A pilot study funded by the U.S. Food and Drug Administration (FDA) that could potentially lead to changes to blood donor eligibility for men who have sex with men is underway and seeking participants in 8 U.S. cities.
The ADVANCE study, which stands for Assessing Donor Variability And New Concepts in Eligibility, is focused on evaluating alternatives to the FDA's blood donor time-based deferral policy for men who have sex with men (MSM). FDA currently recommends that a man who has had sex with another man be deferred from donating blood for three months following the most recent sexual contact with another man. In April 2020, the FDA adopted this three-month deferral policy, shortening the deferral period from the previous 12-month period.
The ADVANCE study is a first step in providing data that will help the FDA determine if a blood donor history questionnaire (DHQ) based on individual risk could be as effective as the time-based deferral in reducing the risk of HIV among gay and bisexual men who present to donate blood. For this to be possible, a change would need to be made to the blood donor history questionnaire. The DHQ consists of a series of FDA-regulated questions that all potential blood donors must answer before donating. The questions are written to identify risk factors associated with transfusion-transmissible infections, including HIV, that may affect the safety of the blood product.
Three of the nation's largest blood centers, Vitalant, OneBlood, and the American Red Cross, which together represent approximately 60% of the blood supply in the United States, are conducting the study. To gather the necessary data the blood centers are partnering with LGBTQ+ centers in Atlanta, Los Angeles, Memphis, Miami, New Orleans/Baton Rouge, Orlando, San Francisco, and Washington, DC, to reach and engage the gay and bisexual community. The study sites in those eight communities are seeking gay or bisexual men aged 18 to 39 to participate.
Eligible participants in the study will have a blood sample drawn for HIV testing and will answer questions designed to determine individual HIV risk factors. A few weeks after enrolling in the study, participants will be asked to return to the study location to learn their test results. Depending upon the test results, participants will be asked to complete an additional questionnaire. They will also be connected to appropriate HIV prevention or care services based on their test results. Participants will be financially compensated for their time.
The study will assess if the individual risk-based questions are effective in distinguishing between men who have sex with men who have recently acquired HIV and those who do not have HIV. The findings of this study will help determine the next steps that would be needed to modify the donor history questionnaire and the deferral policy.
"The FDA is committed to considering alternatives to the time-based deferral currently in place for men who have sex with men, that are based on scientific evidence supporting an effective individual risk assessment-based blood donor questionnaire," said Nicole Verdun, M.D., director of the Office of Blood Research and Review at the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.
Learn more about the ADVANCE Study, schedule an appointment to enroll at one of the study sites, and learn more about how FDA fulfills its responsibility to ensure the safety of the blood supply at the ADVANCE Study website.