{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T07:26:48Z","timestamp":1740122808480,"version":"3.37.3"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2023,11,10]],"date-time":"2023-11-10T00:00:00Z","timestamp":1699574400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,11,10]],"date-time":"2023-11-10T00:00:00Z","timestamp":1699574400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100006392","name":"AIDS Clinical Trials Group","doi-asserted-by":"publisher","award":["UM1-AI-068636"],"award-info":[{"award-number":["UM1-AI-068636"]}],"id":[{"id":"10.13039\/100006392","id-type":"DOI","asserted-by":"publisher"}]},{"name":"HPTN","award":["UM1-AI068619","UM1-AI068613","UM1-AI068617)"],"award-info":[{"award-number":["UM1-AI068619","UM1-AI068613","UM1-AI068617)"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["AIDS Behav"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Adherence to HIV pre-exposure prophylaxis (PrEP) study drug is critical for safety, tolerability, and efficacy trials, and may be affected by how adherence is communicated by the study staff to trial participants. Increasingly, clinical trials investigating PrEP are creating and implementing \u2018participant-centered\u2019 approaches that discuss potential non-adherence neutrally (without negative judgement) and support efforts to adhere versus insisting on perfect adherence. In the HPTN069\/ACTG A5305 study, we evaluated participant experiences of potentially negative adherence-related interactions with study teams using ten items to characterize the frequency of such experiences. We related these individual items and a combined set of seven negative experience items (total negative experience score) to drug concentrations (detectable or consistent with daily-dosing). The exploratory analyses used logistic regression for each experience item on the full sample and disaggregated by sex. Several experiences were related to drug detection and to daily-dosing, although more so for participants identifying as men than women. Total negative experience scores associated with not having detection drug concentrations for the full sample, and remained significant even when controlling for sex, age, and race. Daily dosing was associated with total negative experience score for men in the sample. Additional investigations into adherence-related interactions with study teams that are most problematic or helpful in general and uniquely for men and women are warranted.<\/jats:p>","DOI":"10.1007\/s10461-023-04215-9","type":"journal-article","created":{"date-parts":[[2023,11,10]],"date-time":"2023-11-10T10:02:03Z","timestamp":1699610523000},"page":"1058-1067","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Influence of Participant Perceptions of Adherence-Related Interactions with Study\/Study Team on Drug Levels: HPTN069 Analysis of Self-Reported Adherence Experiences While on Study"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4458-6934","authenticated-orcid":false,"given":"K. R.","family":"Amico","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. 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FDA approves first drug for reducing the risk of sexually acquired HIV infection. 2012. http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm312210.htm. Accessed July, 2012."},{"issue":"9","key":"4215_CR2","doi-asserted-by":"publisher","first-page":"844","DOI":"10.1001\/jama.2019.1343","volume":"321","author":"AS Fauci","year":"2019","unstructured":"Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV epidemic: a plan for the United States. JAMA: J Am Med Assoc. 2019;321(9):844\u20135.","journal-title":"JAMA: J Am Med Assoc"},{"issue":"5","key":"4215_CR3","doi-asserted-by":"publisher","first-page":"1243","DOI":"10.1007\/s10461-012-0182-5","volume":"16","author":"KR Amico","year":"2012","unstructured":"Amico KR, McMahan V, Goicochea P, et al. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. 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Dr. Amico reports a grant from Gilead Sciences outside the submitted work. Dr. Mayer has received research grants from Gilead Sciences and Merck, Inc. outside of the submitted work. Dr.\u00a0Wilkin\u00a0has received grant fund (paid to Weill Cornell) from Gilead, GlaxoSmithKline\/ViiV Healthcare, and Merck. ADr.\u00a0Wilkin\u00a0has served as an ad hoc consultant to GlaxoSmithKline\/ViiV Healthcare and Merck.\u00a0Authors not named here have disclosed no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}