LGBTQ+ inclusivity in blood donation: Sexual behavior‐based screening is the first step to getting it right

In this issue of TRANSFUSION, Fisher et al. describe a randomized, three-arm mixed methods study evaluating how current Canadian blood donors reacted to a donor history questionnaire (DHQ) containing questions about individual sexual behavior. Donors were asked to complete either the existing DHQ, which included questions on male donors' sexual contact with other men, a modified DHQ with questions for all donors on recent sexual contact, or a DHQ with the same modified sexual behavior-based questions plus brief explanations as to why the questions were included to mitigate donor discomfort. The authors assert that current donors deemed an individualized sexual behavior-based DHQ acceptable. Donors completing the modified DHQ with mitigating explanations were significantly more likely to find the questions “justified” than donors completing the existing DHQ. Additionally, donors completing the modified DHQ with explanations found the questions significantly less offensive than did the donors completing the existing DHQ or the modified DHQ without explanations. (However, overall offensiveness for all three versions was low). Less than 2% of donors reported that they would stop donating if the DHQ they answered were put into practice; this was true for all three versions. This study is an exciting addition to the literature, especially given the recent shift to sexual behavior-based donor screening in Canada.1 Since the study's recruitment period predated approval of Canada's sexual behavior-based DHQ, gay, bisexual, and other men who have sex with men (gbMSM) donors affected by the policy change were not likely able to participate. Additionally, new donors, whose discomfort may be a more significant deterrent to returning in the future, were grouped with all donors with 5 or fewer donations. This discomfort could be especially notable for LGBTQ+ (lesbian, gay, bisexual, transgender, queer or questioning, and other sexual orientations/gender identities) individuals, who have been historically marginalized by the blood donation policies restricting gbMSM donors. It is crucial that the blood banking community partners with the LGBTQ+ community, in particular gbMSM individuals, to advocate together for a donor screening strategy that is evidence-based and equitable. This effort is now of paramount importance in the United States given the recent Food and Drug Administration (FDA) draft recommendations proposing individual sexual behavior-based donor screening.2 It is important to understand the history of deferrals for gbMSM donors in the United States to contextualize the recent FDA recommendations. The term “MSM” originated during the HIV/AIDS epidemic in the 1980s when the prevalence of HIV/AIDS was disproportionately high in gbMSM.3 With growing evidence that a bloodborne pathogen was the cause, the FDA adopted policies to keep the blood supply safe, including indefinitely deferring “men who have had sex with another man even one time since 1977.”4 However, even with the introduction of donor blood testing for HIV antibodies and antigen in 19855 and critiques that the FDA policy was based on outdated and discriminatory conceptions of LGBTQ+ persons rather than scientific evidence, the FDA did not implement a 12-month deferral for gbMSM donors until 2015.6-9 Despite making progress, this change still resulted in a functional lifetime ban on most gbMSM individuals based solely on gbMSM status. In 2020, the deferral period for gbMSM donors was further shortened to 3 months in response to the national blood shortage in the early months of the COVID-19 pandemic.10 In 2021, the FDA-sponsored ADVANCE Study (Assessing Donor Variability And New Concepts in Eligibility) began. ADVANCE was designed to investigate the efficacy of individual sexual behavior-based questions to assess the risk of HIV infection among potential gbMSM donors. Subjects were gbMSM between the ages of 18 and 39 years living in eight metropolitan areas with high rates of new HIV infections and/or active pre-exposure prophylaxis (PrEP) programs. Study enrollment ended on September 30, 2022; at this writing, results from the ADVANCE study have not yet been made public. In January 2023, the FDA released draft recommendations supporting the adoption of individualized, sexual behavior-based donor screening questions.2 The revised DHQ would ask all prospective donors, regardless of sexual orientation and gender, about new or multiple sexual partners within the past 3 months and anal intercourse with any of these partners. Potential donors who have had anal intercourse with a new sexual partner or multiple sexual partners within the past 3 months would be deferred from blood donation for 3 months. All other donors (who meet all other eligibility criteria) would be eligible to donate. In addition to the ADVANCE study, the FDA cited multiple data sources that informed the recommendations: findings from the United Kingdom and Canada (where similar individual sexual behavior-based policies have been implemented); data from the Transfusion Transmissible Infections Monitoring System; and efficacy data for nucleic acid testing for HIV, which has dramatically shortened the window period to approximately 9 days.11 While previous policies for gbMSM blood donor eligibility varied considerably among countries with similar HIV epidemiology, there has been an international trend toward individualized sexual behavior-based screening in recent years. For example, the same sexual behavior-based screening criteria proposed by the recent FDA draft recommendations were implemented between 2021 and 2022 in the United Kingdom,12 Canada,1 and Israel.13 In 2022, France and Greece also announced the removal of questions related to sexual orientation from donor screening.14 This is a stark contrast to the previous international landscape, which included time-based deferrals of varying duration for gbMSM donors in the United Kingdom, Canada, and France; indefinite deferral for gbMSM donors who had sexual contact with a man since 1977 in Greece; a “plasma quarantine” program followed by re-testing of gbMSM donors for transfusion-transmitted infections in Israel and France; and individualized sexual behavior-based screening administered by physicians without a national standardized questionnaire in Italy and Spain.15 Given the similarities in HIV epidemiology among these countries, the varied stringency of deferrals for gbMSM donors highlighted the arbitrary nature of policy on the topic. It is invigorating to see the global blood banking community converge toward a more equitable, sexual behavior-based donor screening system. While the term “MSM” is widely used in medical research and policy that discusses blood donation, there is limited literature describing the perspectives of LGBTQ+ people on the topic. Two publications from the United States performed before and after the institution of the 12-month deferral period for gbMSM studied the desire of gbMSM to donate blood and adherence to the contemporaneous deferral periods.16, 17 Both studies, with hundreds of LGBTQ+ participants each, found that an overwhelming majority (over 85%) were interested in donating blood if restrictions were changed. Similar findings were observed in studies on perceptions of 12-month gbMSM deferrals in Israel and Australia, in which over 60% of participants would consider donating blood if able.18, 19 Qualitative studies in Canada of gbMSM perspectives on 3-month deferrals and a hypothetical plasma quarantine also identified enthusiasm toward blood donation and criticism of screening donors based on gender and sexual orientation.20, 21 These findings suggest that individuals prohibited from donating blood due to gbMSM deferrals will readily donate when such policies are removed. Regardless of the enthusiasm for blood donation demonstrated by individuals previously ineligible based on identity-based gbMSM deferrals, it is crucial for the blood banking community to embrace repair work that seeks to rebuild trust with the LGBTQ+ community. While removing identity-based gbMSM questions from donor screening is an important step toward inclusivity, this change alone does not correct the historical wrongs perpetuated through decades of discriminatory policy. As suggested by public health scholar Nathan Lachowsky in response to Canada's shift to sexual behavior-based screening, effective repair work requires an apology and proactive inclusion of the LGBTQ+ community.22 For blood donation to become truly LGBTQ+ inclusive in the United States, transfusion medicine professionals must demonstrate a genuine dedication to forming collaborative partnerships with the LGBTQ+ community. Additionally, community outreach-based recruitment efforts have been shown to successfully increase new donors from marginalized communities.23 LGBTQ+ persons who were previously deferred from the donation (as well as allies who refused to donate in solidarity) may be more willing to donate if blood donor centers organize outreach efforts through partnerships with their local LGBTQ+ community. While shifting to sexual behavior-based screening would eliminate explicit discrimination on the basis of sexual orientation and/or gender, careful attention must be paid to avoid stigmatization of sexual behaviors that lead to deferral. An updated DHQ may require blood banking personnel to discuss the new potentially sensitive sexual behavior-based questions, which they are not accustomed to navigating. To this end, Canadian Blood Services established a variety of initiatives focused on LGBTQ+ inclusion, including sex positivity training, in response to Canada's shift to sexual behavior-based screening.24 While the United States blood banking community waits for the FDA's draft recommendations to be finalized and implemented, we have a unique opportunity to develop a standardized sex positivity curriculum through partnership with LGBTQ+ individuals. In the meantime, there are many free online resources that transfusion medicine professionals can access to begin to educate themselves including the Human Rights Campaign (HRC) report, “Being an LGBTQ Ally,”25 and PFLAG Academy.26 When creating sexual behavior-based questions, the impact of language must be considered. Framing donor screening as a “risk-based” assessment could perpetuate stigmatization of individuals who engage in sexual behaviors labeled as “risky” for blood donation. The FDA and the United States transfusion medicine community can prioritize inclusivity by describing revised screening practices as “sexual behavior-based” rather than “risk-based,” as has been the practice in Canadian Blood Services materials,1 and welcoming the perspectives of LGBTQ+ individuals when crafting the specific wording for an updated DHQ. Incorporating this study's “mitigating explanations” into the DHQ, with a brief justification of the scientific reasoning behind sexual behavior-based questions, could also be a particularly useful step to combat stigmatization. The FDA's recent draft recommendations would not change the eligibility of donors who use oral or injectable HIV pre−/post-exposure prophylaxis (PrEP/PEP) medications, which result in 3-month or 2-year deferral, respectively.27 There is limited data about the detection of HIV RNA in early cases of breakthrough infections in individuals taking PrEP.28 The scant evidence available suggests that seroconversion and the detection of HIV antibodies may be delayed in individuals taking, or having recently taken, PrEP. Perhaps the next iteration of the ADVANCE study could specifically recruit individuals taking PrEP and serially perform the same highly sensitive HIV tests currently used for transfusion-transmitted infection screening. This may help narrow down the window period for RNA detection to guide more evidence-based blood donor eligibility criteria for people taking PrEP. Research investigating PrEP/PEP deferrals will be another step toward LGBTQ+ inclusivity in transfusion medicine practices, due to the historical emphasis on gbMSM in PrEP clinical trials and practice guidelines until the Centers for Disease Control and Prevention expanded its indications for PrEP counseling in 2021.29 Continued PrEP/PEP deferral policies without a strong evidence-based justification may create implicit discrimination against potential gbMSM donors even though the policy does not explicitly tie deferral to gender or sexual orientation. By emphasizing the value of PrEP as an HIV prevention tool and affirming that “undetectable = untransmittable” applies only to sexual contact at this time, transfusion medicine professionals can play a key role in providing non-stigmatizing, sex-positive messaging to potential donors who are deferred because of PrEP use. We are on the precipice of eliminating outdated policies barring willing donors based on historical homophobia rather than evidenced-based, scientific practice. As individualized sexual behavior-based questions are added to the DHQ, the blood banking community must proactively connect with the LGBTQ+ community, acknowledge historical wrongs, and work to rebuild trust. Sex positive training for donor center personnel, intentional language in the DHQ, and additional investigations on PrEP/PEP medication deferrals are also crucial steps to creating an LGBTQ+-affirming environment for blood donation. Ultimately, the recent FDA draft recommendations represent the starting point, not the end goal, to embracing inclusivity in blood banking.

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