In January 2023, the U.S. FDA issued draft guidance recommending individual risk-based assessments for potential donors at higher risk for HIV instead of a 3-month deferral for all men who have sex with men (MSM). The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study evaluated the draft blood donor screening questions in eight cities to determine if they were able to identify low-risk HIV MSM who wish to donate blood. Of the 1566 community-recruited sexually active MSM (ages 18-39) who completed the questionnaire and self-reported sexual behaviors (number of male partners, new partners, and anal sex) and HIV prevention behaviors [pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis use], only four individuals were identified to be living with HIV (0.25%). Among the participants living without HIV, about half (50.4%) reported not using PrEP within the past three months. PrEP use was associated with an increased number of sexual partners, new sexual partners, and anal sex. Sixty-nine percent of participants who did not use PrEP reported no new sexual partners and a lower prevalence of anal sex within the last three months. Results from the ADVANCE study support individual risk assessment questions to identify potential donors at a higher risk for HIV.
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