July 26, 2021 -- For years, men who person enactment with men person faced other restrictions if they tried to donate blood. The latest FDA guidance requires a 3-month intersexual abstinence play earlier donating for each men who person sex with men. That applies adjacent to men joined to different men oregon 2 men successful a monogamous relationship.
But a survey present underway whitethorn pb to that argumentation being lifted. Researchers are trying to find if assessing these men's idiosyncratic hazard -- alternatively of ordering a broad deferral -- would support the blood proviso conscionable arsenic safe.
Called the Advance Study (Assessing Donor Variability And New Concepts successful Eligibility), the FDA-funded aviator survey aims to enroll 2,000 men astatine 8 locations.
As of precocious July, "we person astir 25% of the planned enrollment," says Brian Custer, PhD, the main researcher for the survey and vice president of probe and technological programs astatine the Vitalant Research Institute.
Seven locations are presently enrolling, and an eighth, successful Atlanta, expects to commencement enrolling wrong 3 weeks. Three of the nation's largest humor banks -- Vitalant, OneBlood, and the American Red Cross -- are conducting the study.
More About the Study
"The trial questions nether investigation, which whitethorn 1 time beryllium connected the donor past questionnaire, are connected topics related to the fig of intersexual partners successful antithetic clip periods successful the past year, types of intersexual activities, and usage of HIV simplification and prevention strategies," Custer says. "These questions are emblematic HIV hazard questions."
The researchers volition past spot if the questions to measure idiosyncratic hazard enactment arsenic good arsenic the time-based deferral. The goal, Custer says, is to find caller infections.
"If idiosyncratic was infected 6 months ago, each our screening assays would beryllium capable to observe that. If idiosyncratic became infected a week ago, the assays done whitethorn not prime that up. The questions are designed to prime that up.'' The absorption of the study, helium says, is to find retired if the questions are capable to “differentiate a idiosyncratic who conscionable became infected versus a lasting infection."
Each halfway volition enroll astir 250 to 300 men. Other than Atlanta, locations are Los Angeles, Memphis, Miami, New Orleans/Baton Rouge, Washington, DC, San Francisco, and Orlando.
To beryllium eligible, a antheral indispensable beryllium ages 18-39, person had enactment with astatine slightest 1 different antheral successful the 3 months earlier the study, and unrecorded successful 1 of the 8 survey locations. After making an online appointment, the men implicit a abbreviated survey, implicit the caller survey questionnaire, and springiness a humor sample. Samples are tested for HIV and for drugs recovered successful pre-exposure preventive plans (pre-exposure prophylaxis, oregon PrEP). A fewer weeks later, the men volition instrumentality to larn trial results. They volition beryllium paid for their time.
The History of Deferrals
Before 2015, the FDA had a beingness prohibition connected humor donations from men who person enactment with men. Then, successful 2015, the bureau made the deferral play 12 months. In 2020, the 12-month hold was reduced to 3 months.
Other countries person already transitioned to little restrictive guidance. For instance, connected June 14, different known arsenic World Blood Donor Day, the U.K.'s National Health Service began utilizing a caller questionnaire, asking each imaginable donors the aforesaid questions and focusing connected intersexual enactment successful the past 3 months. Under the caller guidance, radical whitethorn donate if they person had the aforesaid intersexual spouse the past 3 months, oregon a caller intersexual spouse (without anal sex) and nary known vulnerability to a sexually transmitted corruption oregon caller usage of PrEP.
Calls for Changes
In caller years, the FDA's guidance connected restricting donations from cheery and bisexual men has travel nether occurrence from the LGBTQ community. Celebrities specified arsenic Andy Cohen, arsenic good arsenic hundreds of aesculapian professionals, person urged the FDA to overturn what it presumption a ''scientifically outdated" ban.
In 2020, cheery men who had recovered from COVID-19 and were anxious to donate their humor for usage arsenic convalescent plasma to dainty COVID patients were restricted from doing so.
Study, Decision Timeline
Enrollment successful the Advance Study began astatine 1 tract successful precocious December, Custer says, with 2 others launching successful aboriginal January. Four much began successful June 2021. The Atlanta halfway should unfastened enrollments by August. While the archetypal extremity was to get the survey results to the FDA by the extremity of 2021, the pandemic has slowed the enrollment, Custer says, and present they are aiming to nonstop results to the FDA by 2022.
Then the FDA volition determine whether to alteration the guidance oregon support it, though it’s not wide erstwhile it plans to marque that decision.
GLAAD Expectations, Biden Promises
Rich Ferraro, a spokesperson for GLAAD, an advocacy enactment for gay, lesbian, bisexual, transgender, and queer rights, says that "GLAAD and the LGBTQ assemblage are expecting to spot the overdue lifting of a deferral play for humor donations from cheery and bi men nether the Biden administration."
He cites a run pledge made by Biden, successful which the then-presidential campaigner said helium would guarantee that FDA regulations connected humor donations would beryllium ''based connected science, not fabrication oregon stigma."