A Prospective Field Study to Evaluate the Performance and Acceptance of an Oral Fluid-Based HIV Self-Test in Canada

Abstract

Background: Blood and oral fluid-based HIV self-tests are important for reaching the undiagnosed especially in key populations. The study objectives were to: (1) evaluate the oral fluid-based OraQuick® HIV Self-Test (HIV-ST) performance compared with laboratory reference testing; (2) document if intended users can correctly perform the HIV-ST; (3) document if intended users can successfully interpret contrived positive, negative, and invalid results; and (4) document if intended users can understand the key messages in the product labeling. Methods: This cross-sectional study recruited consenting adults who were representative of intended users of HIV self-testing from four community sites in Canadian provinces between June 2022 and January 2024. The results of the observed HIV self-tests were compared with results of the laboratory-based “gold standard” Abbott Alinity HIV Antigen/Antibody Combo test. Usability outcomes for critical and noncritical self-test procedure steps were also determined. Results: Overall, 951 participants were recruited and consented with 911 available for all analyses. With respect to socio-demographics: 84% of participants were between 18-45 years of age, 73% had at least college education, 48% were cis-male, and 45% were employed; 26% identified as White, 23% as African, Caribbean or Black, 5% as Indigenous [First Nations, Métis or Inuit], 33% as Asian, and 6% as LatinX. Primary performance analysis on the 911 completed HIV-ST revealed a positive percent agreement of 100% (1/1) and a negative percent agreement of 100% (880/880, 95% CI: 99.9-100%) with the comparator method. For usability determination, the average success rate for steps identified as “critical” for successful completion of the test was 94.1%. Approximately 97% of participants found the instructions easy to follow, and 98% of participants indicated that they would use the test again. Of the 465 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, most participants were able to interpret the results correctly. Conclusions: Having an oral fluid-based HIV self-test approved in Canada can offer an accurate, acceptable, and less invasive alternative to blood-based HIV self-testing. The addition of an oral-fluid self-test along with the current licensed blood-based HIV self-test could significantly increase HIV testing rates by offering individuals a choice of self-testing devices.