{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T23:55:53Z","timestamp":1788220553305,"version":"build-2803163510"},"reference-count":15,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,4,13]],"date-time":"2025-04-13T00:00:00Z","timestamp":1744502400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["75F40121C00196"],"award-info":[{"award-number":["75F40121C00196"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["75F40120C00101"],"award-info":[{"award-number":["75F40120C00101"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Following FDA guidance, US blood collectors changed donor deferral for men who have sex with men (MSM) from indefinite to a 12 month deferral in 2016 (12\u2009m), and for MSM and several other exposure risks to 3 month deferrals in 2020 (3\u2009m). We evaluated first\u2010time donor (FTD) HIV incidence and demographics during these periods.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>We estimated cross\u2010sectional HIV incidence and incidence rate differences in FTD based on routine donation nucleic acid testing (NAT) and serology with additional limiting antigen (LAg)\u2010Avidity immunoassay and viral load testing. We estimated incidence in the two policy periods (12 and 3\u2009m), incidence trends in two\u2010year intervals between 2015 and 2023, and used multivariable Poisson regression to assess demographic correlates of incident infection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>HIV incidence in FTD during the 12\u2009m deferral period was 2.82 infections\/10<jats:sup>5<\/jats:sup> person\u2010years (PY) [95% CI: 2.12, 3.67] and during the 3\u2009m deferral period, it was 1.88\/10<jats:sup>5<\/jats:sup> PY (95% CI: 1.18, 2.67), a statistically significant decline (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.05). Over the period 2015\u20132023, incidence was stable. Male sex, younger age, Black or African American race, Hispanic ethnicity, and residence in the South were associated with incident infection in regression analysis, but the time\u2010based deferral policy periods were not.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>HIV incidence in FTD did not increase between 2015 and 2023. An overall decline in HIV incidence in the 3\u2009m deferral period compared with the 12\u2009m deferral period was evident. These results provide no indication of an increased residual risk of transfusion\u2010transmitted HIV from FTD in the United States with the reduced deferral periods.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.18195","type":"journal-article","created":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T00:14:40Z","timestamp":1744589680000},"page":"834-840","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["<scp>HIV<\/scp> incidence in <scp>US<\/scp> first\u2010time blood donors during 12 and 3 month deferral policy periods between 2015 and 2023 before implementation of individual donor assessment"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7046-7245","authenticated-orcid":false,"given":"Eduard","family":"Grebe","sequence":"first","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6047-211X","authenticated-orcid":false,"given":"Clara","family":"Di Germanio","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"IV","given":"Edward P.","family":"Notari","sequence":"additional","affiliation":[{"name":"American Red Cross  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mars","family":"Stone","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jahnavi Reddy","family":"Bhaskar","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Venkata","family":"Dayana","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4213-5013","authenticated-orcid":false,"given":"Marion C.","family":"Lanteri","sequence":"additional","affiliation":[{"name":"University of California San Francisco  San Francisco California USA"},{"name":"Creative Testing Solutions  Tempe Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jed","family":"Gorlin","sequence":"additional","affiliation":[{"name":"New York Blood Center Enterprises  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Reik","sequence":"additional","affiliation":[{"name":"OneBlood  St Petersburg Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"Stramer","sequence":"additional","affiliation":[{"name":"Infectious Disease Consultant  North Potomac Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael P.","family":"Busch","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benyam","family":"Hailu","sequence":"additional","affiliation":[{"name":"National Heart, Lung and Blood Institute, National Institutes of Health  Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6848-1224","authenticated-orcid":false,"given":"Artur A.","family":"Belov","sequence":"additional","affiliation":[{"name":"Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Yang","sequence":"additional","affiliation":[{"name":"Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6311-6268","authenticated-orcid":false,"given":"Barbee","family":"Whitaker","sequence":"additional","affiliation":[{"name":"Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6251-366X","authenticated-orcid":false,"given":"Brian","family":"Custer","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"University of California San Francisco  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the US Transfusion\u2010Transmissible Infections Monitoring System (TTIMS)","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,13]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry","author":"Food and Drug Administration","year":"2015"},{"key":"e_1_2_9_3_1","volume-title":"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry","author":"Food and Drug Administration","year":"2020"},{"key":"e_1_2_9_4_1","volume-title":"Recommendations for Evaluating Donor Eligibility Using Individual Risk\u2010Based Questions to Redcuce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products","author":"Food and Drug 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Conference on Retroviruses and Opportunistic Infections; March 4\u20137 2019; Seattle WA2019."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2002.00099.x"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2004.04215.x"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16753"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13482"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16005"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2020006890"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.17851"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.18195","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T05:53:51Z","timestamp":1753682031000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.18195"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,13]]},"references-count":15,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1111\/trf.18195"],"URL":"https:\/\/doi.org\/10.1111\/trf.18195","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,13]]},"assertion":[{"value":"2024-12-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}