At the height of the COVID-19 pandemic before the Delta variant, Stephen Rawlings, MD, PhD, was researching HIV and SARS-CoV-2 when a pair of men, a couple, came to him. Both had had COVID-19. Both wanted to donate convalescent plasma or contribute in other ways to stopping the virus. Rawlings had to tell them no.

For Rawlings and his principal investigator (PI), it was a strange time.

“Here the private investigator was a gay man, I was a gay man, and there were these two men, and neither of us could donate,” Rawlings said. “But we were still, in our own way, forging better science.”

In this case, potential volunteers were able to provide antibodies, not whole blood, that is, blood that has not yet been divided into its components, such as platelets and plasma. This is because since the beginning of the HIV epidemic, gay, bisexual and other men who have sex with men (MSM) were not able to donate whole blood. At first, it once was, even if they had had sex with a man in 1978 and never again. In 2018, the US Food and Drug Administration (FDA) allowed gay men to donate blood if they had been abstinent for 12 months. And then in 2020, considering the impact of the COVID-19 pandemic on the blood supply, the FDA changed the policy again to reduce the withdrawal interval to 3 months.

Many, including White House officials, have recently argued that the current blood donation policy is outdated and unscientific. But what would a more science-based blood donation policy look like?

What we call the American blood donation policy is actually an amalgamation of criteria that people must meet before they are allowed to donate. It includes everything from medical and prescription histories to a series of questions about recent behavior. These include questions about having had sexually transmitted diseases, nonprescription injection drug use, and recent tattoos, among others. Additionally, men must also not have had sex with another man in the last 3 months, and women must not have had sex with a man who has had sex with another man in the last 3 months. Once a person clears all of those hurdles, staff at blood centers like Impact Life, which supplies blood to several dozen hospitals in the U.S., will inspect a person’s arms for needle prints.

Finding none, the visitor “lies down and bleeds,” said Louis Katz, MD, interim chief medical director at Impact Life. The blood vials then pass down the hallway, where they undergo blood typing and testing for everything from cytomegalovirus to West Nile virus, Zika, and hepatitis B and C.

“In heterosexuals, we tolerate a high level of risk and it’s almost like zero tolerance with gay men,” he said of the original lifetime deferral policy. “If you were a heterosexual man who had sex without a condom with a sex worker, it is possible that the procedure would be postponed for 6 months. But it was a life-long reprieve for gay men. “It just doesn’t make any sense if you’re trying to protect people.”

So what most efficiently protects the maximum number of people, with the least risk and the least amount of discrimination? This is what science says.

According to CDC data, receptive anal sex without a condom carries the highest risk of HIV transmission, followed by being the insertive partner in anal sex without a condom. Then, couples receptive to vaginal sex have the next highest risk. The lowest risk is for two women who have non-insertive sex. And although gay men are more likely to have receptive anal sex, they are not the only ones who practice it. A 2020 modeling study in the American Journal of Reproductive Immunology suggested that 41% of new HIV diagnoses in American women were the result of condomless anal sex. There is also some data suggesting that, for unknown reasons, the rectal lining of cisgender women may be most vulnerable to HIV than those of men.

And gay men aren’t the only people who get HIV. For example, nearly 1 in 4 new HIV transmissions in the U.S. occurred in heterosexual adults in 2019. People who inject drugs accounted for 7% of new diagnoses, according to the CDC. However, at this time, the FDA is not studying deferral policies for heterosexuals at higher risk for HIV, Custer said.

However, blood centers postpone blood donation if people have a history of sex work or injecting drugs in the last 3 months.

A more science-based approach may be to ask everyone about their sexual behavior. But that’s not what the Donor Variability Assessment and New Eligibility Concepts (ADVANCE) study is doing. Designed and funded by the FDA, the study is considering other options for how to determine when gay and bisexual men can donate blood. The study asks gay and bisexual men about their sexual behavior, such as how many partners they have recently had and whether they use condoms or HIV prevention medications, known as pre-exposure prophylaxis (PrEP), Custer said. The study will not test those questions among heterosexuals.

“These are questions that could one day be on a future blood donor history questionnaire,” Custer said. “A contemporary, science-based policy approach is exactly what we are trying to do.”

When the ban on gay men donating blood came out, there were no HIV tests. Prohibition was a blunt instrument. But it has long been replaced by accurate HIV testing, Katz said.

“In the late 1990s, we had nucleic acid tests (PCR, basically) that could detect HIV within 7 to 10 days,” he said.

And that should mean, Rawlings said, that a gay man in a mutually monogamous relationship for the past 10 years in which neither of them has HIV should be able to donate the same as anyone else. “I’m pretty sure that monogamous gay men can be shown to be safe” when donating blood, Katz said.

Rawlings himself is one of those men.

“If you had had a new sexual partner and were unprotected and in the last 7 days, you should not donate blood,” he said. “Current policy doesn’t take that into account.”

There could be a problem with that recommendation, said Custer, of the Vitalant Research Institute: Transmission of HIV while someone uses HIV prevention drugs inconsistently, while rare, could result in not enough of the drug in the blood to maintain the level of the virus in the blood. very low. It’s unclear whether current tests would detect that, he said.

That’s where the ADVANCE studio comes into play. In addition to asking questions about the men’s sexual behavior and testing blood for HIV, researchers will also test blood for concentrations of one of the most common PrEP medications, tenofovir. After 2 weeks, participants return to learn their HIV test results and complete another longer questionnaire on personal behavior. By correlating drug concentrations with HIV testing, they hope to determine whether that theoretical risk is a real risk. Custer said they hope to have the results of the study early next year.

It’s also possible, he said, that people taking PrEP have a lower risk of donating blood containing HIV because the drug is 99% effective in preventing HIV. Right now it’s a paradox.

“I don’t know if it will be enough,” he said of the data they will collect. “Through a combination of testing biomarkers of infection and PrEP use, as well as self-reported behaviors, we will get as close as possible to having the evidence.”

But maybe it doesn’t need to be enough. Since the FDA reduced the deferral period for MSM to 3 months in April 2020, the Transfusion Transmissible Infection Monitoring System (TTIMS) has been tracking whether there has been an increase in HIV-containing donations. So far, the researchers have not analyzed that data, but they hope to have results by the end of 2022.

It is also unclear whether the ADVANCE study will result in changes to the FDA’s deferral policies for gay men. If it does, the United States will join the United Kingdom, France and Greece, among others, in donating based on behavior, not identity. That could make 4.2 million people eligible. Depending on the percentage of eligible people who actually donate, that could represent an additional 615,300 pints of blood.

Whatever happens, Katz said it’s clear the FDA will need new data to make its decision.

A better science-based policy, he says, could defer blood donation by non-monogamous gay men for 7 to 10 days after their last sexual experience, so that HIV tests can detect new infection, and then base the donations in actual individual behavior. rather than a blanket deferral based on identity.

“There’s no reason we can’t do better,” he said. “Simply put, we still don’t have a clear idea of ​​what the best behavioral approaches are, and that’s what the research is asking.”