Feasibility of plasma donation with alternative eligibility criteria

Evidence is needed to understand whether any eligibility or policy changes can be put into operation by the blood operators (operational feasibility) and how specific changes would be perceived by the communities affected by the “MSM criteria” and other interested parties. This project investigates the acceptability and operational feasibility of alternative eligibility criteria to include more gay, bi, and all men who have sex with men (gbMSM) in source plasma donation. Source plasma is collected from donors and manufactured into life-saving medical treatments, including plasma protein products like immune globulins. Source plasma can be stored for a quarantine period and is pathogen-inactivated during the fractionation process. These safeguards eliminate concerns about “window-period” infections. This means that source plasma may be the first type of donation where alternative criteria can be used to screen gbMSM. This project engages the blood operator and gbMSM communities to ensure that changes can be implemented sensitively, appropriately and effectively. 

This study worked to develop strategies to address any barriers and enablers to source plasma donation for gbMSM, with a strong focus on active community engagement. Using surveys and interviews with gbMSM, interviews with plasma donors, donor centre staff, and focus groups with all stakeholders, this research asks:  

• Do donor centre staff and gbMSM view additional behavioural questions to be acceptable? 

• What may act as barriers or enablers to gbMSM donating source plasma, and to plasma donor centre staff in implementing alternative donor eligibility criteria? 

• What strategies are best suited to address identified barriers and are feasible and acceptable to plasma donation clinic staff and to gbMSM to implement alternative donor eligibility criteria? 

gbMSM Perspectives on the Acceptability of the Plasma Program 

Interviews with gbMSM 

We completed 53in-depth interviews with 27 gbMSM in London, and Calgary. Men were asked about their thoughts on the acceptability of a new plasma donation program that would allow more gbMSM to donate plasma.  Using the Theoretical Framework of Acceptability to analyze the interviews, we found that while many found the program acceptable, there was a tension between four values influencing participants’ views: altruism, equity, supply sufficiency, and evidence-based policy. The program was viewed as welcome progress on a discriminatory policy, and many were excited to participate. However, tension with inequitable aspects of the program undermined support for the program and interest to contribute to it. The program was anticipated to be burdensome for donors. Those burdens were seen as tolerable by interviewees only if the program would be an incremental step to more equitable donation policies for gbMSM. You can read our published manuscript about these interviews here: https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-15424-1  

Survey with gbMSM 

We developed, piloted, and disseminated a questionnaire informed by the Theoretical Domains Framework (TDF). We recruited gbMSM in London and Calgary to an anonymous, online survey. A total of 246 gbMSM completed the survey. On scales from 1 (strongly disagree) to 5 (strongly agree), general intention to donate was high (mean = 4.24; SD = 0.94). The pilot program itself was mostly acceptable (mean = 3.71, SD = 1.16), but the intention to donate under the unique requirements of the pilot program was lower than general intention (mean = 3.58; SD = 1.26). Two domains from the theoretical domains framework (TDF) (beliefs about consequences of donating plasma and social influences) were independently associated with general intention to donate. 

You can read more about the survey here: https://onlinelibrary.wiley.com/doi/full/10.1111/trf.17398 

CBS Staff Perspectives 

We have completed 28 interviews with donor centre staff: 13 in London and 15 in Calgary. We used the Theoretical Domains Framework to analyze the interviews. Three themes representing eight domains captured key tensions: 

1. Valuing inclusive eligibility criteria: staff support inclusive criteria; many were concerned the new criteria remained discriminatory.  

2. Investing in positive donor experiences: staff wished to foster positive donor experiences; however, they worried gbMSM donors would express anger and disappointment regarding the new criteria, staff would experience unease over using stigmatizing criteria and convey nonverbal cues of discomfort, and recurring plasma donors may behave inappropriately.  

3. Supporting education, training, and transparency of eligibility criteria: participants believed providing in-person training (i.e., to explain criteria rationale, address discomfort, practice responding to donor questions) and ensuring donors and the public were well-informed of the upcoming changes would improve implementation. 

You can read more about what we found in staff interviews here: https://onlinelibrary.wiley.com/doi/10.1111/trf.17000 

Regular Plasma Donors Perspectives 

We completed 30 interviews (15 in London and 15 in Calgary) with existing regular plasma donors who made at least 6 donations in the past year, many of whom donated bi-weekly or even weekly. We interviewed these ‘super donors’ to gain further insight into the factors that keep long-term plasma donors donating and their views about expanding plasma donation eligibility for gbMSM.  Factors that facilitated plasma donation among ‘super donors’ included:  

• The comradery and professionalism of the environment in the donor centre 

• Resources provided by CBS to streamline the process of donation (e.g., CBS app) 

• Creating a habit of donation through consistent advance appointment scheduling 

• Altruism  

Factors perceived as barriers to ‘super donors’ to donate included: 

• Lack of knowledge about plasma donation prior to becoming a blood donor (notably not an option for many gbMSM at the time of interviews) 

• Interpersonal conflict or other issues with a staff member  

• Availability of appointment times and proximity to a small number of plasma donor centres  

We have published the protocol for this study, which describes in detail the use of key informant interviews and surveys to identify modifiable factors associated with source plasma donation motives in gbMSM as well as training needs in donation center staff: https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-020-00643-4  

Our integrated knowledge translation approach involved a partnership between researchers, the national blood operators and gbMSM, and situates knowledge users as key research team members to ensure their perspective informs all aspects of the research. 

We established a local advisory group (LAG) of gbMSM that met monthly with the research team. The group provided guidance on MSM participant selection, study materials (surveys and interview topic guides), and recruitment materials and strategies. To maintain knowledge exchange with our CBS knowledge users, we had monthly meetings with several CBS staff across roles throughout the organization.  In addition, we engaged a Transfusion Medicine Nurse Specialist Supervisor from CBS to meet regularly with the research team. We engaged in several bridging activities between our knowledge user groups – Canadian Blood Services and MSM/2SGBTQ+ communities. Our project team facilitated three separate meetings between these groups, and we submitted three letters on behalf of our local advisory group members to CBS outlining feedback on various CBS resources and processes. Our project team submitted reports to CBS throughout the life of the project. This includes two recommendations documents, and our barrier assessment guides including modifications for the launch of Sexual Behaviour Based Screening criteria. Our team also made a presentation to CBS staff regarding barriers to donation for gbMSM. In addition to these reports, we provided two research summaries for inclusion in CBS’ submissions to Health Canada.  

We developed online content in a variety of mediums as a platform for providing information about plasma donation with direct input from our local advisory group designed as a complement to existing CBS online content, and participation in our study.   

This included developing a website to help address barriers to donation for gbMSM communities. Language and content from our site was adopted on CBS’s blood.ca site following the roll-out of new sexual behaviour based screening criteria. Specifically, language and content from the FAQ section on expandingplasma.ca was adopted on blood.ca for both the MSM plasma program and for the current SBBS criteria. Our research findings and ongoing knowledge exchange activities also informed an article released in January 2023 about donors checking their eligibility: https://www.blood.ca/en/stories/so-you-think-you-cant-donate-check-be-sure-help-us-help-patients.   

We produced a short video, disseminated throughout social media channels and embedded on our website, to support gbMSM with the launch of sexual behaviour-based screening criteria. It provides information about the process of donating and screening, including the new SBBS questions asked during screening. We also released an earlier version to support gbMSM in participating in the pilot MSM plasma program.   

Our gbMSM interview, survey and focus group participants were e-mailed a newsletter-style summary report in April 2023. This included a brief lay summary of some of the findings of our research as well as updates on current screening policies and the shift to sexual behaviour based screening criteria.   

Engagement activities and insights from interviews have highlighted opportunities: to be more considerate with language depending on setting (e.g.: MSM is a term used in research but not a term that the community identifies with, which may impact community-facing recruitment to our study and donation generally) and to be mindful of the impact of past deferral policies on current motivation even if policies change (which our project will directly address). While negative sentiment about existing deferral policies exists, there are also many who want to donate if they could. There are opportunities to continue to work closely with the communities to develop and evaluate interventions to address identified barriers from this project. 

Eligibility for gbMSM to donate both whole blood and plasma expanded with the implementation of sexual behaviour based screening (SBBS) in September 2022. However, eligibility does not necessarily translate into increased donors in donation seats. PI Presseau has been awarded funding from the Canadian Institutes of Health Research to continue and further expand upon this research to understand and support a diversity of new donors to donate plasma. This new study will continue to explore optimizing the screening and donation experience of underrepresented donors. While continuing to focus on gbMSM, this project will also focus on the experiences of racialized people who are impacted by whole blood malaria risk eligibility criteria. Furthermore, Co-I Vesnaver has been awarded funding from the Canadian Institute of Health Research to build on this research and examine the experience of blood donation among newly eligible donors (since the implementation of sexual behaviour based screening). This work will identify opportunities to enhance the donation experience in the context of previous exclusion from donation.

Vesnaver, E., Goldman, M., O'Brien, S., MacPherson, P., Butler-Foster, T., Lapierre, D., Otis, J., Devine, D. V., Germain, M., Rosser, A., MacDonagh, R., Randall, T., Osbourne-Sorrell, W., Clement-Thorne, B., Al-Bakri, T. B., Rubini, K. A., Hill, N. E., & Presseau, J. (2020). Barriers and enablers to source plasma donation by gay, bisexual and other men who have sex with men under revised eligibility criteria: protocol for a multiple stakeholder feasibility study. Health research policy and systems, 18(1), 131. https://doi.org/10.1186/s12961-020-00643-4    

Castillo, G., Vesnaver, E., Gibson, E., Butler-Foster, T., Goldman, M., Hill, N. E., Rosser, A., Lapierre, D., Rubini, K. A., MacDonagh, R., Miguel, G., Palumbo, A., MacPherson, P., Randall, T., Osbourne-Sorrell, W., O'Brien, S. F., Bridel, W., Otis, J., Greaves, M., Al-Bakri, T. B., … Presseau, J. (2022). Staff perspectives on barriers and enablers to implementing alternative source plasma eligibility criteria for gay, bisexual, and other men who have sex with men. Transfusion, 62(8), 1571–1582. https://doi.org/10.1111/trf.17000  

Vesnaver, E., Butler-Foster, T., Goldman, M., Gibson, E., Palumbo, A., Lapierre, D., Hill, N. E., MacDonagh, R., Rubini, K. A., Bridel, W., Miguel, G., Rosser, A., MacPherson, P., Randall, T., Osbourne-Sorrell, W., O'Brien, S. F., Otis, J., Greaves, M., Al-Bakri, T. B., Germain, M., … Presseau, J. (2023). Improved access yet inequitable experience: gay, bisexual and other men who have sex with men's views of more inclusive criteria for source plasma donation. BMC public health, 23(1), 768. https://doi.org/10.1186/s12889-023-15424-1   

Vesnaver, E., Gibson, E., Goldman, M., Butler-Foster, T., Hill, N. E., Lapierre, D., MacDonagh, R., Rubini, K. A., Miguel, G., Rosser, A., MacPherson, P., Palumbo, A., Randall, T., Osbourne-Sorrell, W., O'Brien, S. F., Otis, J., Greaves, M., Al-Bakri, T. B., Reid, M., Labrecque, M., … Presseau, J. (2023). Navigating imperfect policies to donate plasma: Survey on plasma donation and a pilot plasma donation program among men who have sex with men in Canada. Transfusion, 63(6), 1172–1183. https://doi.org/10.1111/trf.17398  

Rubini K. A., Al-Bakri T. B., Bridel W., Clapperton A. T., Greaves M., Hill N. E., Labrecque, M., MacDonagh, R., Miguel, G., Orvis, S., Osbourne-Sorrell W., Randall T., Reid M., Rosser A., Presseau J., & Vesnaver E. Call me by the right name: Engaging community members to ensure culturally specific language is used in research. Submitted to Research Involvement and Engagement  

Findings from this research informed the Canadian Blood Services submission to Health Canada for regulatory approval of "Alternative criteria for Men who have Sex with Men, Source plasma donation, London and Calgary" and informed implementation and optimization of that program (Sept 2021).  This research directly informed staff training by incorporating the perspectives of staff and gbMSM on barriers to and enablers of donation, including aspects related to trust and safe spaces. In addition, this research informed how Canadian Blood Services communicated the change to sexual behaviour-based screening by developing website and video content for LGBTQIA+ community members to explain the change in eligibility criteria and the donation process.