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April 21, 2023

ADVANCE Study Data Available

By America's Blood Centers

Preprint data (non-peer reviewed) from the Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study is available supporting a shift to individual donor assessments for blood donation. The ADVANCE study, which closed enrollment in 2022, focused on evaluating alternatives to the current blood donor deferral policy for sexually active gay and bisexual men.

The authors of the preprint paper explained that the ADVANCE study was a “cross-sectional behavioral and biomarker assessment of sexually active [gay and bisexual men] conducted in eight U.S. metropolitan areas [from] December 2020 to November 2022.” The study orginially included individuals between the ages of 18 and 30 before expanding in 2021 to individuals aged 18 to 39 “to help increase enrollment.”

The study included 1,561 individuals “who complete[d] the HIV risk questionaire and blood draw [and were] notified of their test results.” Of those enrolled participants, “four (0.25 percent) tested HIV-positive. The four had detectable HIV RNA and antibodies and were classified as not having recently acquired HIV infection by limiting antigen avidity [enzyme immunoassay] testing.” The authors also reported in the paper that “we compared self-reported pre-exposure prophylaxis (PrEP) users to non-users. Among HIV-negative participants, 803 (51.7 percent) reported they did not use PrEP in the last month and 789/1,552 (50.8 percent) reported no PrEP use in the last three months…We estimated the proportion of the study population who would meet the proposed donor selection criteria in the [U.S. Food and Drug Administration] (FDA) draft guidance for individual [donor] assessment questions. Each hierarchical analysis was restricted to HIV-negative participants. Among those who were not taking PrEP, 522 of 789 respondents (66.2 percent) reported fewer than two sex partners or not having anal sex with any partner in the past three months. A similar analysis of new sex partners in the last three months showed that among HIV-negative, non-PrEP users, 352 of 510 (69.0 percent) did not have a new partner or did not have anal sex with a new partner in the past three months.”

The paper concluded that the data from the ADVANCE study “demonstrate[s] that, among sexually active [gay and bisexual men], there are subgroups who test HIV-negative, have had no new sexual partners and only one sexual partner within the last three months and are likely at lower risk of HIV infection than those with new or multiple sexual partners. These results support the change from excluding all sexually active [gay and bisexual men] from blood donation as a single group to an individual [donor] assessment that defers those who may have higher HIV risk.”

The FDA funded the ADVANCE study, which included America’s Blood Centers (ABC) members OneBlood and Vitalant, with assistance from Stanford Blood Center, and also included the American Red Cross. The agency has previously explained that data from the ADVANCE study played a pivotal role in the development of the draft guidance published earlier this year titled “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products,” which proposed a shift to individual donor assessments, eliminating time-based deferrals for sexually active gay and bisexual men and women who have sex with sexually active gay and bisexual men.

Citation: Custer, B., Whitaker, B., Pollack, L., et al. “HIV Risk Behavior Profiles Among Men Who Have Sex with Men Interested in Donating Blood: The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study.” 2023.

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