Syphilis is an important sexually transmitted infection which if left untreated, can result in serious consequences. Alberta is currently in the midst of a significant outbreak of infectious syphilis. Many syphilis cases in this outbreak have occurred among populations who are difficult to reach through standard health care services, such as street-involved persons. Cases are also occurring in rural and remote areas where access to services is also limited and may result in delays in treatment. Point of care testing (POCT) for syphilis is widely available for diagnosis and point of care treatment in many countries. There are more than a dozen commercially available tests internationally, but none are approved for use in Canada. In contrast, HIV POCT has been available in Canada since 2006. POCT for syphilis and HIV offers the opportunity for immediate and rapid access to testing and in the case of syphilis, immediate treatment. Immediate treatment can prevent complications of syphilis in the infected individual and limit the spread of syphilis. This study will evaluate the performance and acceptability of two dual HIV/syphilis POCT in field settings in Canada. Their utility in the point of care treatment for syphilis among populations who access outreach or acute care services and in rural/remote areas will also be assessed.
Initiative Objectives and Goals
The primary objective is to evaluate the field performance of two dual HIV/Syphilis POCT (from fingerprick whole blood specimens) when compared to standard testing for HIV and syphilis (from serum-based specimens). Secondary objectives include to assess the acceptance of the POCT to participants and to evaluate the impact on management of cases for syphilis and HIV among high-risk and hard-to-reach populations. Data will be used to support the manufacturers’ applications to Health Canada for license of the respective POCT devices.
The study will also evaluate the impact on management of cases for syphilis and HIV among high-risk and hard to reach populations and assess the participant experience after completing the POCT. Finally, it will assess the operational characteristics and acceptability of the POCTS by Nurse Practitioners, Registered or Licensed Practical Nurses conducting the test.
The Role of this Initiative to End the HIV Epidemic
Infectious syphilis increases the risk of HIV acquisition and transmission. Early diagnosis and treatment of syphilis will prevent ongoing transmission of syphilis and therefore HIV. The POCT may also detect previously undiagnosed cases of HIV allowing earlier linkage to care and prevention of ongoing transmission of HIV.
Meaningful Engagement with People with Lived Experience
Consultations occurred with Indigenous Affairs Canada as well as two First Nations communities in Alberta. The study aims to recruit 1500 participants (Nearly 700 have been recruited to date).
PoSH: Point of care tests for Syphilis and HIV to improve access to testing among inner city, remote, rural and hard to reach populations in Alberta
Key performance indicators
Primary target audience
Health care providers offering screening for syphilis and HIV
Results The study commenced July 27, 2020. Results will be available at a later date.
The study commenced July 27, 2020. Results will be available at a later date.