About the Project
EPIC-NSW stands for ‘Expanded PrEP Implementation in Communities in NSW’.
EPIC-NSW is a study run by the Kirby Institute and funded by the NSW Government, in collaboration with a number of partners such as sexual health services and clinics. EPIC – NSW aims to assess the impact of the rapid expansion in access to HIV pre-exposure prophylaxis (PrEP) amongst those at highest risk of acquiring HIV, in particular, if it will lead to a drop in new HIV infections.
The study will see 3,700 people at high risk of acquiring HIV enrolled in the study as efficiently as possible. EPIC-NSW is a criteria-based access program – which means eligibility for the study will be determined on the basis of HIV risk criteria. The aim is to rapidly enrol eligible people and follow them for up to two years while they take PrEP.
Partners involved in the study include the Kirby Institute, UNSW (leading the study), NSW Health and Local Health Districts, ACON, Positive Life NSW, the Australasian Society for HIV Medicine (Australia’s HIV professional organisation for clinicians) General Practitioners who specialise in HIV, NSW publicly funded sexual health clinics and private practices.
It is important to note that this study is not evaluating the effectiveness of PrEP itself, as this has already been demonstrated in a number of studies. Rather this study is investigating how PrEP is best implemented to maximise its impact at a population level.
The study has Human Research Ethics approval from the St Vincent’s Hospital Sydney Human Research Ethics Committee and from ACON’s Ethics Committee.
The new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual elimination of HIV transmission in NSW by 2020. This extraordinary goal relies on two anti-retroviral therapy (ARV)-related interventions, in addition to traditional behavioural prevention. The first of these interventions, HIV treatment as prevention targeted at HIV positive people, has been ramped up over the 3 years to 2015, and is likely to be approaching maximal levels of population impact. Despite this, new HIV diagnoses in NSW have declined only slightly over the past three years. Critical to the new strategy’s success is the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). TDF/FTC has been extensively used in millions of people with HIV for about 15 years. This large-scale study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will comprise mostly gay and bisexual men (GBM) but will also include small numbers of heterosexuals, injecting drug users, and transgender men and women. The drug will be used according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new intervention over a 12 month period, and following participants for two years on treatments, we expect a reduction of about 50% in new HIV diagnoses in NSW due to decreased infection in the on-treatment cohort, and by a much larger percentage to the interruption of chains of transmission to others not receiving PrEP. Only by the rapid and large-scale roll-out can we work towards the virtual elimination of HIV transmission by 2020. This project occurs within the framework of the new HIV strategy. The importance of this intervention is reflected by the group of investigators assembled.
Primary Objectives are to:
1. Assess the incidence of HIV among PrEP study participants and the number of new HIV diagnoses in the cohort of people prescribed PrEP.
2. Measure the population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over a two-year period.
Secondary objective(s) are to:
1. Evaluate the rate of PrEP uptake among high risk GBM in NSW, and the rate of uptake among other individuals at high risk for HIV, including heterosexuals in serodiscordant partnerships, injecting drug users and transgender people at high-risk for HIV.
2. Assess the incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP.
3. Measure the effect of the rapid roll-out of PrEP on the overall number of notifications of gonorrhoea, chlamydia and infectious syphilis in NSW.
4. Describe patterns of PrEP use and medication adherence to the recommended PrEP medication schedule in those prescribed PrEP.
Design & Method
The study is an implementation research project to mimic the conditions that will occur when PrEP is rolled out at the population level. There is no control arm. The study is conducted within the CTN framework. After collection of consent and enrolment information, all follow-up information will be collected through electronic data capture to allow accurate and timely analyses. The main population group will be 3700 gay men at high risk of HIV infection. This number has been calculated by applying the behavioural criteria for PrEP receipt in the NSW Guidelines on PrEP use to population of sexually active GBM in NSW. In addition, a small number of heterosexuals, injecting drug users, and transgender people at high risk of HIV will be included.
Over 1500 participants had been enrolled by June 2016.
the study aims to rapidly reduce new HIV infections in New south Wales.
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Professor and Program Head
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Dr Iryna Zablotska-Manos
Associate Professor and Program Head
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Associate Professor Janaki Amin
Associate Professor and Postgraduate Coordinator
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QIP and GRHANITE manager
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NSW Ministry of Health and other partner investigators: Jo Holden, Dr Christine Selvey, Dr Heather-Marie Schmidt, Nic Parkhill, Bill Whittaker, Dr Kerry Chant, Craig Cooper, Levinia Crooks
Site investigators include Dr Debbie Allen, Dr David Baker, Dr Mark Bloch, Dr Rohan Bopage, Dr Katherine Brown, Prof Andrew Carr, Dr Christopher Carmody, Dr Kym Collins, Dr Robert Finlayson, Dr Rosalind Foster, Dr Eva Jackson, Professor David Lewis, Dr Josephine Lusk, A/Prof Anna McNulty, A/Prof Catherine O’Connor, Dr Nathan Ryder, Dr David Smith, Dr Phillip Read.
Project Collaborators: External
NSW Health and Local Health Districts, ACON, Positive Life NSW, the Australasian Society for HIV Medicine (Australia’s HIV professional organisation for clinicians) General Practitioners who specialise in HIV, NSW publicly funded sexual health clinics and private practices.