Invalid Results in the GetaKit Study in Ottawa: A Real-World Observation of the INSTI® HIV Self-test Among Persons At Risk for HIV

Abstract

HIV self-testing corresponds with more frequent testing, better user satisfaction, and higher positivity rates compared with clinicbased testing. We implemented an open cohort prospective observational study, which provided a website through which persons could do online HIV self-assessments and, if eligible, receive a free HIV self-test. We implemented this project on July 20, 2021 and used the bioLytical INSTI® test. Herein, we describe the number of tests participants reported as invalid, which started at a rate of one fifth of all ordered tests and decreased to 8% after we provided more instructions on completing the test. Our data suggest that a high rate of invalids occur with self-testing in the real-world. Although this has cost implications, we feel this rate is acceptable, considering that 25% of our cohort reported no previous HIV testing. Our take-away message is that HIV self-testing requires additional supports and resources to function as an effective testing intervention.

HIV self-testing: what GetaKit can tell us about Canada’s $8 million one-time investment

“…A controlled validation study that occurred in clinical settings in Canada also identified an invalid rate of 5.6% and that another 2.7% of participants were unable to interpret their results, meaning that 8.3% of the participants in that study did not obtain usable results (Galli et al, 2021). Real-world data from GetaKit, moreover, showed an invalid rate that started at 25% and decreased to 8% once we began giving participants additional supports and information about how to do the test (O'Byrne et al, 2022). Our interpretation is that, while the INSTI® HIV self-test is highly accurate, it can have a high invalid rate when persons are given the selftest without additional resources and linkages.…”

HIV self-testing in the real world is acceptable for many: post-test participant feedback from the GetaKit study in Ottawa, Canada

“…Our goal for this study was to observe the outcomes associated with this pilot and to obtain user feedback. While we have previously published on GetaKit implementation, preliminary data and invalid results (O’Byrne et al., 2021a, 2021b, 2022), this paper is the first report on participants’ experiences of, and feedback about, participating in HIV self-testing through the GetaKit study.…”