Preventing Respiratory Viral Illness Invisibly (PRiVII): protocol for a pragmatic cluster randomized trial evaluating far-UVC light devices in long-term care facilities to reduce infections.

Chris Theriault, Kenneth Rockwood, Hayden P Nix, Samantha Meeker, Caroline E King, Melissa Andrew, Ian R C Davis, Prosper S Koto, Meaghan Sim, Jennifer Murdoch, Glenn Patriquin, Stephanie Reidy, Michael Rockwood, Tara Sampalli, Samuel D Searle

Journal: Trials 2024;25(1):88

PMID: 38279184

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Abstract

BACKGROUND

Respiratory viral illness (RVI)-e.g., influenza, COVID-19-is a serious threat in long-term care (LTC) facilities. Standard infection control measures are suboptimal in LTC facilities because of residents' cognitive impairments, care needs, and susceptibility to loneliness and mental illness. Further, LTC residents living with high degrees of frailty who contract RVIs often develop the so-called atypical symptoms (e.g., delirium, worse mobility) instead of typical cough and fever, delaying infection diagnosis and treatment. Although far-UVC (222 nm) light devices have shown potent antiviral activity in vitro, clinical efficacy remains unproven.

METHODS

Following a study to assay acceptability at each site, this multicenter, double-blinded, cluster-randomized, placebo-controlled trial aims to assess whether far-UVC light devices impact the incidence of RVIs in LTC facilities. Neighborhoods within LTC facilities are randomized to receive far-UVC light devices (222 nm) or identical placebo light devices that emit only visible spectrum light (400-700 nm) in common areas. All residents are monitored for RVIs using both a standard screening protocol and a novel screening protocol that target atypical symptoms. The 3-year incidence of RVIs will be compared using intention-to-treat analysis. A cost-consequence analysis will follow.

DISCUSSION

This trial aims to inform decisions about whether to implement far-UVC light in LTC facilities for RVI prevention. The trial design features align with this pragmatic intent. Appropriate additional ethical protections have been implemented to mitigate participant vulnerabilities that arise from conducting this study. Knowledge dissemination will be supported through media engagement, peer-reviewed presentations, and publications.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05084898. October 20, 2021.

Address: Geriatric Medicine Research, Halifax, NS, Canada. [email protected].; Department of Medicine, Dalhousie University, Halifax, NS, Canada. [email protected].; Geriatric Medicine Research, Halifax, NS, Canada.; Research, Innovation and Discovery, Nova Scotia Health, Halifax, NS, Canada.; Department of Medicine, Dalhousie University, Halifax, NS, Canada.; Division of Geriatric Medicine, Dalhousie University, Halifax, NS, Canada.; Division of Infectious Diseases, Department of Medicine, Nova Scotia Health, Halifax, NS, Canada.; Department of Pathology, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.; Research Methods Unit, Nova Scotia Health, Halifax, NS, Canada.; Department of Pathology, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.; Division of Microbiology, Department of Pathology and Laboratory Medicine, Nova Scotia Health, Halifax, NS, Canada.; Geriatric Medicine Research, Halifax, NS, Canada.; Division of Rheumatology, Nova Scotia Health, Halifax, NS, Canada.; Division of Geriatric Medicine, Dalhousie University, Halifax, NS, Canada.; Medical Research Council Unit for Lifelong Health and Ageing at University College London, University College London, London, UK.; Division of Geriatric Medicine, Dalhousie University, Halifax, NS, Canada.; Frailty & Elder Care Network, Nova Scotia Health, Halifax, NS, Canada.

DOI: 10.1186/s13063-024-07909-0

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MeSH Terms: Humans, SARS-CoV-2, Long-Term Care, COVID-19, Health Facilities, Skilled Nursing Facilities, Treatment Outcome, Randomized Controlled Trials as Topic, Multicenter Studies as Topic