At a glance
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A Study to Evaluate the Accuracy, Usability and Readability of the OraQuick® HIV Self-Test Performed by Observed Intended Users in Canada
In Brief
A clinical study evaluating OraQuick® HIV Self-Test for HIV Testing and HIV Infections. Completed, enrolled 951 participants across 7 sites.
Detailed Summary
Oral fluid based HIV Self-testing (HIVST) provides another innovative and simple option to increase opportunities for HIV testing. At-home testing for HIV using oral fluid has been FDA approved and in use in the USA since 2012, and studies have also shown that interest and acceptability of HIVST with oral fluid is high in other global settings. However data for oral fluid based HIVST within key populations and those at high risk for HIV infection in Canada is limited. This study involves around 900 persons who are non-healthcare professionals and inexperienced in HIV self-testing (intended users) and are presenting at clinic sites across Canada for HIV testing. It will evaluate the accuracy (sensitivity and specificity), usability (persons performs test correctly) and readability (persons successfully interpret test results) of the OraQuick® HIV Self-Test when performed by persons representing intended users living in Canada. A final report of study results will be provided to the Test manufacturer for inclusion in the Health Canada license application process.
Study Details
Timeline
Interventions
OraQuick® HIV Self-Test in oral fluid conducted by observed intended users (non-healthcare professional and inexperienced in HIV self-testing) compared to laboratory 4th generation Ag/Ab enzyme immunoassay (EIA) results performed on venous blood.