Grant: Operating Grant: Clinical Trials Projects

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, we are proposing a clinical trial of novel investigational point of care (POC) and self-test versions of a rapid diagnostic device that detects treponemal and non-treponemal antibodies to syphilis in less than 5 minutes. Such clinical trial interventions, when applied in studies designed to reach underserved populations at risk of sexually transmitted infections (STI), have been very effective in diagnosing individuals living with STI's and providing opportunities for immediate treatment and linkage to care. We propose to implement this Canada-wide clinical trial intervention of these POC and self-test versions of a rapid syphilis antibody test using an inclusive "test, treat and connect" design to assess device performance and understand how these options, opportunities for immediate treatment for syphilis, and linkage to care can reach the undiagnosed in inner city, remote, rural and underserved populations, and help reverse the rising rates of congenital syphilis. Acceptable performance of these POC and self-test versions in this clinical trial could lead to licensing of these tests in Canada and outcomes from this research project can be used to guide policy and future POC and self-test implementation programs.