Doctors are optimistic that a rapid syphilis test could help curb the spread of an ongoing outbreak of the sexually transmitted infection in the Prairies, due to a promising clinical trial in Alberta.
Infectious disease specialist Dr. Ameeta Singh oversaw the 19-month clinical trial, which tested 1,500 participants at two inner-city emergency departments, a correctional facility in Edmonton and at a First Nations community in northern Alberta.
Two dual rapid HIV and syphilis tests were tested in the study. Both options offered results in less than 15 minutes — and were found to have more than 90 per cent accuracy, according to Singh.
Rapid HIV tests are not new but, in Canada, rapid syphilis tests are.
Preliminary findings for the clinical trial show approximately 500 people tested positive for syphilis, 240 of which were new infections. Those results were later confirmed by laboratory tests.
“We had anticipated that perhaps 10 per cent of our participants would test positive. So this was really incredible and really tells us that we were offering testing at locations that we were very likely to pick up persons at risk for syphilis,” Singh said.
“I think this is going to be an incredible game changer for Canada.”
The rapid tests still need Health Canada approval before they can be used more widely, but the regulator has approved a second clinical trial to use the rapid tests in Saskatchewan.
The companies that would manufacture the products — one test by Medmira another by Biolytical Laboratories — have not yet received Health Canada approval.
Syphilis can affect organ systems
Those infected with syphilis can develop serious brain, heart and nerve complications, and pregnant women who are not treated can transmit the infection to their unborn child.
In Alberta, 183 babies have been born with congenital syphilis since 2016, according to numbers from the provincial government — and 39 of them have died.
“If women are not tested during the pregnancy, and early on in the pregnancy, then we can’t intervene with our treatments,” Singh said.
There has been a resurgence of infectious syphilis in Canada in the past decade. The most recent numbers from Alberta Health Services show 2,500 new infections were reported in 2020. In comparison, 160 cases were reported in 2014.
Singh said the reasons cases have jumped in recent years range from an increase in drug use in the Prairies to the increasing popularity of dating apps, which has made it easier to have casual sex with multiple partners.
Syphilis rates in Canada have been on the rise since the mid-2010s.
The global push for rapid syphilis testing goes back more than two decades, said Dr. Rosanna Peeling, chair of the London School of Hygiene and Tropical Medicine and one of the leading research advocates for accessibility of dual rapid HIV and syphilis tests.
Peeling, who was not involved in the clinical trial but has done similar research for 20 years, said the findings of the trial align with rising syphilis rates.
“I wasn’t surprised by the results because I knew there was a lot of syphilis in Canada,” she said.
WATCH: Rapid syphilis tests mean patients can get faster treatment:
Peeling conducted a meta-analysis of studies on the use of rapid syphilis testing between 2012 and 2016 that was published in the British Medical Journal in 2017, which found that offering the dual screening tests “prevented more adverse outcomes” for mothers who hadn’t known they had the infection.
It’s why she said Canada should move quickly to make these tests more available, noting that babies who are born with congenital syphilis are often the most visible sign that the STI is rampant.
“Why are we doing another study in Saskatchewan?” she said, regarding the second clinical trial. “Shouldn’t this be just rolled out across Canada as a means of preventing further deaths? If this Saskatchewan study takes another 19 months, how many babies would die?”
The barriers to testing
One of the hopes is that rapiding testing will reduce some of the barriers for vulnerable populations.
Dr. Noel Ives, the study’s co-ordinator, said there can often be obstacles for those trying to get syphilis testing. This can range from not having access to transportation or access to a phone in order to make appointments, as well as navigating competing health issues, like addiction.
“Patients often have barriers to get care and book appointments and see primary providers,” Ives said.
On top of that, traditional lab testing can sometimes take a week or longer.
“When people don’t find out about their status right away, it just means that the syphilis is more likely to spread to either their current partners or new sexual partners in the community,” he said.
In the clinical trial, participants who tested positive were offered treatment on the spot — and 84 per cent accepted the offer.
Ives said a fair number of participants were “shocked” when they got their results.
“Most of the participants were glad to have an answer to their health concerns,” Ives said.
What it could mean for patients
At Turning Point, a harm reduction agency in Red Deer, Alta., staff have ramped up syphilis awareness campaigns and are talking to clients about the STI.
“People are concerned about long-term impacts if they don’t get treatment,” said registered nurse Reed Charbonneau.
“They’re aware that’s something that can happen in the third stage [of syphilis] that can impact their organs or even cause death.”
Many clients have a hard time keeping appointments or coming in for follow up, Charbonneau said, so having an immediate result on a syphilis test would be a significant help for the population they work with.
“Sometimes people get a positive test and it’s hard to track them down to let them know they need treatment so that would make a big difference,” they said.
Expanding to Saskatchewan
Saskatchewan has also been dealing with high syphilis rates.
Dr. Stuart Skinner, executive director for Wellness Wheel Medical Outreach Clinic in Regina, said rates in 2020 were 78.4 per 100,000 people, nearly nine times higher than in 2016.
“Getting a rapid diagnosis and easy access to testing is critically important here,” he said.
Skinner said the trial will start at clinics and pharmacies in Regina with the hope it will expand to First Nations communities. He said the goal is to test about 1,600 patients.
“I would expect us to see a large number [of infections], especially in the way we’re looking at testing or testing the patients who are most vulnerable,” he said. “So I expect us to see high rates.”
Singh’s research team will present its Alberta clinical study data at the International AIDS Conference at the end of July.