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Multicenter Study
. 2025 Jan 11;25(1):125.
doi: 10.1186/s12889-024-21228-8.

A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada

Richard A Galli  1 , Darshanand Maraj  1 , Kristin McBain  1 , Jason M Lo Hog Tian  1   2 , Abbey McFarland  1 , Wangari Tharao  3 , Nontobeko P Nkala  3 , Arlene Chan  4 , Mark da Silva  4 , Rejean Thomas  5 , Anne-Fanny Vassal  5 , Martin Lepage  5 , Laurie Ireland  6   7 , Mike Payne  6 , Jared Starr  6 , Chris Fraser  8 , Marion Selfridge  8 , Mona Loutfy  9   10 , Roberta Halpenny  9 , Nirubini Jeyarajah  9 , Vanessa Tran  11 , Tony Mazzulli  11   12 , Sean B Rourke  13   14
Affiliations
Multicenter Study

A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada

Richard A Galli et al. BMC Public Health. .

Abstract

Background: Blood and oral fluid-based HIV self-tests are important for reaching the undiagnosed living with HIV. The study objectives were to evaluate the oral fluid-based OraQuick® HIV Self-Test (HIV-ST) performance in comparison to laboratory reference testing; determine if laypersons can correctly perform the HIV-ST; document if intended users can successfully interpret pre-made contrived positive, negative, and invalid results; and document if intended users can understand the key messages in the product labeling.

Methods: This prospective study enrolled consenting adult intended users of HIV self-testing from six community health centres in four Canadian provinces between June 2022 and January 2024. Positive and negative agreement was determined by comparing the results of the HIV self-tests with the results of the laboratory-based "gold standard" Abbott Alinity HIV Antigen/Antibody Combo test. Descriptive statistics were used to summarize usability self-test procedure steps.

Results: Overall, 951 participants were recruited and consented with 911 available for all analyses. With respect to sociodemographics: 84% of participants were between 18-45 years of age, 73% had at least a college education, 48% were Cis-male, 45% were employed; and 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 efficacy analysis on the 911 who completed HIV-ST revealed a single confirmed positive participant 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 "critical" steps for completing the test was 94.1%. Approximately 97% of participants found the instructions easy to follow and 98% of participants reported they would use the test again. Of the 465 participants who interpreted the strong positive, weak positive, negative, and invalid pre-made contrived results, the average of correct interpretations ranged from 59-97% CONCLUSIONS: A licensed oral fluid-based HIV self-test in Canada can present an accurate, easy-to-use, and less invasive alternative to blood-based HIV testing. The addition of an oral-fluid self-test along with the current licensed blood-based HIV self-test could help reach the undiagnosed with HIV in Canada and positively impact HIV testing rates overall by offering individuals a choice of self-testing devices.

Keywords: Acceptance; Accuracy; HIV testing; OraQuick®; Oral fluid-based HIV self-test; Usability.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Research Ethics Boards (REB) in Ontario, Quebec, British Columbia and Manitoba approved this study at participating recruitment sites including St. Michael’s Hospital REB, University of Toronto REB, Veritas IRB British Columbia, and Quebec, as well as the University of Manitoba HREB. This study was conducted under Health Canada-approved Investigational Testing Authorization (ITA), application ITA# 336702, issued on 11 May 2022. All individual participants provided informed consent prior to study enrollment. The respective REBs approved anonymous participation was approved allowing participants to read the informed consent form with a signature and attestation by the study observer indicating that they received the participant’s verbal consent to participate in the study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Participant enrolment CONSORT flow diagram
See this image and copyright information in PMC

References

    1. Public Health Agency of Canada. HIV in Canada: 2023 Surveillance Highlights Ottawa, Ontario 2024. Available from: https://www.canada.ca/en/public-health/services/publications/diseases-co....
    1. Public Health Agency of Canada. Canada takes action by endorsing global declaration on Undetectable = Untransmittable (U=U) Ottawa, Canada2022. Available from: https://www.canada.ca/en/public-health/news/2022/07/canada-takes-action-....
    1. Public Health Agency of Canada. Canada’s progress towards ending the HIV epidemic. Ottawa; 2024. Available from: https://www.canada.ca/en/publichealth/services/publications/diseases-con....
    1. Lippman SA, Lane T, Rabede O, Gilmore H, Chen Y-H, Mlotshwa N, et al. High Acceptability and Increased HIV-Testing Frequency After Introduction of HIV Self-Testing and Network Distribution Among South African MSM. JAIDS Jo Acquir Immune Defic Syndr. 2018;77(3):279–87. - PMC - PubMed
    1. Johnson C, Baggaley R, Forsythe S, Van Rooyen H, Ford N, Mavedzenge SN, et al. Realizing the potential for HIV self-testing. AIDS Behav. 2014;18(4):391–5. - PubMed

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