Funded research providing evidence needed to evolve eligibility criteria for men who have sex with men


Monday, December 03, 2018 Ross FitzGerald

Today, Canadian men are eligible to give blood if it has been more than one year since their last sexual contact with another man, which is known as the MSM eligibility criteria.

Canadian Blood Services has recently made progress on several fronts that may further evolve the eligibility criteria for men who have sex with men. This includes supporting more research projects as part of the MSM Research Grant Program and working to reduce the waiting period from one year to three months based on the latest evidence.

Supporting research

In October, four additional projects were funded as part of a second round of support available through the MSM Research Grant Program. This unique program, initiated in 2017, now combines research from a total of 15 research teams engaging researchers from across Canada with key partners and stakeholder organizations. Informed by national and international research experts, and actively managed by Canadian Blood Services and Héma-Québec, the program will generate evidence to inform alternative screening approaches for blood and plasma donors.

The newly funded projects investigate the feasibility of implementing source plasma donation with alternative screening approaches; the impact and opportunities for changes to blood donation screening; and mathematical modelling of the risk of transmission of viruses for various different strategies.

Summaries for all funded research projects are available on blood.ca 

The objective of the MSM Research Grant Program is to ensure the generation of adequate evidence-based research for alternative screening approaches for blood or plasma donors, which could evolve the current eligibility criteria for MSM while maintaining the safety of the blood supply. The program is administered by Canadian Blood Services and Héma-Québec with funding support from Health Canada.

Estimating risk 

Dr. Sheila O’Brien, associate director of epidemiology and surveillance with Canadian Blood Services, is the lead investigator of a couple of complementary projects that use mathematical modelling to better understand the risk of transfusion-transmitted infections. The projects, titled ‘Mathematical modelling – Comparing HIV risk between MSM donation strategies’, began in 2017 with support from the MSM Research Grant Program.

Dr. O’Brien is working to create and refine mathematical models that will more accurately estimate the risk of an HIV infectious unit of blood being released for transfusion if any changes are made to the eligibility criteria for donors. By comparing the risk associated with various possible changes to the eligibility criteria, informed decisions can be made as to which option may permit men who have sex with men to donate blood without compromising recipient safety and the sufficiency of the supply of blood products.

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Image of Dr. Sheila O'Brien posing and smiling
Dr. Sheila O'Brien

Mathematical models allow us to estimate the chance of an infectious unit of blood being released to hospitals for transfusion. By changing the data we include in the model, we can compare various donor eligibility criteria and estimate the risk to the safety of the blood supply.” – Dr. Sheila O’Brien

Possible changes to the donor eligibility criteria that are being assessed include individualized risk assessment (in which the MSM question would not be asked) as well as shorter waiting periods.  The mathematical models are informed by data generated by research projects funded by the MSM Research Grant Program.

These interdisciplinary projects bring Canada’s blood operators, Canadian Blood Services and Héma-Québec, together with multiple national and international collaborators including experts from the Australian Red Cross, the American Red Cross, Public Health England, Santé Publique France, and the San Francisco-based Vitalant Research Institute.

Thanks in large part to the mathematical models already developed by this research, Canadian Blood Services and Héma-Québec can more accurately estimate the risks associated with reducing the waiting period for men who have sex with men. This refined risk assessment has been instrumental in setting the stage for a submission to our regulator, Health Canada, to reduce the waiting period for men who have sex with men from one year to three months.

Incremental change: submission to Health Canada 

While research efforts are underway, Canadian Blood Services continues to gather data on each blood unit collected, including pathogens tests results, and performs data analysis on a large scale. This surveillance approach has been instrumental in providing up-to-date information on the impact of reducing the waiting period for men who have sex with men to one year on the safety of the blood supply. We have discussed the results of the analysis with stakeholders (such as patient groups and LGBTQ+ groups) and with Héma-Québec, and are submitting a request to our regulator Health Canada to further reduce the waiting period for men who have sex with men to three months. 

This submission will be the latest incremental step by Canadian Blood Services to evolve the eligibility criteria for men who have sex with men. While the process is still in the early stages, we look forward to keeping the public updated on our progress.

As a blood operator, Canadian Blood Services has a responsibility to collect blood from donors who are at low-risk for any infection that could be transmitted through transfusion and who are unlikely to jeopardize their own health by blood donation. Difficult decisions need to be made about who can and cannot give blood. These decisions are not taken lightly and are not intended as value judgments of individuals. Any change to the eligibility criteria for men who have sex with men must be based on scientific evidence, acceptable to patient groups, and approved by our regulator, Health Canada.

More information about the eligibility criteria for men who have sex with men is available on blood.ca

 


Canadian Blood Services – Driving world-class innovation

Through discovery, development and applied research, Canadian Blood Services drives world-class innovation in blood transfusion, cellular therapy and transplantation—bringing clarity and insight to an increasingly complex healthcare future. Our dedicated research team and extended network of partners engage in exploratory and applied research to create new knowledge, inform and enhance best practices, contribute to the development of new services and technologies, and build capacity through training and collaboration. Find out more about our research impact

The opinions reflected in this post are those of the author and do not necessarily reflect the opinions of Canadian Blood Services nor do they reflect the views of Health Canada or any other funding agency.

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Tuesday, January 30, 2018
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Researchers are invited to apply for funding under the MSM Research Grant Program


Wednesday, February 01, 2017
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A two-day meeting held January 2017 brought together national and international stakeholders to identify research priorities for closing knowledge gaps that impact donor eligibility for men who have sex with men.


Wednesday, June 29, 2016
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Dr. Sheila O’Brien knows the answer. She is the associate director, epidemiology and surveillance, working at Canadian Blood Services head office in Ottawa. Understanding and minimizing the infectious risks associated with blood transfusion is what she does each and every day.