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*, 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, The EPIC-NSW study group

*Corresponding author for this work

Research output: Contribution to journalArticle

23 Citations (Scopus)
66 Downloads (Pure)

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.

Original languageEnglish
Article number210
Pages (from-to)1-10
Number of pages10
JournalBMC Public Health
Volume18
Issue number1
DOIs
Publication statusPublished - 2 Feb 2018

Bibliographical note

Copyright the Author(s) 2018. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Correction After publication of the article, it has been brought to our attention that one of the members of the EPIC-NSW study group has had their name spelt incorrectly in the acknowledgements. The article mentions Muhammad Hammoud when in fact the correct spelling is Mohamed Hammoud.

Keywords

  • antiretroviral medication
  • gay, homosexual or other men who have sex with men
  • HIV incidence, adherence
  • HIV risk
  • implementation research
  • pre-exposure prophylaxis
  • PrEP eligibility

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