{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T20:42:52Z","timestamp":1789072972357,"version":"build-2803163510"},"reference-count":31,"publisher":"American Society of Hematology","issue":"11","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,9,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In 2015, the US Food and Drug Administration published revised guidance that recommended a change in blood donor deferral of men who have sex with men (MSM) from an indefinite to a 12-month deferral since the donor last had sex with a man. We assessed whether HIV incidence in first-time blood donors or associated transfusion risk increased. Donations in 4 major blood collection organizations were monitored for 15 months before and 2 years after implementation of the 12-month MSM deferral policy. HIV-positive donations were classified as recently acquired or long-term using a recent infection testing algorithm and incidence in both periods estimated. Residual transfusion transmission risk was estimated by multiplying incidence by the length of the infectious window period. The latter was estimated using a model based on infectious dose and the sensitivity of nucleic acid testing. Factors associated with incident infection in each period were assessed using Poisson regression. Overall HIV incidence in first-time donors before implementation of the 12-month MSM deferral was estimated at 2.62 cases per 100\u2009000 person-years (105 PY) (95% credible interval [CI], 1.53-3.93 cases\/105 PY), and after implementation at 2.85 cases\/105 PY (95% CI, 1.96-3.93 cases\/105 PY), with no statistically significant change. In male first-time donors, the incidence difference was 0.93 cases\/105 PY (95% CI, \u22121.74-3.58 cases\/105 PY). The residual risk of HIV transfusion transmission through components sourced from first-time donors was estimated at 0.32 transmissions per million (106) packed red blood cell transfusions (95% CI, 0.29-0.65 transmissions\/106 transfusions) before and 0.35 transmissions\/106 transfusions (95% CI, 0.31-0.65 transmissions\/106 transfusions) after implementation. The difference was not statistically significant. Factors associated with incident infection were the same in each period. We observed no increase in HIV incidence or HIV transfusion transmission risk after implementation of a 12-month MSM deferral policy.<\/jats:p>","DOI":"10.1182\/blood.2020007003","type":"journal-article","created":{"date-parts":[[2020,7,21]],"date-time":"2020-07-21T18:56:10Z","timestamp":1595357770000},"page":"1359-1367","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":33,"title":["HIV incidence in US first-time blood donors and transfusion risk with a 12-month deferral for men who have sex with men"],"prefix":"10.1182","volume":"136","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, CA;"},{"name":"Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael P.","family":"Busch","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute, San Francisco, CA;"},{"name":"Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward P.","family":"Notari","sequence":"additional","affiliation":[{"name":"Scientific Affairs, American Red Cross, Rockville and Gaithersburg, MD;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5898-8168","authenticated-orcid":false,"given":"Roberta","family":"Bruhn","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute, San Francisco, CA;"},{"name":"Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Quiner","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute, San Francisco, CA;"},{"name":"RTI International, Research Triangle Park, NC;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Hindes","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mars","family":"Stone","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute, San Francisco, CA;"},{"name":"Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Bakkour","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute, San Francisco, CA;"},{"name":"Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0057-6566","authenticated-orcid":false,"given":"Hong","family":"Yang","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillip","family":"Williamson","sequence":"additional","affiliation":[{"name":"Creative Testing Solutions, Tempe, AZ;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debra","family":"Kessler","sequence":"additional","affiliation":[{"name":"New York Blood Center, New York, NY;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Reik","sequence":"additional","affiliation":[{"name":"OneBlood, St. Petersburg, FL; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"Stramer","sequence":"additional","affiliation":[{"name":"Scientific Affairs, American Red Cross, Rockville and Gaithersburg, MD;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone A.","family":"Glynn","sequence":"additional","affiliation":[{"name":"National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven A.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan E.","family":"Williams","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD;"}],"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, CA;"},{"name":"Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"234","reference":[{"key":"2020091011282830300_B1","unstructured":"U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research\n          . Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry. December 2015. https:\/\/www.regulations.gov\/document?D=FDA-2015-D-1211-0099. Accessed 21 September 2019."},{"key":"2020091011282830300_B2","unstructured":"U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research\n          . Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Draft Guidance for Industry. May 2015. https:\/\/www.regulations.gov\/document?D=FDA-2015-D-1211-0002. Accessed 20 April 2020."},{"issue":"6 pt 2","key":"2020091011282830300_B3","doi-asserted-by":"crossref","first-page":"1499","DOI":"10.1111\/trf.13632","article-title":"Transfusion-transmissible infection monitoring system: a tool to monitor changes in blood safety","volume":"56","author":"Custer","year":"2016","journal-title":"Transfusion"},{"key":"2020091011282830300_B4","doi-asserted-by":"crossref","DOI":"10.1111\/trf.16005","article-title":"Prevalence of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in United States blood donations, 2015 to 2019: The Transfusion-Transmissible Infections Monitoring System (TTIMS) [published online ahead of print 2020]","author":"Steele","year":"2020","journal-title":"Transfusion"},{"issue":"1","key":"2020091011282830300_B5","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1111\/j.1537-2995.2010.02804.x","article-title":"Refinement of a viral transmission risk model for blood donations in seroconversion window phase screened by nucleic acid testing in different pool sizes and repeat test algorithms","volume":"51","author":"Weusten","year":"2011","journal-title":"Transfusion"},{"issue":"1","key":"2020091011282830300_B6","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1089\/aid.2009.0133","article-title":"Development of two avidity-based assays to detect recent HIV type 1 seroconversion using a multisubtype gp41 recombinant protein","volume":"26","author":"Wei","year":"2010","journal-title":"AIDS Res Hum Retroviruses"},{"issue":"5","key":"2020091011282830300_B7","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1097\/EDE.0b013e3182576c07","article-title":"A new general biomarker-based incidence estimator","volume":"23","author":"Kassanjee","year":"2012","journal-title":"Epidemiology"},{"issue":"suppl 1","key":"2020091011282830300_B8","first-page":"483","article-title":"Impact of HIV-1 subtype and sex on sedia limiting antigen avidity assay performance [CROI Abstract 942]. In Special Issue: Abstracts From the 2019 Conference on Retroviruses and Opportunistic Infections","volume":"27","author":"Grebe","year":"2019","journal-title":"Top Antivir Med."},{"issue":"1","key":"2020091011282830300_B31","doi-asserted-by":"crossref","first-page":"153","DOI":"10.22237\/jmasm\/1177992840","article-title":"Better binomial confidence intervals","volume":"6","author":"Reed","year":"2007","journal-title":"J Mod Appl Stat Methods"},{"key":"2020091011282830300_B9","article-title":"Dose-response modelling of the transfusion transmission of HIV [published online ahead of print]","author":"Belov","year":"2020","journal-title":"Transfusion"},{"key":"2020091011282830300_B10","article-title":"HIV incidence in South African blood donors from 2012 to 2016: a comparison of statistical models [published online ahead of print 6 August 2020]","author":"Vermeulen","journal-title":"Vox Sang"},{"key":"2020091011282830300_B11","unstructured":"US Census Bureau\n          . Census Regions and Divisions of the United States.https:\/\/www2.census.gov\/geo\/pdfs\/maps-data\/maps\/reference\/us_regdiv.pdf. Published 2020. Accessed 20 April 2020."},{"issue":"10 pt 2","key":"2020091011282830300_B12","doi-asserted-by":"crossref","first-page":"2399","DOI":"10.1111\/trf.12299","article-title":"Prevalence of human immunodeficiency virus RNA and antibody in first-time, lapsed, and repeat blood donations across five international regions and relative efficacy of alternative screening scenarios","volume":"53","author":"Bruhn","year":"2013","journal-title":"Transfusion"},{"key":"2020091011282830300_B13","unstructured":"Gen-Probe. Procleix Ultrio Plus Assay [manufacturer\u2019s instructions]. 2012. https:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/BloodBloodProducts\/ApprovedProducts\/LicensedProductsBLAs\/BloodDonorScreening\/InfectiousDisease\/UCM092120.pdf. Accessed 4 October 2019."},{"issue":"3","key":"2020091011282830300_B14","doi-asserted-by":"crossref","first-page":"525","DOI":"10.1111\/trf.15677","article-title":"The evolving blood donor deferral policy for men who have sex with men: impact on the risk of HIV transmission by transfusion in France","volume":"60","author":"Pillonel","year":"2020","journal-title":"Transfusion"},{"issue":"2","key":"2020091011282830300_B15","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1111\/vox.12867","article-title":"HIV residual risk in Canada under a three-month deferral for men who have sex with men","volume":"115","author":"O\u2019Brien","year":"2020","journal-title":"Vox Sang"},{"issue":"4","key":"2020091011282830300_B16","doi-asserted-by":"crossref","first-page":"304","DOI":"10.7861\/clinmedicine.18-4-304","article-title":"What is the evidence for the change in the blood-donation deferral period for high-risk groups and does it go far enough?","volume":"18","author":"Sturrock","year":"2018","journal-title":"Clin Med (Lond)"},{"issue":"2","key":"2020091011282830300_B17","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1016\/j.tmrv.2020.02.001","article-title":"Screening blood donors for HIV, HCV, and HBV at the American Red Cross: 10-year trends in prevalence, incidence, and residual risk, 2007 to 2016","volume":"34","author":"Dodd","year":"2020","journal-title":"Transfus Med Rev"},{"issue":"11","key":"2020091011282830300_B18","doi-asserted-by":"crossref","first-page":"1640","DOI":"10.1111\/j.0041-1132.2004.04153.x","article-title":"Patterns of age- and sex-specific prevalence of major blood-borne infections in United States blood donors, 1995 to 2002: American Red Cross blood donor study","volume":"44","author":"Zou","year":"2004","journal-title":"Transfusion"},{"issue":"2","key":"2020091011282830300_B19","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1016\/j.tmrv.2011.07.007","article-title":"Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations","volume":"26","author":"Zou","year":"2012","journal-title":"Transfus Med Rev"},{"issue":"2","key":"2020091011282830300_B20","doi-asserted-by":"crossref","first-page":"404","DOI":"10.1111\/trf.13891","article-title":"Prevalence, incidence, and risk factors of human immunodeficiency virus infection in blood donors in the Southeastern United States","volume":"57","author":"Crowder","year":"2017","journal-title":"Transfusion"},{"issue":"1","key":"2020091011282830300_B21","doi-asserted-by":"crossref","first-page":"964","DOI":"10.1186\/s12889-017-4937-9","article-title":"Health and healthcare disparities among U.S. women and men at the intersection of sexual orientation and race\/ethnicity: a nationally representative cross-sectional study","volume":"17","author":"Trinh","year":"2017","journal-title":"BMC Public Health"},{"issue":"3","key":"2020091011282830300_B22","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1080\/09540121.2016.1211609","article-title":"Racial\/ethnic disparities in delayed HIV diagnosis among men who have sex with men, Florida, 2000-2014","volume":"29","author":"Sheehan","year":"2017","journal-title":"AIDS Care"},{"issue":"9839","key":"2020091011282830300_B23","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1016\/S0140-6736(12)60899-X","article-title":"Comparisons of disparities and risks of HIV infection in black and other men who have sex with men in Canada, UK, and USA: a meta-analysis","volume":"380","author":"Millett","year":"2012","journal-title":"Lancet"},{"key":"2020091011282830300_B24","unstructured":"Centers for Disease Control and Prevention\n          , National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV\/AIDS Prevention. HIV in the Southern United States. Atlanta, GA, 2018. https:\/\/www.cdc.gov\/hiv\/pdf\/policies\/cdc-hiv-in-the-south-issue-brief.pdf. Accessed 11 December 2019."},{"key":"2020091011282830300_B25","unstructured":"Centers for Disease Control and Prevention\n          . HIV Surveillance Report, 2018 (Preliminary). Atlanta, GA, 2019. http:\/\/www.cdc.gov\/hiv\/library\/reports\/hiv-surveillance.html. Accessed 11 December 2019."},{"issue":"8","key":"2020091011282830300_B26","doi-asserted-by":"crossref","first-page":"760","DOI":"10.1056\/NEJMoa040085","article-title":"Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing","volume":"351","author":"Stramer","year":"2004","journal-title":"N Engl J Med"},{"issue":"4","key":"2020091011282830300_B27","doi-asserted-by":"crossref","first-page":"324","DOI":"10.1111\/vox.12375","article-title":"Modeling complete removal of risk assessment questions in the USA predicts the risk of HIV exposure in blood recipients could increase despite the use of nucleic acid testing","volume":"110","author":"Yang","year":"2016","journal-title":"Vox Sang"},{"issue":"suppl 2","key":"2020091011282830300_B28","first-page":"S1","article-title":"Slowing decline in blood collection and transfusion in the United States - 2017","volume":"60","author":"Jones","year":"2020","journal-title":"Transfusion"},{"key":"2020091011282830300_B29","unstructured":"Cerus Corporation\n          . INTERCEPT\u00ae Blood System for Platelets \u2013 Small Volume (SV) Processing Set [manufacturer\u2019s instructions]. Concord, CA. 2016. https:\/\/www.fda.gov\/media\/90073\/download. Accessed 18 June 2020."},{"key":"2020091011282830300_B30","article-title":"HIV antiretroviral therapy and prevention use in US blood donors: a new blood safety concern","author":"Custer","journal-title":"Blood"}],"container-title":["Blood"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/ashpublications.org\/blood\/article-pdf\/136\/11\/1359\/1757570\/bloodbld2020007003.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/ashpublications.org\/blood\/article-pdf\/136\/11\/1359\/1757570\/bloodbld2020007003.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T12:08:16Z","timestamp":1599739696000},"score":1,"resource":{"primary":{"URL":"https:\/\/ashpublications.org\/blood\/article\/136\/11\/1359\/461434\/HIV-incidence-in-US-firsttime-blood-donors-and"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,10]]},"references-count":31,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2020,9,10]]}},"URL":"https:\/\/doi.org\/10.1182\/blood.2020007003","relation":{},"ISSN":["0006-4971","1528-0020"],"issn-type":[{"value":"0006-4971","type":"print"},{"value":"1528-0020","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,10]]}}}