{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T16:26:39Z","timestamp":1773764799389,"version":"3.50.1"},"reference-count":31,"publisher":"BMJ","issue":"6","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,5,26]]},"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Despite a number of HIV prevention strategies, the number of new HIV infections remains high. In Australia, over three-quarters of new HIV diagnoses are in gay and bisexual men (GBM). Pre-exposure prophylaxis (PrEP) has been shown to be effective at preventing new HIV infections in several randomised trials. The\n                      <jats:italic>PRELUDE<\/jats:italic>\n                      study aims to evaluate the implementation of PrEP in healthcare settings in New South Wales (NSW), Australia, among a sample of high-risk adults.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      <jats:italic>PRELUDE<\/jats:italic>\n                      is an ongoing open-label, single-arm demonstration project, conducted in public and private clinics across NSW, Australia. Enrolment began in November 2014. The study is designed for 300 high-risk participants\u2014mainly GBM and heterosexual women. Participants receive daily oral PrEP, composed of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), for up to 2.5\u2005years. Quarterly study visits include testing for HIV and sexually transmitted infections (STIs), assessment of ongoing eligibility and side effects, and self-reported adherence. Following each study visit, online behavioural surveys are administered to collect information on medication adherence, risk behaviours and attitudes. Blood samples will be collected in a subset of patients 1, 6 and 12\u2005months after PrEP initiation to measure FTC\/TDF concentrations. Analyses using longitudinal regression models will focus on feasibility, adherence, safety, tolerability and effects of PrEP on behaviour. This study will inform PrEP policy and guide the implementation of PrEP in Australia in people at high risk of HIV.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study will be conducted in accordance with the Declaration of Helsinki. All patients will provide written informed consent prior to participation in the study. Publications relating to each of the primary end points will be gradually released after 12\u2005months of follow-up is complete.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT02206555; Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-012179","type":"journal-article","created":{"date-parts":[[2016,6,21]],"date-time":"2016-06-21T23:22:59Z","timestamp":1466551379000},"page":"e012179","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) among people at high risk of HIV infection: the NSW Demonstration Project\n                    <i>PRELUDE<\/i>"],"prefix":"10.1136","volume":"6","clinical-trial-number":[{"clinical-trial-number":"nct02206555","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"S","family":"Vaccher","sequence":"first","affiliation":[{"name":"Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A","family":"Grulich","sequence":"additional","affiliation":[{"name":"Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J","family":"McAllister","sequence":"additional","affiliation":[{"name":"St Vincent's Hospital, Darlinghurst, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D J","family":"Templeton","sequence":"additional","affiliation":[{"name":"RPA Sexual Health, Sydney Local Health District, Camperdown, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Bloch","sequence":"additional","affiliation":[{"name":"Holdsworth House Medical Centre, Darlinghurst, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A","family":"McNulty","sequence":"additional","affiliation":[{"name":"Sydney Sexual Health Centre, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J","family":"Holden","sequence":"additional","affiliation":[{"name":"NSW Ministry of Health, North Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I M","family":"Poynten","sequence":"additional","affiliation":[{"name":"Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G","family":"Prestage","sequence":"additional","affiliation":[{"name":"Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia"},{"name":"Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I","family":"Zablotska","sequence":"additional","affiliation":[{"name":"Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2016,6,20]]},"reference":[{"key":"2025121513172583000_6.6.e012179.1","unstructured":"UNAIDS. 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