New study may lead to notable change in blood donor eligibility for gay men
BY MARK ARIEL
Three of the nation’s largest blood centers—Vitalant, OneBlood, and the American Red Cross—are conducting a pilot study funded by the U.S. Food and Drug Administration (FDA) that could lead to a significant change to blood donor eligibility for men who have sex with men.
The study is called the ADVANCE Study, which stands for Assessing Donor Variability And New Concepts in Eligibility.
The purpose of the study is to gather the necessary data to evaluate if individual risk factor questions are as effective as the current time-based deferral for sexually active gay and bisexual men in limiting HIV in the blood supply.
“The study is supported by partnering LGBTQ+ community organizations in each of eight cities we are recruiting in,” states Lauren A. Crowder, Project Manager for the ADVANCE Study for the American Red Cross.
In an interview with THE FIGHT Crowder talks about past and current policies regarding blood donation from gay men and qualifications for the study.
What are the current restrictions on gay men in terms of blood donation?
The FDA is responsible for ensuring safety of the blood supply within the US. As such, they regulate all aspects of blood donation to ensure the safety of the blood supply, blood donors, and patients who receive blood transfusions. All blood centers are regulated by the FDA and are required to comply with all regulations established by the FDA. The current recommendations by FDA state that sexually active gay and bisexual men should be deferred from donating blood for 3 months since their most recent sexual contact with another man. Over the past 40 years, this deferral has changed from a lifetime deferral from the mid-80s until 2015, to a 12-month deferral since last sexual contact from December 2015 through April 2020, and is now a 3-month deferral. The FDA has stated they are committed to ongoing evaluation of this deferral policy and potentially advancing policy based on available scientific evidence.
Eligible participants who complete all parts of the study visits will receive $85 for participating.
What type of qualifications will participants need to meet the study inclusion criteria?
The goal is to recruit 2,000 gay and bisexual men (male sex as assigned at birth), age 18-39 who live in the greater metropolitan areas of Los Angeles, San Francisco, Memphis, New Orleans/Baton Rouge, Atlanta, Orlando, Miami/Fort Lauderdale, and Washington, D.C. Participants are required to be sexually active with at least one male partner in the last 3 months, have no history of HIV infection or recent history of STDs, and have an interest in blood donation at some point in the future.
If our readers would like to participate in the study—what steps will they need to take?
Anyone who is interested in participating in the ADVANCE Study should visit www.advancestudy.org to learn more and sign up for an appointment. In the Los Angeles area, there are three study locations enrolling participants: the Los Angeles LGBT Center in Hollywood (1625 N. Schrader Blvd.), the Culver City American Red Cross Blood Donation Center (5359 Sepulveda Blvd.), and the Pasadena American Red Cross Blood Donation Center (2471 E. Walnut St.).
Eligible participants will be seen at any of these locations for two study visits. The first visit takes about 30 minutes to complete and will include an eligibility questionnaire, risk factor questionnaire, and a blood draw for HIV and PrEP testing. The second visit will occur approximately 3 weeks later and will take another 30 minutes including results reporting for the HIV and PrEP testing, as well as another questionnaire. Eligible participants who complete all parts of both study visits will receive $85 for participating.
For more info visit www.advancestudy.org.
