Perth COVID-19 Infection Study

With the arrival of the Omicron wave in WA, case numbers are now too high for contact tracing teams to find every infection. The study team want to know what proportion of people in the Perth community are infected with COVID-19 at one time. This will help us work out what fraction of all infections are found by the health system. We want to find out by using saliva samples to test people in the community for COVID-19 infection. We would also like to ask you some questions about yourself including your vaccination status and if you have previously had COVID-19.

Should you agree to participate, we will complete a short verbal questionnaire where we ask you some questions about your vaccination status, symptoms, if you have had any previous COVID-19 infections and potential risk factors for COVID-19. You will also then collect a saliva sample by putting a swab in your mouth for 10 seconds If you are the parent/guardian of minors and would like them to take part, you will provide consent and assist them in the questionnaire and collecting the saliva sample. The study will take place at your home, we will not enter your home and the questionnaire and saliva sample collection can be completed at your door. This is expected to take about 30 minutes to complete for the whole household.

We will send you the results of testing your saliva sample within a few days. This will indicate whether you are at higher risk of testing positive on a COVID-19 diagnostic test (PCR or RAT). As this is not an official diagnostic test, you are not required by the health department to isolate either whilst waiting for our test result or if you are found to be at high risk of testing positive. If you are found to be at high risk of testing positive, or if you develop symptoms of COVID-19 at any time, please seek a diagnostic test (PCR or RAT).

If you are found to be at high risk of testing positive, we will get in contact with you within two weeks either through a phone call or email to ask you about any symptoms to may have developed since providing the saliva sample.

Please note that this is a research study and not a replacement for a RAT or PCR test. You should follow all current health directives as advised by WA Health regarding isolating and testing, which includes seeking a diagnostic test (PCR or RAT) if you experience COVID-19 symptoms at any time.

We are using a test called a Loop-Mediated Isothermal Amplification (LAMP) assay. It uses a sample of your saliva to test for the COVID-19 virus. This test has been approved for research use but not for diagnosing COVID-19. We will take your sample and run the test on it and have a result within a few days.

You will receive a test for the COVID-19 virus from a simple saliva sample. This is a research project and the COVID test we are using is not an official test for diagnosing whether you have COVID-19. We will inform you of your test results via an automated text message which will indicate whether or not you are high risk of testing positive on a COVID-19 diagnostic test (PCR or RAT).

This study will provide insights into the progress of the Omicron wave through the population, and the rates of infection among people of different ages and different levels of vaccine protection. By participating you will be helping us to test a large proportion of the Perth population.

We do not foresee any major risks resulting from your participation in this study. Our study team are fully vaccinated, tested negative to COVID-19 this morning and will wear appropriate PPE, provide hand sanitiser if you require and will always keep 2m from you.

However, participation may prompt you to reflect on difficult experiences during COVID-19 restrictions. Thus, participation could be uncomfortable or unsettling for some people, although we expect you are unlikely to experience more than minimal discomfort. If you experience discomfort, we suggest i) seek a discussion with family, friends; or ii) seek discussion with a counsellor. Counselling can be sought from Beyond Blue 1300 22 4636.

No, participation is completely voluntary, and you can stop at any time. If you decide to take part and then change your mind, that is okay, you can withdraw from the study. If you withdraw, your questionnaire data will be destroyed and not analysed, but your saliva swab will only be destroyed after it is processed. In the event, you have withdrawn we will not contact you with you to inform you of the LAMP assay result.

Your saliva sample will be processed as soon as possible, and we will inform you of the result via an automated text message as soon as we have it. We will aim to provide you with the result by Monday night. If you do not have a mobile phone, you can nominate a mobile phone number for your results to be sent to. If you do not have a mobile phone number you can use, you may not be able to take part in this study. At the end of the study, we will send you a summary of the overall results of the study to the email address you provided. Overall prevalence results from this study may be published on the Telethon Kids Institute website and reports, journals or presented at conferences.

We will keep your name and contact information separate to the other information about you. Your contact information will only be used for contacting you. The information you have provided to the study team will be kept on our secure online REDCap database hosted by the Telethon Kids Institute. This information will be kept permanently.  Your sample will be destroyed after testing for COVID-19 through appropriate biological sample disposal methods. None of your identifiable information will be used when analysing the data.

This project is funded by the Western Australian Department of Health. This research project is a collaboration between the Telethon Kids Institute, Curtin University and the WA Department of Health.

If you decide to take part in this research project, you will be providing verbal consent. You will get an opportunity to ask any questions you may have before. By doing so, you are telling us that you have read and understood what has been discussed. Providing your consent also indicates that you consent to having your questionnaire data and sample used for the aforementioned purposes. Please take your time to ask any questions prior to making a decision regarding your participation. A copy of this summary and your consent will be sent to your email address. If you do not have an email address, we will post a physical copy to you.

If you would like to get more information about this research project or have any queries, please contact Professor Nick Golding via +61 8 6319 1632 or nick.golding@curtin.edu.au or Miss Sherlynn Ang via +61 8 6319 1632 or Sherlynn.ang@telethonkids.org.au. If you have any COVID related questions, you can ring the information hotline on 13 COVID (13 26843) or visit  www.healthywa.wa.gov.au/coronavirus.

Curtin University Human Research Ethics Committee (HREC) has approved this study (HREC number HRE2022-0129). Should you wish to discuss the study with someone not directly involved, in particular, any matters concerning the conduct of the study or your rights as a participant, or you wish to make a confidential complaint, you may contact the Ethics Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email hrec@curtin.edu.au