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 newest FDA steering requires a 3-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.
But a research now underway could result in that coverage being lifted. Researchers try to find out if assessing these males’s private threat — as an alternative of ordering a blanket deferral — would preserve the blood provide simply as secure.
Called the Advance Study (Assessing Donor Variability And New Concepts in Eligibility), the FDA-funded pilot research goals to enroll 2,000 males at eight places.
As of late July, “we have about 25% of the planned enrollment,” says Brian Custer, PhD, the principal investigator for the research and vice chairman of analysis and scientific packages on the Vitalant Research 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 Red Cross — are conducting the research.
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 inquiries to assess private threat work in addition to the time-based deferral. The objective, Custer says, is to seek out latest 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 middle will enroll about 250 to 300 males. Other than 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 a minimum of one different man within the 3 months earlier than the research, and reside 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 medication present in pre-exposure preventive plans (pre-exposure prophylaxis, or PrEP). A couple of weeks later, the lads will return to study check outcomes. They might be paid for his or her time.
The History of Deferrals
Before 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 diminished to three months.
Other nations have already transitioned to much less restrictive steering. For occasion, on June 14, in any other case generally known as World Blood Donor Day, the U.Ok.’s National Health Service started utilizing a brand new questionnaire, asking all potential donors the identical questions and specializing in sexual exercise prior to now 3 months. Under the brand new steering, individuals could donate if they’ve had the identical sexual companion the final 3 months, or a brand new sexual companion (with out anal intercourse) and no recognized publicity to a sexually transmitted an infection or latest use of PrEP.
Calls for Changes
In latest years, the FDA’s steering on proscribing donations from homosexual and bisexual males has come underneath hearth from the LGBTQ group. Celebrities equivalent 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 wanting to donate their blood to be used as convalescent plasma to deal with COVID sufferers had been restricted from doing so.
Study, Decision Timeline
Enrollment within the Advance Study started at one web site in late December, Custer says, with two others launching in early January. Four extra started in June 2021. The Atlanta middle ought to open enrollments by August. While 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 resolve whether or not to vary the steering or preserve it, although it’s not clear when it plans to make that call.
GLAAD Expectations, Biden Promises
Rich Ferraro, a spokesperson for GLAAD, an advocacy group for homosexual, 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 marketing campaign pledge made by Biden, by which the then-presidential candidate stated he would be certain that FDA laws on blood donations can be ”based mostly on science, not fiction or stigma.”