This study’s primary objective is to demonstrate the simplicity and accuracy of the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test when used by untrained health care professionals (HCPs) in a clinical setting.
In addition to HIV POC tests, HIV self-tests are an effective and acceptable, low-barrier method to increase access to HIV testing. Currently only one blood-based HIV self-test is licensed for use in Canada, the INSTI HIV Self-Test from bioLytical Laboratories Inc. Having a licensed, oral-fluid HIV self-test in addition to a blood-based HIV self-test available for use in Canada could provide another option to increase the uptake of HIV testing and further increase the potential to reach undiagnosed people living with HIV in Canada.
REACH Nexus designed this study around Health Canada’s Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDT’s) for Use at Point of Care or Self Testing 2017 Guidance document.
INITIATIVE OBJECTIVES AND GOALS
This study’s primary objective is to demonstrate the simplicity and accuracy of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test when used by health care professionals (HCPs) in a clinical setting. A secondary objective is to evaluate the ability of HCPs to correctly interpret a variety of mock test results.
Our data and outcomes from this study will be used to support an application to Health Canada by the manufacturer for license of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use by HCPs in point-of-care testing locations.
This is the first of two sequential field studies that are required in Canada for Health Canada to approve the OraQuick® HIV Self-Test, which is similar to the OraQuick ADVANCE® (POC) Test. The OraQuick HIV Self-Test utilizes an identical device, but contains labeling appropriate for self-testing by lay users rather than point-of-care use by trained healthcare providers. This initial study will assess the performance of the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test when performed by untrained HCP in point-of-care settings. Our intention is to follow this study with a separate prospective study of the OraQuick® HIV Self-Test performed by intended (lay) users.
THE ROLE OF THIS INITIATIVE TO END THE HIV EPIDEMIC
Having a second licensed HIV point-of-care test would increase options for access to HIV testing in Canada.
Additionally, the availability of this test that can be used with oral fluid as well as fingerstick blood could reduce barriers associated with use of blood-based HIV tests, particularly for individuals who are averse to fingerstick or venipuncture blood collection practices.
The non-invasive sampling process for oral fluid collection may be preferred by some people and so can provide more opportunities for reaching those living with HIV who are not yet diagnosed and linking them to care.
MEANINGFUL ENGAGEMENT WITH PEOPLE WITH LIVED EXPERIENCE
A minimum of 200 individuals known to be living with HIV will be asked to visit the study sites and consent to participate in the study. Their participation is essential for determining the overall accuracy of the test device.
PRIMARY TARGET AUDIENCE
Healthcare providers, regulatory
SECONDARY TARGET AUDIENCE