Dual Syphilis and HIV Point of Care Testing (POCT) to Improve Access to Testing Among Inner City, Remote, Rural and Hard to Reach Populations in Alberta
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 1,526
- Locations
- 2
- Primary Endpoint
- Diagnostic accuracy of the Multiplo TP/HIV test and the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test in field settings
Study Overview
Brief Summary
This study will evaluate the performance of two point-of-care dual syphilis and HIV tests [Multiplo TP/HIV test (MedMira Inc, Halifax, Nova Scotia) and the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test (bioLytical Laboratories Inc., Richmond, BC)].
In addition to standard syphilis and HIV testing, point-of care testing (POCT) will be performed on 1,500 consecutive participants who are being screened for syphilis and HIV and who are at least 16 years old. POCT will be conducted using a fingerprick whole blood specimen. The study will be conducted at multiple sites in Northern Alberta (Canada), a region which is currently experiencing a resurgence of infectious syphilis.
Detailed Description
Purpose:
In the context of resurgent syphilis in Alberta (Canada), the investigators will evaluate the performance of two dual HIV/syphilis POCT. 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.
Justification:
Syphilis is an important sexually transmitted infection (STI) caused by the bacterium Treponema pallidum which if left untreated, can result in serious complications and can be transmitted from mother to child during pregnancy resulting in severe consequences (Singh, 1999). Alberta is currently in the midst of an outbreak of infectious syphilis, with rates not reported since 1948 (AH, 2019). Many syphilis cases in this outbreak have occurred among high risk populations, such as street-involved persons, who are difficult to reach through standard health care services and are also at high-risk for HIV infection. 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 diagnostic use 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. With the current syphilis outbreak in Alberta, POCT for syphilis and HIV offers the opportunity for immediate and rapid access to testing and results. For syphilis, POCT also provides the opportunity to provide immediate treatment in remote/rural communities and in non-traditional venues. Immediate treatment can prevent complications of syphilis in the infected individual and limit the spread of syphilis, as well as reduce the demand on limited healthcare resources by allowing treatment to occur at the time of testing, thus reducing the need for an additional visit by the client. In addition, a scoping review found that between 81-97% of Canadians prefer POCT to traditional testing and 96-100% were highly satisfied with the testing process (Minichiello, 2017). Studies using POCT for HIV in British Columbia and Ontario have also demonstrated that POCT is effective in reaching the undiagnosed (Fielden, 2013, Sullivan, 2013).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals who would routinely be screened for syphilis and HIV
Exclusion Criteria
- •< 16 years, unable to provide signed informed consent
Outcomes
Primary Outcomes
Diagnostic accuracy of the Multiplo TP/HIV test and the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test in field settings
Time Frame: Two weeks
Against standard laboratory tests for syphilis and HIV
Secondary Outcomes
- Time to return for standard test results(Two weeks)
- Number returning for standard test results(6-12 months)
