July 26, 2021 — For years, males who’ve intercourse with males have confronted additional restrictions in the event that they tried to donate blood. The most recent FDA steerage requires a Three-month sexual abstinence interval earlier than donating for all males who’ve sex with males. That applies even to males married to different males or two males in a monogamous relationship.
However a examine now underway might result in that coverage being lifted. Researchers are attempting to find out if assessing these males’s private danger — as a substitute of ordering a blanket deferral — would preserve the blood provide simply as protected.
Known as the Advance Study (Assessing Donor Variability And New Ideas in Eligibility), the FDA-funded pilot examine goals to enroll 2,000 males at eight places.
As of late July, “we’ve about 25% of the deliberate enrollment,” says Brian Custer, PhD, the principal investigator for the examine and vp of analysis and scientific applications on the Vitalant Analysis Institute.
Seven places are presently enrolling, and an eighth, in Atlanta, expects to begin enrolling inside Three weeks. Three of the nation’s largest blood banks — Vitalant, OneBlood, and the American Crimson Cross — are conducting the examine.
Extra Concerning the Research
“The take a look at questions below investigation, which can sooner or later be on the donor historical past questionnaire, are on subjects associated to the variety of sexual companions in several time durations within the final yr, varieties of sexual actions, and use of HIV discount and prevention methods,” Custer says. “These questions are typical HIV danger questions.”
The researchers will then see if the inquiries to assess private danger work in addition to the time-based deferral. The aim, Custer says, is to seek out latest infections.
“If somebody was contaminated 6 months in the past, all our screening assays would be capable to detect that. If somebody turned contaminated per week in the past, the assays executed might not choose that up. The questions are designed to choose that up.” The main target of the examine, he says, is to seek out out if the questions are capable of “differentiate an individual who simply turned contaminated versus a standing an infection.”
Every middle will enroll about 250 to 300 males. Apart from Atlanta, places are Los Angeles, Memphis, Miami, New Orleans/Baton Rouge, Washington, DC, San Francisco, and Orlando.
To be eligible, a person should be ages 18-39, have had intercourse with at the very least one different man within the Three months earlier than the examine, and dwell in one of many eight examine places. After making an internet appointment, the boys full a brief survey, full the brand new examine questionnaire, and provides a blood pattern. Samples are examined for HIV and for medication present in pre-exposure preventive plans (pre-exposure prophylaxis, or PrEP). A couple of weeks later, the boys will return to be taught take a look at outcomes. They are going to be paid for his or her time.
The Historical past of Deferrals
Earlier than 2015, the FDA had a lifetime ban on blood donations from males who’ve intercourse with males. Then, in 2015, the company made the deferral interval 12 months. In 2020, the 12-month wait was lowered to three months.
Different nations have already transitioned to much less restrictive steerage. For example, on June 14, in any other case generally known as World Blood Donor Day, the U.Okay.’s Nationwide Well being Service started utilizing a brand new questionnaire, asking all potential donors the identical questions and specializing in sexual exercise prior to now Three months. Beneath the brand new steerage, folks might donate if they’ve had the identical sexual companion the final Three months, or a brand new sexual companion (with out anal intercourse) and no identified publicity to a sexually transmitted an infection or latest use of PrEP.
In recent times, the FDA’s steerage on limiting donations from homosexual and bisexual males has come below hearth from the LGBTQ group. Celebrities akin to Andy Cohen, in addition to a whole lot of medical professionals, have urged the FDA to overturn what it phrases a ”scientifically outdated” ban.
In 2020, homosexual males who had recovered from COVID-19 and had been desirous to donate their blood to be used as convalescent plasma to deal with COVID sufferers had been restricted from doing so.
Research, Resolution Timeline
Enrollment within the Advance Research started at one web site in late December, Custer says, with two others launching in early January. 4 extra started in June 2021. The Atlanta middle ought to open enrollments by August. Whereas the preliminary aim was to get the examine outcomes to the FDA by the top of 2021, the pandemic has slowed the enrollment, Custer says, and now they’re aiming to ship outcomes to the FDA by 2022.
Then the FDA will resolve whether or not to alter the steerage or preserve it, although it’s not clear when it plans to make that call.
GLAAD Expectations, Biden Guarantees
Wealthy Ferraro, a spokesperson for GLAAD, an advocacy group for homosexual, lesbian, bisexual, transgender, and queer rights, says that “GLAAD and the LGBTQ group expect to see the overdue lifting of a deferral interval for blood donations from homosexual and bi males below the Biden administration.”
He cites a marketing campaign pledge made by Biden, through which the then-presidential candidate stated he would make sure that FDA rules on blood donations can be ”primarily based on science, not fiction or stigma.”