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Background and Objectives: Two-Spirit, trans, nonbinary and other gender-diverse (2STGD) donors face challenges in donation. While many blood operators aim to address these challenges, to date, no empirical study with these donors has been conducted to guide their efforts. This paper reports 2STGD donors' views on a two-step approach asking donors their gender and sex assigned at birth (SAAB), and expanding gender options in donor registration., Materials and Methods: A qualitative community-based study was conducted with 2STGD donors (n = 85) in Canada. Semi-structured, in-depth interviews were conducted from July to October 2022, audio-recorded and transcribed. Data were analysed using a thematic analytic framework., Results: Participants were divided on their views of a two-step approach asking gender and SAAB. Themes underlying views in favour of this approach included the following: demonstrating validation and visibility, and treating 2STGD donors and cisgender donors alike. Themes underlying views not in favour or uncertain included potential for harm, compromising physical safety, and invalidation. All participants were in favour of expanding gender options if blood operators must know donors' gender., Conclusion: Results indicate that a two-step approach for all donors is not recommended unless the blood operator must know both a donor's gender and SAAB to ensure donor and/or recipient safety. Gender options should be expanded beyond binary options. Ongoing research and evidence synthesis are needed to determine how best to apply donor safety measures to nonbinary donors., (© 2024 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.)

Competing Interests: The authors declare no funding or conflicts of interest.

Background: In 2021, Canada implemented a pilot plasma program allowing some sexually active men who have sex with men (including but not limited to gay and bisexual men; gbMSM) to donate plasma. Changes to plasma donation policy could help address inequities in access to plasma donation and increase Canada's domestically collected plasma supply if more gbMSM donate as a result. We aimed to (1) examine views regarding plasma donation and the pilot program prior to implementation and (2) identify modifiable theory-informed predictors of gbMSM's intention to donate plasma., Methods: We developed, piloted, and disseminated a questionnaire informed by the Theoretical Domains Framework (TDF). We recruited gbMSM in London (ON) and Calgary (AB) to an anonymous, online cross-sectional survey., Results: 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., Discussion: The pilot plasma program as an incremental step toward more inclusive policies was mostly viewed as acceptable by the impacted communities. Historical and ongoing exclusions create unique barriers to donation. There are clear opportunities for developing theory-informed interventions to support gbMSM to donate plasma as policies continue to become more inclusive and more become eligible to donate., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: Canada has incrementally reduced restrictions to blood and plasma donation that impact men who have sex with men, gay, bisexual, and queer men, and some Two Spirit, transgender and non-binary individuals (MSM/2SGBTQ+). Prior to the launch of a pilot program in 2021 enabling some MSM/2SGBTQ + to donate source plasma, we explored the acceptability of the program among individuals who could become eligible to donate in the program., Methods: We invited men identifying as MSM/2SGBTQ + to participate in two consecutive semi-structured interviews to explore their views on blood and plasma donation policy, plasma donation, and the proposed Canadian plasma donation program. Interview transcripts were analyzed thematically and acceptability-related themes were mapped onto the Theoretical Framework of Acceptability., Results: Twenty-seven men identifying as having sex with men participated in 53 interviews. Eighteen themes were mapped onto the seven construct domains of the Theoretical Framework of Acceptability. Underlying all aspects of acceptability was a tension between four primary values influencing participants' views: altruism, equity, supply sufficiency, and evidence-based policy. The program was viewed as welcome progress on a discriminatory policy, with many excited to participate, yet tension with inequitable aspects of the program undermined support for the program and interest to contribute to it. The high demands of the program are unique for MSM/2SGBTQ + and are only tolerable as part of a program that is an incremental and instrumental step to more equitable donation policies., Conclusion: Findings highlight past experiences of exclusion in Canada as a unique and critical part of the context of the donation experience among MSM/2SGBTQ+. Despite the program's goals of greater inclusivity of MSM/2SGBTQ + individuals, the anticipated experience of the program included continued stigmatization and inequities. Future research should seek to understand the experienced views of MSM/2SGBTQ + donors to ensure that as policies change, policies are implemented equitably., (© 2023. The Author(s).)

Background: Canadian Blood Services introduced new eligibility criteria that allows some sexually active gay, bisexual, and other men who have sex with men (gbMSM) to donate source plasma, marking a significant change from time-based deferral criteria. We aimed to identify potential barriers and enablers to implementing the new criteria from the perspective of donor center staff., Study Design and Methods: We conducted Theoretical Domains Framework-informed interviews with staff from two source plasma donation centers in Canada., Results: We completed 28 interviews between June 2020 and April 2021. Three themes representing eight domains captured key tensions. Valuing inclusive eligibility criteria: staff support inclusive criteria; many were concerned the new criteria remained discriminatory. 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. 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., Discussion: Participant views emphasize the importance of supporting staff through training and transparent communication to optimize the delivery of world-class equitable care for a new cohort of donors who have previously been excluded from plasma donation. Findings inform which staff supports to consider to improve implementation as policies continue to shift internationally., (© 2022 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: Blood donation policy in Canada for gay, bisexual and other men who have had sex with men (gbMSM) has changed progressively in the last decade from indefinite deferral to 3-month deferral from last male-to-male sex. Driven by safety data and overseen by the national regulator, more inclusive policies continue to redress the disparity in donation for gbMSM. At the same time, the need for source plasma to prepare fractionated blood products is growing worldwide. The collection and processing of source plasma ensures greater safety compared to whole blood donation with respect to transfusion-transmitted infection. This greater safety offers an opportunity to evolve policies for gbMSM from time-based to behaviour-based deferral using revised eligibility criteria. However, changing policies does not in itself necessarily guarantee that gbMSM will donate or that staff in donor clinics are ready to support them to do so. In anticipation of a move to behaviour-based donation screening for gbMSM in Canada, we aim to assess the acceptability of and perceived barriers and enablers to source plasma donation using revised screening criteria for gbMSM among key stakeholders to inform policy implementation strategies., Methods: This mixed-methods feasibility study will involve gbMSM and donor centre staff to understand modifiable barriers to implementing more inclusive eligibility criteria. Key informant interviews and surveys will be rooted in the Theoretical Domains Framework to identify modifiable factors associated with source plasma donation motives in gbMSM and training needs in donation centre staff. We will use an integrated knowledge translation approach involving a partnership between researchers, the national blood operator and gbMSM, situating knowledge users as key research team members to ensure their perspectives inform all aspects of the research., Discussion: Our integrated knowledge translation approach will provide a more comprehensive and collaborative understanding of blood operator and gbMSM needs while accelerating the implementation of study findings. Given the historical backdrop of the decades of exclusion of sexually active gbMSM from blood donation, this study has the potential not only to inform a process and policy for gbMSM to donate source plasma, a blood product, but also offers opportunities for new relationships between these knowledge users.

Background: Polycythemia is the most common adverse effect of testosterone replacement therapy (TRT) and may predispose patients to adverse vascular events. Current Canadian guidelines recommend regular laboratory monitoring and discontinuing TRT or reducing the dose if the hematocrit exceeds 54% (hemoglobin ≥180 g/L). This threshold has been interpreted by some physicians and patients to indicate the need for phlebotomy or blood donation while on TRT., Study Design and Methods: We reviewed all male blood donors in Southwestern Ontario at Canadian Blood Services from December 2013 to March 2016 who self-identified or were found on donor screening to be on TRT. Hemoglobin concentration was measured at the time of donation or clinic visit and with each subsequent appointment in repeat donors., Results: We identified 39 patients on TRT who presented for blood donation over a 2-year period. The mean hemoglobin level at all clinic visits was 173 g/L (range, 134-205 g/L; n = 108). Hemoglobin concentrations of 180 g/L or more (calculated hematocrit, ≥54%) were measured at 25% of appointments. Of the 27 repeat donors, 12 (44%) had persistently elevated hemoglobin levels (≥180 g/L) at subsequent donations., Conclusion: Hemoglobin concentrations were elevated in donors on TRT, and significant numbers had hemoglobin levels above those recommended by current guidelines. These data also suggest that repeat blood donation was insufficient to maintain a hematocrit below 54%. Our findings raise concerns about the persistent risk of vascular events in these donors, particularly when coupled with the misperception by patients and health care providers that donation has reduced or eliminated the risks of TRT-induced polycythemia., (© 2017 AABB.)