Plasma

IT'S ABOUT TIME:

SOME MEN WHO HAVE SEX WITH MEN CAN NOW DONATE PLASMA

There is a pilot program at two plasma donation centres. Some gay, bi, queer and men who have sex with men can donate plasma in London, ON and Calgary, AB, IF they have been in an exclusive sexual relationship with another man for at least three months. 

There are other rules and criteria. Check out full details on Canadian Blood Services site:

Expanding eligibility for gay, bisexual and other MSM (blood.ca)

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FAQS - FREQUENTLY ASKED QUESTIONS

The team on this research project have been working on a list of FAQs for our full website. Our apologies for the wall of text below! Below are many of the questions, however this list is not exhaustive.  We included questions from a few different sources, including: 

  • People we interviewed as part of our research 
  • Local Advisory Group members during our monthly meetings
  • Other questions that have come up over the course of our involvement in this work

If you have questions that were not answered here or elsewhere on the site, please contact plasma@toh.ca and our research team will get back to you.

QUESTIONS ABOUT THE PLASMA PROGRAM

What is the plasma program? 

The plasma program is a pilot program at Canadian Bloods Services’ donor centres in London, ON and Calgary, AB. In this program, if you are a sexually active gay, bisexual and other man who have sex with men, you can donate plasma if you and your partner only have sex with each other for three months or longer.* 

*Assuming you meet all other eligibility criteria

How long will the pilot program in London and Calgary last?

The current plasma program will be in place until the next policy changes are approved by Health Canada. In December 2021, Canadian Blood Services submitted a proposal for further changes to Health Canada. The new proposal has sexual behaviour-based questions that are the same for all donors. You can read about it on Canadian Blood Services’ website here.

What is the scientific rationale for the hold period?

There isn’t a scientific reason for the holding period in the current plasma program for gbMSMHealth Canada required that CBS hold donations when CBS applied for the plasma program – but we’re not entirely sure why. Blood and plasma donated during the window period* will not test positive for the virus. This is why countries like France have a hold system. Plasma donated by gbMSM is held until a second donation made at least 60 days later tests negative for infections. At that point the first donation is released.  However, from a risk perspective, the hold was not needed for this change in criteria (source: Aubé et al., 2021).

*The time between the start of a new infection and a test being able to reliably detect it 

How long will plasma units undergo the hold process as part of the MSM plasma program?

All plasma units donated under the plasma program will be held until the person makes another donation at least 60 days later.  This will be the case until the next criteria change is approved by Health Canada (hopefully sometime in 2022). 

What is the point of asking new screening questions if plasma units will be held anyway?

When this plasma program was originally planned, the idea was to gather much-needed data. Data Canadian Blood Services collects from the new plasma program will show Health Canada that gbMSM donors who are in monogamous relationships have low-to-no risk of HIV. By asking the questions, and testing the plasma, Canadian Blood Services will be able to say, with certainty, that this is a safe move.

Since this program was planned, better Canadian data on community samples has become available. This new data is allowing Canadian Blood Services to apply for the next change (sexual behaviour-based screening for all donors and for both blood and plasma) before collecting data from this plasma program. 

The idea that a man in a loving and exclusive relationship with another man and who meets no other risk criteria could somehow bring a new infection into the blood supply is ridiculous. Recent data shows that the additional hold process for men who have had sex with another man is unnecessary (source: Aubé et al., 2021). This is why the 60-day hold will not be a part of the criteria in the latest submission change to the criteria that Canadian Blood Services has made to Health Canada. 

What is the maximum time the plasma will be held before being discarded under the pilot program in London and Calgary?

A donor will have 9 months to return to make another donation. This ensures that there is enough time for processing and shipping to the processing plant before the plasma expires at the 10-month point.  If a donor has not returned by 9 months, the original donation will be discarded.

QUESTIONS ABOUT SCREENING AND ELIGIBILITY

How do I know if I’m eligible to donate in the new plasma program?

At what point in the screening will I be asked about my sexual orientation?

You won’t be asked directly about your sexual orientation during screening. The question men are asked is “Have you had sex with a man in the last 3 months?” While this question clearly does lead to the exclusion of many gay, bi, and queer men, some gbMSM can donate (e.g., someone going through a dry spell, or who is celibate) and some heterosexual men who have sex with men cannot donate.

That said, with the new plasma program, guys in an exclusive relationship with a man (for at least 3 months) could have sex with their partner and donate the very same day.

What is the rationale for the new screening questions?

Canadian Blood Services was looking for ways to reduce donation restrictions for sexually active gbMSM donors.  They asked Health Canada to expand plasma donation to include men who have been in an exclusive relationship with a man for more than three months. The additional screening questions were designed to identify this group of men.  These men would be at exceedingly low risk of a new infection. Other countries that use sexual behaviour-based screening, such as Italy and the UK, use similar questions to get at lower risk groups within the larger population of men who have sex with men.

What is the 60-day hold? Why is it part of the plasma program?

The 60-day hold on plasma donated in the plasma program is ridiculous. It was required by Health Canada when Canadian Blood Services applied to start the plasma program. There is no evidence to show that it provides any safety benefit (see here for a scientific article that gives those details). 

No other groups have a hold on their donated plasma (or other donated products). The goal is for the hold process to be removed. Canadian Blood Services has applied to Health Canada to change the rules around screening questions (see here for details). If and when the new screening comes into practice, it would not include a hold.

Aren’t all donations tested anyway?

Canadian Blood Services tests all donations for a number of blood-borne infections (infections that can be carried in blood). Antibody tests are done on each individual donation. Nucleic acid testing (aka NAT) is done on small batches of donations. This type of testing is more sensitive than antibody testing, and can pick up on an infection sooner. NAT is used to test for HIV, hepatitis B and hepatitis C.

Here’s more info on donation testing.

Unfortunately tests are imperfect.  Tests, even NAT, can not identify very new infections.  The time between the start of a new infection and a test being able to reliably detect it is called the window period.  It is because of window periods that donors are asked certain screening questions about their recent activities (for example, travel, piercings, health-related and sexual activity). These questions help to identify risk of window period infections.

What about straight people? Why does Canadian Blood Services only ask gbMSM about sexual activity? 

There is not a great answer to this. The short (inequitable part) of it is that the current screening for heterosexual donors has not caused any problems. There are very few donations that test positive for HIV positive or Hepatitis C, and no cases where HIV or Hepatitis C has been passed to a recipient.   

Men who have had sex with another man have had to endure extremely personal questions about their sex lives because data from the Public Health Agency of Canada has shown that this is a higher risk group. However, this data set does not consider individual differences within the larger group of gbMSM. For example, someone sleeping with a different person every night – regardless of gender – is clearly at a higher risk for getting a new sexually transmitted infection than someone who has been in an exclusive relationship for the past 5 years. 

This focus on broad category membership is overly simplistic and harmful.  These numbers do not tell the story of institutionalized homophobia, transphobia, and stigma that perpetuate higher rates of new infections. For example, higher HIV infection rates in gbMSM could be due to lack queer sexual education in formative years, access to preventative measures, the impacts of minority stress, and many other factors. There are many social determinants of health* that can and should be addressed to reduce new HIV infections in gbMSM communities. This article gives a short overview of some of these issues. Or you can check out a Public Health Agency of Canada report from 2014 (its a bit dated), which goes into more detail about many of the inequities that queer communities face.

* Personal, social, economic and environmental factors that determine individual and population health

Why is oral sex included in Canadian Blood Services’ definition of sex?

We did some digging to try to figure this one out. There is a suggestion that oral sex may post a slight risk for HIV transmission. It is difficult to study whether HIV can be passed on during oral sex because many people have oral sex as well as other kinds of sex in the same encounter. Anal sex is shown in the research to be associated with the highest risk of HIV infection.

Why are gay, bi and other men who have sex with men only allowed to donate in the plasma program? 

Plasma was thought to be a good first step to opening up donation for a a few reasons:

  • At the time Canadian Blood Services proposed the plasma program to Health Canada, there was not the kind of data that Health Canada requires to make the criteria change in blood, such as good Canadian data on individual risk factors or donor-based data. This is because gbMSM donors have not been allowed to donate!
  • Plasma can be frozen and stored in order to implement a hold and re-test system for gbMSM donors. This is not possible with blood donations.

It was also thought to be a method of collecting data showing no window-period infections to be able to push for further change.  

Since then, better data from Canadian research projects has become available. This has allowed Canadian Blood Services to make a case for asking sexual activity questions to ALL donors, and for ALL blood products in ALL Donation Centres (similar to the policy in the UK). CBS requested this change from Health Canada in December 2021. 

Why not use the same questions for everybody?

Everyone should get the same questions. Canadian Blood Services submitted a proposal in December 2021 to Health Canada asking for exactly that. The current plasma program with the additional two questions was developed when there wasn’t the data needed to be able to make the current ask. 

The proposal under review would ask all donors about anal sex in the context of new or multiple recent partners. The risk of HIV infection is higher among people who have anal sex – male or female – with new or multiple partners.

If Canadian Blood Services wanted to get rid of the blood ban, wouldn’t they have done so by now? It’s their own rule; why can’t they just remove it?

Canadian Blood Services is an independent, non-profit organization, regulated by Health Canada. It was created to be at arm’s length from the government because of the Tainted Blood Scandal. However, because Health Canada oversees anything to do with the health of Canadians, Canadian Blood Services is required to get their approval on any changes they make. In order to make changes to criteria, Canadian Blood Services must prove – with donation-specific data – that the change will not decrease blood safety.

What is the reason for the 3-month waiting period for men after having sex with a man? Why ask about sexual activity in the past three months?

A: All infections have a window period* at the start of a new infection. During that time, the infection cannot be detected by tests.  Screening questions, including the one about sex with a man in the last 3 months, are mostly to reduce the risk of window period infections.

Canadian Blood Services has established 3 months as the minimum window period for Hepatitis B and Syphilis (HIV and Hepatitis C are actually shorter).  The 3-month waiting period was chosen as an interim step between the previous 12-month period and the upcoming sexual behaviour-based screening criteria (source). Mathematical modelling showed that the change from 12 months to 3 months would not significantly increase risk, and that change was approved by Health Canada.

*The time between the start of a new infection and a test being able to reliably detect it.

Why aren’t men in exclusive relationships with more than 1 person (e.g., throuples or other forms of polyfidelity) eligible?

The official answer is this: there is research that shows that all donors, not just men, have an increased risk of sexually transmitted infections when they have multiple partners. 

However, this results in a blanket ban on donation by polyamorous gbMSM. If three people in a relationship are only having sex with each other, it stands to reason that risk would be the same as it would for two people who are only having sex with each other.  Sadly, we’re chalking this up to heteronormative monogamous standards and expectations of relationships – another rule that needs to change!

I identify as trans or nonbinary. Am I eligible to donate? What will the process look like for me?

We are working on a detailed answer to this question, and it will be part of our full site when it launches. 

Why don’t the screening criteria ask about specific sexual health behaviours, such as using condoms and regular testing?

We understand it seems a bit backwards that the recommended safe sex practices for gbMSM are not the primary behaviours that are used in donor screening. 

Condoms

CBS doesn’t ask about condom use because condoms are not completely reliable. Condoms can slip, break, or leak, making them ineffective. Some of the people interviewed for this research project wanted screening for plasma donation to look more like STI screening. This would be more like an interview, with questions like “Tell me about your sex practices: do you always use a condom? Does it ever break? How often do you take recreational drugs with sex?” This kind of interview can give a more detailed, nuanced and individual risk assessment. However, it would require a lot of questions, and Canada would have to better resourced (give more money to) the blood systems to provide this kind of individual risk assessment as each screening would take more time.

Note: Our full website will have info about U=U and PrEP/PEP when we launch. Stay tuned!

Regular HIV Testing

As for getting tested regularly, because of the window period [roll-over/hover definition: The length of time between a new infection and a test’s ability to detect the infection. With nucleic acid testing, the window period for HIV detection is about 9 days.], you and your partner(s) would need to not have sex with any new partners between the time you take the test and the time you donate. There would also need to be a gap long enough between test and donation that the negative result could be confirmed by the tests all donations undergo.

I test every three months. That’s recorded public health data. Why isn’t that good enough to be able to donate?

A: The information that public health has about your sexual health status is confidential. Due to privacy laws, they cannot release it without your consent. That said, under the current regulations of the blood system, CBS has to use their own tests, they can’t use test results from any other organizations or agencies.

I’m interested in getting tested for HIV. Where can I go?

A: There are several options: 

  1. As of November 2020, the INSTI HIV self-test has been approved for use in Canada. You can purchase it directly from the manufacturer.
  2. You can also ask your family doctor.
  3. Some people may prefer an anonymous method. Anonymous tests can be done at various health clinics (see below). 

In London: London InterCommunity Health Centre (LIHC) is a great resource, with 10 different sites across the city. 

In Calgary: HIV Community Link (HIVCL) provides a list of locations that perform testing, updated with COVID-19 restrictions.

GENERAL QUESTIONS ABOUT CANADIAN CRITERIA FOR MEN WHO HAVE SEX WITH MEN

Why wasn’t the policy changed to three months as soon as it was known that testing was reliable after 3 months?

A: Since the ‘tainted blood scandal’ in the 1980s, Canada’s blood system has been extremely risk-averse.  The fear of repeating the tragedy of the 80s has led to a very conservative approach to changes. Gay, bi, and men who have sex with men have borne the burden, despite much of the devastation of the tainted blood scandal being due to failures within the blood system at that time (like not implementing testing as soon as it became available). 

Fear and extreme caution led to an incremental approach to changing the criteria. Men who had had sex with a man even once since 1977 were originally permanently banned from donating. This was gradually reduced to a 5 year, 1 year, then 3 month waiting period between anal or oral sex with another man and being allowed to donate. Each time the waiting period was shortened, Canadian Blood Services had to provide Health Canada with data to show that each change did not increase risk of infections in the blood supply which increased confidence in the new blood system and in the safety of changes to these criteria. CBS was also required to gain the support of both patient and community groups for each change.

Other countries also followed an incremental approach, sometimes in fewer steps. CBS is part of an international alliance of blood operators that share information and research.  CBS’ policies have progressively changed more or less in line with other G7 countries. More details about other countries policies on blood donation for gbMSM will be available on our full site when it goes live.  

 

What efforts are being made to improve testing and other technologies to enable everyone to donate who wants to?

A: The main area  currently under investigation is pathogen inactivation and pathogen reduction. These are technologies that offer treatment against potential pathogens (bacteria, viruses and parasites) within blood and blood products. Parts of the pathogen are targeted and damaged using ultraviolet (UV) light. This prevents the pathogen from reproducing, and stops the pathogen from causing illness. These products are then referred to as being “pathogen reduced.”

There are several technologies to inactivate pathogens under development. Different parts of blood (plasma, platelets, red cells) require different methods.  Plasma is easier to inactivate, without damaging it and losing its function. Red cells are the hardest to inactivate. There is no technology currently available that inactivates pathogens while preserving the function of the red cells.  Please see Canadian Blood Services’ website for more information on pathogen inactivation technology.

 

Why can’t gbMSM donate whole blood using the new screening questions?

A: Plasma is collected for the proteins in it.  It’s a highly processed product, meaning it gets pooled and then different surrounding elements (like heat, pH, and alcohol) are adjusted to extract different proteins.  The processing of plasma makes it a good place to start in a very risk averse blood system. 

QUESTIONS ABOUT COVID-19 AND DONATION

Things are constantly changing with Covid-19. Rules around giving blood or plasma have changed over the course of the pandemic – and we expect that this will continue to be the case. Instead of updating our site with the latest rules related to Covid, below we will direct you to various parts of Canadian Blood Services’ website for the most up-to-date information. 

Covid-19 Updates:

Most information about Covid-19 and donation can be found at this link. This includes information about safety protocols within the donor centre, deferral waiting periods after being sick with Covid, and much more. 

Vaccination:

For information about Covid-19 and vaccines, please see here.

Organs and Tissues: 

For a list of questions and answers with regards to organ and tissue donation, please see here.

Convalescent Plasma to treat Covid-19: 

Canadian Blood Services is part of a study to see whether plasma given by someone recovered from Covid-19 can be used to treat someone who is sick with Covid-19.  For more information on the research, check out here

THANK YOU FOR YOUR INTEREST

IN OUR RESEARCH

As of right now, sexually active gay, bi, and other men who have sex with men (gbMSM) are still not allowed to donate blood or plasma in Canada.  

The current policy is that men need to wait 3 months after their last sexual encounter with a man before becoming eligible to donate, regardless of their sex practices or whether they are in a long-term, committed relationship with one person.*

* Except at the plasma donation centres in London and Calgary. See above for details.  

This policy needs to change. 

A NOTE ABOUT LANGUAGE

We acknowledge that people use different terms to describe their sexual orientation and gender identity. We hope men will see themselves reflected in the terms that we use throughout this site.

We have consulted with our Local Advisory Groups in London and Calgary about appropriate and respectful language and we have tried to use a variety of language to be as inclusive as possible. If you have any questions, concerns, or suggestions please reach out to us at plasma@ohri.ca 

Here are some of the acronyms and terms we use:   

MSM – Men who have sex with men: This term was developed for research and public health purposes to be inclusive of men who are sexually active with men regardless of identity.  

gbMSM – Gay, bisexual, and other men who have sex with men: This term was developed as a modification of MSM to be more inclusive of the relationships between men beyond sexual activity and the identities that men who have sex with men identify with.  

2GBTQ+ – Two-spirit, gay, bisexual, trans, queer men and other minority gender and sexual identities.  

WHAT'S THIS RESEARCH ABOUT?

New screening questions and more inclusive eligibility criteria are being explored. These changes could allow some men who are sexually active with men to donate.

Our research is focused on three things:

  1. What do guys into guys think about current donation policies?
  2. What do guys into guys think about changing the donation screening questions for gbMSM? The new screening questions would be based on sexual behavior – not the time since the guy’s last sexual encounter.
  3. What would support or stop guys into guys from donating plasma once they become eligible?

Health Canada makes the decisions about who can donate.

The information that we collect as part of the study will be used by Canadian Blood Services to consider how to best implement policy changes.

What's this research about
Where is this research happenening

WHERE IS THIS RESEARCH HAPPENING?

The research is taking place in two locations: London, Ontario and Calgary, Alberta.

These cities were chosen because they have large volume, source plasma donation sites (not all blood donation centres collect plasma).

Have your voice heard!







SO, WHAT IS PLASMA?

Plasma is a protein-rich liquid in blood that helps other blood components circulate throughout the body.

Plasma is used to treat immune system disorders, bleeding disorders, trauma, and burn injuries.

Canada currently doesn’t collect enough plasma from Canadian donors to meet the needs of Canadians.

Get involved.

Blood Vs. Plasma Long Infographic

MEET SOME OF THE RESEARCH TEAM

We’re a team of researchers located at the Ottawa Hospital Research Institute. Our full team also includes scientists at other institutions, collaborators at Canadian Blood Services and 13 men from the London and Calgary 2GBTQ+ communities. 

Dr. Justin Presseau is the lead investigator on the project.

ElisabethVesnaver_headshot 2020

Dr. Elisabeth Vesnaver is a post-doctoral fellow running the project.

Nolan Hill Headshot

Nolan E. Hill leads our Local Advisory Group in Calgary, Alberta.

Andrew Rosser Headshot

Andrew Rosser leads our Local Advisory Group in London, Ontario

Local Advisory Group Members

Calgary, Alberta

Andrew Taylor Clapperton

Glenndl Miguel

Marco Reid

Mark Greaves

Maximilian Labrecque

Shane Orvis

William Bridel

London, Ontario

Broderic Clement-Thorne

Kyle Rubini

Richard MacDonagh

Taim Bilal Al-Bakri

Taylor Randall

William Osbourne-Sorrell

Full website coming later this year

Featuring:

  • Full details about the research study
  • Info about plasma donation for guys into guys
  • History of the Blood Ban and the Tainted Blood Scandal in Canada
  • Timeline and history of the donation policies that impact gbMSM
  • gbMSM blood donation screening policies in effect around the world
  • Outline of current donor eligibility restrictions for gbMSM, Trans people, and people who are HIV+ or who use PrEP/PEP
  • FAQ

Until our full website is ready, you can get more information about the research project and our work here: bit.ly/plasmastudy.

Get involved in the development of the website content here.

JOIN THE FIGHT

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We need your help!

If you’re interested in sharing your opinions and experiences to better inform policy changes, we need volunteers at every step of the research process, and we’d love to hear from you. See below for current opportunities or contact us.

If you’d like to be emailed with news, study updates, and participation opportunities, contact us and we’ll be happy to keep you in the loop! Contact us

Current Opportunities to Get Involved

London, Ontario

Thank you to all who have participated in our interviews and survey in London.  We are analyzing the data and we will share some findings soon. See below for opportunities to get involved in website and video development.

Calgary, Alberta

Survey

Please stay tuned for opportunities to get involved!

 

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