ADVANCE Study, designed to assess feasibility of updating MSM deferral policy, begins enrolling participants

December 18, 2020

A landmark pilot study designed to assess the feasibility of alternatives to the current blood donation deferral policy for HIV risk recently began enrolling its first participants.  

The ADVANCE Study (Assessing Donor Variability and New Concepts in Eligibility), funded through a contract from the U.S. Food and Drug Administration and conducted by researchers at American Red Cross, OneBlood and Vitalant, represents a significant advancement in research to assess current blood donation policy and analyze the feasibility of alternative approaches.

The study is designed to determine whether changes to the donor deferral policy for men who have sex with men (MSM) could be implemented without compromising the safety of the blood supply. The researchers will assess whether deferral criteria could be based on a donor’s individual risk for HIV infection instead of the date of their last sexual contact with another man.  

AABB welcomes the commencement of the ADVANCE Study. AABB has long supported research to develop deferral policies based on science; the Association also champions more inclusivity in the blood donation process. 

“Ensuring an adequate blood supply is essential to our nation’s health care system—particularly in the midst of the ongoing COVID-19 pandemic—and a critical component of that effort is expanding the pool of potential donors. The ADVANCE study is a welcome contributor to this effort,” said Debra BenAvram, CEO of AABB. “AABB applauds the efforts of researchers at AABB-accredited facilities whose work will lead us to a better understanding of optimal donor deferral policies and may, ultimately, help more people join the community of donors who save lives every day.”

Essential Data  
FDA officials have previously stated the agency’s interest in additional data on MSM blood donation is necessary before policy changes could potentially be implemented. If the results of the ADVANCE Study confirm alternative approaches to assess donor risk could be implemented without impacting the safety of the blood supply, it could lead to more inclusive donation policies for gay and bisexual men.

“The ADVANCE Study is a pilot study that seeks to assess if a specific set of questions might be able to be added to the donor history questionnaire,” Brian Custer, PhD, MPH, principal investigator of the ADVANCE Study, told AABB. “The study is focused on evaluating alternatives to the FDA’s blood donor deferral policy for gay and bisexual men.”  

Custer, who also serves as the director of epidemiology and policy science at Vitalant Research Institute San Francisco and vice president of research and scientific program at Vitalant, said this study may help determine if the United States could potentially update its MSM blood donation policy and move toward a policy similar to that which was recently announced in the United Kingdom. “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,” Custer said.

The study will be conducted as a partnership between blood centers and LGBTQ+ centers in eight metropolitan areas: Washington D.C., San Francisco, Orlando, New Orleans/Baton Rouge, Miami, Memphis, Los Angeles and Atlanta. The study is expected to enroll 2,000 gay and bisexual men who are interested in donating blood and who have had a sexual encounter with at least one other man in the three months before joining in the study. Results of the study are expected in late 2021.

AABB Event to Provide More Information
More information about FDA’s support for research to better understand donor deferral policies will be included in an AABB eCast on January 7, 2021. The program, “COVID-19 Vaccines, PrEP, MSM – What You Need to Know Heading Into 2021,” will feature a presentation by Custer on HIV detection in the ART/PrEP era. AABB has invited Peter Marks, MD, PhD; and Nicole Verdun, MD, from the FDA who will provide an update on the agency’s approach to MSM deferrals and ongoing research. Sharon Carayiannis, AABB’s senior director of regulatory affairs, will moderate the event.