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A new study funded by the Food and Drug Administration is seeking to develop donor screening questions to determine risk of transmission of blood-borne diseases, in the hope of eventually eliminating the de facto ban on gay and bisexual men donating blood.
The ADVANCE Study, as it is known, involves three of the nation’s largest blood centers: Vitalant, OneBlood, and the American Red Cross.
All three centers will determine risk factors of individual participants and take blood samples to determine if the screening questions successfully weed out those at risk of transmissible diseases like HIV or hepatitis.
To recruit participants for the study, the blood centers are currently working with LGBTQ centers and local health clinics in San Francisco, Orlando, and Washington, D.C., and have plans to expand to sites in Miami, Memphis, Los Angeles, Atlanta, and a New Orleans/Baton Rouge joint site.
Eligible participants need to be gay or bisexual men, between the ages of 18 and 30, who are interested in donating blood and have had sex with at least one other man in the three months prior to the study, and who live in one of the eight communities where the study is being performed.
Through their partner organizations’ outreach efforts, study authors hope to enroll about 250 participants at each site, or 2,000 overall.
The study is expected to last a full year, and, if successful, could lead the FDA to revise its current guidelines recommending a deferral period for gay and bisexual men.
“The study is an opportunity for the community, particularly gay and bisexual men, to get involved and to attempt to try to change the current policy, and incorporate us into the system so that we can donate blood safely and effectively without discrimination,” says Christopher Cannon, the director of research operation at the local federally-qualified community health center Whitman-Walker Health, which is running outreach efforts in the D.C. area. Whitman-Walker will refer potential participants to the American Red Cross, which will actually do the blood collection and analysis.
Cannon explains that researchers will develop and ask risk assessment questions and determine, through statistical analysis, if the screening questions successfully flagged participants at higher risk of transmissible diseases, such as those with more sexual partners, or who engage in condomless sex on a regular basis.
If the FDA determines that the screening criteria is effective, it would then likely move to institute a policy change that would eliminate the deferral period for men who have sex with men.
“The main part of the study is determining sexual risk and the idea that this risk-based assessment will become universal, that it won’t just be isolated to gay and bisexual men,” Cannon says. “Because right now, the general question is: have you had sex with a man since 1977? … So the idea is to create a risk assessment that would be universal, based on to individual activities and risk to determine [blood donor] eligibility criteria.
“This will also be looking at how PrEP will be playing into the equation of risk assessment and risk behavior,” he adds. “So they’ll start testing to see if people are taking PrEP, as part of the laboratory screening that they’re doing.”
Daniel Bruner, the senior director of policy at Whitman-Walker Health, says the fundamental aim of the study is to be able to identify specific behaviors over a short period of time that are associated with any kind of measurable risk of transmitting HIV or other blood-borne diseases.
If those specific behaviors and a short “window period” during which diseases might develop or be transmitted can be determined, the FDA would be able to pinpoint specific behavior, rather than relying on outdated screening, developed at the height of the AIDS epidemic, that singles out men who have sex with men.
“At the end of the day, there would be some individuals who still would be deferred or would not be able to donate blood. But it would be, first, a whole lot fewer people. And, second, the reason for it would be very recent high risk behavior, as opposed to tarring everyone with the same brush just because they’re not heterosexual,” Bruner says.
Bruner notes that Whitman-Walker Health has been advocating for the elimination of its blanket deferral policy for gay and bisexual donors for years, arguing that it is unnecessary and stigmatizing, and that there are other ways of ensuring the safety of the blood supply.
But for many decades, the FDA had refused to budge from its 1980s-era position, only moving to a one-year deferral period a little more than five years ago and a three-month deferral period in April of 2020.
“2015 was the first time in a number of years that the FDA actually started a regulatory process to examine what the deferral period was, which was essentially a lifetime, if you were a man who had sex with another man at any time since the early 1970s,” Bruner says. “So once they started to look at that process or that policy, we were in there along with, you know, other medical groups and advocacy groups, and our position was that at most, there should be a deferral period of no more than a month. Certainly not a lifetime, or one year, or three months.”
Bruner adds: “Even that wasn’t really the right way or the best way to go, that there should really be an assessment of each individual who wants to donate based on their own sexual behavior.”
Despite the frustration of activists at the slow pace of the FDA’s willingness to change its policy on blood donations, Bruner says the FDA, through the ADVANCE Study, is signaling its openness to change the policy, but wants to find sufficient evidence that would foster enough support for doing so, both in the scientific community, and among the political class — some of whom may be inclined to scare-monger if the FDA begins revising its own guidelines.
That said, he notes, there wasn’t as much opposition, even under the Trump administration, from senior FDA officials as one might expect.
“It’s important to remember that these discussions with senior FDA people were going on pretty much all during the four years at the Trump administration. And those officials were still with us on how they were headed,” Bruner says. “And perhaps one reason things have moved pretty slowly in the past several years is that those officials, during the Trump years, felt like the best thing was to proceed cautiously and to keep things under the radar, rather than risk coming to the attention of political appointees who might have had a different view…. But our sense has been that even the FDA commissioners, the political appointees during the Trump years, were not at all opposed to developing a study to make blood donation policy more scientifically-based.”
Bruner expresses hope that, even if the balance of political power should shift, the policy change would still move forward, noting: “We have not seen that there is real opposition to this among Republicans on the Hill.”
At the same time, Bruner notes that the LGBTQ community is justified in its frustration at the slow pace of change — but hopefully, the ADVANCE Study will serve as the light at the end of a dark tunnel for those men who have sex with men who wish to donate blood and plasma.
“There are a lot of folks in the community, that, in this day and age, want to donate blood to help people that they know or care about. And they’re turned away for what seems, to them, to be an irrational reason,” he says. “And it’s frustrating that it takes this long to turn the ship around or change the direction of the ship, but we are encouraged that the agency is moving in the right direction and will continue to do so.”
For more information on the ADVANCE Study or questions about enrolling, visit www.AdvanceStudy.org.
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