About

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. The study will enroll a total of 2,000 gay and bisexual men (250 – 300 from each area) who meet the study eligibility criteria.

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.

Schedule an Appointment

Appointments are required to enroll in the ADVANCE study. Please click on the location near you to schedule your appointment. The study is being started in different cities over the next several months. If the link for your location is not active, the study has not yet started in your city.

If you want to find out more about the study please contact the research staff at the nearest enrollment site.

You can email or call the number listed for each location.

Irwin Donation Center


Phone: 888-301-9122
E-mail: ADVANCEStudy@vitalant.org

The Center


Phone: 727-304-8487
E-mail: ADVANCE@oneblood.org

American Red Cross


Phone: 888-689-0001
E-mail: arcadvancestudy@redcross.org

CrescentCare NOLA & Vitalant BR



Phone: 888-301-9122
E-mail: ADVANCEStudy@vitalant.org

The Corner



Phone: 888-301-9122
E-mail: ADVANCEStudy@vitalant.org

OneBlood



Phone: 727-304-8487
E-mail: ADVANCE@oneblood.org

Pasadena Red Cross


Phone: 888-689-0001
E-mail: arcadvancestudy@redcross.org

American Red Cross



Phone: 888-689-0001
E-mail: arcadvancestudy@redcross.org

Pridelines



Phone: 727-304-8487
E-mail: ADVANCE@oneblood.org

American Red Cross



Phone: 888-689-0001
E-mail: arcadvancestudy@redcross.org

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 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.

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 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.

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 – 300 from each area).

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

The results are expected in mid-2022. 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.

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 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.

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?

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.

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.

Sponsors

In the News

May 18, 2021
PRNewswire – Blood centers conducting research that could lead to…

READ MORE >>

 

May 18, 2021
WMFE – Rep. Demings shows support for ADVANCE Study that could make it easier…

READ MORE >>

 

July 1, 2021
KCRA– FDA funding study around blood donations from gay men. 

READ MORE >>