Participant information sheet

STUDY TITLE: BE-DIRECT: Broadening our understanding of Early versus Late InfluEnza Vaccine Effectiveness - Determining the Immune Response in Ethnic minority healthcare workers to COVID-19 infecTion, (a sub-study of UK-REACH)

PARTICIPANT INFORMATION SHEET (INFECTION): BE-DIRECT v1.0 07/01/2022

COVERS ADDITIONAL SAMPLING - ONLY TO BE USED IN THOSE WITH SUSPECTED OR CONFIRMED COVID-19.

Introduction

Thank you for taking the time to read this information.

This information sheet contains information about an additional aspect of the BE-DIRECT research study. When you initially consented to participate in the study you kindly indicated that you would contact us if you developed confirmed or suspected COVID-19 so that we could arrange an additional study visit to collect a swab test for detection of viruses and a blood test.

Please note, this information sheet only details aspects of the study undertaken by those who develop infection. All other aspects of the study are covered in the information sheet you were given at the time of recruitment into BE-DIRECT. If you need another copy of this document please email the study team using the address below.

What is the purpose of this additional aspect of the BE-DIRECT study?

In light of the emergence of the new variant of SARS-CoV-2 and the impact of breakthrough infection (infection in people who have been vaccinated) on individual healthcare workers and the healthcare workforce. We would like to study the immune response to breakthrough infection in further detail.

In order to do this, in addition to the swab and blood test you have already consented for, we would like to collect a further swab test and blood test at the end of your isolation period.

What will happen if I decide to take part?

You have already kindly consented to provide one swab of your nose and throat and one blood sample. We will aim to collect this sample as soon as is practical after your diagnosis/suspected diagnosis of COVID-19 (usually within 7 days of a positive test).

We would like to collect a further swab of your nose and throat and an additional blood test (around 40ml of blood will be collected) upon your return to work after isolation. If you are happy to, we will instruct you on how to take the swab sample yourself. If not, a trained researcher will collect the sample.

If, after reading this information sheet, you are happy to provide the extra samples we will ask you to consent online. Once you have consented we will ask that you contact the study team, using the contact details provided, to arrange an appointment for the swab & blood test on your return to work.

Most appointments will be held after you return to work at an appropriate place at the LRI, LGH or GGH. In the case of an unusually prolonged isolation period we may contact you to ask if repeat sampling could be undertaken at your home/wherever you are isolating. We understand that healthcare workers are extremely busy and it is easy to forget to arrange an appointment. With this in mind, we will contact you approximately 10 days after your diagnosis/suspected diagnosis to attempt to arrange an appointment.

Will I receive results of the swab test?

The swab test is only for research purposes, results will not be available quickly and we are unsure what a positive result for coronavirus would mean regarding infectivity. We will therefore not be giving out results of swab tests but would strongly encourage participants to follow current trust/government guidelines regarding isolation periods.

What are the possible disadvantages of taking part?

The collection of blood samples may cause mild discomfort and could leave a small bruise. Collection of the swab sample may cause mild discomfort.

Do I have to take part?

You do not have to take part in this additional aspect of the study.

Thank you for reading this information sheet. For information about all other aspects of the study including details on how samples will be stored/processed and how your data will be used, please refer to the information sheet you received at recruitment.

For further information, please contact the DIRECT / UK-REACH study team:

Email: DIRECTStudy@uhl-tr.nhs.uk

Tel: 07425 611865