An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada
Abstract Background Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test...
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figshare
2021
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Online Access: | https://dx.doi.org/10.6084/m9.figshare.c.5517624 https://springernature.figshare.com/collections/An_observed_prospective_field_study_to_evaluate_the_performance_and_acceptance_of_a_blood-based_HIV_self-test_in_Canada/5517624 |
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Medicine 59999 Environmental Sciences not elsewhere classified FOS Earth and related environmental sciences Sociology FOS Sociology 69999 Biological Sciences not elsewhere classified FOS Biological sciences Science Policy Galli, Richard A. Lo Hog Tian, Jason M. Sumner-Williams, Michelle McBain, Kristin Stanizai, Emal Tharao, Wangari Aden, Muna Jamieson, Heather Da Silva, Mark Vassal, Anne-Fanny Guilbault, Lorie Ireland, Laurie Witges, Kim King, Alexandra Ametepee, Kehinde Lachowsky, Nathan J. Pant Pai, Nitika Mazzulli, Tony Rourke, Sean B. An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada |
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Medicine 59999 Environmental Sciences not elsewhere classified FOS Earth and related environmental sciences Sociology FOS Sociology 69999 Biological Sciences not elsewhere classified FOS Biological sciences Science Policy |
description |
Abstract Background Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes. Methods The study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Usability outcomes for critical (e.g., lancing finger, blood droplet into bottle, shaking bottle four times) and noncritical self-test procedure steps were also determined. Results Overall, 77% (n = 522) of participants were between 18 and 45 years of age, 61% (n = 410) were male, 71% (n = 480) had some college or more education, and 45% (n = 307) were employed; identity for race and ethnicity: Caucasian (44%; n = 296), African, Caribbean or Black (17%; n = 113), Indigenous [First Nations, Métis or Inuit] (14%; n = 95), Asian (16%; n = 106), Latin American (7%; n = 46). Primary performance analysis on 678 completed HIV self-tests revealed a positive percent agreement of 100% (5/5, 95% CI: 43.6–97.0%) and a negative percent agreement of 99.5% (614/617, 95% CI: 98.6–99.8%) with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5% (n = 633). For the 708 participants who took part in the usability study, the average success rate for steps determined to be “critical” for successful completion of the test was 92.4%. 97% (n = 670) of participants found the instructions easy to follow, and 95% (n = 655) of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive, n = 366) to 99.3% (for negative, n = 401). Conclusions The addition of a regulatory-approved self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions. |
format |
Article in Journal/Newspaper |
author |
Galli, Richard A. Lo Hog Tian, Jason M. Sumner-Williams, Michelle McBain, Kristin Stanizai, Emal Tharao, Wangari Aden, Muna Jamieson, Heather Da Silva, Mark Vassal, Anne-Fanny Guilbault, Lorie Ireland, Laurie Witges, Kim King, Alexandra Ametepee, Kehinde Lachowsky, Nathan J. Pant Pai, Nitika Mazzulli, Tony Rourke, Sean B. |
author_facet |
Galli, Richard A. Lo Hog Tian, Jason M. Sumner-Williams, Michelle McBain, Kristin Stanizai, Emal Tharao, Wangari Aden, Muna Jamieson, Heather Da Silva, Mark Vassal, Anne-Fanny Guilbault, Lorie Ireland, Laurie Witges, Kim King, Alexandra Ametepee, Kehinde Lachowsky, Nathan J. Pant Pai, Nitika Mazzulli, Tony Rourke, Sean B. |
author_sort |
Galli, Richard A. |
title |
An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada |
title_short |
An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada |
title_full |
An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada |
title_fullStr |
An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada |
title_full_unstemmed |
An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada |
title_sort |
observed, prospective field study to evaluate the performance and acceptance of a blood-based hiv self-test in canada |
publisher |
figshare |
publishDate |
2021 |
url |
https://dx.doi.org/10.6084/m9.figshare.c.5517624 https://springernature.figshare.com/collections/An_observed_prospective_field_study_to_evaluate_the_performance_and_acceptance_of_a_blood-based_HIV_self-test_in_Canada/5517624 |
long_lat |
ENVELOPE(-62.133,-62.133,-64.100,-64.100) |
geographic |
Canada Abbott |
geographic_facet |
Canada Abbott |
genre |
First Nations inuit |
genre_facet |
First Nations inuit |
op_relation |
https://dx.doi.org/10.1186/s12889-021-11418-z |
op_rights |
Creative Commons Attribution 4.0 International https://creativecommons.org/licenses/by/4.0/legalcode cc-by-4.0 |
op_rightsnorm |
CC-BY |
op_doi |
https://doi.org/10.6084/m9.figshare.c.5517624 https://doi.org/10.1186/s12889-021-11418-z |
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1766003143454228480 |
spelling |
ftdatacite:10.6084/m9.figshare.c.5517624 2023-05-15T16:17:18+02:00 An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada Galli, Richard A. Lo Hog Tian, Jason M. Sumner-Williams, Michelle McBain, Kristin Stanizai, Emal Tharao, Wangari Aden, Muna Jamieson, Heather Da Silva, Mark Vassal, Anne-Fanny Guilbault, Lorie Ireland, Laurie Witges, Kim King, Alexandra Ametepee, Kehinde Lachowsky, Nathan J. Pant Pai, Nitika Mazzulli, Tony Rourke, Sean B. 2021 https://dx.doi.org/10.6084/m9.figshare.c.5517624 https://springernature.figshare.com/collections/An_observed_prospective_field_study_to_evaluate_the_performance_and_acceptance_of_a_blood-based_HIV_self-test_in_Canada/5517624 unknown figshare https://dx.doi.org/10.1186/s12889-021-11418-z Creative Commons Attribution 4.0 International https://creativecommons.org/licenses/by/4.0/legalcode cc-by-4.0 CC-BY Medicine 59999 Environmental Sciences not elsewhere classified FOS Earth and related environmental sciences Sociology FOS Sociology 69999 Biological Sciences not elsewhere classified FOS Biological sciences Science Policy Collection article 2021 ftdatacite https://doi.org/10.6084/m9.figshare.c.5517624 https://doi.org/10.1186/s12889-021-11418-z 2021-11-05T12:55:41Z Abstract Background Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes. Methods The study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Usability outcomes for critical (e.g., lancing finger, blood droplet into bottle, shaking bottle four times) and noncritical self-test procedure steps were also determined. Results Overall, 77% (n = 522) of participants were between 18 and 45 years of age, 61% (n = 410) were male, 71% (n = 480) had some college or more education, and 45% (n = 307) were employed; identity for race and ethnicity: Caucasian (44%; n = 296), African, Caribbean or Black (17%; n = 113), Indigenous [First Nations, Métis or Inuit] (14%; n = 95), Asian (16%; n = 106), Latin American (7%; n = 46). Primary performance analysis on 678 completed HIV self-tests revealed a positive percent agreement of 100% (5/5, 95% CI: 43.6–97.0%) and a negative percent agreement of 99.5% (614/617, 95% CI: 98.6–99.8%) with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5% (n = 633). For the 708 participants who took part in the usability study, the average success rate for steps determined to be “critical” for successful completion of the test was 92.4%. 97% (n = 670) of participants found the instructions easy to follow, and 95% (n = 655) of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive, n = 366) to 99.3% (for negative, n = 401). Conclusions The addition of a regulatory-approved self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions. Article in Journal/Newspaper First Nations inuit DataCite Metadata Store (German National Library of Science and Technology) Canada Abbott ENVELOPE(-62.133,-62.133,-64.100,-64.100) |