Effectiveness of germicidal ultraviolet Light in an Upper room Configuration In Decreasing COVID-19 in Aged-care Residential facilities (ELUCIDAR): A cluster randomised controlled trial

This study aims to determine if, in Residential Aged Care Facilities (RACFs) in metropolitan Melbourne and Greater Geelong, Victoria, Australia, the installation of upper room germicidal ultraviolet light luminaires (UR-GUV) in common areas reduces the event rate of COVID-19 among residents, compared to standard practices alone, over 12 months. This is an open-label cluster randomised controlled trial (cRCT) conducted in a real-world setting. Enrollment and randomisation will occur at the RACF level, which are the clusters. Following engagement, provision of information to RACF management, staff and residents, facility management or providers (companies who are the owners) will enter an agreement to participate in the trial with the Victorian Department of Health. Individual consent will not be obtained. The study will aim to have 30 RACFs in the intervention arm and 30 in the control arm. Following randomisation (group allocation), installation will be completed in all intervention facilities. The study period commences when the intervention commences, ie, UR-GUV luminaires will be simultaneously turned on in all intervention facilities to operate continuously and concludes after 12 months. Intervention (arm 1) = Upper room germicidal ultraviolet lights (UVC 254nm wavelength), in addition to standard infection control measures (as described in the standard of care arm 2). Description: This study involves installing UR-GUV onto the ceilings or high on the walls in the intervention facilities. The UR-GUV lights will emit ultraviolet-C (UVC) irradiation at the 254nm wavelength, which has been shown to reduce the transmission of airborne pathogens, such as tuberculosis and inactivate SARS-CoV-2 and influenza viruses in the laboratory. When the devices are turned on, this creates a zone of disinfection at the top of the room, while people can safely spend time in the occupied part of the room below without detectable UV light exposure, as per established regulatory standards. Normal air circulation in the room will bring airborne pathogens into the disinfection zone, just below the ceiling, where the ultraviolet light is designed to inactivate them to prevent them from causing further infections. Standardised parameters for UR-GUV installation have been developed to optimise efficacy while maintaining the safety of residents and staff and adhering to relevant standards. Installation will be conducted by a single commercial supplier following agreements between the facility or provider management and the Victorian Department of Health. The luminaires will be installed in common areas such as dining rooms and shared activity rooms. A common area has a standardised operational definition that includes an area or room inside the RACF that includes criteria for open access, prolonged occupancy and clustered interactions. Examples include dining rooms, lounge or sitting rooms, or libraries. Once UR-GUV installation in all intervention facilities is complete, the study will commence. The luminaires will be activated to operate continuously and data collection will commence and then be performed for a 12 month period. There are safety protocols and mechanisms in place that will allow the lights to be turned off by facilities for short periods to allow personal to enter the upper zone of the room when required (e.g. for maintenance, replacing light globes in other light fittings etc). Remote monitoring of the lighting will be in place to allow for measuring light adherence. Additionally, facilities will be required, as per the trial operating procedures, to report any suspected device faults or safety incidences to the Department of Health and the UR-GUV luminaire supplier. After commissioning UR-GUV in a RACF, the UR-GUV luminaire installer will conduct onsite checks every 12-weeks, confirming lamp operation and adherence, UV safety levels, and to clean the light fittings. The installer will also measure and ensure that the UV light levels achieved in the upper disinfection zone (at 2.3m height) are as expected. Measurements of UVC light levels will also be conducted at various points in the lower inhabited zone, at standing eye height (1.83 metres) to ensure no unsafe levels of UV light are produced. Interventional facilities will use UR-GUV in addition to standard of care (see control group arm 2 for description).