July 26, 2021 – For years, men who have sex with men have faced additional restrictions when trying to donate blood. The latest FDA directive requires all men who have sex with men to be sexually abstinent for 3 months prior to donation. This even applies to men who are married to other men or who have two men in a monogamous relationship.
However, an ongoing study could result in this policy being repealed. Researchers are trying to find out whether an assessment of the personal risk of these men – rather than ordering a blanket delay – would keep the blood supply just as secure.
The FDA-funded pilot study, called the Advance Study (Assessing Donor Variability And New Concepts in Eligibility), aims to enroll 2,000 men in eight locations.
At the end of July, “we have about 25% of the planned enrollment,” says Brian Custer, PhD, the study’s principal investigator and vice president of research and scientific programs at Vitalant Research Institute.
Seven locations are currently registering, and an eighth in Atlanta is expected to begin registering within 3 weeks. Three of the largest blood banks in the country – Vitalant, OneBlood, and the American Red Cross – are conducting the study.
More about the study
“The test questions examined, which may one day appear on the donor history questionnaire, relate to the number of sexual partners in different time periods over the past year, the types of sexual activity, and the use of HIV reduction and prevention strategies,” says Custer. These questions are typical HIV risk questions. “
The researchers will then see whether the personal risk assessment questions work as well as the time lag. The goal, says Custer, is to find recent infections.
“If someone was infected 6 months ago, all of our screening assays could detect it. If someone was infected a week ago, the tests we did might not be able to capture it. The questions are designed to capture this.” Of the study he says, be it to find out whether the questions are able to “distinguish a person who has just become infected from a standing infection”.
Each center will enroll around 250 to 300 men. In addition to Atlanta, the locations are Los Angeles, Memphis, Miami, New Orleans / Baton Rouge, Washington, DC, San Francisco and Orlando.
To be eligible, a man must be between 18 and 39 years old, have had sex with at least one other man in the 3 months prior to the study, and live in one of the eight study locations. After making an online appointment, the men fill out a short survey, fill out the new study questionnaire and give a blood sample. Samples are tested for HIV and for drugs included in pre-exposure prevention (pre-exposure prophylaxis, or PrEP) plans. A few weeks later, the men will return to hear the test results. They are paid for their time.
The story of procrastination
Prior to 2015, the FDA had a lifetime ban on donating blood from men who have sex with men. Then, in 2015, the agency made the grace period 12 months. In 2020 the waiting period was reduced from 12 months to 3 months.
Other countries have already switched to less restrictive guidelines. For example, on June 14th, also known as World Blood Donation Day, the UK’s National Health Service began using a new questionnaire asking all potential donors the same questions and focusing on sexual activity over the past 3 months. Under the new guidelines, people can donate if they have had the same sexual partner or a new sexual partner (excluding anal sex) in the past 3 months and have not been known to have a sexually transmitted infection or have recently used PrEP.
Calls for changes
In recent years, the FDA’s policy on restricting donations by gay and bisexual men has come under fire from the LGBTQ community. Celebrities like Andy Cohen and hundreds of medical professionals have urged the FDA to lift the so-called “scientifically obsolete” ban.
In 2020, gay men who had recovered from COVID-19 and wished to donate their blood for use as convalescent plasma to treat COVID patients were banned from doing so.
Study, decision schedule
Enrollment in the pre-study began at one site in late December, says Custer, while two more will start in early January. Four more began in June 2021. The Atlanta center should open enrollments through August. While the original goal was to submit the study results to the FDA by the end of 2021, the pandemic has slowed enrollment, says Custer, and now they aim to submit the results to the FDA by 2022.
Then the FDA will decide whether to change or maintain the guidelines, although it is not clear when that decision should be made.
GLAAD expectations, Biden promises
Rich Ferraro, a spokesman for GLAAD, an advocacy group for gay, lesbian, bisexual, transgender and queer rights, says that “GLAAD and the LGBTQ community are awaiting the overdue lifting of a grace period for blood donation by gays and bees men under the Biden administration . “
He cites an election promise made by Biden in which the then presidential candidate said he would ensure that FDA regulations on donating blood are “based on science, not fiction or stigma.”
WebMD health news
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Brian Custer, PhD, Vice President, Research and Scientific Programs, Vitalant Research Institute, San Francisco; Associate Professor of Laboratory Medicine, University of California, San Francisco.
Rich Ferraro, Chief Communications Officer, GLAAD.
JoeBiden.com: “The Biden Plan to Advance LGBTQ + Equality in America and Around the World.”
AdvanceStudy.org.
NHS Blood and Transplant: “UK is changing blood donation eligibility on World Blood Donation Day by introducing a new donor safety rating.”
FDA: “Revised Recommendations to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”
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