GetaKit – Research Consent

Project Title

GetaKit: Online Testing in Ontario

 

Principal Investigator

Patrick O’Byrne RN-EC PhD

Full Professor, School of Nursing, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, [email protected]

 

Co-Investigators

Abigail Kroch PhD, MPH

Director, Data and Applied Science, Ontario HIV Treatment Network, 600-1300 Yonge St, Toronto, Ontario, M4T 1X3

Alexandra Musten MA

Senior Lead, Testing and Clinical Initiatives, Ontario HIV Treatment Network, 600-1300 Yonge St, Toronto, Ontario M4T 1X3

 

Funding Source

Ontario HIV Treatment Network

 

Invitation to Participate

We are inviting you to participant in a study about online testing for sexually transmitted infections (STIs) and HIV and COVID in Ontario. The purpose of this consent form is to give you the information you need to decide if you want to participate. Please read the form carefully. You might have questions about the purpose of the study, your role, the possible risks and benefits or anything else about the study that this form does not address. If you feel that all your questions have been answered, then you can decide if you want to participate in the study. This is referred to as ‘informed consent’. You can download a copy of this consent form if you wish.

The purpose of the GetaKit study is to evaluate the outcomes associated with an online, mail-out system for HIV self-tests, sexually transmitted and bloodborne infection serology requisition, and self-collection swabs for STI testing (in select cities), plus for COVID self-tests. We want to see who uses these services and the associated outcomes related to test results (e.g., if participants have positive tests, obtain care, do follow-up).

If you choose to participate, you will be asked to provide your full name, email, and phone number to ensure the study team can contact you to follow-up on your test results or if there is an issue with your self-test kits.

Upon registration and completion of a self-assessment, the study team will send out STI and/or HIV and/or COVID testing materials that are relevant to you. This might include an HIV self-test and any other necessary self-collection tools for STI testing (for select locations) or COVID self-testing. If eligible, you can order these test items to your home or any other address of your choice. To complete some of this testing, you will need present to a local laboratory to deposit specimens (swabs or urine) and have blood drawn.

Test results take approximately 3 weeks to process. If you have not been contacted in that time, your results are negative.

If you are eligible for an HIV self-test, you can use it whenever you like, wherever you feel most comfortable. Once you have used to test, you are invited to report your result on a secure website.

The self-assessment at the beginning of the study will ask you questions about who you are and about your testing history for HIV and other sexually transmitted and bloodborne infections. This information will help us do two things: (1) understand who is using online, mail-out testing in Ontario, and (2) request the best and most appropriate STI and HIV and COVID testing for you.

GetaKit – Risks and Benefits

Risks and Discomforts

The self-assessment may include questions that are uncomfortable for you. We are aware of the intrusive nature of this study and that certain questions may evoke some distress or even suffering on your part. Therefore, you are free to refuse to answer some questions should you feel they evoke any form of distress. Also, the researcher is committed to referring you to appropriate counselling resources, should you express this need. Some questions, however, require answers. If you do not feel comfortable completing these questions, you will be unable to obtain the HIV self-test kit and/or appropriate sexually transmitted and bloodborne infection testing and/or COVID testing services that we would offer you. This is because the answers to these questions are important to determine what testing is best and most appropriate for you.

This study uses bioLytical’s HIV self-test, which was approved for use in Canada on November 3, 2020. When using the HIV self-test, you will need to poke the tip of your finger with a small needle (a lancet) to produce the drop of blood necessary for the test. This might be painful, but the risk of injury is minimal. This lancet is included in the test kit you will receive.

There is a possibility that you may receive a preliminary positive result while participating in this study. A preliminary positive result for HIV could be distressing, and each kit includes information about linkage to care and next steps as well as a number to call for support.

For the HIV self-test kit and other relevant STI testing, you will need to provide an email address, shipping address, and phone number as part of the study registration process. There is a possibility that someone other you could see the package containing the HIV or STI or COVID tests when it/they arrive(s) at the provided shipping address. As well, someone other than you could see the texts, email messages, online surveys on the participant’s computer.

Another risk of this project is that you could receive a phone call from your local public health unit to do follow-up about the STI or HIV or COVID infection that was diagnosed as part of this study. This follow-up occurs by law and cannot be stopped once you submit specimens. If you do not wish this to occur, please do not participate. Instead, visit your local STI/HIV clinic or COVID assessment centre to discuss testing options.

 

Benefits

By agreeing to participate in this study, you will provide valuable data to inform a distribution and support system in Ontario for STI and HIV self-testing and COVID self-testing.

Participating in this study will also offer linkage to programs like HIV pre-exposure prophylaxis (PrEP) or other HIV prevention services (such as free condoms), or to immediate clinical care if you receive a preliminary positive result.

For these referrals, if you get a preliminary positive from your self-test, someone will contact you and offer an appointment for counselling and confirmatory HIV testing (done by blood test). This appointment will be to a location near where you live. You are also under no obligation to accept this appointment. If that test is positive, you will receive information about HIV transmission and HIV care, and will offer you a referral for HIV treatment. With HIV treatment, a person’s health status and life expectancy are the same as people who are HIV-negative. Also, treatment can make an HIV-positive person unable to transmit HIV to others. You are under no obligation to accept this referral, and if you decline it, you may always return for a referral in the future.

If you receive a negative HIV self-test result, we would like to offer you HIV PrEP. HIV PrEP is the use of HIV medications to keep you HIV-negative. HIV PrEP, when taken daily, can prevent you from becoming HIV-positive by 99%. This referral for PrEP would be to a location of your choosing in a geographical area close to you. Again, you are under no obligation to accept this referral, and if you do decline the referral, you may always return to us to obtain PrEP in the future.

 

Confidentiality and Anonymity

All registration and survey data, included self-reported HIV results, will be encrypted and hosted on a secure Montreal-based server (through Google SQL cloud). Information on the security of the Google system can be found here: https://cloud.google.com/security/compliance/phipa. This information is only accessible by Authorized Users at participating GetaKit satellite sites and the OHTN and the Principal Investigator. Information collected will be accessed for three reasons:

  1. To support a referral for HIV care based on a preliminary positive result or if you want to access HIV PrEP, as well as in the event that a positive STI or COVID result. This will be to ensure you receive appropriate supports, medical treatment, and HIV prevention services. You will be reminded at the time of referral that your information is being shared with the physician or nurse practitioner to whom we refer you.
  2. For evaluation reports for monitoring and improvement of GetaKit, either at individual sites or the whole project. To produce these reports GetaKit may link to other databases. These evaluations will only include summary data, i.e., no individual identifiable data.
  3. To publish findings regarding the acceptability and feasibility of the GetaKit project in a peer reviewed journal. In this case, as well, data will only be included as summaries and no individual identifiable data will be published.

All downloaded data is anonymized (your name, address, contact details and OHIP, if applicable, will not be included). All data will be represented as aggregate, or summary, and no individual line data will be included in any internal reports or publications.

The research information collected about you today will be kept in a locked file room at the University of Ottawa for 10 years. Any digital files will be stored as password protected files on Dr. O’Byrne’s password protected University of Ottawa computer. No survey data will be stored at 179 Clarence, nor will it be linked to your clinical files if you agree to any referral. To ensure anonymity, all data will be identified by a code.

 

Limitation to Confidentiality

In Ontario, the Health Protection and Promotion Act requires that testing providers report any positive STBBI and COVID results. As such, were one of your test results be positive, we would be required to notify the local public health unit, who will engage in follow-up to ensure that you are linked to care and that your previous partners obtain testing as well. This process is fully confidential and is mandatory. If you have concerns about such reporting, please do not proceed with testing, and instead seek care in person to review privacy and mandatory legal reporting requirements for STBBIs and COVID in Ontario.

 

Withdrawal and Conservation of Information

You can withdraw at any point if you no longer want to participate in the GetaKit study. Your information will not be used in any GetaKit reports after the date of your withdrawal, however because summary data is used in reporting, we cannot retroactively withdraw your data from any reports that were generated before that date.

Because your account contains health information it cannot be deleted and is subject to the same retention requirements as any other health record. It will instead be set to ‘inactive’ so that your records can still be accessed as per health records regulations but your information will not be included in any reports or publications after the date of your withdrawal.

 

Communication of Results

The final stage of the research involves communicating the results in the form of scientific articles or conferences. By participating in this research, you accept that the results obtained from an analysis of your survey may be used for scientific or teaching purposes. All such presentations will use anonymized data.

 

Voluntary Participation

As part of this study, you may access sexually transmitted and bloodborne infections or HIV or COVID self-testing as indicated in guidelines from the Public Health Agency of Canada and the Ministry of Health of Ontario. These frequencies vary based on your reported practices.

You are under no obligation to participate in this study, and you can withdraw at any point by notifying the Research Coordinator. Your data will be excluded from the study’s findings report. However, we will be unable to delete your information once you have registered, as these records must be retained for healthcare purposes.

If you agree to a referral for HIV care or prevention (i.e., PrEP), you can decline it at any point. If you decline a referral, you can return for a referral at any time. If you agree to a referral, you can always decline care when the HIV treatment or PrEP clinic contacts you. You are under NO obligation to access services. These are available if you want. It is important to note that not agreeing to a referral could put your health at risk due to untreated infection or because you will remain at-risk for HIV.

 

Questions

If I have any questions regarding the ethical conduct of this study, I may contact the Protocol Officer for Ethics in Research, University of Ottawa, Tabaret Hall, 550 Cumberland Street, Room 154, Ottawa, ON K1N 6N5, Tel.: (613) 562-5387, Email: [email protected]

Register

To register, please complete the following form:

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