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

From Healthy Debate

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 100 per cent accurate.

“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. He also currently has a funding proposal under review that will do the same in 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.”

Family doctors barely keeping up with Canada’s population, report says

Dr. Tara Kiran spoke with the Toronto Star about a recent CIHI report. “Increasingly people are living longer with more chronic conditions, and our social system is under stress,” said Dr. Kiran. “All of that changes the workload for existing family doctors. Even with the same number of patients, it would take potentially longer to care for the same number of patients.” 

ERs used as warming centres by Ontario’s homeless residents with nowhere else to go

“There was a fairly significant jump in the number and rate of ED (emergency department) visits that are really not attributable to anything other than avoidance of cold weather exposure that does point to a lack of community-based support,” said Lucie Richard, adjunct scientist and senior research associate at MAP, shared with The Hamilton Spectator.

St. Michael’s research leads to Health Canada approval of dual HIV-Syphilis rapid test

Federal regulators have approved a new dual HIV-Syphilis rapid test, a critical point-of-care tool to address the public health crises of rising HIV/Syphilis rates in Canada, particularly in the Prairies.

Health Canada granted a medical device licence on Dec. 24, 2024 to Nova Scotia-based MedMira Inc. for its Multiplo® TP/HIV Rapid Test. The device allows healthcare professionals to detect both HIV-1/2 and syphilis antibodies using one blood sample from a single finger prick that delivers results immediately.

Health Canada’s licensure of the device is based on the results of a landmark clinical study in Alberta, co-led by Dr. Sean B. Rourke, director of REACH Nexus and a scientist with the MAP Centre for Urban Health Solutions at St. Michael’s Hospital (Unity Health Toronto) and Dr. Ameeta Singh at the University of Alberta.

“We urgently need more rapid testing options to reach the undiagnosed with HIV, syphilis and other blood-borne infections and sexually transmitted infections (STBBIs),” said Dr. Rourke, the director of REACH Nexus at MAP. “We are very excited about the critical implementation science work that went into getting this device approved and into the hands of healthcare professionals.”

The latest data from the Public Health Agency of Canada shows that new HIV diagnoses risen more than 35 per cent from 2022 to 2023, with rates in Manitoba rising by more than 40 per cent. In Saskatchewan, the rate of HIV was 19.4 per 100,000 people, more than three times the national rate.

Syphilis rates have also seen a significant rise in recent years. In 2022, there were 13,953 reported syphilis cases, with rates increasing by 109 per cent compared to 2018, and with congenital syphilis cases seeing a seven per cent increase from 2021 and a 599 per cent increase from 2018.  

“Our Multiplo® TP/HIV device is the fastest testing solution for HIV-1/2 and Syphilis and provides an immediate result which does not fade. The Health Canada Medical Device License for professional-use will immediately address critical gaps in healthcare settings at a fraction of the costs of conventional testing systems,” said Hermes Chan, CEO of MedMira.

“Together with REACH Nexus we aim to supply urban and remote communities across Canada, and with it provide access to a critical needed screening tool. This test will have a tremendous impact on the already stretched and overburdened health care system by providing a fast and cost-efficient screening method.”

As part of Health Canada’s review and authorization process, Dr. Rourke’s team of researchers sourced funding and conducted the study working closely with healthcare providers, provincial health ministry and laboratory agencies, community stakeholders, and people with lived experience.

The study, conducted from 2020-2022, included over 1,500 participants from clinical settings in Edmonton and northern Alberta. The study found the Multiplo® TP/HIV test to be 100 per cent accurate in identifying HIV infection, and more than 98 per cent accurate in detecting syphilis. 

Dr. Rourke’s work also played a critical role in getting Canada’s first HIV self-test approved by Health Canada based in 2020.

More testing options are seen as vital tools in HIV prevention as it allows people to learn their status and get connect to treatment and care.

In Canada, an estimated 65,000 people live with HIV, the virus that causes AIDS, and 14 per cent of those are unaware of their status.

“Not everyone has access to the testing they need for STBBIs because of health inequities, stigma and various forms of discrimination,” said Dr. Rourke. “These tests are game-changers amid the rising number of STBBIs and will have real-life impacts.”

By Andrew Russell

Nearly a third of fatal overdose victims sought health care the week before their deaths, study finds

Dr. Tara Gomes is part of a team of researchers who have found that nearly a third of people who died were in hospital in-patient wards or emergency rooms within a week of their deaths, the researchers found. “That is an enormous number of people who are coming into our hospital system looking for some kind of help with their health-care needs and are leaving without getting that help,” Dr. Gomes told the Toronto Star.