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The ADVANCE Study: Rethinking HIV Risk-Assessment for Gay Blood Donors

In the midst of a national blood crisis, the FDA is funding a study to examine if different questioning can be used to determine the HIV risk of gay or bisexual men who want to donate blood.

By April 2020, incoming blood donations began to decrease as the COVID-19 pandemic spread. The swiftness of the blood shortage led the US Federal Drug Administration to amend some of their eligibility requirements for donating.

Almost 2 years later, the blood supply remains critically low.

Earlier this month, the American Red Cross declared a national blood crisis for the first time in history. The nation’s blood reserve routinely holds a 5-day supply of blood. The current supply doesn’t even account for a full-day’s worth of blood.

The current crisis has provoked a re-assessment of certain eligibility requirements. The FDA is funding a study to examine if different questioning on the donor questionnaire could be effective in determining the HIV risk of individual gay and bisexual men, as opposed to deferring them based on their last sexual contact.

When the study launched in May 2021, results were expected in late 2021. However, due to low enrollment, results can be expected in mid-2022.

FDA Blood Donor Eligibility Amendments

In order to donate blood, gay and bisexual men, or men who have sex with men, must wait 3 months since their last sexual encounter. Prior to April 2020, the FDA recommendation was 1 year.

Prior to 2015, gay and bisexual men were banned by the FDA from donating blood altogether.

This recommendation also applies to women who have sex with men, who have had sex with other men, as well as individuals with new tattoos or piercings. The FDA allocated these recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.

Additionally, individuals on HIV preventative medications such as PrEP, PEP, tenofovir, emtricitabine, dolutegravir and raltegravir must wait 3 months after their last dose to give blood, according to the American Red Cross.

Rethinking Risk-Assessment

As the blood supply is diminishing, the FDA is enrolling gay and bisexual men in a pilot study to evaluate alternatives to the blood donor deferral policy known as men who have sex with men (MSM).

The study is called ADVANCE, Assessing Donor Variability And New Concepts in Eligibility.

The purpose of the study is to determine if different eligibility criteria for gay and bisexual men can be used at blood centers nationwide, according to the ADVANCE study website.

Investigators will examine specific questions regarding the donor’s history to determine if the donor questionnaire can be updated to include questions based on an individual risk of HIV infection, instead of the amount of time since a sexual encounter.

The nation’s largest blood centers, Vitalant, OneBlood, and the American Red Cross, are conducting the study and currently enrolling gay or bisexual men between the ages of 18-39.

Eligible participants include men who are interested in giving blood and who have had sex with another man within the 3 months before joining the study.

Blood centers in 8 cities have partnered with LGBTQ+ centers to enroll 2,000 men in the research. Locations include San Francisco Bay Area, Greater Los Angeles Area, Memphis, TN, New Orleans & Baton Rouge, LA, Atlanta, GA, Washington DC, Orlando, FL, and Miami, FL.

Possibility for Change?

Previous studies have been conducted regarding this aspect of the blood donor policy, but according to the study’s website, this time is different.

"The ADVANCE study is groundbreaking because it's the first time a study is being conducted that could result in individual risk assessment for men who have sex with men to donate blood," Rita Reik, MD, chief medical officer for OneBlood, said in a statement.

The ADVANCE study website states that if the scientific evidence supports the use of the additional questions, it could mean MSM who present to donate would be assessed based upon their own individual risk for HIV infection and not according to when their last sexual contact with another man occurred.

Investigators conducting this study will assess the effectiveness of the behavior-related questions in distinguishing between men who have recently become infected with HIV and men who do not have the infection.

"We are hopeful the ADVANCE study will conclude that state-of-the-art testing of the blood supply, combined with an individual risk assessment, will support a change to the blood donor deferral policy so that all men who have sex with men can be considered potential blood donors," Denise Spivak, CEO of CenterLink, said in a statement.