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Enrollment is Complete – THANK YOU!

A heartfelt thank you to our LGBTQ+ community partners, study participants, and all those who supported the groundbreaking ADVANCE Study as we all seek to make blood donation a more inclusive process while maintaining the safety of the blood supply. Together, the LGBTQ+ community, blood centers and the FDA are collaborating to determine if a blood donor history questionnaire based on individual risk would be an acceptable alternative to a time-based deferral in reducing the risk of HIV among gay and bisexual men who present to donate blood. This could potentially lead to changes to the FDA’s current three-month deferral policy for men who have sex with men or MSM.

Study enrollment concluded on September 30, 2022. Researchers from the participating blood centers – Vitalant, OneBlood and the American Red Cross – continue to share study data with the FDA. The FDA will determine the next steps, including when and how the study results may be made public once they receive all the data and their analysis is complete. We look forward to learning more from the FDA.

 

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The first set of results from the study is now available and can be accessed here:

HIV Risk Behavior Profiles Among Men Who Have Sex with Men Interested in Donating Blood: The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study

 

The paper has not yet been peer-reviewed or accepted for publication.

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Three of the nation’s largest blood centers – Vitalant, OneBlood, and the American Red Cross – are conducting a pilot study funded by the U.S. Food and Drug Administration (FDA) that could lead to a significant change to blood donor eligibility for men who have sex with men.

The study is called the ADVANCE Study, which stands for Assessing Donor Variability And New Concepts in Eligibility.

The study is focused on evaluating alternatives to the blood donor deferral policy known as men who have sex with men (MSM). 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 purpose of the study is to determine whether a different donor deferral policy can be used at blood centers nationwide while maintaining the safety of the blood supply. For this to be possible, a change would need to be made to the donor history questionnaire, and this study is the first step in assessing the safety of a change.

The donor history questionnaire consists of a series of questions that all potential blood donors answer before donating. The questions are written to assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV.

The ADVANCE study is a first step in providing data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as time-based deferral, in reducing the risk of HIV in the blood supply.

If the scientific evidence supports the use of the different questions it could mean men who have sex with 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 result in individual risk assessment for men who have sex with men to donate blood.

To gather the necessary data the blood centers will partner with LGBTQ+ Centers in Washington D.C., San Francisco, Orlando, New Orleans/Baton Rouge, Miami, Memphis, Los Angeles, and Atlanta.

Eligibility

The study will include gay and bisexual men who are interested in donating blood, and who have had sex with at least one other man in the three months before joining in the study.

Potential participants will complete a short survey to assess if they meet the study inclusion criteria. If the potential participants are qualified, staff conducting the study will enroll the participants into the study and obtain informed consent.

Eligible participants will also need to be 18 to 39 years old and live in one of the eight communities where the pilot study is being done.

Participants will be financially compensated for their time.

What to Expect

  • 1. Potential participants will complete a short survey to determine if they meet eligibility requirements.
  • 2. Eligible participants will need to provide informed consent.
  • 3. Participants will then complete the ADVANCE Study questionnaire.
  • 4. Participants will also have a blood sample collected. This blood sample will be tested in a research laboratory for HIV, as well as for anti-retroviral drugs found in pre-exposure prophylaxis (PrEP).
  • 5. A few weeks after enrolling in the study, participants will be asked to return to the location where they enrolled to learn of their test results. Depending upon the test results, participants will be asked to complete an additional questionnaire.

Locations & Appointments

A heartfelt thank you to our LGBTQ+ community partners, study participants, and all those who supported the groundbreaking ADVANCE Study as we all seek to make blood donation a more inclusive process while maintaining the safety of the blood supply.

ADVANCE Study enrollment concluded on Sept. 30, 2022.

Researchers from the participating blood centers – Vitalant, OneBlood and the American Red Cross – continue to share study data with the FDA. The FDA will determine the next steps, including when and how the study results may be made public once they receive all the data and their analysis is complete. We look forward to learning more from the FDA. 

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All Locations

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San Francisco, Oakland & Palo Alto
Location: San Francisco Bay Area
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Pasadena, Culver City & Hollywood
Location: Greater Los Angeles Area
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Memphis
Location: Memphis
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New Orleans & Baton Rouge
Location: Greater New Orleans & Baton Rouge
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Atlanta
Location: Atlanta
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Orlando
Location: Orlando
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Fort Lauderdale & Miami
Location: South Florida
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Washington, D.C.
Location: Washington, D.C.
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San Francisco, Oakland & Palo Alto
Community Partners: Project MORE
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Pasadena, Culver City & Hollywood
Community Partners: LA LGBT Center, City of Hope, Pride in the City
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Memphis
Location: Memphis
Additional Information +
Phone: 901-569-4567 E-mail: ADVANCEStudy@vitalant.org Thanks for your interest! Enrollment concluded on September 30, 2022.
Community Partners: The Corner, Friends for Life, OUT Memphis
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New Orleans & Baton Rouge
Community Partners: CrescentCare, LGBT Community Center of New Orleans, PFLAG, Baton Rouge Pride
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Atlanta
Location: Atlanta
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Phone: 888-689-0001 E-mail: ARCADVANCEStudy@redcross.org Thanks for your interest! Enrollment concluded on September 30, 2022.
Community Partners: Atlanta Pride
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Orlando
Location: Orlando
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Phone: 727-304-8487 E-mail: ADVANCE@oneblood.org Thanks for your interest! Enrollment concluded on September 30, 2022.
Community Partners: The Center
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Fort Lauderdale & Miami
Community Partners: Pridelines, SunServe, The Pride Center
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Washington, D.C.
Location: Washington, D.C.
Additional Information +
Phone: 888-689-0001 E-mail: ARCadvancestudy@redcross.org Thanks for your interest! Enrollment concluded on September 30, 2022.
Community Partners: Whitman Walker Institute

FAQs

The following are a list of Frequently Asked Questions regarding the ADVANCE Study.

What does ADVANCE stand for?

Assessing Donor Variability And New Concepts in Eligibility.

What is the ultimate goal of ADVANCE Study?

The ADVANCE Study is a first step in providing data that will help the FDA determine if a blood donor history questionnaire based on individual risk would be as effective as time-based deferral in reducing the risk of HIV among gay and bisexual men who present to donate blood.

The study will collect responses from qualified study participants to questions that could be added to the donor history questionnaire in the future. The study is designed to assess if the questions related to behaviors may be effective in distinguishing between gay and bisexual men who have recently become infected with HIV and those who do not have HIV infection.

What is the current donor deferral policy for men who have sex with men (MSM)?

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.

What will the pilot study examine?

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.

Other studies have been done regarding the blood donor deferral policy known as men who have sex with men (MSM). 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 MSM 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.

What type of additional questions will be included in ADVANCE Study?

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

What is the role of the LGBTQ+ Centers in the pilot study?

The blood centers are partnering with LGBTQ+ Centers in the eight locations to identify and enroll 2,000 qualified participants into the study (250 – 500 from each area).

When are results expected and how will they be communicated for this study?

The results are expected in late-2022. The findings of the pilot ADVANCE Study will be submitted to the FDA who will review the data and decide the next steps.

How did the LGBTQ+ Centers get involved in the ADVANCE Study?

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.

Why are Vitalant, OneBlood and the American Red Cross leading this study?

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.

Why can’t gay and bisexual men in other cities participate?

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.

When do you plan to expand to additional cities?

Right now, the ADVANCE Study is focused on completing the 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.

Why are you limiting the number of participants?

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.

Why is the study limited to individuals between the ages of 18 and 39?

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.

What is the role of the FDA in blood donor eligibility?

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.

What is the history of the blood donor deferral policy known as men who have sex with men (MSM)?

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.

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