On the top of the pre-Delta pressure of the COVID-19 pandemic, Stephen Rawlings, MD, PhD, was researching HIV and SARS-CoV-2 when a number of males, a pair, approached him. Each had had COVID-19. Each wished to donate convalescent plasma or contribute to stopping the virus in another manner. Rawlings needed to say no.

It was a weird second for Rawlings and his principal investigator (PI).

“Right here the PI was a homosexual man, I used to be a homosexual man, and there have been two males — and we couldn't all donate,” Rawlings stated. “However we had been nonetheless, in our personal manner, forging higher science.”

On this case, the potential volunteers may contribute antibodies, and never complete blood, that’s, blood that has not but been divided into its element elements, comparable to platelets and plasma. That's as a result of homosexual, bisexual and different males who’ve intercourse with males (MSM) haven’t been capable of donate complete blood because the early HIV epidemic. Initially, that was as soon as the case, though they’d had intercourse with one man in 1978 and by no means once more. In 2018, the US Meals and Drug Administration (FDA) allowed homosexual males to donate blood if they’d abstained for 12 months. After which, in 2020, given the affect of the COVID-19 pandemic on the blood provide, the FDA modified the coverage once more to scale back the abstinence interval to 3 months.

Many, together with White Home officers, have not too long ago argued that present blood donation insurance policies are outdated and unscientific. However what may a extra scientifically primarily based blood donation coverage seem like?

What we name America's blood donation coverage is definitely an amalgam of standards that folks should meet earlier than they will donate. It covers every thing from medical historical past and prescription historical past to a slew of questions on latest habits. These embrace questions on having sexually transmitted illnesses, utilizing injection medicine with no prescription, and up to date tattoos. As well as, males might not have had intercourse with one other man previously 3 months, and ladies might not have had intercourse with a person who has had intercourse with one other man previously 3 months. As soon as an individual has overcome all these hurdles, workers at blood facilities like Influence Life, which provides blood to dozens of hospitals throughout the US, will examine an individual's arms for needle marks.

Discovering nothing, the customer “lay down and bled,” says Louis Katz, MD, appearing chief medical officer of Influence Life. Blood vials then journey down the corridor, the place they bear blood typing and testing for every thing from cytomegalovirus to West Nile virus to Zika to hepatitis B and C.

“With heterosexuals we tolerate a excessive stage of danger and with homosexual males it's nearly like zero tolerance,” he stated of the unique lifetime deferment coverage. “If you’re a heterosexual man and have had condomless intercourse with a intercourse employee, you will get a six-month deferral. However it was a lifelong delay for homosexual males. There's simply no level in attempting to guard individuals.”

So what protects the utmost variety of individuals most effectively, with the least danger and the least quantity of discrimination? That is what the science says.

In line with CDC information, receptive condomless anal intercourse carries the best danger of HIV transmission, adopted by the insertive companion in condomless anal intercourse. Then receptive companions have the second highest danger throughout vaginal intercourse. The bottom danger is for 2 girls who’ve non-insertive intercourse. And whereas homosexual males are the most definitely to have receptive anal intercourse, they're not the one ones doing so. A 2020 mannequin research within the American Journal of Reproductive Immunology steered that 41% of latest HIV diagnoses in American girls resulted from anal intercourse with no condom. There may be additionally some information suggesting that, for unknown causes, the rectal lining of cisgender girls could also be extra weak to HIV than that of males.

And homosexual males aren't the one individuals who get HIV. For instance, in 2019, practically 1 in 4 new HIV transmissions within the US occurred amongst heterosexual adults. In line with the CDC, individuals who inject medicine accounted for 7% of latest diagnoses. Nevertheless, at the moment the FDA isn’t finding out deferral insurance policies for heterosexuals at larger danger for HIV, Custer stated.

Nevertheless, blood facilities do discourage individuals from donating blood if they’ve a historical past of intercourse work or injecting medicine previously three months.

A extra science-based strategy could be to ask everybody about their sexual habits. However that isn’t what the ADVANCE research (Assessing Donor Variability And New Ideas in Eligibility) does. The research, designed and funded by the FDA, considers different choices for figuring out when homosexual and bisexual males can donate blood. The research asks homosexual and bisexual males questions on their sexual habits, comparable to what number of companions males have had not too long ago and whether or not they use condoms or HIV prevention medicine, generally known as pre-exposure prophylaxis (PrEP), Custer stated. The research won’t take a look at these questions amongst heterosexuals.

“These are the questions that might in the future be on a future blood donor historical past questionnaire,” Custer stated. “A up to date, science-based strategy to coverage is precisely what we try to do.”

When the ban on blood donation by homosexual males was enacted, there have been no assessments for HIV. A ban was a blunt instrument. However it has lengthy been changed by correct HIV testing, Katz stated.

“Within the late Nineties we had nucleic acid assessments – principally PCR – that might detect HIV inside seven to 10 days,” he stated.

And that ought to imply, Rawlings stated, {that a} homosexual man who has been in a mutually monogamous relationship for the previous decade and by which neither companion has HIV ought to be capable to donate the identical as anybody else. “I'm fairly certain it may be proven that monogamous homosexual males are secure” by donating blood, Katz stated.

Rawlings himself is such a person.

“If I had a brand new intercourse companion and it was unprotected and throughout the final seven days, I might not donate blood,” he stated. “The present coverage doesn’t take this under consideration.”

There could possibly be one flaw in that suggestion, stated Custer of the Vitalant Analysis Institute: HIV transmission whereas somebody is inconsistently taking HIV prevention medicine, whereas uncommon, may end in simply sufficient treatment within the blood to maintain the virus ranges within the blood to take care of the extent. very low. It's unclear whether or not present testing would present that, he stated.

That's the place the ADVANCE research is available in. Along with asking questions on males's sexual habits and testing blood for HIV, researchers can even take a look at blood for concentrations of one of the vital widespread PrEP medicines, tenofovir. After two weeks, individuals return to listen to the outcomes of the HIV take a look at and full one other, longer questionnaire about private habits. By correlating concentrations of the drug with HIV assessments, they hope to seek out out whether or not that theoretical danger is an actual danger. Custer stated they hope to have the research outcomes early subsequent 12 months.

It's additionally potential, he stated, that folks taking PrEP might have a decrease danger of donating blood containing HIV as a result of the drug is 99% efficient at stopping HIV. Proper now it's a paradox.

“I don't know if it is going to be sufficient,” he stated of the information they’ll gather. “By way of a mixture of testing biomarkers for an infection and PrEP use, in addition to self-reported habits, we are going to get as near the proof as potential.”

However possibly it doesn't must be sufficient. For the reason that FDA lowered the grace interval for MSM to 3 months in April 2020, the Transfusion-Transmissible An infection Monitoring System (TTIMS) has been monitoring whether or not there is a rise within the variety of donations containing HIV. To this point, researchers haven't analyzed that information, however they count on to have outcomes by the top of 2022.

It's additionally unclear whether or not the ADVANCE research will end in adjustments to the FDA's deferral coverage for homosexual males. In that case, the US will be a part of the likes of Britain, France and Greece in donating primarily based on habits, not id. That would make 4.2 million individuals eligible. Based mostly on the share of eligible individuals who truly donate, that could possibly be one other 615,300 pints of blood.

No matter occurs, Katz stated it's clear the FDA wants new information to decide.

He stated a greater science-based coverage may be sure that non-monogamous homosexual males don’t donate blood for seven to 10 days after their final sexual expertise, in order that HIV testing can detect new an infection, after which base donations on precise particular person habits. relatively than a blanket postponement primarily based on id.

“There's no purpose why we are able to't do higher,” he stated. “The underside line is that we don't but have a great sense of the very best behavioral approaches, and that's what the analysis requires.”