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

Content Provider	Springer Nature : BioMed Central
Author	Galli, Richard A. Maraj, Darshanand McBain, Kristin Lo Hog Tian, Jason M. McFarland, Abbey Tharao, Wangari Nkala, Nontobeko P. Chan, Arlene da Silva, Mark Thomas, Rejean Vassal, Anne-Fanny Lepage, Martin Ireland, Laurie Payne, Mike Starr, Jared Fraser, Chris Selfridge, Marion Loutfy, Mona Halpenny, Roberta Jeyarajah, Nirubini Tran, Vanessa Mazzulli, Tony Rourke, Sean B.
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.
Related Links	https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-024-21228-8.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
ISSN	14712458
DOI	10.1186/s12889-024-21228-8
Journal	BMC Public Health
Issue Number	1
Volume Number	25
Language	English
Publisher	BioMed Central
Publisher Date	2025-01-11
Access Restriction	Open
Subject Keyword	Public Health Medicine Epidemiology Biostatistics Vaccine Environmental Health HIV testing OraQuick® Oral fluid-based HIV self-test Accuracy Usability Acceptance Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health
Journal Impact Factor	3.5/2023
5-Year Journal Impact Factor	3.9/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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