Background
In New South Wales (NSW), Australia, research findings in HIV treatment as prevention [
1] were followed in 2012 by a state-wide HIV strategy that had an over-arching aim of working towards the virtual elimination of HIV by 2020 [
2]. In response to widespread implementation of policy actions directed towards HIV treatment as prevention [
3], HIV testing rates and ART coverage among people diagnosed with HIV have increased considerably. By 2015, an estimated 93% of people with HIV in NSW were diagnosed; 89.3% of those diagnosed were on treatment, of which 91.3% had suppressed viral load over the preceding 12 months [
4‐
6]. However, by the end of 2015, new HIV diagnoses in NSW had not declined substantially, and more than 80% of diagnoses continued to be in gay and bisexual men (GBM) [
7]. Undiagnosed, and thus untreated, HIV infections among GBM [
8], combined with increasing levels of condomless anal intercourse with casual partners [
9], continued to drive the HIV epidemic despite very substantial increases in HIV testing and treatment. In order to achieve a significant reduction in new HIV diagnoses, additional strategies were required. In this context, the NSW HIV Strategy 2016–2020 proposed the population-level roll-out of HIV pre-exposure prophylaxis (PrEP), in combination with strengthening condom use, testing, and treatment, in order to move forward towards the ambitious goal of virtually eliminating HIV transmission by 2020 [
10].
PrEP, in the form of combined tenofovir disoproxil fumarate 300 mg (TDF) and emtricitabine 200 mg (FTC), is effective for primary HIV prevention [
11‐
13]. TDF/FTC has a favorable safety profile [
14] and effectively penetrates the anorectal mucosa [
15‐
17], which makes it an ideal prophylactic agent for GBM. PrEP efficacy is closely related to adherence [
14], and adherence has been higher in people who are well-informed about HIV and PrEP [
12,
13,
18]. TDF/FTC is now recommended as PrEP for people at high risk of HIV acquisition in national or regional guidelines in the US, Europe and Australia [
19‐
21], as well as by the WHO guidelines globally [
22].
At the time when EPIC-NSW began recruitment in March 2016, TDF/FTC as PrEP was not approved by the Australian Therapeutic Goods Administration (TGA) [
23]. The first guidance for PrEP prescribing, which became available in NSW in October 2014 (formally published in 2016 [
24]), defined the eligibility for PrEP in a PrEP demonstration project PRELUDE [
25]. Funded by the NSW Government, PRELUDE provided access to PrEP to about 300 individuals, predominately GBM from November 2014–November 2016 [
25]. However, PrEP demand rapidly surpassed the PRELUDE project’s capacity. Ongoing PrEP research in NSW [
25‐
27], PrEP guidelines [
24] and the new NSW HIV Strategy 2016–2020 [
10] provided the framework for a population-level implementation project “Expanded PrEP Implementation in Communities in NSW”(EPIC-NSW).
While PrEP implementation among GBM has been in various stages of roll-out in other countries (e.g., in the US and France), EPIC-NSW is novel in being a hybrid research and implementation project targeting PrEP to all people at high risk of HIV infection in NSW, and measuring the public health benefit of this program with respect to reduction in HIV transmissions in the state.
This study protocol describes the population-level introduction of PrEP in NSW through a public health intervention, which is widely supported across the spectrum of researchers, clinicians, community organisations, and government policymakers.
Acknowledgements
Clinical Operational Team at the Kirby Institute, UNSW Sydney including Barbara Yeung (Project Manager), Gesalit Levitt (Project Coordinator) and Erin Ogilvie (Research Assistant). Database management team at the Kirby |Institute, UNSW Sydney including Stefanie Vaccher (management of behavioural data), Mo Hammoud (database design) and Nasir Wabe (management of enrolment and clinical data). Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) study including: Lucy Watchirs Smith (management of ACCESS sexual health clinic data, analysis and interpretation of clinical data); Hamish McManus (biostatistical advice) and Denton Callander (scoping of patient management systems) at the Kirby Institute, UNSW Sydney; Jason Asselin (management of the ACCESS general practice data and connections) at the Burnet Institute; Douglas Boyle and Sandra Henley-Smith (development and deployment of scrambled clinic IDs used by GHRANITE software) from the Research Information Technology Unit (HaBIC R2) at The University of Melbourne.
Our community partner ACON and its team including Karen Price (Director of HIV and Sexual Health, ACON) and Matthew Vaughan (Principal Planner – Engagement Strategies Unit, ACON).
Study participants
Study site coordinators
Michael Williamson(Holden Street Clinic), Lesley Williams (East Sydney Doctors), Jessie Payne (Holdsworth House Medical Practice), Raghib Ahmad (The Albion Centre), Jodie-lee Little (Illawarra Sexual Health Clinic), John William McAllister (St Vincent’s Hospital, NSW),Anik Ray (Liverpool Sexual Health Clinic), Alison Kincaid (Albury Sexual Health Clinic and Brookong Sexual Health Centre), Loc Le (Taylor Square Private Clinic), Brett Hadlow (Clinic 16), Adriana Trujillo (Nepean Hospital), Melissa Power (Western Sydney Sexual Health Centre), Damien Brown (Short Street Clinic), Ruthy McIver (Sydney Sexual Health Centre), Roisin Dyer (Orange Sexual Health Centre, and Dubbo Sexual Health Centre), Brett Sinclair (Royal Prince Alfred Sexual Health), Michael O’Reilly (Newcastle Community Health Centre), Andrew Buggy (Lismore Sexual Health Centre), Nives Houlihan (Coffs Harbour Sexual Health), Karen Chronister (Kirketon Road Centre), Shane Hewitt (Dr Doong’s Surgery).
The EPIC-NSW study group is:
Andrew E. Grulich, The Kirby Institute, UNSW Sydney, NSW, Australia Email: agrulich@kirby.unsw.edu.au
David A. Cooper, The Kirby Institute, UNSW Sydney, NSW, Australia Email: dcooper@kirby.unsw.edu.au
Iryna B. Zablotska, The Kirby Institute, UNSW Sydney, NSW, Australia Email: izablotska@kirby.unsw.edu.au
Rebecca Guy, The Kirby Institute, UNSW Sydney, NSW, Australia Email: rguy@kirby.unsw.edu.au
Janaki Amin, Mcquarie University and The Kirby Institute, UNSW Sydney, NSW, Australia Email: Janaki.amin@mq.edu.au
Fengyi Jin, The Kirby Institute, UNSW Sydney, NSW, Australia Email: jjin@kirby.unsw.edu.au
Christine Selvey, NSW Ministry of Health, NSW, Australia Email: Christine.Selvey@doh.health.nsw.gov.au
Jo Holden, NSW Ministry of Health, NSW, Australia Email: jo.holden@doh.health.nsw.gov.au
Heather-Marie Schmidt, NSW Ministry of Health, NSW, Australia Email: Heather-marie.schmidt@doh.health.nsw.gov.au
Bill Whittaker, NSW Ministry of Health, NSW, Australia.
Karen Price, AIDS Council of New South Wales (ACON), Sydney, NSW, Australia Email: KPrice@acon.org.au
Nic Parkhill, AIDS Council of New South Wales (ACON), Sydney, NSW, Australia.
Kerry Chant, NSW Ministry of Health, NSW, Australia.
Craig Cooper, Positive Life NSW, NSW, Australia.
Levinia Crooks, Australasian Society for HIV Medicine, NSW, Australia.
Debbie Allen, Holden Street Clinic, NSW, Australia.
David Baker, East Sydney Doctors, NSW, Australia.
Mark Bloch, Holdsworth House Medical Practice, NSW, Australia.
Rohan Bopage, The Albion Centre, NSW, Australia.
Katherine Brown, Illawarra Sexual Health Clinic, NSW, Australia.
Andrew Carr, St Vincent’s Hospital, NSW, Australia.
Christopher Carmody, Liverpool Sexual Health Clinic, NSW, Australia.
Kym Collins, Albury Sexual Health Clinic and Brookong Sexual Health Centre, NSW, Australia.
Robert Finlayson, Taylor Square Private Clinic, NSW, Australia.
Rosalind Foster, Clinic 16, NSW, Australia.
Eva Jackson, Nepean Hospital, NSW, Australia.
David Lewis, Western Sydney Sexual Health Centre, NSW, Australia.
Josephine Lusk, Short Street Clinic, NSW, Australia.
Anna McNulty, Sydney Sexual Health Centre, Orange Sexual Health Centre, and Dubbo Sexual Health Centre, NSW, Australia Email: Anna.McNulty@HEALTH.NSW.GOV.AU
Catherine O’Connor, Royal Prince Alfred Sexual Health, NSW, Australia.
Nathan Ryder, Newcastle Community Health Centre, NSW, Australia.
David Smith, Lismore Sexual Health Centre, NSW, Australia Email: DrDavidJ.Smith@ncahs.health.nsw.gov.au
Emanuel Vlahakis, Coffs Harbour Sexual Health, NSW, Australia.
Phillip Read, Kirketon Road Centre, NSW, Australia.
Barbara Yeung, The Kirby Institute, UNSW Sydney, NSW, Australia.
Gesalit Levitt, The Kirby Institute, UNSW Sydney, NSW, Australia.
Erin Ogilvie, The Kirby Institute, UNSW Sydney, NSW, Australia.
Stefanie Vaccher, The Kirby Institute, UNSW Sydney, NSW, Australia.
Muhammad Hammoud, The Kirby Institute, UNSW Sydney, NSW, Australia.
Lucy Watchirs-Smith, the Kirby Institute, UNSW Sydney, NSW, Australia.
Nasir Wabe, The Kirby Institute, UNSW Sydney, NSW, Australia.