Abstract
Blood Center/Blood Hospital-Based Donor Center
Ruchika Goel, MD, MPH, CABP (she/her/hers)
Senior Medical Director, Corporate Medical Affairs. Professor of Internal Medicine and Pediatrics
Vitalant and Johns Hopkins University
Scottsdale, Arizona, United States
Disclosure(s): No financial relationships to disclose
As infectious disease testing has become more sensitive, the deferral period for men who have sex with men (MSM) in the US progressively decreased from permanent deferral to 12 months to 3 months. US FDA introduced new screening guidelines in 2023 to allow IDA of US donors. Implementation of gender-neutral IDA based upon known HIV risk behaviors allowed previously deferred donors to return. We trace the change in gender-specific deferral rates under changing MSM criteria over time to IDA-based criteria in a large national US blood collector.
Study
Design/Methods:
IDA was implemented enterprise-wide in our organization in August 2023. We analyzed allogeneic interviews from the same blood centers in similar 7-month calendar periods (September-March) from 2015 to 2024. We compared the proportion of disqualifying “Yes” responses to the DHQ for MSM and female sex with MSM (FMSM) risk questions across policy changes: MSM/FMSM since 1977 (MSM-perm/FMSM12), MSM/FMSM in previous 12 months (MSM12), MSM/FMSM in previous 3 months (MSM3) to the current IDA questions on having anal sex with new or multiple sex partners in the previous 3 months (IDA). For interviews during the MSM-perm/FMSM12, MSM12, and MSM3 periods, we combined two similar 7-month calendar periods since we had longer experience under those criteria (Figure A).
Results/Findings:
In male donors, switching from MSM-perm (0.128%) to MSM12 (0.121%) did not result in a significant change in deferral rates (p=0.29), but further switching to MSM3 resulted in a significant decrease in deferrals to 0.083% (p< 0.001). Finally, switching from MSM3 to IDA further significantly decreased male donor deferrals to 0.064% (p< 0.01) (Figure A).
In comparison, the % of deferred FMSM (females having sexual contact with MSM) significantly decreased from 0.023% for MSM-perm/FMSM12 to 0.016% for MSM12, (p< 0.05) and 0.008% for MSM3 (p< 0.001). Notably since IDA implementation, the deferral rates for female donors increased significantly to 0.052% (p< 0.001).
The overall % deferral for male MSM were significantly higher than FMSM across all MSM periods (MSM-perm/FMSM12, MSM12, MSM3); (p< 0.001). Since IDA implementation however, there was no statistical difference between % male deferrals (0.064%) and % female deferrals (0.052%), p=0.12.
Conclusions: At this national US blood collector, switching MSM-perm/FMSM12 to MSM12 did not significantly decrease male donor deferrals, but a switch to MSM3 and eventually IDA significantly decreased deferrals. Overall, male-MSM deferral rates were higher than female-MSM deferral rates across MSM-perm/FMSM12, MSM12, and MSM3 criteria, but when gender-neutral individual risk-based deferral criteria were introduced in August 2023, for the first time, deferral rates became similar for both males and females.