The American Red Cross Los Angeles Region is starting community outreach for The ADVANCE Study (“Assessing Donor Variability And New Concepts in Eligibility”) which is a pilot study focused on the US Food and Drug Administration’s (FDA) “donor deferral policy” for men who have sex with men (MSM). The current donor deferral policy prohibits a man who has had sex with another man from donating blood for three months following the most recent sexual contact.
A virtual informational webinar will take place on Tuesday, December 14, 2021 from 12 p.m. to 1 p.m. via the Zoom platform. Register here.
“Growing up, I was acutely aware of the barriers before me as a gay man, should I ever want to donate blood,” said City of West Hollywood Councilmember John M. Erickson. “Draconian policies that prohibit or function as barriers to gay men donating blood still exist today. These policies were first established during the early days of the HIV/AIDS epidemic and they should have been ended decades ago. Donation of blood should not be determined by methods that seek information about sexual orientation, nor should blood donation carry stigma for men who have sex with men. Blood donation saves lives and the ADVANCE study is the first step in a pilot that could lead to a significant change in blood-donor eligibility for gay and bisexual men. I am proud of the City of West Hollywood, which has always fought to overturn these horrendous policies since our City’s incorporation nearly four decades ago. Finally, we’re seeing momentum on this issue.”
The purpose of the ADVANCE study is to determine if different eligibility criteria for gay and bisexual men can be used at blood centers nationwide. 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. If this pilot study shows promising results, the next step would be a larger study to test these questions.
The purpose of the new study is a first step in determining 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.
The donor history questionnaire consists of a series of questions that all potential blood donors answer before donating. The questions assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV.
To gather the necessary data the blood centers are partnering 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 participants (250 – 300 from each area) who meet the study eligibility criteria. Participants in the study will have a blood sample drawn for HIV testing and will answer different questions designed to determine individual HIV risk factors. The study will assess if the questions related to behavior are effective in distinguishing between men who have sex with men who have recently become infected with HIV and those who do not have HIV infection. The findings of this study will help determine the next steps that would be needed to modify the donor history questionnaire.
The ADVANCE Study is being conducted by Vitalant, OneBlood, and the American Red Cross, together representing approximately 60 percent of the blood supply in the United States. It plans to provide its findings to the FDA for review.
The City of West Hollywood has been on record for decades urging the FDA to create new blood donor guidelines. For many years, the FDA banned any man who had sex with another man once since 1977 from donating blood. These discriminatory policies were adopted in 1983 in direct response to the HIV/AIDS crisis of the time. In 2006, the American Red Cross, America’s Blood Centers, and the Americans Association of Blood Banks reported to the FDA that this ban was medically and scientifically unwarranted, but it remained in place. In 2015, the policy was finally reduced from an indefinite deferral period to a twelve month deferral. The policy was further reduced to three months in April 2020 to address the urgent and immediate need for blood during the COVID-19 pandemic. It is anticipated the deferral period will remain three months on an ongoing basis, even after the pandemic ends.
To learn more about the ADVANCE study and to enroll, visit ADVANCEstudy.org.
For more information about the City of West Hollywood’s ADVANCE Study Day, please contact Jasmine Duckworth, City of West Hollywood Community Affairs Coordinator, at (323) 848-6559 or at [email protected] For people who are Deaf or hard of hearing, please call TTY (323) 848-6496. For more information, please contact the Red Cross at [email protected] or visit www.redcross.org/LA.