“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 findings of this study will help determine the next steps that would be needed to modify the donor history questionnaire. The study will assess if the questions related to behavior are effective in distinguishing between men who have sex with men who have recently become infected with HIV and those who do not have HIV infection. Participants in the study will have a blood sample drawn for HIV testing and will answer different questions designed to determine individual HIV risk factors. “The ADVANCE study is a first step in providing data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as time-based deferral, in reducing the risk of HIV in the blood supply,” said Brian Custer, Ph.D., vice president of Research and Scientific Programs with Vitalant Research Institute. The questions assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV.
CAN GAY MEN DONATE BLOOD IN THE USA SERIES
The donor history questionnaire consists of a series of questions that all potential blood donors answer before donating. For this to be possible, a change would need to be made to the donor history questionnaire. The purpose of the new study is a first step in determining whether a different donor deferral can be used at blood centers nationwide while maintaining the safety of the blood supply. The FDA adopted the three-month deferral policy in April 2020. FDA 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.
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The study is focused on evaluating alternatives to the FDA’s blood donor deferral policy for men who have sex with men (MSM). Participants who are 18 to 39 years old are needed in eight communities as the study ramps up. Vitalant, OneBlood, and the American Red Cross, together representing approximately 60% of the blood supply in the United States, are conducting the ADVANCE study, which stands for A ssessing Donor Variability And New Concepts in Eligibility. Food and Drug Administration (FDA) that could potentially lead to changes to blood donor eligibility for men who have sex with men.
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Three of the nation’s largest blood centers have launched a pilot study through a contract funded by the U.S.