Well-Being Medical Advances

FDA-funded study aims to lift restrictions on blood donation for gay, bisexual men

(Europa Press News/Getty Images)

Story at a glance

  • A new study is evaluating an FDA policy barring some men from donating blood.
  • Under current FDA guidelines, men who have sex with other men may not donate blood if they have had sexual contact with another man less than three months prior to donation.
  • The study aims to develop a questionnaire based on individual risk assessment to replace the FDA’s existing abstinence policy.

A new study currently underway could ease eligibility requirements for gay and bisexual men seeking to donate blood.

The study, funded by the U.S. Food and Drug Administration (FDA), aims to evaluate alternatives to the blood donor deferral policy known as men who have sex with men, or MSM, put in place to reduce the transmission of Human Immunodeficiency Virus, or HIV.

Under current FDA guidelines, men who have sex with men are ineligible to donate blood if they have had sexual contact with another man less than three months prior to donation.

The ADVANCE study (standing for Assessing Donor Variability And New Concepts in Eligibility) will recruit a total of 2,000 gay or bisexual men in eight cities across the U.S., including San Francisco, Los Angeles, New Orleans, Miami and Washington, D.C., according to the study’s website. Between 250 and 300 participants will be recruited in each city.


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To be eligible for the study, individuals must be between 18 and 39 years old, express an interest in donating blood, have had sex with at least one other man in the three months before joining the study, and agree to an HIV test — the results of which must be negative.

Study participants will test the reliability of a donor history questionnaire based on individual risk of HIV transmission. If the study is successful, the new questionnaire could replace the FDA’s deferral requirement.

The FDA had initiated a lifetime ban for men who have sex with men in 1983 at the start of the AIDS crisis, when little was known about the spread of the disease. That was relaxed to a yearlong abstinence period in 2015.

The agency’s current deferral period of three months was adopted in 2020 to address the “urgent need” for blood during the COVID-19 pandemic.

The American Red Cross last week declared its first-ever national blood crisis, warning that doctors are being cornered into making “difficult decisions” about which patients receive blood transfusions over others.

In a letter sent to the FDA Thursday, a group of House Democrats called on the agency to reassess its current deferral period, writing that the existing policy “continues to stigmatize gay and bisexual men” and “undermine crucial efforts to ensure an adequate and stable national blood supply.”

Recruitment efforts for the ADVANCE study, which began in March, are nearing completion.

“We are currently at 276 as of last Friday’s report,” Christopher Cannon, director of research operations at the Whitman-Walker Institute in Washington, D.C., one of the community organizations involved in the study, told the Los Angeles Blade. “The current goal is now 300, so we’re hoping to push this over that goal line in the coming days and weeks.”

According to Cannon, as of last week, organizers had recruited a total of 879 study participants nationwide. Pandemic-related roadblocks have led to some delays in recruitment efforts, but organizers are hopeful the study will be completed by the summer, he said.


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