As It Happens·Q&A

HIV self-test will remove barriers that keep people from getting diagnosed: scientist

Canada has approved its first self-test for HIV, and fewer undiagnosed Canadians will "fall through the cracks" as a result, says scientist Sean Rourke.

Health Canada grants medical device licence for one-minute finger-prick blood test

A man in a suit looks to the left with a St. Michael's Hospital sign behind him
Dr. Sean Rourke, a scientist with the Centre for Urban Health Solutions at St. Michael's Hospital, was the principal investigator of a clinical trial that helped clear the way for regulatory approval of a finger-prick blood test for HIV. (Yuri Markarov/Unity Health Toronto/The Canadian Press)

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Canada has approved its first self-test for HIV, and fewer undiagnosed Canadians will "fall through the cracks" as a result, says scientist Sean Rourke.

Health Canada on Monday granted a medical device licence to B.C.-based bioLytical Laboratories for a finger-prick HIV blood test that provides results in just one minute. 

Rourke, a scientist with the Centre for Urban Health Solutions at St. Michael's Hospital in Toronto, was the principal investigator of a study that helped the test get approved. He says it could be a game changer in a country where, despite major advancements in HIV prevention and treatment, HIV rates are on the rise. 

According to the Public Health Agency of Canada, HIV infections in Canada rose 25.3 per cent between 2014 and 2018. What's more, Rourke says many people with HIV don't even know they have it.

That's why, as the director of the CIHR Centre for REACH in HIV/AIDS, he's partnering with community organizations across the country to launch a telehealth program in January that will distribute 60,000 of the tests for free. Here is part of his conversation with As It Happens host Carol Off. 

I know you have been working to get this test in Canada for a long time. How does it feel [now] that it's finally been approved?

It's very exciting. It's a proud moment for Canada.

And for you?

I've been working in the sector for 25 years.… To help make this happen is really a great place to be, and [to] be part of helping to influence change.

Why is it so important?

HIV treatments have come a very long way. We have medications now that, if taken right away, can help people live normal lifespans.

Part of that, though, is to make sure people get tested and diagnosed when they're positive. [This test] allows us to really be able to provide options.

There are a significant amount of people in Canada that are undiagnosed with HIV. These are people living with HIV that don't know it. They're not coming forward for testing for a variety of reasons. Having now a lower barrier option. A self-test … is simple. It's safe. It's highly accurate … [and] confidential. 

Jane Greer of the Hassle Free Clinic unboxes an HIV self-testing kit in Toronto. It can deliver results in as little as one minute. (Tijana Martin/The Canadian Press)

But this self-testing, this home test, has been available elsewhere for some time now. Why has it taken so long to arrive in Canada?

Several reasons, but I think it's leadership. Bringing the right people together, not just thinking about the problems and the barriers, but finding a path to bring it to market, getting the funding that's needed, the right team, building a case for why it's important and effective intervention and making it happen. 

I think that's where we stepped in and have really rallied across the country.

For those who remember what it was like in the '80s and '90s to lose friends, to lose family members, to see people just ravaged by this disease, it's just so extraordinary that we have so many treatments now that can work with it. But I understand that the HIV rates in Canada have been going up.

That's correct. And it shouldn't happen in a place like Canada, right? This is where we need more testing options and a better connection between health, public health and the front-line sector to fill in the gaps of where people fall through the cracks. 

I mean, we're hearing about that in COVID right now, right? There are these health inequities that are driving why certain populations ... are more at risk. We need to do a better job at filling in those gaps and making sure people have the tools they need for their health.

There are people within large cities, but also in remote communities, who have very little access to the kind of testing you're describing. What kind of a game changer is this for those communities?

Well, it's a game changer to have it licensed. But you're right … Canada is a vast country. 

Now that it's licensed, we've been working for four or five months to put in place a program that will be starting in the new year to make sure that people can access self-testing online.

So we're building a program ... for people to order a test kit, have it sent to their home or to pick it up somewhere, and then also have an opportunity to get counselling and support for that testing. Intentionally linking people to care … is so important, certainly for people when they're positive, but also, you know, for those who test negative. 

We're purchasing 60,000 HIV self-tests that'll be accessible for free across the country.

HIV self-test kit launching clinical trial, could be on sale in 2020

5 years ago
Duration 2:31
As HIV rates continue to climb in Canada, researchers are launching a clinical trial for an HIV self-testing kit that could be on sale in 2020.

When you mentioned that giving people the kinds of counselling they need … are you still going to be able to do that if people are able to just get a free test and go home?

We're doing this intentionally, but we also recognize that people want a choice. They want opportunities for deciding the intensity of that service.

People can use [our] app to get a test kit, but actually have the right information at their fingertips to know about the counselling, the supports and the videos that might help them through [the process]. They can be linked to PrEP [medication to prevent HIV infection] … or treatment services and then have access to care navigators who will help them.

We want to reach those who are undiagnosed, those people who aren't coming forward because of stigma, and we want to really have the right supports in place that people will feel that that's a safe and culturally appropriate way of getting the access to the services they need in the ways that they want it.

What chances are there that this will go a long way to helping to eradicate HIV in Canada?

It certainly is our plan. We're now working on bringing the second HIV self-test to Canada with these test devices. With novel interventions that are very pragmatic, we can end HIV in Canada by 2025 if we bring the right people together, do the right things and get governments to work together, much like they're doing now with COVID.

It's going to take some work, but we're confident we can get there. 


Written by Sheena Goodyear and Mehek Mazhar, with files from The Canadian Press. Interview produced by Lisa Bryn Rundle. Q&A has been edited for length and clarity. 

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