Versiti is helping to make blood donation and transfusion more accessible to the blood donor community.
As the HIV/AIDS epidemic spread around the world in the ‘70s and ‘80s, the U.S. Food and Drug Administration (FDA) determined that the best way to keep the blood supply safe was to prohibit homosexual men—the group with the highest risk of contracting HIV—from donating blood. This policy, established in 1985, stated that any man who had ever had sexual intercourse with another man from 1977 to the present was, by law, unable to donate blood.
In 1989, the National Heart, Lung and Blood Institute (NHLBI) established the Retroviral Epidemiology Donor Study (REDS) to prevent the spread of HIV and ensure a safe blood supply. Over the years, prevention, detection and treatment methods for HIV/AIDS have improved and the REDS program—now in its fourth installment—has evolved to focus less on HIV/AIDS and more on the overall safety of blood transfusions.
Versiti Blood Research Institute Senior Investigator Alan Mast, MD, PhD, has been involved in the REDS program since its second iteration and, in 2014, he facilitated Versiti Blood Center of Wisconsin’s involvement in a study conducted by the University of California, San Francisco (UCSF) Center for AIDS Prevention Studies and Blood Systems Research Institute, whose goal was to obtain information from male blood donors and inform updated policies regarding MSM donation.
Gathering important donor data
UCSF researchers began by polling nearly 800 male blood donors in San Francisco, Connecticut, Pittsburgh and Milwaukee about their sexual history. Nearly 22% of survey recipients from Milwaukee—all Versiti donors—completed the questionnaire, the highest number of respondents overall. “That says a lot about our blood donor community,” Dr. Mast said. “They’re very committed.”
It also brought something else to light: 2.6% of the men who responded to the survey said that they had had sex with another man since 1977 and had donated blood even when they knew they shouldn’t have. “The younger the donor was, the more likely they were to have broken the rules,” Dr. Mast said, suggesting that younger gay men saw the restriction as out of touch.
Understanding donor perspectives
In a follow-up to the initial questionnaire, researchers conducted interviews with 40 survey respondents, all of whom were homosexual, HIV-negative men over the age of 18 who had donated blood recently. Thirty-eight participants in the study endorsed modifying the existing MSM blood donation policy, suggesting that new guidelines shorten deferral periods, incorporate questions that assess sexual practices at high risk for HIV transmission, and apply these screening and deferral procedures to all blood donors, regardless of their sexual orientation or practice.
About 20% of interviewees suggested that the deferral period should reflect the amount of time that HIV remains undetected in blood. Most interviewees expected that time to be 3-6 months; however, nucleic acid testing done on donated blood can detect HIV in as few as 7-10 days. Based on this information, interviewees thought that the current MSM donation policy wasn’t based on scientific findings, didn’t adequately assess the risk of the blood supply, and was discriminatory.
“MSM donors were concerned with blood safety, but they felt if they were in a monogamous relationship, it was safe to donate blood,” Dr. Mast said. “Their opinion was that there should be more questions about HIV risk in general, not just about homosexual encounters.”
Affecting change at a higher level
Thanks in part to Dr. Mast’s involvement, Versiti donors’ willingness to participate in the survey, and UCSF’s findings, in December 2014, the FDA announced updated regulations regarding blood donor deferral periods for MSM. Instead of prohibiting MSM from donating entirely, they were deferred from donating one year after their most recent sexual encounter with another man. And in April 2020, in the wake of the COVID-19 pandemic, the FDA announced that it would reduce the deferral period from one year to three months to enable MSM to more easily donate blood, as well as plasma from individuals who have recovered from COVID-19 and developed antibodies to the virus.
But that doesn’t mean there isn’t still room for improvement. “In the future, I would be in favor of doing what these men suggested, which is to equally evaluate risky sexual behavior regardless of sexual orientation,” Dr. Mast said. His involvement with REDS-IV-P perfectly positions him to initiate this type of research. “There are many similar situations in which the REDS program has conducted research like this,” he said.
“Versiti is a research-based organization unlike many other blood centers across the country,” he continued. “We want the Versiti community to know what the REDS program is, and that it affects our donors in a meaningful way.”
Alan Mast, MD, PhD, is a senior investigator at Versiti Blood Research Institute, a medical director at Versiti Medical Sciences Institute, and the Walter A. Schroeder Endowed Chair for Blood Research. He also serves as an associate professor in the Department of Pathology and the Department of Cell Biology, Neurobiology and Anatomy at the Medical College of Wisconsin.