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

HIV self-testing corresponds with more frequent testing, better user satisfaction, and higher positivity rates compared with clinic-based 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.