About

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

The pilot 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 FDA’s blood donor deferral policy for men who have sex with men (MSM). FDA recommends that a man who has had sex with another man be deferred from donating blood for three months following the most recent sexual contact with another man.

The purpose of the study is to determine whether a different donor deferral 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 between the ages of 18 and 30 years, and also will need to live in one of the eight communities where the pilot study is being done.

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.

Participation

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, Orlando


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

American Red Cross


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

The study has not yet started at this location, but if you are interested in participating, please contact us at the email or phone # below and we will follow up at a later date.

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

The study has not yet started at this location, but if you are interested in participating, please contact us at the email or phone # below and we will follow up at a later date.

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

The study has not yet started at this location, but if you are interested in participating, please contact us at the email or phone # below and we will follow up at a later date.

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

The study has not yet started at this location, but if you are interested in participating, please contact us at the email or phone # below and we will follow up at a later date.

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

The study has not yet started at this location, but if you are interested in participating, please contact us at the email or phone # below and we will follow up at a later date.

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

FAQ

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 men who have sex with men (MSM) 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. If this pilot study shows promising results, the next step would be a larger study to test these questions.

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 MSM who present to donate blood.

Other studies have been done regarding the MSM policy 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 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 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.

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