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BMC Public Health
Published in: BMC Public Health 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Iryna B. Zablotska, Christine Selvey, Rebecca Guy, Karen Price, Jo Holden, Heather-Marie Schmidt, Anna McNulty, David Smith, Fengyi Jin, Janaki Amin, David A. Cooper, Andrew E. Grulich, on behalf of the EPIC-NSW study group

Published in: BMC Public Health | Issue 1/2018

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Iryna B. Zablotska
Christine Selvey
Rebecca Guy
Karen Price
Jo Holden
Heather-Marie Schmidt
Anna McNulty
David Smith
Fengyi Jin
Janaki Amin
David A. Cooper
Andrew E. Grulich
on behalf of the EPIC-NSW study group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2018
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-017-5018-9

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