UPDATE March 28, 2023, at 12 a.m.: Health Canada has approved a dual HIV-syphilis rapid test after the University of Alberta’s two-year clinical trial found it was 100 per cent accurate in identifying HIV infections and 98 per cent accurate for active syphilis.
A University of Alberta clinical trial will screen 1,500 people with point-of-care dual HIV and syphilis test kits in an effort to combat the syphilis outbreak in Edmonton and northern Alberta.
Alberta Health Services declared the outbreak last year after 12 stillborn births and 1,753 newly diagnosed cases of syphilis, 68 per cent of them in the Edmonton area.
Syphilis is a highly infectious sexually transmitted infection with symptoms ranging from genital sores to vision and hearing loss, heart attack and dementia, depending on how long it is left untreated. When women acquire syphilis during pregnancy, it is almost always passed on to the baby, leading to stillbirth or developmental delays. Syphilis can be cured with penicillin.
“The advantage, if these tests work, is that you could provide treatment at the same visit if the test result was positive,” said principal investigator 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.
“That would be fantastic because we can prevent the patient from developing further complications and we can also prevent ongoing spread,” said Singh, who is also a member of the Women and Children’s Health Research Institute. “Penicillin renders syphilis non-infectious within 24 hours.”
Canadian-made tests could help prevent future outbreaks, infant deaths
Alberta has one of the highest rates of syphilis in the country, Singh said. Syphilis screening usually involves taking a blood sample and sending it to a lab, where the serum is separated using a centrifuge and then tested. It can take up to two weeks to get results.
“Syphilis affects populations who are at times hard to reach—they may be transient, have unstable housing or may have mental health or addictions issues,” Singh said. “Because of their unstable social situations, they sometimes don’t return for followup.”
The point-of-care tests in the clinical trial allow health-care staff to test for both HIV and syphilis with a simple finger prick blood test, much like the test for blood sugar. Results are returned within five minutes and treatment with penicillin can be provided immediately.
Singh said it is important to test for both syphilis and HIV at the same time because syphilis increases a person’s chances of acquiring or passing on HIV if they are exposed to both infections at the same time.
“This is exciting work that Dr. Singh is leading, ‘implementation science’ that we hope will have a life-changing impact on the health and well-being of moms and their infants,” said Sean B. Rourke, a scientist at the MAP Centre for Urban Health Solutions at St. Michael’s Hospital of Unity Health Toronto, and director of the CIHR Centre for REACH in HIV/AIDS, which is the major funder of the trial along with strategic funding from the Canadian Foundation for AIDS Research (CANFAR).
A major aim for REACH is to bring new testing technologies, including self-testing, point-of-care and multiplex testing, to market in Canada to reach those undiagnosed with HIV, HCV and other STIs (including syphilis). It is also building teams with community stakeholders and affected key populations to ensure that the testing innovations are implemented in the right way to reach those who need them the most, and in ways that provide cultural safety and support.
Rourke recently generated the evidence required by Health Canada to approve the first HIV self-test kits in the country. His collaboration with Singh at the U of A and Alberta Health Services is part of a joint effort to get more tests licensed in Canada. Both test kits that are being evaluated are made by Canadian manufacturers and have been licensed for use in other countries but are not yet approved for use in Canada. As part of this partnership, the companies have committed to apply for Health Canada licensing of their medical devices if the U of A study results are positive.
During the trial, individuals at risk for syphilis and HIV—such as gay and bisexual men, people from Indigenous communities experiencing a resurgence of syphilis, and those experiencing homelessness, mental health issues or addictions—will undergo testing at homeless shelters, the Edmonton Remand Centre, the emergency departments of the Royal Alexandra Hospital and Northeast Community Health Centre, and other community clinics.
All of the participants will also get the standard laboratory test to confirm the accuracy of the trial test kits. Singh said she is hoping to see 90 per cent accuracy.
She noted that while every pregnant woman in Alberta is supposed to be tested for syphilis, often vulnerable women don’t access prenatal care until the time of delivery, when it is too late to avoid transmission to the infant.
“What we are hoping with this project is that if we can reach women in field settings and offer testing in the field, we might eventually be able to reach and treat more women who are infected, thus preventing or reducing the harmful effects of syphilis on both the mother and her unborn child,” she said.
Singh expects the study to take up to 18 months to complete. The project is also supported by Alberta Health Services and Indigenous Services Canada.