COVID-19 RESPPONSE Study

RESPPONSE: Rapid Evidence Study of a Provincial Population Based COhort for GeNder and SEx

If you would like to participate in this study, please click on the following link to begin the online consent form:

The Women’s Health Research Institute (WHRI) is seeking to understand the prevalence of COVID-19 and its impacts on communities of diverse sexes, genders, ages and locations.

This study is led by Investigators at the Women’s Health Research Institute, including: Dr. Lori Brotto, Dr. Gina Ogilvie, Dr. Liisa Galea, Dr. Angela Kaida, Dr. Manish Sadarangani, and Dr. David Goldfarb. It will provide the first provincial estimates of COVID-19 infection as well as identify specific impacts on sex and gender. Ultimately, the outcomes of this study will be used to aid in informing future public health decisions including the development of social policies to better support vulnerable populations during current and future pandemics.

Participants will be asked to complete online surveys and provide a self-collected dry blood spot sample (via finger prick) which will test for COVID-19 antibodies.

Important Note: The tests being used in this study have been validated for research use only. While we will inform you if the tests are positive, these are not a replacement for medical diagnostic tests for COVID-19. If at any time during this study you are recommended by a healthcare provider to have a test for COVID-19 or if you need a COVID-19 test for any other reason, you should still go ahead and have that test at a standard testing clinic.

Participants will be automatically entered into a draw to receive a $100 gift card. 200 participants will be selected.

  1. I made a mistake while collecting my Dried Blood Spot (DBS) sample. Can I have another kit/extra equipment mailed to me?

Unfortunately, the RESPPONSE team does not have the capacity to provide any additional kits or materials to participants who have already received a complete self-collection kit, even if you have made a mistake. In case you do make a mistake, a second lancet has already been included in your kit. Please take extra care to follow the instructions provided in your kit.

  1. What does a positive test result mean for this study?

The tests being used in this study have been validated for research use only. While we will inform you if the tests are positive, these are not a replacement for medical diagnostic tests for COVID-19. If at any time during this study you are recommended by a healthcare provider to have a test for COVID-19 or if you need a COVID-19 test for any other reason, you should still go ahead and have that test at a standard testing clinic.

  1. I am outside of the age-range (25-44 or 65-69 years old). Can I still participate?

This study is at capacity for all other age brackets. This means that you cannot participate in this study if you are not 25-44 or 65-69 years old. However, there are a variety of other COVID-19-related studies that are recruiting research participants via the REACH BC platform. You can register with REACH BC here: https://www.reachbc.ca/. There is also an inventory kept by the Academic Health Sciences Network that you can search here: https://bcahsn.ca/covid-19-response/covid-19-research-inventory/.

  1. Can my friend participate in this study?

The RESPPONSE study is now open to the public and is available on our study website at https://whri.org/covid-19-respponse-study/ and the REACH BC platform at https://www.reachbc.ca/. However, this study is only enrolling individuals between the ages of 25-44 or 65-69 years old as it is at capacity for all other age brackets. If your friend satisfies this criteria, then they may participate.

  1. How will my taking part in this study be kept confidential?

Participant confidentially will be respected. Your rights and privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is maintained.

If you decide to partake in this study, you will be assigned a unique study number. This number will be used on any research-related information (including DBS samples) collected about you during the course of this study, so that your identity will be kept confidential. Your DBS samples will be stored in a freezer at the Vaccine Evaluation Centre at BC Women’s Hospital until the end of the study, for a maximum of 10 years. After this 10-year maximum, your samples will be destroyed if they were not already.

Your survey data and a copy of your informed consent will be stored on REDCap – a database that meets strict hospital-level privacy and security standards. Information that contains your identity will remain only with the Principal Investigator and/or her designate for the purpose of monitoring the research. No information that discloses your identity will be removed or released without your consent unless required by law.

  1. Who will use this data and what for? 

This study is being led by Dr. Lori Brotto and Dr. Gina Ogilvie, and is funded by the BC Women’s Health Foundation. The study team and its funders will use the results of this study to help inform public health decisions and policies related to COVID-19, and to help inform policies and responses to future pandemics. Results of the study may be published online, in peer-reviewed journal articles, and presented at national or international conferences. Your participation will always remain strictly confidential, and your name will never appear in any publication of the results.

  1. Is this study only open to BC residents? 

Yes, you must be a current resident of British Columbia to participate in this study.

  1. Is this study just for women living with HIV?

No, the RESPPONSE Project is recruiting a diverse population of adults who are residents of British Columbia. This includes individuals who are living with HIV, as well as those who are not.

  1. I am pregnant. Can I still participate?

Yes, you can still participate in this study if you are pregnant.

  1. How long will the survey take to complete?

The survey will take about 30-45 minutes to complete.

  1. What is the difference between gender and sex in your study?

Asking about sex and gender in scientifically accurate, valid, respectful, and safe ways is essential—particularly for us in the Women’s Health Research Institute. We are very fortunate in Canada that there are experts who have devoted their scientific studies to engage with participants about the best means of asking about sex and gender.

We have followed the recommendations by Dr. Greta Bauer, Professor of Women’s Studies and Feminist Research at Western University. Her recommendations for how to assess sex and gender have also been adopted by the Canadian Institutes of Health Research, as well as the national Canadian COVID research collective. For more information, please check out this short video: http://womensxchange.womensresearch.ca/inclusive-sex-and-gender-data-collection-in-survey-research/

 

  1. There is some additional information about me that I would like researchers to know, that I did not get to address in the survey. How can I provide researchers with this information?

There are open-comment boxes at the end of each survey module for you to provide researchers with any additional information.

  1. How accurate are the antibody tests?

The technology for COVID-19 antibody assays is rapidly evolving. COVID-19 testing is a dynamic field and our team of laboratory experts will be making final decisions on instrument selections in the upcoming weeks, based on the test characteristics.

  1. Why is my postal code being collected?

The RESPPONSE study team recognizes that different communities within British Columbia may have been impacted differently by COVID-19. We are collecting your postal code so that we can identify what areas in British Columbia all who have responded to the survey live.

  1. What is my Dried Blood Spot (DBS) going to be used for?

We are collecting DBS samples to test for antibodies to COVID-19 which may indicate a past infection. After our study, your samples will be destroyed.

  1. Will I get the results of my Dried Blood Spot (DBS) sample?

Yes. If your test indicates that you may have had a COVID-19 infection, your results and what they mean will be reported to you by a nurse or a physician over the phone.  Negative (no evidence of current or past COVID) results will be sent to you in an email.

Please be aware that it may take some time for us to receive your sample in the mail. We will return your results to you as soon as we can.

  1. When can I expect to receive my Dried Blood Spot (DBS) sample collection kit?

It may take over 8 weeks for you to receive your sample collection kit, depending upon your location within British Columbia. Your sample kit will arrive from Canada Post. Do not expect any calls from us indicating that your package has been sent. Please feel free to contact a study research assistant at covid19study@cw.bc.ca if you have any questions or concerns about the whereabouts of your study kit.

  1. Will my participation in the COVID-19 RESPPONSE Project require any follow-up? 

You will be given the option to participate in the longitudinal component of the COVID-19 RESPPONSE project. We plan to send out additional surveys and collection kits to a group of individuals who were found to have evidence of a COVID-19 infection, and a small group of individuals who did not have COVID-19. This follow-up would happen at 3 months, 6 months, 9 months, and 12 months. Your participation in any component of this study is completely voluntary and you may withdraw at any time by contacting covid19study@cw.bc.ca.

  1. I consented to complete additional surveys in the future (longitudinal component of the study) but I never received any. Why?

You may be contacted with additional surveys if you signed up for the longitudinal component of the study. Not everyone who signs up for the longitudinal component of the RESPPONSE Project will be contacted.

  1. What happens if I find out that I am positive for COVID-19 ?

If you discover that you are positive for a COVID-19 infection, it is a legal requirement that the Medical Health Officer (MHO) be informed. The MHO will advise on clinical management and self-isolation.

  1. Will this study reimburse me?

We are grateful to all residents of BC who participate in the COVID-19 RESPPONSE Project. As a result, all who participate will be automatically entered into a draw to receive a $100 e-gift card for completing the surveys and self-collection kit. 200 participants will be selected. The gift card will be sent to you via email. For each of the longitudinal activities (3, 6, 9, or 12 months) that you complete, you will be entered in an additional draw for a $100 e-gift card.

  1. When will we see the data/results? 

Study results and findings will be posted on the study website at https://whri.org/covid-19-respponse-study/ after the research is completed.

  1. I still do not understand what this study is about. 

The goal of this study is to better understand how COVID-19 has affected many different aspects of the lives of people living in British Columbia, and to better understand how many individuals in BC have had an asymptomatic (showing no symptoms) COVID-19 infection. The RESPPONSE team is doing this by inviting individuals living in BC, to complete a 30-45 minute survey that will ask a variety of questions. In addition, we will be asking those who participate to  provide a dried blood spot (DBS) sample using an at-home-testing kit that we will provide to you, to assess possible current infection or past exposure to COVID-19.

  1. Who can I contact with additional questions about study procedures that are not addressed here?

If you have any questions or desire further information about this study before or during participation, you can contact a study Research Assistant at covid19study@cw.bc.ca or by calling 604-875-2424 x 4665. Please note that response time is shorter for inquires submitted by email than by phone. If you have already submitted an email, please do not submit the same inquiry through our phone-line.

In the event of an emergency, please call 9-1-1. For mental health support, please call 310-6789.

 

 

Study Progress
Regulatory Approval > Participant Recruitment > Data Collection > Data Analysis > Knowledge Translation
Regulatory Approval > Participant Recruitment

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