{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T21:58:13Z","timestamp":1777499893520,"version":"3.51.4"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2021,4,17]],"date-time":"2021-04-17T00:00:00Z","timestamp":1618617600000},"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\/100005192","name":"California HIV\/AIDS Research Program","doi-asserted-by":"publisher","award":["EI11-SD-005B"],"award-info":[{"award-number":["EI11-SD-005B"]}],"id":[{"id":"10.13039\/100005192","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005192","name":"California HIV\/AIDS Research Program","doi-asserted-by":"publisher","award":["E111-LA-002B"],"award-info":[{"award-number":["E111-LA-002B"]}],"id":[{"id":"10.13039\/100005192","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017823","name":"UCLA Center for AIDS Research","doi-asserted-by":"publisher","award":["5P30AI028697"],"award-info":[{"award-number":["5P30AI028697"]}],"id":[{"id":"10.13039\/100017823","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","award":["KL2TR001444"],"award-info":[{"award-number":["KL2TR001444"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"San Diego Center for AIDS Research","award":["#P30AI036214"],"award-info":[{"award-number":["#P30AI036214"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Daily oral tenofovir disoproxil fumarate\/emtricitabine (TDF\/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF\/FTC in cisgender women \u226518 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF\/FTC adherence, retention, and persistence.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12\/31) of those on study but off PrEP throughout the study discontinued TDF\/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses\/week; 22 (18%) had consistent \u22656 doses\/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab328","type":"journal-article","created":{"date-parts":[[2021,4,16]],"date-time":"2021-04-16T20:47:43Z","timestamp":1618606063000},"page":"1149-1156","source":"Crossref","is-referenced-by-count":25,"title":["Results from a Pre-exposure Prophylaxis Demonstration Project for At-risk Cisgender Women in the United States"],"prefix":"10.1093","volume":"73","author":[{"given":"Jill","family":"Blumenthal","sequence":"first","affiliation":[{"name":"Department of Medicine, University of California San Diego, San Diego, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonia","family":"Jain","sequence":"additional","affiliation":[{"name":"Department of Family Medicine and Public Health, University of California San Diego, San Diego, California, 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