A prospective multi-site study to evaluate the performance and usability 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 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...
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2025-01-01
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| Online Access: | https://doi.org/10.1186/s12889-024-21228-8 |
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| author | Richard A. Galli Darshanand Maraj Kristin McBain Jason M. Lo Hog Tian Abbey McFarland Wangari Tharao Nontobeko P. Nkala Arlene Chan Mark da Silva Rejean Thomas Anne-Fanny Vassal Martin Lepage Laurie Ireland Mike Payne Jared Starr Chris Fraser Marion Selfridge Mona Loutfy Roberta Halpenny Nirubini Jeyarajah Vanessa Tran Tony Mazzulli Sean B. Rourke |
| author_facet | Richard A. Galli Darshanand Maraj Kristin McBain Jason M. Lo Hog Tian Abbey McFarland Wangari Tharao Nontobeko P. Nkala Arlene Chan Mark da Silva Rejean Thomas Anne-Fanny Vassal Martin Lepage Laurie Ireland Mike Payne Jared Starr Chris Fraser Marion Selfridge Mona Loutfy Roberta Halpenny Nirubini Jeyarajah Vanessa Tran Tony Mazzulli Sean B. Rourke |
| author_sort | Richard A. Galli |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-777c40bb504745409216780bdfa75dc9 |
| institution | Kabale University |
| issn | 1471-2458 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
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| series | BMC Public Health |
| spelling | doaj-art-777c40bb504745409216780bdfa75dc92025-01-12T12:43:00ZengBMCBMC Public Health1471-24582025-01-0125111210.1186/s12889-024-21228-8A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in CanadaRichard A. Galli0Darshanand Maraj1Kristin McBain2Jason M. Lo Hog Tian3Abbey McFarland4Wangari Tharao5Nontobeko P. Nkala6Arlene Chan7Mark da Silva8Rejean Thomas9Anne-Fanny Vassal10Martin Lepage11Laurie Ireland12Mike Payne13Jared Starr14Chris Fraser15Marion Selfridge16Mona Loutfy17Roberta Halpenny18Nirubini Jeyarajah19Vanessa Tran20Tony Mazzulli21Sean B. Rourke22MAP Centre for Urban Health Solutions, Unity Health TorontoMAP Centre for Urban Health Solutions, Unity Health TorontoMAP Centre for Urban Health Solutions, Unity Health TorontoMAP Centre for Urban Health Solutions, Unity Health TorontoMAP Centre for Urban Health Solutions, Unity Health TorontoWomen’s Health in Women’s Hands Community Health CentreWomen’s Health in Women’s Hands Community Health CentreHassle Free ClinicHassle Free ClinicClinique Médicale L’ActuelClinique Médicale L’ActuelClinique Médicale L’ActuelNine Circles Community Health CentreNine Circles Community Health CentreNine Circles Community Health CentreCool Aid Community Health CentreCool Aid Community Health CentreMaple Leaf ResearchMaple Leaf ResearchMaple Leaf ResearchPublic Health Ontario LaboratoryPublic Health Ontario LaboratoryMAP Centre for Urban Health Solutions, Unity Health TorontoAbstract 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.https://doi.org/10.1186/s12889-024-21228-8HIV testingOraQuick®Oral fluid-based HIV self-testAccuracyUsabilityAcceptance |
| spellingShingle | Richard A. Galli Darshanand Maraj Kristin McBain Jason M. Lo Hog Tian Abbey McFarland Wangari Tharao Nontobeko P. Nkala Arlene Chan Mark da Silva Rejean Thomas Anne-Fanny Vassal Martin Lepage Laurie Ireland Mike Payne Jared Starr Chris Fraser Marion Selfridge Mona Loutfy Roberta Halpenny Nirubini Jeyarajah Vanessa Tran Tony Mazzulli Sean B. Rourke A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada BMC Public Health HIV testing OraQuick® Oral fluid-based HIV self-test Accuracy Usability Acceptance |
| title | A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada |
| title_full | A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada |
| title_fullStr | A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada |
| title_full_unstemmed | A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada |
| title_short | A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada |
| title_sort | prospective multi site study to evaluate the performance and usability of an oral fluid based hiv self test in canada |
| topic | HIV testing OraQuick® Oral fluid-based HIV self-test Accuracy Usability Acceptance |
| url | https://doi.org/10.1186/s12889-024-21228-8 |
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