As of September 6, 2023, We Are Blood implemented the latest FDA guidance, expanding blood donor eligibility LGBTQ community members! With this update, the gender of a donor and their sexual partners will no longer be a consideration for donor eligibility. We Are Blood is dedicated to protecting the safety of the community blood supply and creating safe and inclusive spaces for our donor community.
What is the New Guidance?
The new FDA guidance recommends (1) the removal of donor eligibility questions that consider the gender of a donor and their sexual partners and (2) the implementation of new donor eligibility questions related to sexual activity that do not consider gender.
Prior FDA guidance required a three-month deferral for any male who has had sex with another male in the past three months.
The following donor eligibility questions will now be asked of all individuals who arrive to donate at our donor centers and mobile drives:
- All potential donors will be asked if they have had new or multiple sexual partners in the past three months.
- If answering yes to either, a potential donor would then be asked about a history of anal sex in the past three months.
- If a potential donor has had a new sexual partner or more than one sexual partner and had anal sex in the past three months, they will be deferred from donation for three months.
- Under the new FDA guidance, a potential donor who has had anal sex in the past three months, but no new or multiple sexual partners, may be eligible to donate, provided all other eligibility criteria are met.
To learn more, read our May 12 blog post.
Previously Deferred?
If you or your friends, family, or loved ones are currently deferred at We Are Blood for the donor eligibility criteria related to sexual history, please complete the Deferral Eligibility Change Request Form.
Once the reentry request has been processed, they’ll be notified by We Are Blood when they can come in to attempt to donate.
Individuals who have never been deferred at We Are Blood for those criteria are now able to come in to donate under the new eligibility criteria.
What About PrEP or PEP HIV Medication?
Medications taken to prevent or reduce the likelihood of HIV infection (PrEP or PEP) will result in deferral for three months if taken as an oral medication or two years if taken via injection. PrEP/PEP medications are highly effective in minimizing the risk of HIV transmission during sexual activity; however, the risk remains for transmission during a potential blood transfusion due to the volume of blood. Current testing is most effective at detecting HIV 90 days after exposure; these medications may also delay HIV detection by current screening tests for blood donations, potentially resulting in false negative results.
We Are Blood recommends that potential donors follow the advice of their physicians about taking PrEP or PEP medications and does not recommend stopping any prescribed medication to be able to donate blood.
We Are Blood Community Partners
We Are Blood is connecting with organizations who serve and advocate for LGBTQ community members locally, to share detailed information about the upcoming eligibility changes and receive feedback. This collaboration helps ensure that We Are Blood supports and welcomes newly eligible donors in our community with respect and humility.
Compassion and transparency are a priority for We Are Blood as we implement these changes. Our goal is to foster an inclusive blood donor community which reflects the vibrant and diverse patient community we serve.
FAQs
Is this change being made because of political correctness?
No. Donor eligibility undergoes frequent revisions resulting in changes based on current scientific evidence. Research shows that men who have sex with men in monogamous relationships are no more likely than anyone else to have undiagnosed HIV.
We want to welcome as many donors who can safely donate as possible. Inclusive donation policies are the right thing to do and expands our donor base, which means there are more life-saving treatments available.
Why does it take so long to change the eligibility criteria?
Only the FDA has the authority to approve changes to the eligibility criteria in line with evidence.
Are donors eligible if they have multiple partners if it’s vaginal/oral sex?
The new donor eligibility screening criteria focuses on anal sex in the context of new or multiple partners, rather than vaginal or oral sex. This is because, statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex.
Multiple sexual partners can also increase the chance of HIV transmission. This does not account for individuals’ safe sex practices but is based on an evidence-based approach to overall risk.
Does it count as anal sex if I use sex toys/hands/fingers?
No, using sex toys/hands/fingers is not considered anal sex in the context of our donor eligibility.
Why can’t people in exclusive relationships with more than one partner donate (polyamory/polyfidelity)?
More research is needed regarding transmissible disease risk in those who have multiple dedicated partners. This doesn’t mean that people in non-monogamous or new relationships have sexual practices that are inherently risky or not “normal.” The FDA just does not have the data to support changes to our criteria at this time.
I’ve heard undetectable means untransmissible (U=U). Why can’t HIV positive individuals donate if their viral load is undetectable?
It’s amazing that HIV care has reached a point where people’s viral loads can be undetectable.
Undetectable equals untransmissible only applies to sexual transmission of HIV. Unfortunately, this does not apply to the risk for blood transfusion-transmission. Even blood donated by those who have an undetectable viral load could potentially put a patient at risk for HIV following a blood transfusion. The risk of transmission is much higher with a unit of blood due to the large volume of a blood transfusion and the much higher total amount of virus present.
Isn’t all blood tested? Why are screening questions necessary?
Yes, every donation is tested for an array of infections that could potentially be transmitted by blood transfusion. But no test is perfect, and there are some infections for which there is no reliable test available.
One important reason we use eligibility criteria on top of testing is because of something called a “window period.” The window period is the time between when a donor has been exposed to a virus and when a blood test can detect it. If an HIV or hepatitis infection is new, currently available testing may not pick it up. The Donor History Questionnaire helps identify people who may be at a higher risk of a newly acquired infection.
How does this change affect transgender donors?
The new Donor History Questionnaire is gender-neutral and will ask all questions to all donors regardless of their gender or sexual orientation. Transgender individuals are welcome to donate blood.
How was it determined that it was safe to change to an individual donor assessment approach?
Evidence from the ADVANCE Study, the TTIMS monitoring system, and other scientific data assessed by the FDA support making this change. The new approach to donor screening will continue to defer those with a higher chance of acquiring a new HIV infection while making the eligibility process more equitable. Other criteria already in place identify additional risk factors for acquiring HIV, and these will continue to be applied.
All available evidence confirms that an individual donor assessment approach to screening will continue to ensure the highest safety and quality for the blood supply.
How has blood donor eligibility changed and why?
- With the new FDA guidance being implemented at We Are Blood on September 6, 2023, our blood donor history questionnaire now asks all donors, regardless of gender or sexual orientation, if they have had new and/or multiple sexual partners in the past three months.
- If they answer yes to either, they will be asked if they've had anal sex.
- Donors who report having had a new sexual partner, or more than one sexual partner in the past three months and anal sex in the past three months, must wait to donate for three months from the date they most recently had anal sex.
- Donors who report they have not had anal sex with a new and/or multiple partners in the past three months and meet all other eligibility criteria, will be able to.
Questions asked about anal sex in the context of new or multiple recent partners helps We Are Blood identify an increased chance of a newly acquired transfusion-transmissible HIV infection that could go undetected shortly after infection. These eligibility changes are the result of a year long study conducted by the FDA to identify safe alternatives to the prior questions and guidance.
Is this just another version of the previous policy using “anal sex” instead of asking men if they’ve had sex with men?
We Are Blood recognizes the hurt this policy has caused to many in the LGBTQ+ community and believes blood donation eligibility should not be determined based upon sexual orientation. We are committed to protecting the safety of the community blood supply and creating safe and inclusive spaces for our donor community.
The new individual donor assessment questions will ask all donors about anal sex if they have had a new sexual partner or have had multiple sexual partners in the past three months. Donors who have one sexual partner they’ve been with for three months or longer won’t be asked about anal sex.
Donors who have anal sex with one partner who they’ve been with for three months or longer will be eligible, as long as they meet all other eligibility criteria.
Why are people who have used PrEP/PEP deferred?
PrEP and PEP are highly effective preventative medications when taken as prescribed. While these medications are effective at preventing the transmission of HIV during sexual activity, the same is not true during a blood transfusion due to the volume of blood.
In the event of a potential breakthrough infection in an individual taking PrEP or PEP, the FDA is concerned about the risk of undetectable levels of HIV not being caught by current testing and posing a risk to a patient who is transfused.
For now, individuals who take PrEP or PEP are unable to donate for 3 months from their last oral dose or 2 years from their last injectable dose.
Why are there questions about anal sex with multiple partners?
Data shows that the risk of a new/recent infection of HIV increases with new sexual partners and multiple sexual partners and may not be detected by current testing methods (particularly “window period” infections).
Statistically, anal sex has a significantly higher risk of HIV transmission per sex act compared with vaginal or oral sex. Multiple sexual partners can increase the chance of HIV transmission.
Why are there not questions about condom use?
Condom use, while an excellent sexual health practice, isn’t an evidence-based method of screening donors because condoms are not always effective and can break or slip.
The updated donor history questionnaire is designed to be applied as broadly as possible to screen a large number of potential donors and identify the possibility of new exposures to certain viruses within the window period of testing platforms.
Why the focus on anal sex?
Statistically, anal sex has a much higher chance of HIV transmission per sex act than vaginal or oral sex. This does not account for individuals’ safe sex practices, but is based on an evidence-based approach to overall risk.
I’m monogamous. Can I donate and have anal sex with my partner?
Yes. If you are having anal sex with one person you’ve been with for at least three months, you will be able to donate as long as you meet all other eligibility criteria.
All donors are asked if they’ve had a new partner in the past three months, or multiple partners in the past three months. Donors who have one sexual partner they’ve been with three months or longer won’t be asked about anal sex.
Can I show up and donate if I have been deferred for my gender and those of my sexual partners?
If you have been deferred at another blood center, yes. You can schedule your donation appointment. However, if you have been previously deferred at We Are Blood, you can complete
the donor eligibility change request form or call 512.206.1108 to be reinstated as an eligible donor.
I have been a donor for years, why am I being asked these sexual history questions now?
The FDA recently released guidelines recommending an individual donor assessment approach to screening donors. That means, all donors, regardless of gender or sexual orientation, will be asked the same questions, including those about sexual behaviors associated with a higher risk of acquiring a new transfusion-transmissible infection.
