Blood donation policies for men who have sex with men (MSM) have been the subject of much attention in recent years. Throughout the world, countries are reexamining their policies; many have reduced deferral times for MSM, while others have eliminated them altogether or implemented alternative policies to address infectious disease risk.
In the United Kingdom, for example, a new a new donor eligibility process was implemented this summer in which all blood donors – regardless of gender – are asked about recent sexual activity. Similarly, in Italy and Spain, MSM are no longer addressed in deferral policies; instead, the deferral policies are based on alternative criteria.
In the United States, the MSM deferral was reduced from “if even one time since 1977” to 12 months in 2018; it was reduced further – to three months – last year. Currently in the United States, the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study is ongoing and is designed to evaluate behavioral screening questions. The results will help determine if alternative deferral policies are feasible.
The 2021 AABB Annual Meeting session titled “Hot Topic: Men Who Have Sex with Men (MSM) – Movement Toward Individual Risk Assessment” provided updates on the latest news with MSM policies and the ADVANCE study. Sponsored by the AABB Donor History Task Force and the ISBT Transfusion Transmitted Infectious Diseases Working Party, the session also offered insight on MSM deferral policies throughout the world.
Brian Custer, PhD, MPH, vice president of research and scientific programs at Vitalant, discussed the evolution of MSM deferral policies in the United States in recent years before highlighting the ADVANCE study, for which he is the principal investigator. Custer noted that the study is funded by the FDA and was designed through a collaborative process called the Blood Equality Working Group.
“The ADVANCE study is designed to provide FDA with evidence by which to consider alternatives to the blood donor deferral policy for MSM while maintaining the safety of the blood supply,” Custer said. “The study’s primary objective is to conduct an initial assessment of the discriminant function of revised donor history questions for predicting recent infection with HIV in MSM who wish to donate blood.” Custer noted that there are currently about 650 participants enrolled in the study out of a goal of 2,000.
Mindy Goldman, MD, medical director of donation policy and studies at Canadian Blood Services, offered insight about the Canadian experience with MSM deferral policies. “The Canadian federal government funded a MSM research program to inform the development of alternative screening approaches in February 2017,” she said, “A second federally funded program focused on operational preparedness for implementation for source plasma began in August 2019.”
She said these research programs led the way for a “successful implementation of progressively shorter time-based deferrals, with no change in HIV rates, risk per unit transfused, or compliance.”
In addition, Health Canada is currently reviewing a proposed policy that would move to a gender-neutral, risk-based behavior criteria for all blood donors. Goldman said the policy must still undergo additional assessment, including a review of a risk model and a post-implementation surveillance plan. “The review will take several months and, if approval is received, implementation could occur in the first half of 2022,” she said.