The ADVANCE Study is a pilot study that is focused on the FDA’s donor deferral policy known as men who have sex with men (MSM). The current policy prohibits a man who has had sex with another man from donating blood for three months following the most recent sexual contact. The purpose of the study is to determine if different eligibility criteria for gay and bisexual men can be used at blood centers nationwide.

Currently, the FDA recommends that men who have had sex with another man be deferred from donating blood for three months after the most recent sexual contact with another man.

The ADVANCE Study will examine if different questions could be added to the donor history questionnaire that are based on individual risk of HIV infection. The study will examine if the addition of these questions would be as effective as a time-based deferral in reducing the risk of HIV among gay and bisexual men who present to donate blood.

The ADVANCE Study is designed to assess if the questions related to behaviors are effective in distinguishing between gay and bisexual men who have recently become infected with HIV and those who do not have HIV infection. Depending on the findings, the additional questions may be added to the donor history questionnaire in the future.

Other studies have been done regarding the policy known as men who have sex with men (MSM) so what makes this study different?
The ADVANCE Study is groundbreaking because it’s the first time a study is being conducted that could be a first step towards changing the eligibility criteria for gay and bisexual men to donate blood, depending on the results. If the scientific evidence supports the use of the additional questions, it could mean gay and bisexual men 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.

The ADVANCE Study is groundbreaking because it’s the first time a study is being conducted that could be a first step towards changing the eligibility criteria for MSM to donate blood, depending on the results. 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.

The study includes questions on individual behaviors that may be associated with new HIV infection in gay and bisexual men.

The blood centers are partnering with LGBTQ+ Centers in the eight locations to identify and enroll 2,000 qualified participants into the study (250 – 300 from each area).

The results are expected in late 2021. The findings of the pilot ADVANCE Study will be submitted to the FDA who will review the data and decide the next steps. The FDA will decide the best way to publicly share the study results. If the pilot study shows promising results, one likely next step would be a larger study to assess if the ADVANCE Study questions related to behaviors work the same way in gay and bisexual men interested in blood donation in other parts of the country.

The blood centers reached out to the LGBTQ+ community Centers in the cities where the study is being done to see if the community Centers wanted to partner on the study. The community Centers are helping to coordinate outreach to members of the LGBTQ+ community to create general awareness about the study and to help recruit potential participants.

As blood collection organizations dedicated to helping save lives, Vitalant, OneBlood, and the American Red Cross, have a shared goal to better assess and qualify eligible individuals to donate blood to meet patient needs while continuing to protect the safety of the nation’s blood supply. As we work together toward a more inclusive blood donation process, the ADVANCE Study is an important first step towards potentially changing the donor eligibility criteria for gay and bisexual men depending on the results of this pilot study.

The ADVANCE Study is focused on eight metropolitan areas with high rates of new HIV infections or active PrEP (pre-exposure prophylaxis) programs. The three blood centers and the FDA have collaborated to determine the study locations and sample size to ensure that the study will collect necessary data as a first step to determine the feasibility of modifying donor eligibility criteria. In this pilot study it is not possible to include all locations where gay and bisexual men are interested in participating.

Right now, the ADVANCE Study is focused on launching this new study in eight metropolitan areas including Washington D.C., San Francisco, Orlando, New Orleans/Baton Rouge, Miami, Memphis, Los Angeles, and Atlanta. There are no plans to expand locations as part of this pilot.

The study is a first step in providing additional data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as a time-based deferral in reducing the risk of HIV in the blood supply. If the pilot study’s scientific evidence supports the use of the different questions it could lead to further efforts to change the eligibility criteria for gay and bisexual men to be based upon individual risk for HIV infection and not their last sexual contact with another man. One possible next step after the pilot is expanding this study to other locations.

The three participating blood centers and the FDA have determined the locations and size to ensure the study could collect necessary data as a first step to determine the feasibility of modifying donor eligibility criteria. The results of this first pilot study will provide information for consideration by the FDA.

Originally, the study was limited to individuals between the ages of 18 and 30 but it was expanded to 18-39 in order to obtain a broader demographic analysis. The study is limited to individuals between the ages of 18 and 39 because that age range represents the highest incidence age group for HIV infection. The study is designed to evaluate the survey questions compared to the current process. These data will help inform potential changes to the policy.

The FDA is responsible for protecting the public health, including the safety of the U.S. blood supply. The FDA determines blood donor deferral policies using scientific data. The FDA policies are intended to ensure the safety of the blood supply, for blood donors, and patients who receive blood transfusions. All blood centers are regulated by the FDA. As regulated agencies, all blood centers in the U.S. are required to comply with all regulations established by the FDA. If a blood center does not comply with FDA regulations, the center would be in jeopardy of losing its license and could be shutdown.

The deferral dates to 1983 when the FDA instituted a lifetime deferral on blood donations for men who have sex with men. The regulation was intended to reduce the chance of HIV in the blood supply at a time when HIV testing was limited or non-existent. In 2015, the FDA revised the donor deferral policy known as men who have sex with men (MSM) and moved to a 12-month deferral period following the most recent sex with another man. In April 2020, citing a public health emergency related to the COVID-19 pandemic the FDA eased its restrictions on blood donations and lifted the 12-month deferral and moved to a 3-month deferral. The FDA’s decision was made after careful evaluation of the available data which suggested the 3-month deferral could be implemented without any adverse effect on the safety of the blood supply. The FDA stated that implementation of the 3-month deferral for men who have sex with men may help to address significant blood shortages that are occurring as a result of the COVID-19 health emergency.