author":"EY-Oxford Health Analytics Consortium","year":"2023"},{"key":"pone.0324908.ref018","doi-asserted-by":"crossref","first-page":"232","DOI":"10.12688\/wellcomeopenres.16193.2","article-title":"Study Protocol: Understanding SARS-Cov-2 infection, immunity and its duration in care home residents and staff in England (VIVALDI)","volume":"5","author":"M Krutikov","year":"2021","journal-title":"Wellcome Open Res"},{"issue":"1","key":"pone.0324908.ref019","article-title":"Prevalence and duration of detectable SARS-CoV-2 nucleocapsid antibodies in staff and residents of long-term care facilities over the first year of the pandemic (VIVALDI study): prospective cohort study in England","volume":"3","author":"M Krutikov","year":"2022","journal-title":"Lancet Healthy Longev"},{"issue":"1","key":"pone.0324908.ref020","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1038\/s43587-022-00328-3","article-title":"Strong peak immunogenicity but rapid antibody waning following third vaccine dose in older residents of care homes","volume":"3","author":"G Tut","year":"2023","journal-title":"Nature Aging"},{"issue":"8","key":"pone.0324908.ref021","doi-asserted-by":"crossref","DOI":"10.1093\/ageing\/afad141","article-title":"Effectiveness of successive booster vaccine doses against SARS-CoV-2 related mortality in residents of long-term care facilities in the VIVALDI study","volume":"52","author":"O Stirrup","year":"2023","journal-title":"Age Ageing"},{"issue":"1","key":"pone.0324908.ref022","doi-asserted-by":"crossref","DOI":"10.1093\/ofid\/ofac694","article-title":"Clinical Effectiveness of SARS-CoV-2 Booster Vaccine Against Omicron Infection in Residents and Staff of Long-term Care Facilities: A Prospective Cohort Study (VIVALDI)","volume":"10","author":"O Stirrup","year":"2022","journal-title":"Open Forum Infect Dis"},{"issue":"11","key":"pone.0324908.ref023","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2023-076210","article-title":"Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)","volume":"13","author":"N Adams","year":"2023","journal-title":"BMJ Open"},{"key":"pone.0324908.ref024","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1186\/s12874-016-0141-3","article-title":"A comparison of methods to adjust for continuous covariates in the analysis of randomised trials","volume":"16","author":"BC Kahan","year":"2016","journal-title":"BMC Med Res Methodol"},{"issue":"20","key":"pone.0324908.ref025","doi-asserted-by":"crossref","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects","volume":"310","author":"M Association W","year":"2013","journal-title":"JAMA"},{"issue":"4","key":"pone.0324908.ref026","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1003980","article-title":"Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis","volume":"19","author":"B Speich","year":"2022","journal-title":"PLoS Med"},{"issue":"10","key":"pone.0324908.ref027","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.1001\/jama.2014.1361","article-title":"Prevalence, characteristics, and publication of discontinued randomized trials","volume":"311","author":"B Kasenda","year":"2014","journal-title":"JAMA"},{"issue":"1","key":"pone.0324908.ref028","doi-asserted-by":"crossref","first-page":"236","DOI":"10.1186\/s12877-023-03935-w","article-title":"Registered care home managers\u2019 experiences of responding to the national care home visiting guidance in England during the Covid-19 pandemic; a multi-method qualitative study","volume":"23","author":"J Dixon","year":"2023","journal-title":"BMC Geriatr"},{"issue":"9","key":"pone.0324908.ref029","doi-asserted-by":"crossref","DOI":"10.1016\/j.ajic.2015.05.043","article-title":"Impact of hand hygiene on the infectious risk in nursing home residents: A systematic review","volume":"43","author":"MN Hocine","year":"2015","journal-title":"Am J Infect Control"},{"issue":"1","key":"pone.0324908.ref030","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1186\/s13756-021-00946-3","article-title":"The effect of a hand hygiene intervention on infections in residents of nursing homes: a cluster randomized controlled trial","volume":"10","author":"GR Teesing","year":"2021","journal-title":"Antimicrob Resist Infect Control"},{"issue":"8","key":"pone.0324908.ref031","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1016\/j.jamda.2017.03.003","article-title":"Implementing a Pilot Trial of an Infection Control Program in Nursing Homes: Results of a Matched Cluster Randomized Trial","volume":"18","author":"KW McConeghy","year":"2017","journal-title":"J Am Med Dir Assoc"},{"issue":"7581","key":"pone.0324908.ref032","doi-asserted-by":"crossref","first-page":"1241","DOI":"10.1136\/bmj.39010.581354.55","article-title":"Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial","volume":"333","author":"AC Hayward","year":"2006","journal-title":"BMJ"},{"issue":"6","key":"pone.0324908.ref033","doi-asserted-by":"crossref","first-page":"849","DOI":"10.1093\/cid\/ciu935","article-title":"A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders","volume":"60","author":"M Juthani-Mehta","year":"2015","journal-title":"Clin Infect Dis"},{"issue":"6","key":"pone.0324908.ref034","doi-asserted-by":"crossref","DOI":"10.1016\/j.jamda.2012.04.008","article-title":"A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial","volume":"13","author":"K Chami","year":"2012","journal-title":"J Am Med Dir Assoc"},{"issue":"1","key":"pone.0324908.ref035","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/S0196-6553(00)90004-X","article-title":"Effect of a comprehensive infection control program on the incidence of infections in long-term care facilities","volume":"28","author":"AT Makris","year":"2000","journal-title":"Am J Infect Control"},{"key":"pone.0324908.ref036","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1016\/j.jhin.2023.10.021","article-title":"COVID-19-related mortality and hospital admissions in the VIVALDI study cohort: October 2020 to March 2023","volume":"143","author":"O Stirrup","year":"2024","journal-title":"J Hosp Infect"},{"issue":"1","key":"pone.0324908.ref037","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1186\/s13063-018-2915-x","article-title":"Recruiting care homes to a randomised controlled trial","volume":"19","author":"A Ellwood","year":"2018","journal-title":"Trials"},{"issue":"5","key":"pone.0324908.ref038","doi-asserted-by":"crossref","first-page":"1648","DOI":"10.1093\/ije\/dyad064","article-title":"Key considerations for designing, conducting and analysing a cluster randomized trial","volume":"52","author":"K Hemming","year":"2023","journal-title":"Int J Epidemiol"},{"issue":"5","key":"pone.0324908.ref039","doi-asserted-by":"crossref","DOI":"10.1016\/S2666-7568(22)00093-9","article-title":"Outcomes of SARS-CoV-2 omicron infection in residents of long-term care facilities in England (VIVALDI): a prospective, cohort study","volume":"3","author":"M Krutikov","year":"2022","journal-title":"Lancet Healthy Longev"},{"key":"pone.0324908.ref040","doi-asserted-by":"crossref","first-page":"4","DOI":"10.3310\/nihropenres.13530.1","article-title":"Protocol for VIVALDI social care: Pilot study to reduce infections, outbreaks and antimicrobial resistance in care homes for older adults","volume":"4","author":"M Krutikov","year":"2024","journal-title":"NIHR Open Res"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0324908","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,2]],"date-time":"2025-07-02T17:28:58Z","timestamp":1751477338000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0324908"}},"subtitle":[],"editor":[{"given":"Sascha","family":"K\u00f6pke","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,7,2]]},"references-count":40,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7,2]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0324908","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,2]]}}}