July 26, 2021 -- For years, men who have sex with men have faced extra restrictions if they tried to donate blood. The latest FDA guidance requires a 3-month sexual abstinence period before donating for all men who have sex with men. That applies even to men married to other men or two men in a monogamous relationship.
But a study now underway may lead to that policy being lifted. Researchers are trying to determine if assessing these men's personal risk -- instead of ordering a blanket deferral -- would keep the blood supply just as safe.
Called the Advance Study (Assessing Donor Variability And New Concepts in Eligibility), the FDA-funded pilot study aims to enroll 2,000 men at eight locations.
As of late July, "we have about 25% of the planned enrollment," says Brian Custer, PhD, the principal investigator for the study and vice president of research and scientific programs at the Vitalant Research Institute.
Seven locations are currently enrolling, and an eighth, in Atlanta, expects to start enrolling within 3 weeks. Three of the nation's largest blood banks -- Vitalant, OneBlood, and the American Red Cross -- are conducting the study.
More About the Study
"The test questions under investigation, which may one day be on the donor history questionnaire, are on topics related to the number of sexual partners in different time periods in the last year, types of sexual activities, and use of HIV reduction and prevention strategies," Custer says. "These questions are typical HIV risk questions."
The researchers will then see if the questions to assess personal risk work as well as the time-based deferral. The goal, Custer says, is to find recent infections.
"If someone was infected 6 months ago, all our screening assays would be able to detect that. If someone became infected a week ago, the assays done may not pick that up. The questions are designed to pick that up.'' The focus of the study, he says, is to find out if the questions are able to “differentiate a person who just became infected versus a standing infection."
Each center will enroll about 250 to 300 men. Other than Atlanta, locations are Los Angeles, Memphis, Miami, New Orleans/Baton Rouge, Washington, DC, San Francisco, and Orlando.
To be eligible, a man must be ages 18-39, have had sex with at least one other man in the 3 months before the study, and live in one of the eight study locations. After making an online appointment, the men complete a short survey, complete the new study questionnaire, and give a blood sample. Samples are tested for HIV and for drugs found in pre-exposure preventive plans (pre-exposure prophylaxis, or PrEP). A few weeks later, the men will return to learn test results. They will be paid for their time.
The History of Deferrals
Before 2015, the FDA had a lifetime ban on blood donations from men who have sex with men. Then, in 2015, the agency made the deferral period 12 months. In 2020, the 12-month wait was reduced to 3 months.
Other countries have already transitioned to less restrictive guidance. For instance, on June 14, otherwise known as World Blood Donor Day, the U.K.'s National Health Service began using a new questionnaire, asking all potential donors the same questions and focusing on sexual activity in the past 3 months. Under the new guidance, people may donate if they have had the same sexual partner the last 3 months, or a new sexual partner (without anal sex) and no known exposure to a sexually transmitted infection or recent use of PrEP.
Calls for Changes
In recent years, the FDA's guidance on restricting donations from gay and bisexual men has come under fire from the LGBTQ community. Celebrities such as Andy Cohen, as well as hundreds of medical professionals, have urged the FDA to overturn what it terms a ''scientifically outdated" ban.
In 2020, gay men who had recovered from COVID-19 and were eager to donate their blood for use as convalescent plasma to treat COVID patients were restricted from doing so.
Study, Decision Timeline
Enrollment in the Advance Study began at one site in late December, Custer says, with two others launching in early January. Four more began in June 2021. The Atlanta center should open enrollments by August. While the initial goal was to get the study results to the FDA by the end of 2021, the pandemic has slowed the enrollment, Custer says, and now they are aiming to send results to the FDA by 2022.
Then the FDA will decide whether to change the guidance or keep it, though it’s not clear when it plans to make that decision.
GLAAD Expectations, Biden Promises
Rich Ferraro, a spokesperson for GLAAD, an advocacy organization for gay, lesbian, bisexual, transgender, and queer rights, says that "GLAAD and the LGBTQ community are expecting to see the overdue lifting of a deferral period for blood donations from gay and bi men under the Biden administration."
He cites a campaign pledge made by Biden, in which the then-presidential candidate said he would ensure that FDA regulations on blood donations would be ''based on science, not fiction or stigma."