Please note that the only way to consent to participate in the I’m Ready research program is through the I’m Ready, Test app once you have downloaded the app to your smart phone. This full consent form is for reference only.
Letter of Information and Consent to Participate in a Research Program
I’m Ready: National implementation science program for access to HIV self-testing and connections to care with peer navigators
Dr. Sean B. Rourke
Scientist, MAP Centre for Urban Health Solutions, Unity Health Toronto
Director, REACH Nexus (CIHR Centre for REACH in HIV/AIDS)
Professor of Psychiatry, University of Toronto
Address: 30 Bond St. Toronto, ON M5B 1W8
Phone #:1-877-462-4581 (toll free)
Darshanand Maraj, MBBS
Research Coordinator, MAP Centre for Urban Health Solutions, Unity Health Toronto
Address: 30 Bond St. Toronto, ON M5B 1W8
Dr. Nathan Lachowsky
Research Director, Community Based Research Centre / University of Victoria
Associate Professor, School of Public Health & Social Policy, University of Victoria
Address: P.O Box 1700, STN CSC Victoria, BC V8W 2Y2
Phone #:250-472-5739 (Please call during regular business hours)
Director of Research and Programs, Women’s Health in Women’s Hands Community Health Centre
Address: 2 Carlton Street, Suite 500 Toronto, ON M5B 1J3
Phone #:416-593-7655 (Please call during regular business hours)
This study is funded by the Canadian Institutes of Health Research.
Conflict of interest
The Principal Investigator, Co-Investigators, and research staff do not have any conflicts of interest, financial or otherwise, related to this research or its outcome.
I’m Ready is an implementation science research program that provides participants with information about HIV self-testing, access to up to three (3) free self-test kits, support to take the HIV self-test kit (optional), and opportunities to get connected to care and/or prevention after administering the HIV self-test as required.
You will control your own pathway through the program by ordering your INSTI HIV Self Test kit(s) with delivery to your home or another address of your choosing, or by picking it up at a local community-based organization. You can complete the INSTI HIV Self Test with the help of a peer navigator (supported) or by doing it yourself (unassisted) with the direction of the mobile app.
You will have access to resources and support either through a web-based telehealth platform (supported) or provided within the mobile app (unassisted).
More details can be found on the program website readytoknow.ca.
Purpose of the program
The purpose of the I’m Ready implementation science program is to distribute the INSTI HIV Self Test to intended users with the anticipation that we will reach the undiagnosed in Canada (those living with HIV but not aware of their diagnosis). The study will measure participant preferences and support requirements while taking an HIV self-test, either through a do-it-yourself (unassisted pathway) or with the help of peer navigators at any point (supported pathway). Access to the INSTI HIV Self Test kit is available to any person living in Canada, 18 years or older, who is interested in HIV self-testing either with or without assistance. For all participants, the I’m Ready program aims to support and connect those who take the test to appropriate care regardless of their test result.
You are being asked to participate in this study because you are interested in obtaining up to three (3) INSTI HIV Self Test(s) through the I’m Ready implementation science research program.
If you agree to participate in our research implementation program you will have the option of accessing supported (assisted) HIV self-testing, HIV self-testing (Do-It-Yourself [DIY]) approach or a combination of both.
Consent, creating a profile and a PIN
In order to participate, you will need to provide your consent by selecting “I agree” at the end of the document. Once you agree to participate, you will be prompted to create a profile in the I’m Ready, Test app which will generate an anonymous, unique participant ID. You will be able to create a PIN with your profile for added privacy, but if you lose this PIN it cannot be recovered. For more information on this, see our Privacy section in this consent form.
After creating your profile and ordering your INSTI HIV Self Test kit(s), a pre-testing survey will be prompted within the app. This 10-15 minute questionnaire will ask you questions about you—e.g., your health, your living situation, employment status, past testing behaviours, reasons for wanting a self-test, baseline HIV risk knowledge and behavior. You can skip any questions you do not feel comfortable answering.
Ordering a test
Once a profile is created, you will be able to order between one to three (1-3) kits to an address of your choosing, or to pick these up at one of our available pick up locations that is convenient for you. The INSTI HIV Self Test kit(s) will be mailed to the address provided within five to ten (5-10) days (based on location) or can be picked up at the community-based organization of your choice during operating hours. If you decide to pick up the INSTI HIV Self Test kit(s) at a designated location, you will have to show staff at the location that you are “claiming” your kit pickup codes in the app. These are confirmation tokens that are generated once you place your kit order for pick up. The packaging of the INSTI HIV Self Test will not have any information regarding what is in the package. The address you provide will only be used for mailing the kit(s) from our distributor, and not be stored or used for any additional purpose. For more information on this, see our Privacy section in this consent form.
Taking the HIV Self-Test
Once the INSTI HIV Self Test kit arrives or is in your possession, you will be guided to activate the kit into the program by scanning the Quick Response Code (QR code) on the packaging. Once the kit is scanned, you will open the test device pouch and be able see instructions within the app as well as the package insert on how to administer the self-test. Next:
- You will place the device on a flat surface and remove the cap from Bottle #1.
- You will twist and pull out the lancet tip and discard the tip.
- You will rub your finger to increase the blood flow and place the lancet on the side of your finger tip. You will hear a click and rub your finger to produce a large drop of blood. Let one drop of blood fall into Bottle #1 and twist on the cap for Bottle #1.
- Shake Bottle #1, four times and pour all liquid into the test device well. Once all liquid disappears, shake Bottle #2, four times and pour all liquid into the test device well. Once all liquid disappears shake Bottle #3, four times and pour all liquid into the test device.
- After this you will be able to immediately view your test result which will remain for up to 1 hour.
Test results and survey
Once the test is taken you will be prompted to enter your test results and will have the option of taking a photo of the test results within the app. Please note that the test results and the data collected are completely anonymous, as we are not collecting any identifying information about you in this program. Once the test results are entered, a post-testing survey will be prompted within the app. This 5-minute survey will ask you questions about ease of use of the self-test and other questions about the satisfaction of this program. For more information on this, see our privacy and confidentiality section in this consent form.
Getting connected to care
You will also be provided with resources to assist with connection to care according to your result. If your test result was negative (non-reactive), these resources will include where to access prevention services including pre-exposure prophylaxis (PrEP) – medicine people at risk of HIV take to prevent getting HIV from sex or injection drug use, and post-exposure prophylaxis (PEP) – medicine people take to prevent HIV after a possible high risk exposure. If your test result was positive (reactive), these resources will include post-test counseling, confirmatory testing for HIV and treatment services within your region.
Options with do-it-yourself
If you choose to complete the program on your own with the direction of the I’m Ready, Test mobile app alone, you will be following the Do-It-Yourself (DIY) arm, or unassisted arm of the program. If you would prefer to have the assistance of a peer navigator with you along the testing process, they can be accessed through a third party telehealth platform, I’m Ready, Talk, by booking an appointment. For more information about the platform, see the privacy and confidentiality section in this consent form.
Completing the program with a peer navigator places you in the supported (assisted) arm of the program. Please note: If at any time you want to switch from the unassisted pathway (DIY) to the supported (assisted) pathway, the mobile app has an icon (I’m Ready, Talk) on the bottom of the screen which will connect you to the telehealth platform.
Access and booking an appointment for support
If you decide to access our program peer navigators, you will be redirected to a secondary platform (I’m Ready, Talk) where you will be asked for a few additional details which include your first and last name (you don’t have to use your real name, you can make one up), and an active email address. The email address is a required field for the booking of an appointment with one of our peer navigators. Your unique participant ID from the I’m Ready, Test mobile app will be automatically carried over to your profile in the I’m Ready, Talk telehealth platform.
Your peer options for support
While requesting an appointment you will be asked a few matching questions to filter down our list of peer navigators to find a person who you would prefer to assist you through the testing process. These questions include region, language (English or French), and the purpose of the appointment. Once you answer these initial questions you will be able to pick from a list of peer navigators with their pictures and brief biographies to help you with deciding who you would like to talk to. You will select a date/time that works for you and confirm the appointment. The telehealth appointments can be audio only, or video calls. There is also a text messaging service that will be available for participants. If you require additional appointments with peer navigators, you can book these at your convenience as long as you are a participant within the I’m Ready research program. Please note that a peer navigator is not intended to provide healthcare, and is not a regulated healthcare professional.
Follow-up surveys and appointments
You will also be contacted through the I’m Ready, Test app with follow-up surveys at one (1), three (3) and six (6) months after you’ve entered your test results into the app with additional brief questions concerning your experience, questions about your care and services you’ve been offered or connected with. These should take no longer than 10-15 minutes to complete and you can skip any questions you do not feel comfortable answering. If you complete the testing experience through the supported (assisted) pathway we will also ask you questions about your satisfaction with the peer navigators and experience in the telehealth platform.
Notifications and survey reminders
Throughout your participation in the program, you will be contacted with notifications and reminders through the I’m Ready, Test app. If you haven’t completed steps (like ordering a kit after creating your profile) or haven’t responded to questionnaires (for example completing the post-test questionnaire within 7 days of entering your test results), you will be sent a notification through the I’m Ready, Test mobile app as a reminder.
All of the procedures described above are for research purposes only. The results from this program will inform how well the program worked to reach people, and how well they were able to test and get linked to care. Keeping your notifications on in your phone is important so we can evaluate how well the program is working to support people with HIV self-testing and connections to care.
Please note: If you requested more than one (1) INSTI HIV Self Test kit, the remaining kits can be used either by yourself after a secondary risk exposure, for routine testing 3 months later, or may be given to family, friends, or sexual partners for them to use the HIV self-test kit and program.
All test kits provided through the I’m Ready research program are for personal use and not for sale. Test kits should be activated through the I’m Ready, Test mobile app. If tests are given to family, friends or sexual partners, please ask that they also download the I’m Ready, Test mobile app and complete the HIV self-test self-through one of our two program arms.
Participation in the I’m Ready research program is only for eligible individuals who consent to this study. You cannot consent on behalf of someone else, or use a device that does not belong to you to participate.
The duration of the program is 6 months after taking or using your last (up to 3) INSTI HIV Self-Tests.
Potential harms and discomforts
Pricking your finger to take a blood sample for self-testing may cause minimal bruising, fainting, mild pain or discomfort.
All INSTI HIV Self Test kits used in the program are sealed and will be opened only by you. As such, the test integrity and lancet sterility are maintained.
The self-test is very accurate: from previous INSTI HIV Self Test studies, only about one to two (1-2) persons per 1,000 self-testers are at risk for a false positive (someone who does not have HIV but tests positive for HIV) or false negative self-test result (someone who has HIV but tests negative for HIV).
There may be a slight risk of psychological distress with having your blood collected from your finger, or from interpreting your self-test result. If you become distressed or experience anxiety from any portion of this program, you can connect to a peer navigator who can provide support, linkage to care and counseling on further HIV testing according to provincial guidelines or you can access our other support and care resources available on the I’m Ready, Test mobile app. You may also choose to withdraw from the program at any time.
The benefit to participating is the provision of up to three (3) free INSTI HIV Self Test kits for individual use, or secondary distribution to family, friends or sexual partners. Information learned from this program will help us reach those who are undiagnosed with HIV, and may help others who are tested for HIV in the future.
Alternatives to participation
Participation in this research is completely voluntary and you do not have to take part to receive HIV testing or medical care. Choosing not to participate will not affect your care in any way. You can talk to a healthcare provider (like your family doctor) about getting tested for HIV and opportunities to get connected to care and prevention services.
Privacy and confidentiality
Your privacy is important to us. The I’m Ready program (the research study) is completed by REACH Nexus. We are funded by the Canadian Institutes of Health Research and REACH Nexus is part of MAP Centre for Urban Health Solutions at St. Michael’s Hospital, Unity Health Toronto.
The I’m Ready research program is not a government testing initiative, and there are no government or healthcare organizations that are tracking your participation. We will be sharing aggregate and anonymous data to show how access to HIV testing and connections to care can be better understood and improved.
We limit what we collect and use
As you will see below, you will be given a unique participant ID, which allows our research team to know that the information we collect through this research all comes from the same person. Our study team will not attempt to re-identify you. We will make efforts to ensure that the research data is accurate and will be securely archived by our research team for 7 years after the end of the study, which is usual research practice. This research is bound by our ethics certificate and approval by Unity Health Toronto.
How we collect, use, store and protect your information in this program
The I’m Ready, Test app (mandatory)
The I’m Ready, Test app is owned by Unity Health Toronto and will be used to generate a unique participant ID that will be used in all study activities to keep you as anonymous as possible (see options below) and to facilitate the steps involved in this research, including submitting your test results from the HIV self-test kit. When you download the app, you will be asked for your year of birth and province. You will also be asked to create a PIN (personal identification number) to keep the app secure on your phone.
This app uses push notifications to remind you to order and use your kit, to connect with a peer and to complete research surveys. You may disable push notifications through the app in your device settings, but note that keeping your notifications on will help you to get the most out of this research study. We will also be able to collect data anonymously to better understand and support other people using HIV self-testing.
Ordering a kit
If you need to order a kit(s), you can choose to have it delivered to your home or to be picked up at a pickup location of your choice. The information related to ordering your kit is not kept in the app, but is securely collected by Unity Health (see “ordering your test kit” below). To use the kit, you will have to use your I’m Ready, Test app to scan the QR code on the package. This will let our study team know that the kit has been used.
The surveys you’ll complete in the app are provided by Qualtrics, a survey service. This means that we share your unique participant ID with Qualtrics so that our research team can identify your answers when they download the survey responses from Qualtrics. While Qualtrics’ own data handling practices will apply to the surveys, Qualtrics will not be able to identify you. Your survey data is removed from Qualtrics by our research team at the end of the study.
If you choose to connect to a peer navigator through the I’m Ready, Talk secure telehealth service, the I’m Ready, Test app will send your unique participant ID to the I’m Ready, Talk app (see below for more details).
The I’m Ready, Test app uses Google Analytics to help us identify how people use our app so that we can continue to improve it over time. Google Analytics may track IP addresses, but does not give our research team access to any information that can identify you.
All information in the app (including your year of birth, province, unique participant ID, kit serial number, and test result) will stay in the app on your device until you delete the app from your device. The information in the app will also be kept securely in “the cloud” (on web servers) for use by our researchers until the end of the research study.
Ordering and getting your test kit
When you order a kit through the I’m Ready, Test App, you will be redirected to a web-based order form. Your unique participant ID will automatically be sent to the order form, which is at Unity Health Toronto, separate from other research data.
You can choose to have the kit(s) delivered to your home or to another address of your choosing. If you choose to have the kit(s) mailed to you, the information (recipient name and address) you provide on the delivery form will be securely transferred from Unity Health Toronto to our distributor and will only be used for mailing the kit(s) to you. This information will only be kept by Unity Health Toronto for the duration of the study, but may be kept longer by the distributor for the purposes of administrative record keeping. You can choose to use your legal name or a made-up name on the delivery form. The kit(s) will be mailed from the distributor via Canada Post.
The study team has no control over delivery times or possible interruptions to mail services. You should also be aware that there is a chance (however small) that the package may be lost or delivered to the wrong address. We estimate that your kit(s) should arrive within 1-2 weeks of being ordered, however we can’t guarantee this. If you don’t get your kit(s) within 3 weeks of ordering, please reach out to a member of our study team.
If you choose to pick up a kit(s) at a pickup location, the order form will create a pickup code for you to use at the location. Staff at the pickup location will only need to see your code to give you your kit and will not need to know or record your identity. This pickup code will be sent to the app and viewable in the “my pickup codes” section of the app menu.
The I’m Ready, Talk app (optional)
At any time throughout this study you can choose to get peer support. This is provided through the secure I’m Ready, Talk service, which is a version of OnCall’s telehealth platform that Unity Health Toronto is licensed to use for this study.
To use I’m Ready, Talk, you will be asked for a name and a functioning email address. You can choose to use your legal name or you can make one up. This information is only used to book appointments, share appointment information with you and connect you with our peer navigators. In addition to audio or video appointments, you can send messages securely through the chat in I’m Ready, Talk.
If you have downloaded I’m Ready, Talk as a mobile app onto your device instead of accessing it through a web browser, any information in the app will stay in the app until you delete the app from your device.
Your peer navigator may make notes during your appointment in the I’m Ready, Talk platform. These notes will be protected but will not appear to you. Notes are general and used only to help the peer remember what you’ve talked about to support your ongoing conversations even if you connect with a different peer navigator later on.
Messages and peer navigation notes are not shared with our research team and will be deleted from OnCall’s secure system every 8 months. OnCall will also delete all data in their system at the end of this research study. OnCall does shares basic information with our research team through your use of the app, such as frequency, type, and length of appointments. This information will help our research team to improve services in the future.
In the event that you mention causing harm to yourself or others, the peer navigators will use your information to do what they can to ensure that you or others receive help and are safe.
As noted above, by giving your email to I’m Ready, Talk you may receive emails that identify you as a user of the app. Anyone who sees these emails could know that you are a participant in this HIV research because emails are not secure in the way a phone call or regular mail would be. Copies of an email may continue to exist, even after efforts to delete the email have been made. Please note: you must not use email for medical emergencies. If you require immediate help, call your clinic or care provider or seek emergency services.
This website at readytoknow.ca
The I’m Ready to Know website and the information it collects is securely stored. Unity Health Toronto only collects and uses the information that you choose to provide to us through our contact form and newsletter subscription box. This website uses Google Analytics to help Unity Health Toronto understand how people are using our website so that we can continue to improve it over time. Google also tracks IP addresses for its own uses.
Readytoknow.ca stands alone and does not have any integrations with other apps or products that are part of the I’m Ready research program, aside from regular links embedded in its webpages.
Your rights to research data
In this research study, you will have access to some of your research data. As long as you keep the I’m Ready, Test and I’m Ready, Talk apps on your device you will have access to your test results, chat history with peers, and all other information you put into each app.
Our researchers will have access to other research data (as described above) that is linked to your unique participant ID. You are free to stop your participation in this research at any time. Our researchers have the right to keep all of the information that you submitted or that was generated in the apps and services associated with this research program until the time that you stop your participation. Our researchers will use and hold on to the research data to do the research as approved.
The results of this program may be presented at a scientific conference or published in a scientific journal, and/or shared with local, regional, provincial or federal agencies to help improve access to HIV self-testing and connections to care and services. You will never be personally identified in any publication or presentation that is made. Results of the research will be grouped such that you cannot be identified.
Participation in this research program is completely voluntary and you do not have to participate if you do not want to. If you decide not to be in the program, you will not be punished or lose any benefits. You are free to stop your participation in the program at any time. Your research records will be retained in the program files. As participation is anonymous we cannot remove your data after you have decided to stop participating but we will not collect any further data from you for the program. Choosing not to participate will not affect your or your family’s current or future care in any way.
There is no additional compensation for participating in this program, but you will have access to up to three (3) free INSTI HIV Self Test kits.
Compensation for injury
If you suffer a physical injury from the medical device or participation in this program, medical care will be provided to you in the same manner as you would ordinarily obtain any other medical treatment. In no way does signing this form waive your legal rights nor release the program doctor(s), Principal Investigator or involved institutions from their legal and professional responsibilities.
New findings or information
As this program is anonymous, we will not be able to contact you regarding new findings or information.
Research Ethics Board contact
Should you have any concerns regarding this research program, you may contact the Principal Investigator: Dr. Sean B. Rourke at Sean.Rourke@unityhealth.to or 1-877-462-4581.
To participate you must agree that you have read the details of this consent form. This means that you are aware of what the program is about, what procedures will be done, what you are expected to do and that you have no objections. You are also free to leave the program at any time, with no questions asked. Once you delete the I’m Ready, Test mobile app from your phone, you will not be able to retrieve this information again as it is only stored on your device, not on any servers for the program.
In consenting, you understand that you will perform an HIV self-test on yourself by following the instructions either on your own or with the assistance of a peer navigator.
Participant statement of consent
By providing your consent to participate in this research, you acknowledge that you have read about and/or had explained to you the details of the I’m Ready: National implementation science program for access to HIV self-testing and connections to care with peer navigators, and that you understand that participation in this research program is strictly voluntary. You also understand that your care will not be affected if you choose not to participate or to withdraw from the program.
If you agree to participate, please provide your consent by checking ALL of the boxes below:
☐ I have read and understand the information in this consent form
☐ I understand that this is a research program
☐ I understand my participation is voluntary and anonymous
☐ I am living in Canada and 18 years of age or older
☐ I am currently unaware of my HIV status (unknown or negative)
☐ I agree to complete the research surveys and other tasks
☐ I agree to participate in the I’m Ready Implementation Science Program