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 PRELUDE. Issue 6 (20th June 2016)

• Record Type: Journal Article
• Authors: Vaccher, S; Grulich, A; McAllister, J; Templeton, D J; Bloch, M; McNulty, A; Holden, J; Poynten, I M; Prestage, G; Zablotska, I
• Other Names: author non-byline.; Carr Andrew author non-byline.; Foster Rosalind author non-byline.; Gianacas Chris author non-byline.; Guy Rebecca author non-byline.; Holt Martin author non-byline.; Kaldor John author non-byline.; Mackie Brent author non-byline.; Mayer Kenneth author non-byline.; Murphy Dean author non-byline.; Ooi Catriona author non-byline.; Pell Cathy author non-byline.; Poynten Mary author non-byline.; Ryder Nathan author non-byline.; Templeton David author non-byline.; de Wit John author non-byline.; Wright Edwina author non-byline.
• Is Part Of: BMJ open. Volume 6:Issue 6(2016)
• Publication Date: 2016-06-20
• Subjects: pre-exposure prophylaxis -- Truvada -- implementation research -- gay, homosexual, and other men who have sex with men; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2016-012179
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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 PRELUDE study aims to evaluate the implementation of PrEP in healthcare settings in New South Wales (NSW), Australia, among a sample of high-risk adults. Methods and analysis: PRELUDE 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—mainly GBM and heterosexual women. Participants receive daily oral PrEP, composed of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), for up to 2.5 years. 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 months 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. Ethics and dissemination: 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 months of follow-up is complete. Trial registration number: NCT02206555; Pre-results.