Imperial College London

Academic Institute

Bethan DaviesAndrew Haywarderic johnsonEno Umoh

Health Data Research UKOffice for National StatisticsUK Research and Innovation

3727650000000000

This application is to support Study 5, one element of the REal-time Assessment of Community Transmission 2 (REACT 2): Usability and feasibility study of widespread home self-testing for SARS-CoV-2 antibodies, being conducted by Imperial College London (sponsor) on behalf of the Department of Health and Social Care (funder). - Study 1: Usability, acceptability and performance of LFTs in individuals with COVID - Study 2: Usability, acceptability and design of LFT self-testing in public volunteers - Study 3: Usability and feasibility of LFT self-testing in the community - Study 4: Usability and validity of LFT self-testing in key workers - Study 5: A nationally representative sero-prevalence study through self-administered lateral flow tests This research is being carried out to help the Government develop its approach to COVID-19 testing. The lawful basis for processing is Article 6(1) (e) - “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller and Article 9(2) (j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes’. This means that DHSC and Imperial College London (the Data Controllers) can use the personal data they hold about individuals for research with appropriate safeguards in place. Health and care research should serve the public interest, which means that the Data Controllers have to demonstrate that their research serves the interests of society as a whole. They do this by following the UK Policy Framework for Health and Social Care Research. The survey will involve processing special category data in relation to the health and ethnicity of individuals taking part. The results will be used for processing relevant information to support the current efforts of the UK government authorities for understanding the prevalence and spread of COVID-19, informing the public health response to the ongoing pandemic. While the legal basis is public interest the research has had ethical approval from the South Central Berkshire B Research Ethics Committee (REC) and Health Regulator Authority (HRA). There will also be two brief online or telephone questionnaires to complete. There are no invasive procedures, although finger prick may cause some short-lived discomfort. There is minimal risk from completing a Lateral flow immune-assay test (LTF) but those with a medical condition that might increase bleeding risk from a self-delivered finger prick test with a lancet are excluded. In addition, as part of Studies 1-3 the process of home testing with the device that will be used has been extensively evaluated. The choice of testing kits and materials provided have been optimised based on feedback from healthcare professionals and public representatives to support their safe and effective use in home settings. There is a risk that individuals may change their behaviour based on the belief that a positive tests offers them protection if they put themselves at greater risk of infection or adhere less closely to public health protection advice. In all materials it will be made clear that these are research test and that participants should not change their behaviour based on the results. The research aims to contact a representative sample of adults (aged 18+) in England in order to meet the study aims: 1. To estimate the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to June 2020. 2. To characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to June 2020 3. To investigate the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES). 4. To establish a baseline prevalence at a level reached soon after the end of the initial lockdown and hence provide crucial reference data for future (repeated) surveys. This sample will be selected from the PDS – considered an almost complete sample frame of adults in England, allowing stratification by gender, age and local authority. This study is one element of the REal-time Assessment of Community Transmission 2 (REACT 2): Usability and feasibility study of widespread home self-testing for SARS-CoV-2 antibodies, being conducted by Imperial College London (sponsor) on behalf of the Department of Health and Social Care (funder). It is currently unclear how many people in the UK population have been infected by SARS-CoV-2. One way to explore this question is to measure antibodies in blood of a large number of people, to perform sero-epidemiology. Lateral flow immune-assay test (LFTs) are point of care tests to measure specific antibody in blood. A number have been developed by commercial entities and attained CE mark. However, before widescale use of any LFT for self-testing can be introduced to assess seroprevalence of SARS CoV-2 antibody in the UK population there should be pilot work on the acceptability, usability and reliability of the use of self-tests in real world settings. For example, whether such tests can be used in the home and what degree of confidence could be placed in the results self-reported by the user. These should be conducted at the same time as laboratory-based assessments are being conducted of the performance and validity of the tests in comparison with a gold standard. The overall objective of REACT 2 is to assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community. The work proposed under this application is part of the REACT 2 programme – there are 5 linked sub studies and this is study 5. - Study 1: Usability, acceptability and performance of LFTs in individuals with COVID - Study 2: Usability, acceptability and design of LFT self-testing in public volunteers - Study 3: Usability and feasibility of LFT self-testing in the community - Study 4: Usability and validity of LFT self-testing in key workers - Study 5: A nationally representative sero-prevalence study through self-administered lateral flow tests The data requested from the Patient Demographic Service (PDS) will be used in order to select a nationally representative sample of adults to take part in the testing. The study needs to provide reliable estimates of infection point seroprevalence at the level of local authority, as this is the administrative level responsible for local government and will feed into the local public health response. This will be particularly important to inform disease control measures such as contact tracing at local level. It is also powered to explore differences by key sociodemographic variables (age, gender, ethnicity and socio-economic status (SES)). This study is one component of a larger programme: the REal-time Assessment of Community Transmission 2 (REACT 2): Usability and feasibility study of widespread home self-testing for SARS-CoV-2 antibodies. The research aims to contact a representative sample of adults (aged 18+) in England in order to meet the study aims: 1. To estimate the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to June 2020. 2. To characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to June 2020 3. To investigate the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES). 4. To establish a baseline prevalence at a level reached soon after the end of the initial lockdown and hence provide crucial reference data for future (repeated) surveys. The data required is demographic information from the Personal Demographics Service, to allow individuals aged 18+ to be contacted for the purpose of undertaking a survey of seroprevalence using self-administered lateral flow assays from an age-stratified representative population sample. The data is requested in two stages - 1 – pseudonymised population (including NHS ID, patient postcode, gender and age band) in order to allow selection of a representative sample - 2 – identifiable data request for selected sample only (including NHS ID, patient address, gender, age (month and year), telephone number and email – where available) Current data held on the system only. The identifiable contact information will be securely destroyed by Ipsos MORI once the analysis has been completed. This has been communicated to participants in the privacy notice as December 2020. Individuals in England, in all local authorities, since this is the administrative level responsible for local government and the data will feed into the public health response. There is no other national register of the population that would allow contact with a named and representative sample of adults. The data request is in two stages to ensure that only pseudonymised data is requested at the population level. Identifiable data is only requested for the selected sample. Month and year of birth is sufficient for processing, rather than full date of birth). Data controllers: • Department of Health and Social Care • Imperial College London Data processor: • Ipsos MORI Ipsos MORI are working with the following suppliers to deliver the project: • Print and despatch • Mail service • Online data collection These suppliers are approved and compliant with the General Data Protection Regulations.

There is a direct public health benefit in understanding the infection point seroprevalence of COVID-19 at the level of local authority. The testing programme will allow estimates of cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to June 2020. It will help characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to June 2020. It will also help establish the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES). It also provides a crucial reference data for future (repeated) surveys – happening at the end of the initial lockdown. This study is part of a wider study of understanding COVID-19 and determining the government’s public health response to the pandemic. Overall study aim: To assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community. To achieve the overall study aim, this study (Study 5) is a nationally representative sero-prevalence study through self-administered lateral flow tests. The objectives of the study overall are to understand current diagnostic tests and will inform testing and the public health response to the COVID-19 pandemic.

19/04/2021

Personally Identifiable

CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d); Other-COPI Legislation

Statutory exemption to flow confidential data without consent

One-Off

TRE