{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T17:53:54Z","timestamp":1791568434192,"version":"4.3.4"},"reference-count":39,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2019,9,11]],"date-time":"2019-09-11T00:00:00Z","timestamp":1568160000000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Intern AIDS Soc"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Tenofovir\u2010containing oral pre\u2010exposure prophylaxis (PrEP) is recommended for those at substantial risk as part of combination HIV prevention. However, there are limited data, beyond clinical trial settings, to guide the introduction of PrEP in healthcare services with adequate levels of adherence. Since young women in Africa are at high risk of HIV and likely to utilize family planning (FP) services, the feasibility, acceptability and effectiveness of integrating topical PrEP provision into routine FP services was assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This two\u2010arm, randomized controlled, non\u2010inferiority, open\u2010label extension trial was undertaken in urban and rural KwaZulu\u2010Natal, South Africa. HIV\u2010negative eligible women (n\u00a0=\u00a0372) from the parent trial (Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004) were randomized to receive tenofovir gel either through intervention (FP clinics, n\u00a0=\u00a0189) or control clinics (CAPRISA research clinics, n\u00a0=\u00a0183). Non\u2010inferiority was predefined as gel use in the intervention clinics would be no more than 20% lower than in the control clinics. Adherence, retention and HIV incidence rates were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Women were enrolled between November 2012 and October 2014, and followed up for 682.3 women\u2010years (mean\u00a0=\u00a022\u00a0months). Baseline characteristics of women in intervention and control clinics were comparable and retention rates were 92.1% and 92.3% respectively. Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of \u22120.47 (CI: \u22121.16 to 0.21). Per\u2010protocol estimates were on average 5.5 (CI: 5.0 to 6.1) and 5.8 (CI: 5.3 to 6.3) respectively, with a mean difference of \u22120.25 (CI: \u22120.98 to 0.48), meeting the non\u2010inferiority criteria. Adherence, based on proportion of reported sex acts covered by two gel doses, was 79.9% (CI: 76.7 to 83.2) in intervention compared with 73.9% (CI: 70.7 to 77.1) in control clinics; mean difference:6.0% (CI: 1.5 to 10.6) (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.009). HIV incidence rates were 3.5 (CI: 1.8 to 6.0) and 3.6 (CI: 1.9 to 6.3) per 100 women\u2010years in intervention and control clinics respectively. Both these incidence rates were lower than the age\u2010standardized rate of 6.2 per 100 women\u2010years (n\u00a0=\u00a0444) in the placebo arm of the parent trial (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.019).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Provision of topical PrEP as part of an integrated FP service achieved higher adherence, and was as feasible, acceptable and effective in preventing HIV as provision through a research setting. This provides useful evidence for scale\u2010up of oral PrEP in urban and rural high burden communities.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25381","type":"journal-article","created":{"date-parts":[[2019,9,11]],"date-time":"2019-09-11T07:09:22Z","timestamp":1568185762000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Integrated provision of topical pre\u2010exposure prophylaxis in routine family planning services in South Africa: a non\u2010inferiority randomized controlled trial"],"prefix":"10.1002","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7607-348X","authenticated-orcid":false,"given":"Leila E","family":"Mansoor","sequence":"first","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nonhlanhla","family":"Yende\u2010Zuma","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Baxter","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn T","family":"Mngadi","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Halima","family":"Dawood","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanuja N","family":"Gengiah","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Samsunder","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill L","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School CONRAD Arlington VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo F","family":"Doncel","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School CONRAD Arlington VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quarraisha","family":"Abdool Karim","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA) Durban South Africa"},{"name":"Department of Epidemiology Mailman School of Public Health Columbia University New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,9,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1193748"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1506110"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1602046"},{"key":"e_1_2_9_5_1","unstructured":"BaetenJ Palanee\u2010PhillipsT MgodiN MayoA NelA RosenbergZ et\u00a0al.High uptake and reduced HIV\u20101 incidence in an open\u2010label trial of the dapivirine ring(Abstract: 143LB). Conference of Retroviruses and Opportunistic Infections Boston MA;2018."},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1105243"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1108524"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(14)70847-3"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1011205"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00056-2"},{"key":"e_1_2_9_11_1","unstructured":"MolinaJ\u2010M CapitantC SpireB PialouxG ChidiacC CharreauI et\u00a0al. editors.On demand PrEP with oral TDF\u2010FTC in MSM: results of the ANRS Ipergay trial(Abstract 23LB). Conference on Retroviruses and Opportunistic Infections (CROI); 2015 Feb 23\u201026;Seattle WA;2015."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1110711"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1202614"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402269"},{"key":"e_1_2_9_15_1","volume-title":"Right to health","author":"UNAIDS","year":"2017"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.aai9383"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ298"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(16)30186-2"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1086\/651483"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.4102\/phcfm.v5i1.559"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-15-496"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198901053200110"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.328.7448.1124"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/intqhc\/14.6.439"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-014-0752-9"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-014-0751-x"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3003174"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000607"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002099"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(18)30428-6"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.7196\/SAMJ.7605"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-9-406"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1093\/intqhc\/mzt039"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12961-016-0115-2"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1093\/inthealth\/iht011"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjqs-2011-000381"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1807653"},{"key":"e_1_2_9_38_1","unstructured":"AVAC.PrEPWatch.2019[cited 2019 Jun 13]. 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