MSM Research Program
Sessions at the Forum reflected the Program’s research priorities. Each project addresses one or more of these priorities and three or four projects were presented in each session.
Developing alternative eligibility criteria
Results suggest many gbMSM support changing the blood donor eligibility criteria. A high percentage of gbMSM would be willing to donate blood if they were eligible to do so. Research is underway regarding issues of privacy, confidentiality and access to blood donation for gbMSM living in rural and urban areas. Research is also underway to understand the experiences of blood donation specific to diverse gbMSM communities, such as those who identify as African, Caribbean and Black. The importance of relationship repair with communities affected by MSM-related donor policies arose from research presented in this session and the next, and in discussions at the Forum.
Acceptability of alternative policies
The current approach to MSM donor eligibility considers MSM as a population and assesses transfusion-transmissible infectious disease risk in that population as a whole rather than assessing risk based on an individual’s behaviour. The majority of gbMSM surveyed view the current population-based risk approach as discriminatory and therefore not acceptable. Findings of research conducted to date suggests that the order in which questions are currently asked in the donor health questionnaire (i.e. proximity of the MSM question to socially stigmatized behaviours) may unintentionally generate negative implicit bias toward gbMSM in people completing the questionnaire. Among gbMSM study participants, there was limited understanding of, or excitement for, an MSM plasma donation program where the donated plasma would be used to manufacture plasma protein products (i.e. drugs) to treat patients. Research is examining whether changing to an individual behaviour-based approach to donor screening (vs. the current population-based approach) would be acceptable, and how it would impact current donors’ intentions to donate and donor deferral rates.
Risk modelling is used to assess how changes to donor eligibility criteria might impact blood safety and sufficiency. Risk modelling research funded by the Program suggested that the additional risk with a three-month MSM deferral period would be very low. These results informed an application to Health Canada to make this change in 2019. Research is examining the prevalence and incident rates of HIV in a gbMSM population identified as low-risk based on sexual behaviour. Several potential behavioural indicators that could be used in an individual behaviour-based donor screening process are also being studied.
The operational feasibility of screening all donors using individual risk-based questions (e.g. asking about number of sexual partners, or number of new partners, or sexual behaviours) was investigated. Preliminary results suggest that applying an individual risk-based screening approach to all whole blood donors may increase deferrals, particularly in younger age groups. This could result in a significant loss of currently safe donors. Other studies are addressing the feasibility of a plasma donation program for MSM. While gbMSM study participants expressed some interest in such a program, barriers exist. These include a lack of knowledge about plasma donation, the stigma associated with applying any differential treatment to MSM plasma donations, and an ongoing inability for sexually active gbMSM to donate whole blood.
Applying the research knowledge
Three broad principles were considered during discussions about the preliminary research findings: acceptability, safety and feasibility. These principles can be applied to the various approaches that are addressed by the research (e.g. the current population-based approach with time-based deferrals; applying an individual risk behaviour-based approach to all donors or to MSM for either whole blood donation or plasma donation).
- Even if the current population-based risk approach led to a shorter time-based deferral period, it would likely not yield many more donors and does not address the perception that the policy is discriminatory.
- There was much discussion about use of a “capture” question, which is a screening question to identify MSM donors and direct them to additional questions that assess risk behaviours. It is not clear if this would be acceptable to gbMSM, even if it was viewed as a stepping stone towards more inclusive criteria and may result in eligibility of a cohort of gbMSM with behaviors associated with a lower risk of infectious disease exposure.
- The most acceptable approaches are those that are viewed as equitable (i.e. apply the same screening to everyone).
- Donors (and Canadians in general) need to understand the reason behind screening questions and deferrals (not only those related to MSM). Whatever approach to donor policy is taken, there is a clear need for coordinated education and communication to ensure current and prospective donors, patients and patient groups understand the blood donor eligibility criteria and the evidence supporting them.
- Risk modelling research informed the Health Canada application requesting a change to a three-month deferral period for men since their last sexual contact with a man.
- The consensus from experts at the Forum was that once the ongoing studies are completed, we will have better data to inform risk modelling studies and potential future changes to the eligibility criteria.
- While some potential ways to screen donors based on behaviours associated with higher infectious disease risk were discussed (e.g. number of sexual partners), more research is needed to identify which indicators would be most effective, acceptable, and feasible.
- When considering asking risk behaviour-based questions for all donors, the impact on the number of currently eligible donors must be considered. Too great a loss of current donors may affect the sufficiency of the Canadian blood supply.
- For any approach to be successful, clear communication of why donors are being asked screening questions is essential, particularly if those questions might make people uncomfortable and discourage them from donating.
- If potential donors are being asked to provide sensitive or potentially stigmatizing information, privacy/confidentiality would need to be assured. The risk of stigmatization could be a barrier to donation for some MSM.
- There was some interest among gbMSM study participants in a plasma donation program where donations would be used to make plasma protein products to treat patients. However, there are also potential barriers. More education about plasma donation is needed. Two research projects are underway to examine the feasibility of this kind of program.
Emerging challenges in blood donor eligibility criteria
Pre-exposure Prophylaxis (PrEP) and Post-exposure Prophylaxis (PEP)
Currently, Health Canada requires the blood operators to defer donors taking PrEP/PEP. PrEP/PEP may delay the time from infection to detection and interfere with infectious disease testing of donated blood. This area requires further research.
U ≠ U for blood transfusion
U = U, or “Undetectable equals Untransmittable”, is a global informational campaign about how effective HIV medications are in preventing sexual transmission of HIV. It is based on evidence that the risk of sexual transmission of HIV is zero if viral load is low (<200 copies/ml). However, this campaign does not apply for blood transfusion. This is because during transfusion a large volume of blood is delivered intravenously, that is, directly into the blood stream. In this way, even a very small number of viral particles could transmit the infection. While blood operators test every donation for HIV, the sensitivity of the testing method may not be enough to detect low viral loads. It is thus important that the public understand the potential risk to the blood system and the need to disclose their HIV status as well as refrain from blood donation.
Trans blood donors
There is a lack of data and research on blood donor policy specific to trans and gender non-binary individuals. Although research on trans blood donation is specifically not addressed by the Program, the impact MSM eligibility criteria has on trans communities came up frequently, highlighting this as an area that needs more research and attention by the blood operators.
During the “Knowledge Café”, Forum participants were split into three groups. In these groups, they had facilitated discussions focused on three broad questions ("What have we learned?", "What does it mean?" and "How to share what we've learned?"). Forum participants’ responses to the questions were captured and collated. Below are some of the Forum participants’ opinions as expressed during the Knowledge Café.
What research did you find most compelling or most important?
- Appreciated the sheer volume of data generated, the dedication of the research teams, and the commitment from Canadian Blood Services and Héma-Québec to advance blood donor eligibility criteria specific to MSM.
- Recognized the challenge of developing more inclusive eligibility criteria while protecting blood safety and sufficiency.
- Found very compelling the study that indicated that the order of questions in the donor health questionnaire could lead to implicit bias.
- Found important the studies that suggested relationship repair with affected communities will be needed.
- Felt that being inclusive, bringing marginalized voices to the centre; and including trans perspectives, and ethnically diverse/multicultural perspectives are necessary to effectively advance blood donor policy.
What research or information gaps did you notice?
- A lack of data about:
- Trans donors;
- African, Caribbean and Black (ACB) and other marginalized groups within LGBTQ+ communities.
- Research gaps remain around:
- The impacts of further evolving the criteria (e.g. who will start or stop donating blood if criteria are changed);
- How new technologies and innovation (including pathogen reduction technologies) might impact the basis of donor eligibility criteria;
- How best to identify sexually active low-risk MSM;
- Which questions might be used to apply a gender-blind or individual risk-behaviour-based screen to all donors;
- Trans donor screening.
- There is a need for:
- Better education, particularly of deferred donors to help them understand why they are deferred;
- More effective engagement, particularly with marginalized groups including trans and ACB gbMSM communities;
- Clearer explanations of the scientific basis of current and future blood donor eligibility criteria.
How do you think this current research might affect you/your community?
- Patient groups recognized the current eligibility criteria are viewed as discriminatory and understood social justice concerns raised by current donor eligibility criteria. They believe that the evidence being gathered will assure them of the continued safety and sufficiency of the blood supply.
- Echoing the research findings, several participants felt there was a need for relationship repair with communities historically affected by the criteria, in particular marginalized groups such as ACB gbMSM.
- Some felt that blood operators have a responsibility to affected communities and need to think carefully about how to best position alternative approaches to blood donation by MSM (e.g., a plasma donation program for MSM, MSM “capture” question).
Based on current findings, what actions or next steps would you suggest to Canadian Blood Services and Héma-Québec to readily move towards broader eligibility criteria?
- Re-ordering or repositioning of screening questions to reduce implicit negative bias towards gbMSM.
- Blood operators need to improve and modernize their communication, social marketing and education; information should be easier to access than it currently is. Better communication and education could help improve relationships with affected communities.
- The regulators and blood operators need to be more transparent about what evidence is required to make further changes.
How would you/your community share and make use of the knowledge generated by the Program?
- That knowledge dissemination should be specific to the audience, well-timed, with a clear aim. Follow through with change to the eligibility criteria is critical.
- Audiences for knowledge dissemination should include blood operator staff (to help build confidence among people who receive and donate blood) and the next generation of researchers, health-care providers / clinical practitioners; students, as well as LGBTQ+ and patient groups.
- More information about the rationales for donor deferrals is needed for the general public.
- Knowledge dissemination and communication from a social-equity lens (i.e. for whom-by whom?) needs to be considered; inclusion and participation of diverse community groups throughout knowledge dissemination processes is important.
How can Canadian Blood Services and Héma-Québec best disseminate the research findings?
- An anti-stigmatizing, anti-discriminatory perspective should be applied to communications.
- Consider safety and how to avoid stigmatizing communities/marginalized groups.
- Be aware that not all research will speak to all groups (e.g. ACB gbMSM, trans communities); apply an intersectional approach when considering communication with diverse groups.
- Work with community groups (e.g. co-create materials to ensure communities’ values and perspectives are acknowledged) but recognize the burden of effective communication lies with the blood operators, not the communities.
- Traditional written reports may not be the most effective way to disseminate this knowledge effectively to all audiences. Multimedia, social media, videos, webinars, etc., should be considered.