by Chris Reeder Young
The early 1980’s were both a terrifying and confusing time as the HIV/AIDS epidemic surged through communities. Medical institutions, public health leaders, and blood donation suppliers raced to make sense of it all.
Amidst the quick reaction to manage potential HIV transmission in the blood supply, public health leadership and scientists made policy recommendations to ban men who have sex with men (termed MSM in policy) from donating blood. So, while little was known, much effort to address HIV transmission in the blood supply was placed on the assumption that banning MSM was the only “trustworthy” line of defense to prevent exposure as the time period lacked the advanced screening and cultural understanding we have now.
The most recent U.S. Food and Drug Administration (FDA) policy on MSM blood donations was revised in April 2020 that changed a December 2015 twelve-month deferral policy to a three-month deferral policy. The blood donor questionnaire states the following: if a person who is MSM, whether Assigned Male at Birth (AMAB) or Assigned Female at Birth (AFAB) has sex with another MSM, then they have to wait three months while abstaining from sexual activity before donating blood. This is a limiting policy.
This policy ignores that people can be sexually active and safe simultaneously, and indeed ignores many heterosexual risk scenarios. Scientific communities are piloting blood donation processes that identify individual risk rather than leaning on the assumption that all MSM are high risk even if they are in committed monogamous relationship and/ or use safe sex practices. This is an effort to be more inclusive, less discriminatory, and also encourage more blood donation via previously excluded populations. For example, a UK study found that a shift from their five-year deferral policy for MSM to a one-year deferral policy generated a 46% increase of MSM who could donate blood safely.
The ADVANCE Study in Memphis
Regardless of sexual identity and orientation, some aspects of the current policy makes potentially eligible gay and bisexual men blood donors completely ineligible (e.g. a sexually active monogamous couple) when the US is in a blood supply crisis.
One of the first steps in changing the deferral policy is to update the intake donor history questionnaire that a person fills out before donating. The FDA is funding a study called Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) that will pilot a more inclusive questionnaire for individuals to define their own sexual histories more thoroughly.
To help implement the study and to connect with people whose experiences will inform the study most effectively, the FDA is working with the three of the largest US blood donation centers, Vitalant, OneBlood, and the American Red Cross in areas of the country with documented high rates of HIV acquisition, which includes Memphis. Each city and blood donation center is working with LGBTQ+ anchors in those areas and is seeking to cumulatively enroll 2,000 MSM/gay/bisexual men who meet the study eligibility criteria.
In Memphis, Vitalant is working with LGBTQ+ anchors such as Friends for Life, the Corner, and OUTMemphis on outreach efforts to recruit at least 250 participants. One participant, Shahin Samiei, shared that he chose to participate in the study because “the cultural context of blood donation is rooted in 1980’s fear and that the current scientific policy is lagging indicator of science and harmful stigma, not a reflection of organized steps in the right direction toward equity and safety in blood donations. It’s wild that we have enough data in the last 40 years to update policy, and we are still in the same place profiling and stigmatizing MSM who could donate blood. The ADVANCE study is an opportunity to change those policy features by removing sexual health stigmas through open and honest individual questionnaire assessments and utilizing our voices to inform official policy spheres with the FDA. We know so much more, we can do so much better, so by golly, let’s do it.”
Dr. Brian Custer, Director of Epidemiology and Policy Science at Vitalant Research Institute (VRI) San Francisco and Vice President of Research and Scientific Program at Vitalant highlighted that the Memphis ADVANCE Study is seeking to enroll 250 participants to go through a mock blood donation process, wherein MSM fill out a pilot questionnaire and consent to a blood draw (not a full blood donation). The questionnaire assesses individual and personal risk factors and the participant is fully informed of the testing of the blood draw. The aggregated analysis of the work in Memphis and other study locations will inform what “higher risk” behaviors actually means in relation to HIV/AIDS prevalence given safe sex practices and behaviors such as monogamy.
Custer continued to share that there are social and political pressures to expand and include current evidence- based policy in order to address discrimination and inequities in blood donations, especially when groups refuse to host donations on the basis of old, exclusive policy. He shared, “Memphis has a significant [blood] shortage, and even if the FDA changes the blanket deferral policies on MSM, we will still have some shortages. Working to address dated policy will also help to attract allies who currently may not be donating because they are acting in solidarity with MSM. Currently, three out of four units of blood transfused in Memphis do not come from Memphis. The need for blood for transfusions is not going away. This pilot is also opening conversations about how we get as many people as possible to be donors in a way that is safe and fair to all.”
After the 2016 Pulse Club Massacre in Orlando, people lined up to donate blood. Unfortunately, MSM were deferred based on restrictive and discriminatory guidelines when they could have otherwise donated to a disaster in their own community. The need for improved blood donation policy couldn’t have been more crucial. “Accidents and traumas happen every day, there were huge groups of people who were trying to donate to the Pulse victims but couldn’t because of policy that was set in stone. Piloting studies like ADVANCE can chip away at that stone”, Samiei shared.
Catherine Sullivan, Epidemiology Research Associate with Vitalant, shared one instance where a terrible tragedy could inform more honorable blood donation policy. On the fifth anniversary of the Pulse Massacre, members of Congress issued a letter to thank and encourage the FDA for the ADVANCE study as it reflected a “willingness to engage in discussion related to the deferral policy, but emphasized that reductions in the deferral period should not be tied to sexual orientation or disaster-based supply issues. An individual’s risk profile, regardless of sexual orientation and based on scientific and technological progress, should guide the policy.” This congressional support made huge strides in piloting work that could improve the blood donation supply and donor equity.
The Future of Blood Donation Policy
Sullivan emphasized that working with LGBTQ+centers is significant to the success of a study like this, “I feel fortunate to be able to work with the Corner, Friends for Life, and OUTMemphis. One of our considerations for implementing the study includes where to meet with participants and making sure that it is as welcoming as possible for anyone who may identify as LGBTQ+, and a blood donation center doesn’t feel very welcoming. That makes a big difference for people’s willingness to join the study and the Corner is ideal for this as I meet with participants and encourage a comfortable environment.”
As a public health researcher and participant, Samiei said, “if more folks talk about these things, and the types of inclusive details on the sexual history questionnaires, it will encourage people to stay tested, be more comfortable, and it can inform conversations about health disparity and how certain groups of people are treated differently in healthcare policy. This could make profound changes for future MSM blood donations. It can keep the supply safe while also saving lives. We are generating science and conversations that are proximally and distally addressing future public policy.”
Thanks to science, epidemiology, and LGBTQ+ infused voices that inform the collective understanding of HIV/AIDS, the US has strategies on how to keep donors and recipients safe. However, we still have a way to go for improving strategies. There are still elements of inequitable, archaic assumptions that limit MSM from donating more immediately to the much, much needed blood supply. This study is pivotal for changing policy to include more blood donors, to save more lives, but also expanding public health discussion around HIV/AIDS.
For more information, please visit: https://advancestudy.org/ or call Catherine directly at 901-529-6363.
Eligible participants can earn up to $85 for participating in the pilot study.
