RESPPONSE: Rapid Evidence Study of a Provincial Population Based COhort for GeNder and SEx
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.
Important Note: If you have received a COVID-19 vaccine, you are still eligible for this study. After your self-collection kit has arrived at the Vaccine Evaluation Centre lab, you will receive a short (1-5 questions) follow-up survey asking about your vaccination status at the time that you completed self-collection.
Participants will be automatically entered into a draw to receive a $100 gift card. 200 participants will be selected.
- Can I still participate in this study?
We have closed enrolment for this study, which means that no new participants can take part.
- Is it too late for me to complete my at-home self-collection kit?
To uphold rigorous quality-control standards, the deadline for sample processing for this study is June 4th, 2021. This means that if your sample arrives at the VEC after this date, your sample will not be processed.
I have received a COVID-19 vaccine. Can I still complete self-collection?
If you have received a COVID-19 vaccine you are still eligible for this study. After your self-collection kit has arrived at the Vaccine Evaluation Centre lab, you will receive a short (1-5 questions) follow-up survey asking about your vaccination status at the time that you completed self-collection. It’s important that you indicate on the survey if you have received a COVID-19 vaccine.
- Will I get the results of my Dried Blood Spot (DBS) sample?
Yes. All DBS sample results will be reported to participants via email.
- What does a positive test result mean for this study?
A positive result means you have developed antibodies to the COVID-19 virus either through infection or vaccination. However, it is important to note that the test being used in this study has been validated for research use only. While we will inform you of your test result, it is 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, it’s important you follow any public health or medical professional recommendations you have received.
- If my DBS sample tests positive for COVID-19 antibodies, does that mean I do not need to get a COVID-19 vaccine?
As stated above, the test being used in this study has been validated for research use only. This test should not inform any clinical decision making, including decisions surrounding COVID-19 vaccination. We strongly recommend that you follow the BCCDC guidelines and speak to a health professional if you have questions about receiving your COVID-19 vaccination.
In general, the BC CDC recommends that people who have had and recovered from COVID-19 should still be vaccinated.
- I returned by DBS sample to the Vaccine Evaluation Centre over 30 days ago, but I have not received my COVID-19 antibody research test result. Did something go wrong?
Our research team is experiencing delays in reporting antibody results to participants due to delays at the BCCDC and competing priorities for sample processing. Timelines for sample processing have been managed in accordance with public health and research priorities. We acknowledge that this may have resulted in an extension of the timeframe that we initially anticipated and communicated to you, and we sincerely apologize for the delay.
Sample processing and results reporting is now underway. Our study team is contacting participants via email with results from their antibody test on a rolling basis. Results reporting is a top priority to all of us and we are in close and regular communication with our laboratory partners.
- I received my self-collection kit. Which card do I use to collect my blood?
Please use the ‘Protein Saver Card’ to collect your blood samples. Please do not use the ‘SCS Humidity Indicator’ card. The ‘SCS Humidity Indicator’ card is included in your kit for laboratory use only.
- I wanted to participate in this study but it is now closed. Where can I find other COVID-19 research opportunities?
REACH BC is an online platform that pairs volunteers with research opportunities in British Columbia that match their interests. You can register with REACH BC here. There is also an inventory of COVID-19 research opportunities kept by the Academic Health Sciences Network that you can search here.
- Where can I read about the study findings?
We have released a preliminary snapshot of our findings focused on the psychosocial outcomes: https://whri.org/wp-content/uploads/2021/02/COVID-19-RESPPONSE_Mental-Health-Report_Feb-18-2021_FINAL.pdf. We will continue to release reports on other aspects of the main findings on our study website: https://whri.org/covid-19-respponse-study/, as well as seeking publication of the scientific findings in journals.
- 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.
We will never ask you for personal information such as your Personal Health Number, mother’s maiden name, or place of birth. However, please be aware that this study does ask for postal code, contact information, and mailing address. 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. Your contact information is collected to communicate with you about your participation in this study and report results from your DBS sample to you. Mailing address is collected to mail you your at-home kit for self-collection.
- 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.
We are collecting DBS samples to test for antibodies to COVID-19 which may indicate a past infection. Also included in the consent for this study is the consent for your DBS sample to be stored for up to 10 years, for possible use in future studies. If your sample is requested for future testing it will be de-identified. Your participation will always remain strictly confidential, and your name will never appear in any publication of the results.
- 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/
- Will my participation in the COVID-19 RESPPONSE Project require any follow-up?
You may be given the option to participate in the longitudinal component of the COVID-19 RESPPONSE project. We may 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. Your participation in any component of this study is completely voluntary and you may withdraw at any time by contacting email@example.com.
- 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.
- 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 able to enter into a draw to receive a $100 e-gift card for completing the surveys and self-collection kit. If you are randomly selected to receive one, the gift card will be sent to you via email.
- 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. Please note that this study is now closed to enrolment.
- 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, you can contact the study Research Assistant at firstname.lastname@example.org 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.
Please continue to revisit this page to receive updates on the study.