July 26, 2021 — For years, males who’ve intercourse with males have confronted further restrictions in the event that they tried to donate blood. The newest FDA steering requires a 3-month sexual abstinence interval earlier than donating for all males who’ve intercourse with males. That applies even to males married to different males or two males in a monogamous relationship.
However a research now underway could result in that coverage being lifted. Researchers are attempting to find out if assessing these males’s private threat — as a substitute of ordering a blanket deferral — would maintain the blood provide simply as secure.
Known as the Advance Research (Assessing Donor Variability And New Ideas in Eligibility), the FDA-funded pilot research goals to enroll 2,000 males at eight places.
As of late July, “we now have about 25% of the deliberate enrollment,” says Brian Custer, PhD, the principal investigator for the research and vp of analysis and scientific applications on the Vitalant Analysis Institute.
Seven places are presently enrolling, and an eighth, in Atlanta, expects to start out enrolling inside 3 weeks. Three of the nation’s largest blood banks — Vitalant, OneBlood, and the American Pink Cross — are conducting the research.
Extra Concerning the Research
“The take a look at questions beneath investigation, which can someday be on the donor historical past questionnaire, are on matters associated to the variety of sexual companions in several time durations within the final 12 months, varieties of sexual actions, and use of HIV discount and prevention methods,” Custer says. “These questions are typical HIV threat questions.”
The researchers will then see if the inquiries to assess private threat work in addition to the time-based deferral. The objective, Custer says, is to seek out latest infections.
“If somebody was contaminated 6 months in the past, all our screening assays would be capable of detect that. If somebody turned contaminated every week in the past, the assays completed could not choose that up. The questions are designed to choose that up.” The main focus of the research, he says, is to seek out out if the questions are in a position to “differentiate an individual who simply turned contaminated versus a standing an infection.”
Every heart will enroll about 250 to 300 males. Aside from Atlanta, places are Los Angeles, Memphis, Miami, New Orleans/Baton Rouge, Washington, DC, San Francisco, and Orlando.
To be eligible, a person have to be ages 18-39, have had intercourse with not less than one different man within the 3 months earlier than the research, and dwell in one of many eight research places. After making a web based appointment, the lads full a brief survey, full the brand new research questionnaire, and provides a blood pattern. Samples are examined for HIV and for medicine present in pre-exposure preventive plans (pre-exposure prophylaxis, or PrEP). A couple of weeks later, the lads 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 decreased to three months.
Different international locations have already transitioned to much less restrictive steering. For example, on June 14, in any other case referred to as World Blood Donor Day, the U.Ok.’s Nationwide Well being Service started utilizing a brand new questionnaire, asking all potential donors the identical questions and specializing in sexual exercise previously 3 months. Below the brand new steering, individuals could donate if they’ve had the identical sexual accomplice the final 3 months, or a brand new sexual accomplice (with out anal intercourse) and no recognized publicity to a sexually transmitted an infection or latest use of PrEP.
In recent times, the FDA’s steering on limiting donations from homosexual and bisexual males has come beneath hearth from the LGBTQ group. Celebrities corresponding to Andy Cohen, in addition to lots of 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 website in late December, Custer says, with two others launching in early January. 4 extra started in June 2021. The Atlanta heart ought to open enrollments by August. Whereas the preliminary objective was to get the research 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 determine whether or not to alter the steering or maintain 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 beneath the Biden administration.”
He cites a marketing campaign pledge made by Biden, during which the then-presidential candidate stated he would make sure that FDA laws on blood donations can be ”primarily based on science, not fiction or stigma.”