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. 2018 Feb 2;18(1):210.
doi: 10.1186/s12889-017-5018-9.

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial

Iryna B Zablotska  1 , Christine Selvey  2 , Rebecca Guy  3 , Karen Price  4 , Jo Holden  2 , Heather-Marie Schmidt  2 , Anna McNulty  5 , David Smith  6 , Fengyi Jin  3 , Janaki Amin  3   7 , David A Cooper  3 , Andrew E Grulich  8 ; EPIC-NSW study group
Collaborators, Affiliations

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial

Iryna B Zablotska et al. BMC Public Health. .

Erratum in

Abstract

Background: The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals.

Methods: EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW.

Discussion: EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV epidemic.

Trial registration: https://clinicaltrials.gov/ (identifying number NCT02870790 ; registration date 14 August 2016), pre-results stage.

Keywords: Antiretroviral medication; Gay, homosexual or other men who have sex with men; HIV incidence, adherence; HIV risk; Implementation research; PrEP eligibility; Pre-exposure prophylaxis.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol is approved by the St. Vincent’s Hospital, Sydney, Australia HREC (primary review, protocol number 1511; reference number HREC/15/SVH/436) and ACON HREC (reference number RERC2015/23). The ClinicalTrials.gov identifying number is NCT02870790. Site-specific assessments are obtained from each public health service’s Research Office. The design and implementation of this study follows The Declaration of Helsinki and European Committee for Proprietary Medicinal Products/ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (CPMP/ICH) Guidelines for Good Clinical Practice. All EPIC-NSW participants have provided written informed consent to participate in the study.

Consent for publication

Not applicable

Competing interests

DAC has received honoraria from Gilead Sciences, ViiV and Merck Sharp & Dohme. AG has received research funding from BioCSL Ltd., Viiv and Gilead Sciences, as well as conference travel funding and honoraria for educational presentations from Merck. IZ has received funding and supply of the study medication from Gilead Sciences. DS has received funding to attend local (within Australia) educational events from Gilead, and funding from ViiV, BMS, Merck, Roche, Boehringer Ingleheim and Gilead to hold local education events for health practitioners. CS, H-MS, JA, FJ, JH, KP, RG have no conflicts of interest to declare.

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