(Above image from The Center Orlando’s Facebook page)
ORLANDO | The Food and Drug Administration (FDA) is funding a study to look into its own policy which currently bans men who have sex with men (MSM) from donating blood. The policy was established in the 1980’s during the height of the AIDS pandemic.
The pilot study — called Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) — 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. Current policy states that MSM can donate only after a three-month period has passed since last having sex with another man.
The study will be conducted by Vitalant and OneBlood, the two largest community-based blood centers in the U.S., and the American Red Cross and will be done in partnership with LGBTQ community centers in the country.
“The findings of this study will help determine the next steps that would be needed to modify the donor history questionnaire,” says Susan Forbes, senior vice president of corporate communications & public relations for OneBlood. “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 study, which is expected to take about a year to complete, will be conducted at eight locations in the U.S., with the LGBT+ Center Orlando being one of them.
“The blood centers reached out to us personally to see if we would like to work with them on the study,” says Dr. George Wallace, The Center Orlando’s executive director. “We are helping coordinate outreach to the LGBTQ+ community to create awareness about the study and potential participants can be identified. The policies that discriminate against gay and bisexual men are outdated and stigmatizing and I hope that The Center Orlando can play even a small role in getting these changed. It is a subject that I am passionate about so when the opportunity to work on the national study came about, I knew that I wanted Orlando to be part of it.”
To be eligible to participate in the ADVANCE study you must be a gay or bisexual man between the ages of 18-30, interested in donating blood and have had sex with at least one man in the three months before joining 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,” Forbes says.
The FDA study comes three months after U.S. Reps. Val Demings (FL-10) and Mike Quigley (IL-5) introduced in the House the Science in Blood Donation Act of 2020, which would require the FDA to revise its guidelines to be based on an assessment of current testing accuracy and individual risk-based analysis, rather than categorization.
The study will begin enrolling participants soon at ADVANCEstudy.org.
