Latest Transfusion Podcast Highlights the ADVANCE Study

In the latest episode of the Transfusion Monthly Podcast, Brian Custer, PhD, MPH, joins to discuss findings from the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study. Custer, the study’s lead author, is director of the Vitalant Research Institute in San Francisco and the senior vice president of research and scientific programs at Vitalant. He is also an adjunct professor in the Department of Laboratory Medicine at UCSF.

In this study, Custer and his co-investigators found that questions designed to assess risk of HIV acquisition among men who have sex with men (MSM) were able to identify sexually active, HIV-negative MSM who report lower risk sexual behaviors. Furthermore, investigators found that around a quarter of enrolled study participants would be potentially eligible blood donors using individual risk assessment questions.

In a conversation with host Yara Park, MD, Custer described the study design, how the Food and Drug Administration helped bring the study to fruition, and how the results informed FDA’s May 2023 decision to approve individual donor assessment (IDA) to determine blood donor eligibility. In addition, Custer discussed how the results from the ADVANCE study differed from the investigators’ expectations and from the experience of the United Kingdom and Canada, which previously introduced IDA. Custer and Park also focused on pre-exposure prophylaxis (PrEP), a medication used to prevent HIV acquisition, and discussed whether donor eligibility could potentially be expanded in the future to include individuals taking PrEP.

The episode also addressed engagement with the LGBTQ+ community, recruiting study participants and how current donors have responded to the introduction of IDA.