GetaKit – Research Consent

Project Title

Get a Kit: Feasibility Study of HIV Self-Testing Uptake 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]

Nurse Practitioner, Ottawa Public Health, Sexual Health Clinic, 179 Clarence Street, Ottawa, Ontario, K1N 5P7, [email protected]

Funding Sources

Ontario HIV Treatment Network

Invitation to Participate

We are inviting you to participant in a feasibility study. 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’. A copy of this Consent Form will be emailed to you.

Purpose

The purpose of the GetaKit study is to determine if a mail-out system for HIV self-test kits is feasible and whether participants are willing to use a HIV self-test either at home or at a local AIDS Service Organization. We want to see if participants can follow test kit instructions, successfully complete the test and read, report their results. We also want to know if a participant who receives a preliminary positive will seek out medical treatment.

Participation

If you choose to participate in this study, you will be asked to provide your full name, an email, and a mobile phone number to ensure that the study team can contact you in the event that there is an issue with your kit.

Upon registration and completion of a baseline survey, the study team will send out a welcome kit that will include one HIV self-test. You can use this self-test whenever you would like, wherever you feel most comfortable. Once you have used to test, you are invited to self-report your result on a secure website. You can order this test kit to your home or any other address of your choice.

You will also be asked to complete 1 survey at the beginning of the study. The survey will ask you questions about who you are and about your testing history for HIV and other sexually transmitted infections. This information will help us understand who is using HIV self-testing in Ontario.

A note on coercion

HIV self-test kits may be used to force another person to test for HIV. While the HIV kits can be shared with your network, it is important to clarify that no one should test for HIV if they do not want to. This means no one can force you to take an HIV test, and you should not force someone else to take the test. Consent and willingness to test is a fundamental feature of HIV testing.

Risks and Discomforts

This study uses bioLytical’s HIV self-test, which was approved for use in Canada on November 3, 2020. This kit has been shown to be effective, safe, and accurate in a self-test home study. It is similar to bioLytical’s HIV point-of-care (or rapid) test which is also approved for use in Canada generally. Consenting to participate in this study means agreeing to use the self-test.

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.

The survey may include questions that are uncomfortable. 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.

Sexual Health Clinic

179 Clarence Street

Ottawa, Ontario

613.580.6719

Max Ottawa

400 Cooper Street, 9th Floor

Ottawa, Ontario

613.440.3237

AIDS Committee of Ottawa

19 Main Street

Ottawa, Ontario

613.238.5014

Benefits

By agreeing to participate in this study, you will provide valuable data to inform a distribution and support system in Ontario.

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. This contact will occur by phone and/or email.

For these referrals, if you get a preliminary positive from your self-test, a nurse 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, the nurse will give you counselling 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 96-99%. 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 hosted on a secure website that is only accessibly by the Research Coordinators and Assistants and the Principal Investigators. Information will only be shared if a referral for HIV care is made based on a preliminary positive result or if you want to access HIV PrEP. 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.

For data analysis, all participants will be attributed a unique identification code preventing any possibility of links between their real identity and their responses given. As the participant, you will select this unique identification code during registration.

Conservation of Information and Communication of Results

The research information collected about you today will be kept in a locked file room at the University of Ottawa for 10 years. 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 research data will be identified by a code. 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. The researcher will use a code to protect your identity.

Voluntary Participation

As part of this study, you may access an HIV self-test for free every three months. This frequency of HIV self-testing follows guidelines from the Public Health Agency of Canada.

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.

If you agree to a referral for HIV care or HIV prevention (i.e., PrEP), you can decline this referral at any point. If you decline a referral, you can return for a referral at any time in the future. Even if you agree to a referral, you can always decline care when the HIV treatment or HIV 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 HIV 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]

GetaKit – Risks and Benefits

To participate in GetaKit, you will need to share your personal information with us.

When you test with GetaKit, we will help you know your sexual health status, be connected to care, get treatment, feel better, live a healthier life, and reduce the risk of future transmission of sexually transmitted infections or possible complications to your own health.

Please consider the following regarding the security and confidentiality of your personal data:

  • To maintain account security, do not share your login ID and password with anyone. Please use a unique and complex password. You will be required to use two-factor authentication to access your account. Please ensure that the phone number and email accounts you use are secure.
  • All data is stored encrypted on secure cloud-based servers, and only essential personnel will have access to your information. Although we have implemented the highest level of security precautions and measures, we cannot represent, or guarantee that the service will be free from any compromise of data loss or corruption, service outage from malicious attacks via malware, viruses, unethical hacking, or other types of security intrusions. We also disclaim any liability related thereto.
  • Please notify the GetaKit team immediately of any security breach of your account. You are aware of these risks, assume them, and wish to proceed with your GetaKit order.

Please consider the following, in the event of a positive result:

  1. Many sexually transmitted infections are reportable to local public health units, who do follow-up with you and your contacts. By law, we must notify the local public health unit regarding reportable infections.
  2. It is important to know your HIV status to take care of your health, but it is also important for you to know about the laws that might impact people living with HIV. Legally, you do not have tell most people that you are living with HIV, but it can be considered a crime not to tell a sexual partner. To better understand the law, contact the HIV & AIDS Legal Clinic Ontario halco.org. If you test positive for HIV, it is important for you to understand your rights and how the law impacts you before you disclose your status.

Please consider the following regarding accessing care.

  • Online assessments do not replace in-person care with a healthcare professional.
  • If you have symptoms or questions or concerns, please visit a local service provider for a full assessment.

For any questions or concerns, please contact Patrick O’Byrne at [email protected]

Register

To register, please complete the following form:

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