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Expansion of the VIVALDI Study

Expanded study to test thousands more care home staff and residents for immunity to COVID-19

What is the Vivaldi study?
Vivaldi 2 is a study into COVID-19 among care-home residents and staff in England. It involves the regular drawing of blood samples from participants to analyse their immunity to the virus. This data is analysed together with results from the national swab testing programme in care homes participating in the study, and epidemiological data.
Vivaldi 2 follows on from Vivaldi 1, which analysed the relationship between certain care-home characteristics and their prevalence of COVID-19. This study is now complete.

Why are you expanding this study?
The Vivaldi 2 study began with one care-home provider, Four Seasons Healthcare Limited. We have expanded the study to include a larger number of participants from a wider selection of care homes to improve the reliability of the conclusions which can be drawn from a larger data set, and so they can be generalised on a national scale.

What is the process for testing care home residents? 
The study involves blood samples being taken by trained phlebotomists in successive rounds. We expect there will be between three and five rounds of blood sampling in total, depending on future waves of the virus.
This data are combined with positivity data from the regular testing in care homes which began in England on 6 July, and epidemiological data from the study participants. This allows conclusions to be drawn which will inform planning and the national public health response to COVID-19. It will also help inform wider social-care policy.

How frequently will tests be carried out on staff and residents during the expanded study?
The Government anticipates that there will be five rounds of testing that should take place from November 2020 to December 2021.

When will testing begin?
The expansion of the study into a wider selection of care homes in England started this month [November], with the first round of blood samples being taken in phases.
The taking of blood samples as part of the Vivaldi 2 study in the Four Seasons Healthcare care-home chain began on 11 June.
Regular swab testing in care homes – including those which are now part of the Vivaldi 2 study – took place on 6 July.

Why can’t I visit my relative in a care home, but scientists/phlebotomists can?
The phlebotomists entering care homes for this study do so with strict adherence to government guidelines and with appropriate PPE. The information that they are gathering is essential in providing the information that will help us to understand the virus and potential immunity which is necessary to help to ensure that loved ones can be reunited sooner rather than later.
The Government have begun a trial of testing visitors to care homes this week to support care home providers and families to work together to find the right balance between the benefits of visiting on wellbeing and quality of life, and the risk of transmission of COVID-19 to social care staff and vulnerable residents. We aim to roll this out nationally in December.

Why do you need to conduct research on vulnerable care-home residents?
Consent is requested from all participants in the study, and they are able to refuse consent if they do not wish to take part.
For care-home residents who lack the capacity to provide consent (such as those suffering from advanced dementia), consent is sought from family members.
If a family member cannot be identified, a nominated consultee, such as the care home manager or a member of staff will be asked to complete a professional declaration form to provide consent for the resident in question. This approach meets the four criteria for HRA approval as set out in sections 31–33 of the Mental Capacity Act 2005
We have found that the vast majority of residents and staff are enthusiastic about participating in the Vivaldi study due its importance in the scientific effort to fight the disease.

How are you ensuring that phlebotomists don’t spread the virus into care homes?
Maintaining the safety of care home residents and staff is the foremost priority of all testing in the Vivaldi study.
Phlebotomists are obliged to follow strict infection control guidance, wear Personal Protective Equipment (PPE), and are regularly tested for COVID-19. They also participate in a separate contract tracing system so any potential outbreak can be quickly isolated.
Phlebotomists working on the study are judged to be essential workers, and their entrance to care homes is at the discretion of care-home managers.

Why can’t you extrapolate data from other sources such as REACT or UK Biobank?
Vivaldi is the only academic study which is focussing on the vulnerable demographic of elderly care-home residents – we can’t get data on this age group from any other surveillance studies.
This study will provide vital information in understanding how COVID impacts this particularly vulnerable group, the relationship between age and the body’s immune response to the virus, and how immunity changes over time. All of this data will have important implications for public health, including for future vaccines, therapeutics and diagnostics for COVID-19.

Is this study the same thing as NHS Test and Trace in care homes?
No, but the Vivaldi study uses data from the regular swab testing of care home residents and staff which began in England on 6 July. However, it also involves the taking of blood samples from residents to test for antibodies, which is not undertaken by NHS Test and Trace.

How many participants will be tested?
We anticipate that the expansion of the study will lead to testing of around 14,000 participants (4,000 in Vivaldi 2, and 10,000 in the expansion). Approximately one third of this total will be care-home residents, with the remainder being staff.

Which care homes are included in the expansion?
The original Vivaldi 2 study, which began on 11 June, involved care homes from the provider Four Seasons Healthcare.
The expansion will involve care homes from a larger number of providers including HC-One, Orders of St. John Care Homes and other smaller chains and independent care homes.

When will the study end?
The exact end date will be determined by how prevalent COVID-19 is in the tested care homes – when prevalence is higher, the study can gather more data and may determine conclusions sooner.

What is the geographical spread of the care homes in the expansion?
The expansion of the study includes a representative sample of care-homes in England from a variety of regions.

Why is the expansion only in England?
Adult social-care policy is a devolved matter, and the responsibility of each devolved administration.