{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T12:41:07Z","timestamp":1773924067433,"version":"3.50.1"},"reference-count":15,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2015,2,25]],"date-time":"2015-02-25T00:00:00Z","timestamp":1424822400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"crossref","award":["UM1-AI068641"],"award-info":[{"award-number":["UM1-AI068641"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000098","name":"NIH Clinical Center","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000098","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000050","name":"National Heart, Lung, and Blood Institute","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000050","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"crossref"}]},{"name":"National Institute of Arthritis and Musculoskeletal Disorders"},{"name":"French Agence Nationale de Recherches sur le SIDA et les H\u00e9patites Virales (ANRS)"},{"name":"German Ministry of Education and Research"},{"name":"European AIDS Treatment Network (NEAT)"},{"name":"Australian National Health and Medical Research Council"},{"DOI":"10.13039\/501100000265","name":"UK Medical Research Council","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"crossref"}]},{"name":"National Institute for Heath Research"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2015,4]]},"abstract":"Objectives<\/jats:title>The aim of this report is to describe the challenges, successes and patterns of enrolment in the S<\/jats:styled-content>trategic T<\/jats:styled-content>iming of AntiRetroviral T<\/jats:styled-content>reatment (START<\/jats:styled-content>) study.<\/jats:p><\/jats:sec>Methods<\/jats:title>START<\/jats:styled-content> is a collaboration of many partners with central coordination provided by the protocol team, the statistical and data management centre (SDMC<\/jats:styled-content>), the I<\/jats:styled-content>nternational N<\/jats:styled-content>etwork for S<\/jats:styled-content>trategic I<\/jats:styled-content>nitiatives in G<\/jats:styled-content>lobal HIV T<\/jats:styled-content>rials (INSIGHT<\/jats:styled-content>) network leadership, international coordinating centres and site coordinating centres. The SDMC<\/jats:styled-content> prepared reports on study accrual, baseline characteristics and site performance that allowed monitoring of enrolment and data quality and helped to ensure the successful enrolment of this large international trial. We describe the pattern of enrolment and challenges faced during the enrolment period of the trial.<\/jats:p><\/jats:sec>Results<\/jats:title>An initial pilot phase began in A<\/jats:styled-content>pril 2009 and established feasibility of accrual at 101 sites. In A<\/jats:styled-content>ugust 2010, funding approval for an expanded definitive phase led to the successful accrual of 4688 participants from 215 sites in 35 countries by D<\/jats:styled-content>ecember 2013. Challenges to accrual included regulatory delays (e.g. national\/local ethics approval and drug importation approval) and logistical obstacles (e.g. execution of contracts with pharmaceutical companies, setting up of a central drug repository and translation of participant materials). The personal engagement of investigators, strong central study coordination, and frequent and transparent communication with site investigators, community members and participants were key contributing factors to this success.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Accrual into START<\/jats:styled-content> was completed in a timely fashion despite multiple challenges. This success was attributable to the efforts of site investigators committed to maintaining study equipoise, transparent and responsive study coordination, and community involvement in problem\u2010solving.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12229","type":"journal-article","created":{"date-parts":[[2015,2,25]],"date-time":"2015-02-25T09:55:37Z","timestamp":1424858137000},"page":"14-23","source":"Crossref","is-referenced-by-count":5,"title":["Challenges, successes and patterns of enrolment in the INSIGHT S<\/scp>trategic T<\/scp>iming of AntiRetroviral T<\/scp>reatment (START<\/scp>) trial"],"prefix":"10.1111","volume":"16","author":[{"given":"J","family":"Grarup","sequence":"first","affiliation":[{"name":"Copenhagen HIV Programme, Rigshospitalet University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C","family":"Rappoport","sequence":"additional","affiliation":[{"name":"University of California, San Francisco DOM\/HIV\/AIDS Division San Francisco General Hospital San Francisco CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"NW","family":"Engen","sequence":"additional","affiliation":[{"name":"Coordinating Centers for Biometric Research Division of Biostatistics School of Public Health University of Minnesota Minneapolis MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C","family":"Carey","sequence":"additional","affiliation":[{"name":"Kirby Institute University of New South Wales Sydney Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F","family":"Hudson","sequence":"additional","affiliation":[{"name":"Medical Research Council Clinical Trials Unit at UCL University College London London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E","family":"Denning","sequence":"additional","affiliation":[{"name":"Coordinating Centers for Biometric Research Division of Biostatistics School of Public Health University of Minnesota Minneapolis MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S","family":"Sharma","sequence":"additional","affiliation":[{"name":"Coordinating Centers for Biometric Research Division of Biostatistics School of Public Health University of Minnesota Minneapolis MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E","family":"Florence","sequence":"additional","affiliation":[{"name":"Institute of Tropical Medicine Antwerp Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MJ","family":"Vjecha","sequence":"additional","affiliation":[{"name":"Institute for Clinical Research, Inc. Veterans Affairs Medical Center Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,2,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774512440342"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12227"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12228"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774510376547"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1105243"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e328360d546"},{"key":"e_1_2_8_8_1","first-page":"3","article-title":"START \u2026 and why the time is now","volume":"197","author":"Collins S","year":"2010","journal-title":"HIV Treat Updat"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000024"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12239"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12230"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12242"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12240"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12241"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/hiv.12238"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(13)70692-3"}],"container-title":["HIV Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhiv.12229","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.12229","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hiv.12229","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hiv.12229","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T04:23:46Z","timestamp":1694492626000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hiv.12229"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,2,25]]},"references-count":15,"journal-issue":{"issue":"S1","published-print":{"date-parts":[[2015,4]]}},"alternative-id":["10.1111\/hiv.12229"],"URL":"https:\/\/doi.org\/10.1111\/hiv.12229","archive":["Portico"],"relation":{},"ISSN":["1464-2662","1468-1293"],"issn-type":[{"value":"1464-2662","type":"print"},{"value":"1468-1293","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,2,25]]}}}