Abstract
BackgroundSelf testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes.MethodsThe study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Usability outcomes for critical (e.g., lancing finger, blood droplet into bottle, shaking bottle four times) and noncritical self-test procedure steps were also determined.ResultsOverall, 77% (n = 522) of participants were between 18 and 45 years of age, 61% (n = 410) were male, 71% (n = 480) had some college or more education, and 45% (n = 307) were employed; identity for race and ethnicity: Caucasian (44%; n = 296), African, Caribbean or Black (17%; n = 113), Indigenous [First Nations, Métis or Inuit] (14%; n = 95), Asian (16%; n = 106), Latin American (7%; n = 46). Primary performance analysis on 678 completed HIV self-tests revealed a positive percent agreement of 100% (5/5, 95% CI: 43.6–97.0%) and a negative percent agreement of 99.5% (614/617, 95% CI: 98.6–99.8%) with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5% (n = 633). For the 708 participants who took part in the usability study, the average success rate for steps determined to be “critical” for successful completion of the test was 92.4%. 97% (n = 670) of participants found the instructions easy to follow, and 95% (n = 655) of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive, n = 366) to 99.3% (for negative, n = 401).ConclusionsThe addition of a regulatory-approved self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.
Highlights
Self testing for Human Immunodeficiency Virus (HIV) is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations
Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, when impacted by Coronavirus pandemic restrictions
To assess if favourable outcomes similar to those of the oral fluid self test studies conducted earlier can be achieved with a blood-based self test, this study aims to provide independent data on the INSTI HIV Self-Test (BioLytical Laboratories, Richmond, BC, Canada) performance, acceptance, and usability in the hands of intended users in Canada
Summary
Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. Canada had endorsed the initial UNAIDS 90–90-90 target (90% diagnosed, 90% of those on treatment and in care, and 90% of those achieving viral suppression) [2], only 87% of the estimated 62,050 people living with HIV are diagnosed (1st 90 target) – indicating these 8000+ individuals who have undiagnosed HIV infection across the country may not be adequately served by or connected to our health care system. For those people diagnosed with HIV, 85% were on antiretroviral treatment (2nd 90 target), and of those, 94% had suppressed viral load (3rd 90 target) by the end of 2018 [3]. Diagnosing HIV is critically important for reaching targets aimed at controlling the HIV epidemic [4]
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