{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T03:12:26Z","timestamp":1784257946575,"version":"3.55.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2019,9,29]],"date-time":"2019-09-29T00:00:00Z","timestamp":1569715200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["UM1 AI068634"],"award-info":[{"award-number":["UM1 AI068634"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["AI069481"],"award-info":[{"award-number":["AI069481"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["AI27757"],"award-info":[{"award-number":["AI27757"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["AI069494"],"award-info":[{"award-number":["AI069494"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI068636"],"award-info":[{"award-number":["UM1 AI068636"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1 AI106701"],"award-info":[{"award-number":["UM1 AI106701"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,8,22]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Women are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted an analysis of screening and enrollment during 2003\u20132013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling (\u201cscreen out\u201d) varied by various individual, trial, or site characteristics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 10 744 persons screened, 18.9% were women. The percentages of women and men who screened out were 27.9% and 26.5%, respectively (P = .19); this small difference did not significantly vary by race, ethnicity, or age group. Most common reasons for screening out were not meeting eligibility criteria (30\u201335%) and opting out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In the absence of evidence of significantly higher trial screen-out for women, approaching more women to screen may increase female representation in HIV trials.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciz959","type":"journal-article","created":{"date-parts":[[2019,9,26]],"date-time":"2019-09-26T11:27:13Z","timestamp":1569497233000},"page":"1300-1305","source":"Crossref","is-referenced-by-count":10,"title":["Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States"],"prefix":"10.1093","volume":"71","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7243-4703","authenticated-orcid":false,"given":"Laura M","family":"Smeaton","sequence":"first","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Kacanek","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kateryna","family":"Mykhalchenko","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, BronxCare Health, Bronx, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristine","family":"Coughlin","sequence":"additional","affiliation":[{"name":"Frontier Science and Technology Research Foundation, Inc, Amherst, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin L","family":"Klingman","sequence":"additional","affiliation":[{"name":"Division of Acquired Immune Deficiency Syndrome, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L","family":"Koletar","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, The Ohio State University, Columbus, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Barr","sequence":"additional","affiliation":[{"name":"AIDS Clinical Trials Group Community Scientific Subcommittee, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann C","family":"Collier","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,9,29]]},"reference":[{"key":"2020082200571969000_CIT0001","volume-title":"HIV surveillance report, 2017; vol. 29","author":"Centers for Disease Control and Prevention","year":"2018"},{"key":"2020082200571969000_CIT0002","doi-asserted-by":"crossref","first-page":"1885","DOI":"10.1097\/01.aids.0000189866.67182.f7","article-title":"Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols","volume":"19","author":"Gandhi","year":"2005","journal-title":"AIDS"},{"key":"2020082200571969000_CIT0003","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1089\/jwh.2010.2469","article-title":"Inclusion, analysis, and reporting of sex and race\/ethnicity in clinical trials: have we made progress?","volume":"20","author":"Geller","year":"2011","journal-title":"J Womens Health (Larchmt)"},{"key":"2020082200571969000_CIT0004","doi-asserted-by":"crossref","first-page":"1233","DOI":"10.1001\/jama.297.11.1233","article-title":"Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review","volume":"297","author":"Van Spall","year":"2007","journal-title":"JAMA"},{"key":"2020082200571969000_CIT0005","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1089\/apc.2011.0278","article-title":"Meta-analysis of gender differences in efficacy outcomes for HIV-positive subjects in randomized controlled clinical trials of antiretroviral therapy (2000-2008)","volume":"26","author":"Soon","year":"2012","journal-title":"AIDS Patient Care STDS"},{"key":"2020082200571969000_CIT0006","volume-title":"Sex-specific medical research. 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A report of the Mary Horrigan Connors Center for Women\u2019s Health and Gender Biology at Brigham and Women\u2019s Hospital","author":"Johnson","year":"2014"},{"key":"2020082200571969000_CIT0007","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.whi.2017.11.004","article-title":"Advancing sex- and gender-informed approaches to health in an academic medical center","volume":"28","author":"Pace","year":"2018","journal-title":"Womens Health Issues"},{"key":"2020082200571969000_CIT0008","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1089\/aid.2014.0205","article-title":"Sex, age, race and intervention type in clinical studies of HIV cure: a systematic review","volume":"31","author":"Johnston","year":"2015","journal-title":"AIDS Res Hum Retroviruses"},{"key":"2020082200571969000_CIT0009","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1007\/s11904-018-0383-2","article-title":"Sex differences in HIV infection","volume":"15","author":"Scully","year":"2018","journal-title":"Curr HIV\/AIDS Rep"},{"key":"2020082200571969000_CIT0010","doi-asserted-by":"crossref","first-page":"20706","DOI":"10.7448\/IAS.19.1.20706","article-title":"Barriers to a cure for HIV in women","volume":"19","author":"Gianella","year":"2016","journal-title":"J Int AIDS Soc"},{"key":"2020082200571969000_CIT0011"},{"key":"2020082200571969000_CIT0012","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1097\/QAI.0000000000000842","article-title":"A systematic review of the inclusion (or Exclusion) of women in HIV research: from clinical studies of antiretrovirals and vaccines to cure strategies","volume":"71","author":"Curno","year":"2016","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2020082200571969000_CIT0013","year":"2008"},{"key":"2020082200571969000_CIT0014","volume-title":"Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States","author":"Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission"},{"key":"2020082200571969000_CIT0015","volume-title":"AIDS Clinical Trials Group home page","author":"actgnetwork.org [Internet]"},{"key":"2020082200571969000_CIT0016","volume-title":"SAS\/STAT software, version 9 of the SAS System for Unix"},{"key":"2020082200571969000_CIT0017","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1177\/1536867X0800800102","article-title":"sbe24_2. 2008. 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