Grant: Op. Gr.:Addressing Infectious/Congenital Syphilis-Syphilis Impl. Science-General

Rates and cases of infectious and congenital syphilis are reaching crisis proportions in Canada, particularly in the Prairie Provinces. The national rate of infectious syphilis increased from 5.1 per 100,000 population in 2011 to 30 per 100,000 population in 2021 with the Prairie Provinces reporting the greatest relative increases from 2017 to 2021. Moreover, for confirmed and probable congenital syphilis cases, in rates in Manitoba rose from 6/100,000 live births in 2017 to 433/100,000 live births. Rates in Alberta rose from 4/100,000 in 2017 to 161/100,000 in 2022 and Saskatchewan saw rates increase from 0 in 2018 to 462/100,000 in 2022. With this urgent health crisis due to the rapidly rising rates of syphilis and congenital syphilis in Canada, and to potentially expand testing opportunities, we are proposing a study of point of care (POC) and self-test versions of a rapid diagnostic device that detects HIV and syphilis antibodies performed by personnel and individuals with no prior training or experience performing the test. Current use of this device is restricted to trained healthcare providers. This study can provide evidence that the test is simple enough to be performed by individuals with no training without increased risk of obtaining erroneous results. We propose to implement this Canada-wide clinical trial intervention of these POC and self-test versions of a rapid HIV/ syphilis antibody test using an inclusive study design to assess device performance and understand how these expanded testing options can provide broader opportunities for immediate treatment and linkage to care, and reach the undiagnosed in inner city, remote, rural and underserved populations. Acceptable performance of these POC and self-test versions in this clinical trial could lead to new and amended licensing of these tests in Canada and outcomes can be used to guide policy and future POC and self-test implementation programs.