{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T18:44:33Z","timestamp":1779129873832,"version":"3.51.4"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,5,12]],"date-time":"2020-05-12T00:00:00Z","timestamp":1589241600000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000200","name":"United States Agency for International Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006661","name":"United Nations Population Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006661","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1032115"],"award-info":[{"award-number":["OPP1032115"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Intern AIDS Soc"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Global guidelines emphasize the ethical obligation of investigators to help participants in HIV\u2010endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre\u2010exposure prophylaxis (PrEP) has increasingly become part of state\u2010of\u2010the\u2010art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ECHO was an open\u2010label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35\u00a0years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18\u00a0months, from 2015 to 2018. Part\u2010way through the course of the trial, oral PrEP was provided to study participants either off\u2010site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi\u2010squared tests or t\u2010tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow\u2010up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all <jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05). PrEP initiation did not differ across study randomized groups (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.7). Two\u2010thirds of PrEP users were continuing PrEP at study exit.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25491","type":"journal-article","created":{"date-parts":[[2020,5,12]],"date-time":"2020-05-12T19:12:57Z","timestamp":1589310777000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Integrating oral PrEP delivery among African women in a large HIV endpoint\u2010driven clinical trial"],"prefix":"10.1002","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4889-8123","authenticated-orcid":false,"given":"Ivana","family":"Beesham","sequence":"first","affiliation":[{"name":"MatCH Research Unit (MRU) Faculty of Health Sciences University of the Witwatersrand Durban South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia D","family":"Welch","sequence":"additional","affiliation":[{"name":"FHI 360 Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6039-0352","authenticated-orcid":false,"given":"Renee","family":"Heffron","sequence":"additional","affiliation":[{"name":"University of Washington Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melanie","family":"Pleaner","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute Faculty of Health Sciences University of the Witwatersrand Johannesburg South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lara","family":"Kidoguchi","sequence":"additional","affiliation":[{"name":"University of Washington Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thesla","family":"Palanee\u2010Phillips","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute Faculty of Health Sciences University of the Witwatersrand Johannesburg South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khatija","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Setshaba Research Centre Tshwane South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5439-2538","authenticated-orcid":false,"given":"Deborah","family":"Baron","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute Faculty of Health Sciences University of the Witwatersrand Johannesburg South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth A","family":"Bukusi","sequence":"additional","affiliation":[{"name":"University of Washington Seattle WA USA"},{"name":"Kenya Medical Research Institute (KEMRI) Nairobi Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Louw","sequence":"additional","affiliation":[{"name":"Madibeng Centre for Research Brits South Africa"},{"name":"Department of Family Medicine Faculty of Health Sciences University of Pretoria Pretoria South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy D","family":"Mastro","sequence":"additional","affiliation":[{"name":"FHI 360 Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Smit","sequence":"additional","affiliation":[{"name":"MatCH Research Unit (MRU) Faculty of Health Sciences University of the Witwatersrand Durban South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne R","family":"Batting","sequence":"additional","affiliation":[{"name":"Effective Care Research Unit (ECRU) Fort Hare and Eastern Cape Department of Health Universities of the Witwatersrand East London South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mookho","family":"Malahleha","sequence":"additional","affiliation":[{"name":"Setshaba Research Centre Tshwane South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronique C","family":"Bailey","sequence":"additional","affiliation":[{"name":"Setshaba Research Centre Tshwane South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mags","family":"Beksinska","sequence":"additional","affiliation":[{"name":"MatCH Research Unit (MRU) Faculty of Health Sciences University of the Witwatersrand Durban South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Donnell","sequence":"additional","affiliation":[{"name":"University of Washington Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8242-8438","authenticated-orcid":false,"given":"Jared M","family":"Baeten","sequence":"additional","affiliation":[{"name":"University of Washington Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the ECHO Trial 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