ADVANCE Study Results Support Individual Donor Assessment

Among sexually active men who have sex with men (MSM), many are at a lower risk for HIV infection and, therefore, should be considered eligible blood donors, according to highly anticipated results from the ADVANCE Study, published this week in Transfusion.  

These results offer additional support for FDA’s May 2023 final guidance, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products,” which recommended the implementation of individual donor assessment (IDA) to determine blood donor eligibility for all blood collection facilities in the United States. 

The ADVANCE Study’s data indicated that about half of HIV-negative participants (50.4%) reported they did not use pre-exposure prophylaxis (PrEP) in the past three months. Among this group, 66.2% reported one sexual partner or no anal sex in the past three months, and 69% reported no new sexual partners or no anal sex with a new partner in the past three months. 

Critical Data 
The ADVANCE (Assessing Donor Variability and New Concepts in Eligibility) Study was designed as a cross-sectional behavioral and biomarker assessment of sexually active MSM, conducted in Atlanta, Ga.; Los Angeles, Calif.; Memphis, Tenn.; Miami, Fla.; New Orleans/Baton Rouge, La.; Orlando, Fla.; San Francisco, Calif.; and Washington, DC, between December 2020 and November 2022. Eligible sexually active MSM who were recruited to participate in the study completed an initial questionnaire and had blood collected to determine HIV status. Initially, eligibility for a follow-up questionnaire was limited to those who tested HIV-positive or tested HIV-negative and PrEP-reactive. The study provided critical data, which served as one of several key factors in leading to the FDA’s IDA recommendation. 

The ADVANCE Study’s researchers, led by Brian Custer, PhD, vice president of research and scientific programs at Vitalant, said that although the study was conducted in eight locations, some of the findings would be similar throughout the country. “The number of sexual partners and type of sex reported by study participants are likely generalizable to the MSM population in other areas of the country. However, access to PrEP varies by geography and is likely to differ even within metropolitan areas, thereby precluding analytical adjustment for these differences,” the researchers wrote. 

The researchers also noted that these data indicate that the changes set forth in FDA’s final guidance recommending IDA can be implemented safely and effectively and will expand donor eligibility to some groups that had previously been deferred unnecessarily. “The results from ADVANCE indicate that, among sexually active MSM interested in blood donation, there are subgroups who test HIV-negative and have had no new sexual partners and only one sexual partner within the past three months; studies in MSM cohorts suggest that these men are likely at lower risk of HIV infection than those with new or multiple sexual partners,” the researchers wrote. “ADVANCE results indicate that questions can distinguish different groups of MSM, some of whom will meet the new individual risk assessment blood donation criteria, allowing persons previously not permitted to become blood donors.” 

IDA Resources Available 
AABB is offering a complimentary resource library comprising training materials and job aids for blood collection facilities to implement IDA protocols. The IDA resource library can be found online at www.aabb.org/IDA. It includes multiple documents and tools, as well as links to on-demand education modules. All resources are free to members of the blood and biotherapies community; AABB encourages all members to take advantage of these resources.