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HIV self-testing is an accepted, effective method to reach undiagnosed individuals in global settings, however at the time of this study there was still no licensed self-test publicly available to Canadians. This multi-site study of the INSTI HIV Self-Test, funded by CIHR and CANFAR, was initiated in August 2019 to provide performance data for license application to Health Canada. This was the first Canadian study to get INSTI HIV Self-Testing approved in Canada. The study was conducted under a Health Canada approved Investigational Testing Authorization (ITA). Approval will make the INSTI HIV Self-Test accessible and convenient, and provide additional testing options for key populations susceptible to HIV. This observational prospective study of the blood-based INSTI HIV Self-Test measured its performance, usability and readability in 1,000 consenting adults with broad demographic diversity, from sites in Toronto, Montreal and Winnipeg. All subjects participated in the performance study, comparing self-test results to 4th generation Abbott Architect results from venous blood, along with a qualitative usability study. Selected participants also participated in a readability study arm.
The main three objectives of this study were to: evaluate the self-test device’s diagnostic performance among intended users from these key populations (i.e. sensitivity, specificity, positive and negative predictive values) compared to laboratory reference testing conducted on matching venous blood for all participants; document if intended users in key priority populations (non-professional and inexperienced in HIV self-testing) can successfully perform the steps to use the HIV self-test device without product familiarization and without significant risk of erroneous results; and document if those same intended users can successfully interpret contrived strong positive, weak positive, negative and a range of invalid test results.
A major outcome from this study will be licensing of the first HIV self-test in Canada. Accessibility will occur through retail procurement, program partnerships, federal and provincial initiatives, and community-based programs. The addition of an HIV self-test device to the current HIV testing options, coupled with digital health technologies to facilitate linkages to care, and peer navigation can collectively be a powerful tool to reach the undiagnosed in difficult to reach populations.
Of the total approved study enrolment of 1,000 participants of unknown HIV status, part of the study criteria was that 400 of these were “at risk” for HIV infection. The approved protocol included the following self-reported risk categories: unprotected sex with men or women; injection drug user; multiple sexual partners; sexual partner who is a bisexual male or an HIV positive partner.
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This first Canadian field study of the blood-based INSTI HIV Self-Test provides strong indications that it is accurate, acceptable and easy to use by self-testers with diverse backgrounds. Recruitment of participants for the study who are potential intended users of the INSTI HIV ST was carried out in three provinces (Ontario, Manitoba and Québec) between August 2019 and March 2020. A total of 767 participants were recruited before the study had to be discontinued because of the COVID-19 pandemic. Primary efficacy analysis with 678 participants who completed the HIV self-testing study revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% when comparing the valid self-tester results to the Abbott Architect. Overall usability index for the 708 participants who completed the self-test was calculated to be 91.8% and usability for the self-test procedure steps determined to be “critical” for successful completion of the test was 92.4%. It is important to note that 5 of the 6 participants who were identified as undiagnosed with HIV were successfully linked to care at the clinic where testing was conducted as part of the standard of care protocol with the INSTI HIV Point of Care Test.