OneBlood Chief Medical Officer Rita Reik speaks with a member of the press at the LGBT+ Center in Orlando May 20. (Photo by Tomás Diniz Santos)
OneBlood, Vitalant and the American Red Cross — three of the nation’s largest blood centers — have launched a pilot study funded by the U.S. Food and Drug Administration (FDA) that may lead to changes to blood donor eligibility for men who have sex with men (MSM).
The study — called the ADVANCE study, which stands for Assessing Donor Variability And New Concepts in Eligibility — focuses on finding alternatives to the FDA’s blood donor deferral policy for MSM, which the FDA currently recommends that MSM be deferred from donating blood for three months following the most recent sexual contact with another man.
“We’re hoping to learn that this broad time-based deferral is really not the best approach. That asking the individual about, ‘What did you do Saturday night,’ is a better way to protect the blood supply but, even if you’re not a scientist, you can imagine how complicated that algorithm is for trying to sort through all of that, so we need to have a certain number of people to have enough power in the study to give significance to any findings,” says Rita Reik, M.D., chief medical officer for OneBlood.
For this study’s purpose to be possible, Reik says, the donor history questionnaire would need a change. The questionnaire consists of several questions that all potential blood donors answer before donating. They assess risk factors that could determine possible infection with a transfusion transmissible infection, including HIV.
“If the scientific evidence supports the use of the different questions it could mean gay and bisexual men who present to donate would be assessed based upon their own individual risk for HIV infection and not according to when their last sexual contact with another man occurred,” said Susan Stramer, Ph.D., vice president of Scientific Affairs, with American Red Cross Biomedical Services.
The three blood centers involved with the study combined represent approximately 60% of the total blood supply in the United States.
The blood centers are partnering with LGBTQ+ Centers across eight cities which consist of Miami, Orlando, Washington D.C., Los Angeles, Atlanta, New Orleans/Baton Rouge, San Francisco and Memphis. A total of 250-300 participants from each area will be enrolled in the study.
“The study participants are a very select group. They’re males who are between 18 and 39 years old. It had been 30 years old, but the FDA just raised it to 39 years old to try to increase participation and they have to express an interest in possibly at one point being a donor,” Reik says.
The FDA will review the findings and research upon receiving the data from the ADVANCE study and decide the steps for the future then.
Scott Moriczdetecso, a participant in the ADVANCE study in Orlando, says his immediate reaction to finding out about the study was to participate, especially since the first time he learned about the blood donation ban on MSM was when he heard of the study.
“Change is something that happens over time and in small steps. It’s usually very small steps, so this is just one small step towards a much bigger step,” Moriczdetecso said. “It’s finally getting gay people to be able to stand in a room or donate blood and not be ‘a gay person’ but just another person in the room.”
To learn more about the ADVANCE study or to enroll, visit their website at ADVANCEStudy.org.
