Initiative Objectives/goals; Why is it important
Initiative Objectives/goals; Why is it important
Summary
The primary objective of the PoSH study 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.
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.
multiplex POC testing for syphilis and HIV
Region
National
INITIATIVE FUNDING
REACH Funded
FOCUS
Linking Testing To Care
LEADS
University of Alberta, Dr. Ameeta Singh
TARGET AUDIENCE
Health care providers offering screening for syphilis and HIV
singular importance of this initiative
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.
TARGET SCHEDULE / TIMELINE
July 26, 2020 - December 2021
“The advantage, if these tests work, is that you could provide treatment at the same visit if the test result was positive.”
Ameeta Singh
clinical professor of medicine in the Faculty of Medicine & Dentistry and infectious diseases specialist at the Royal Alexandra Hospital and the Edmonton Sexually Transmitted Infections Clinic.
Meaningful engagement with people with lived experience
Consultations occurred with Indigenous Affairs Canada as well as two First Nations communities in Alberta.
Marketing
RESULTS
The study commenced July 27, 2020. Results will be available at a later date.
Results
Recruitment of participants for the study who are potential intended users of the INSTI HIV ST was carried out in three provinces (Ontario, Manitoba and Québec) between August 2019 and March 2020. A total of 767 participants were recruited before the study had to be discontinued because of COVID-19.
Primary efficacy analysis with 678 participants who completed the HIV self-testing study revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% when comparing the valid self-tester results to the Abbott Architect.
Overall usability index for the 708 participants who completed the self-test was calculated to be 91.8% and usability for the self-test procedure steps determined to be “critical” for successful completion of the test was 92.4%.
It is important to note that 5 of the 6 participants who were identified as undiagnosed with HIV were successfully linked to care at the clinic where testing was conducted as part of the standard of care protocol with the INSTI HIV POCT.
In addition to two sexual health clinics in Toronto, data will be collected from facilities in Montreal, Saskatoon, Winnipeg and Victoria.
The clinics in the trial were selected because they cater to populations considered to be at higher risk for HIV, including men who have sex with men, injection drug users, Indigenous populations and immigrants from countries where the virus is prevalent.
The World Health Organization has recommended countries implement self-testing strategies as a way to reduce the number of people living with undiagnosed HIV.
“Diagnosing the roughly 9,000 Canadians who don’t know they have HIV is critical to helping them access life-extending treatments and preventing further transmission of the disease.”
Sean Rourke,
neuropsychologist at Centre for Urban Health
Solutions at St. Michael’s Hospital, Toronto
