Dual HIV/syphilis rapid test aims to lessen stigma, reach underserved communities

As rates of syphilis and HIV continue to climb in Canada, a dual rapid test recently was approved by federal regulators, making it the second of its kind to become available in the country.

The expansion of the availability of these devices comes at a pertinent time. Syphilis rates have climbed by 109 per cent in the last six years. Congenital syphilis, in which the infection passes to a fetus during pregnancy and can lead to serious complications and stillbirth, has risen nearly 600 per cent in the same time. Rates of HIV have likewise risen in several provinces in recent years, with unprecedented increases in Manitoba and Saskatchewan. Recent studies show that the Prairies now account for nearly 40 per cent of all new HIV diagnoses in the country.

“There are about 8,000 people in Canada living with HIV who don’t know they have it,” says Sean B. Rourke, director of REACH Nexus and a scientist with the MAP Centre for Urban Health Solutions at St. Michael’s Hospital in Toronto.

In a 2023 study done in Alberta, Rourke co-led a team with researcher Ameeta Singh analyzing the performance and treatment outcomes of two dual syphilis/HIV point-of-care tests. The landmark clinical study led to Health Canada’s approval of the new Multiplo TP/HIV Rapid Test by Nova Scotian company, MedMira.

In the study, nurses performed testing at two emergency departments, a First Nations community, a correctional facility and a sexually transmitted infection clinic. The tests were compared with results of standard serological testing and were found to be 98 to 100 per cent accurate against active syphilis and HIV.

“Many people who have these conditions are undiagnosed because they don’t necessarily interact with the health-care system,” says Rourke, adding that a disproportionate number of people infected in the Prairies are members of Indigenous communities. “The root of [this issue] is colonization, stigma and trauma … Many people have been mistreated in health-care settings. We failed a lot of people in these communities just by not having a health-care system that meets them in ways that are good for them.”

Of the more than 1,500 study participants who were tested, the team was able to redirect the 24 patients with positive HIV tests to care, and 85 per cent of syphilis-positive patients received treatment the same day they were tested.

For Rourke, the Health Canada approval of the MedMira dual HIV/syphilis test is just the most recent win in a long career spent targetting these issues. Rourke has worked as a clinical neuropsychologist at St. Michael’s since 1995 and set up the first clinic for HIV-related cognitive concerns at the old Wellesley Hospital. Since then, Rourke has worn many hats working alongside provincial and federal governments in the health care, public health and community care spaces.

Through his work, Rourke says he sees the extent of the disconnect between these three sectors. “All the money goes to health care, but our public health systems are significantly underfunded, and our community-based systems are even more underfunded,” he says. “My job is sort of standing in the middle and bridging those gaps, in this case to hopefully end HIV cases in Canada and address the epidemics that we’re seeing with congenital syphilis in particular.”

In part inspired by the availability of COVID-19 at-home rapid testing, Rourke has been highly motivated over the last several years to make rapid tests for HIV and syphilis available throughout the country.

He says it’s important to have options available outside of the traditional health authority’s lab testing. “The [federal] and provincial governments have not taken any steps to get point-of-care rapid testing available for HIV and other [sexually transmitted infections] … [We need] to have those options available for people to use in other care settings.”

In November 2020, Rourke helped get the first HIV Self-Test approved in Canada. “That was really a game changer, because other G7 countries already had at least one [test available],” he says.

To get that test developed and approved, Rourke worked closely with B.C.-based biotech company, bioLytical, and helped coordinate research that would be needed to gain Health Canada licensure. That was followed by the development of the first dual HIV/syphilis test, which was approved in 2023.

Rourke says the goal always was to get at least two dual tests available in the country. “We wanted people to have a choice for different ones … and in terms of the economics, it’s useful to have some competition to keep prices low.” The second and most recent test, MedMira’s dual HIV/syphilis test, was approved for professional use on Christmas Eve 2024, though Rourke says they are in the process of getting a MedMira at-home dual test approved and making it available online alongside bioLytical’s.

But getting the tests approved for use in Canada is only the first step, Rourke says. He has also been a part of several research projects and public health initiatives across Canada working to expand access to testing and treatment for these infections. In 2022, Rourke and the REACH Nexus team launched the “I’m Ready to Know” program to provide 50,000 free and low-barrier self-testing kits for HIV across the country. He says the program has so far been able to access more than 15,000 people.

He says that campaigns like these that raise awareness, encourage testing and address stigma are important parts of the equation. “There’s a concern about whether you know your status for HIV because you still may not be able to access treatment for a variety of reasons. And if you do find out, you could be ostracized by your community.”

Despite these concerns, Rourke says that when a recent study offered testing for HIV, syphilis or both to 1,500 people living in rural communities in Saskatchewan “we found out that people will actually choose … to want to get testing and treatment for both.”

On Feb. 19, Rourke will be assisting in the launch of the Ayaangwaamiziwin Initiative, a project that will aim to provide culturally appropriate testing and care for HIV and syphilis for about 10,000 people living in the Prairies.

Ayaangwaamiziwin is the Ojibwe word for carefulness and preparedness. Rourke says the project will be the first of its size and scale in Canada to address more than one infectious disease at a time. REACH Nexus has also recently received $3.75 million from the Canadian Institutes of Health Research to expand the Ayaangwaamiziwin Initiative to the Yukon, Nunavut and Northwest Territories.

Despite the obstacles, Rourke says that he is proud of the work that they’ve been able to accomplish in recent years.  “We still have another four or five [tests] that are coming,” he says, “We’re not going to reach those parts of the population who are the most in need and underserved in Canada unless we have these options.”

Editor’s Note: This story was updated on Jan. 31 to incorporate the recent funding received by REACH Nexus for the Ayaangwaamiziwin Initiative.