After years spent waiting, more widespread access to Pre-Exposure Prophylaxis (PrEP) in Ontario finally seems to be taking shape. Health Canada approval for generic forms of tenofovir disoproxil fumarate/emtricitabine (the drug combination used for PrEP) has drastically decreased out of pocket costs for PrEP. This development, along with concerted lobbying from HIV activists, also led to the addition of PrEP to the Ontario Drug Benefit formulary in September 2017. While these changes don’t mean universal access to PrEP, they have created an environment where PrEP is a realistic option for significantly more Ontarians. All of this change has service providers and community members contemplating what this new era of HIV prevention will look like in Ontario.
The Ontario PrEP Cohort Study is one attempt to better grasp this changing environment. "PrEP use is starting to increase significantly in Ontario, and it's critical to understand how this will impact sexually transmitted infections, side effects, health service utilization and other key outcomes as this happens,” says Dr. Darrell Tan, a clinician-scientist at St. Michael’s Hospital and one of the study’s Co-Principal Investigators. “We are excited to be studying these questions in a rigourous, collaborative and community-based project."
Jointly led by Dr. Tan and Ryan Lisk of the AIDS Committee of Toronto, the project will begin enrolling people using PrEP at participating clinics across the province and gathering data about their experiences and health outcomes using PrEP. With a target enrollment of 1250 people from sites in Toronto, Ottawa, Windsor, London, Guelph, and Hamilton (and possible additional sites in the future), the project will be the most wide-ranging and comprehensive look at the impact of PrEP in the province. Investigators at St. Michael’s Hospital in Toronto expect to start enrolling patients in February 2018 with other sites launching in the coming months. Participants in the study will be enrolled for 2 years of ongoing follow-up, and be asked to complete surveys at their PrEP-related appointments every 6 months. The research team will also ask for permission to complete reviews of participants’ medical charts and collect data on their HIV and sexually transmitted infection (STI) testing.
"Investigators at St. Michael’s Hospital in Toronto expect to start enrolling patients in February 2018 with other sites launching in the coming months."
The breadth of data being collected is intended to help answer the wide range of questions about what “real-world” PrEP use looks like in the province. As in other large PrEP trials and implementation projects, the research team will be looking at a host of clinical factors like PrEP users’ potential exposure to HIV, their drug adherence, STI rates and engagement in care. The study also looks at a number of experiential questions that have come up around PrEP like people’s motivations for using PrEP, how it impacts their relationships and sexual activity, and whether PrEP use might alter anxiety about HIV or change stigmatizing attitudes about people living with HIV. Another key component of the study includes examining access issues related to PrEP from cost and coverage for medication, to how easily participants were able to find a provider, their experience of accessing PrEP care, and whether things like travel time, physical accessibility, and other logistical barriers may make staying on PrEP unsustainable.
“Certain populations may be impacted differently by the availability of PrEP,” says Molly Bannerman, Director of the provincial Women & HIV/AIDS Initiative (WHAI) and a member of the research team. “With increased access to PrEP, people who sex work may face increased pressures to have condomless sex. People who are incarcerated may face more barriers to accessing PrEP, or continuing PrEP when imprisoned. At the same time, people who are living in situations where they are coerced into sex or needle sharing may benefit from having a prevention option that they can take without others knowing. All of these dynamics are important for us to understand as we build awareness and work to support those who face systemic risk factors for HIV acquisition.”
The project is being run by a team of over 40 experts in Ontario’s community, clinical and research response to HIV. The varied expertise on the team has been critical to shaping the project to ask questions different stakeholders have about PrEP. As the project progresses, the research team will be equally critical in helping turn study data into meaningful and accessible information about PrEP for communities across the province. “Racialized folks and newcomers to Canada face many additional barriers to their health,” says Praney Anand, provincial research team member and Men’s Outreach Coordinator at the Alliance for South Asian AIDS Prevention (ASAAP). “To be effective, information about PrEP use and HIV risk must be culturally inclusive and in a language people can understand. I am glad The Ontario PrEP Cohort study has teamed up with several ethno-specific ASOs to examine these health barriers and communicate information about PrEP back to communities that need it”.
The team is committed to an ongoing dialogue with communities most impacted by HIV, with a variety of PrEP related information and educational activities planned as part of the study’s recruitment phase and further community engagement planned as results from the study become available. Ultimately, the team behind the Cohort study hopes to improve access to PrEP by shaping how education and medical services related to PrEP are provided and helping people better understand if PrEP is right for them. While barriers to accessing PrEP remain, the Ontario PrEP Cohort Study is another step towards greater access to PrEP that many in the province have been waiting for.
Jack Mohr is Research Coordinator at the Ontario PrEP Cohort Study.