TY - JOUR
T1 - Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW)
T2 - design of an open label, single arm implementation trial
AU - Zablotska, Iryna B.
AU - Selvey, Christine
AU - Guy, Rebecca
AU - Price, Karen
AU - Holden, Jo
AU - Schmidt, Heather Marie
AU - McNulty, Anna
AU - Smith, David
AU - Jin, Fengyi
AU - Amin, Janaki
AU - Cooper, David A.
AU - Grulich, Andrew E.
AU - Parkhill, Nic
AU - Chant, Kerry
AU - Cooper, Craig
AU - Crooks, Levinia
AU - Allen, Debbie
AU - Baker, David
AU - Bloch, Mark
AU - Bopage, Rohan
AU - Brown, Katherine
AU - Carr, Andrew
AU - Carmody, Christopher
AU - Collins, Kym
AU - Finlayson, Robert
AU - Foster, Rosalind
AU - Jackson, Eva
AU - Lewis, David
AU - Lusk, Josephine
AU - O'Connor, Catherine
AU - Ryder, Nathan
AU - Vlahakis, Emanuel
AU - Read, Phillip
AU - Yeung, Barbara
AU - Levitt, Gesalit
AU - Ogilvie, Erin
AU - Vaccher, Stefanie
AU - Hammoud, Mohamed
AU - Watchirs-Smith, Lucy
AU - Wabe, Nasir
AU - The EPIC-NSW study group
N1 - 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.
PY - 2018/2/2
Y1 - 2018/2/2
N2 - 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.
AB - 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.
KW - antiretroviral medication
KW - gay, homosexual or other men who have sex with men
KW - HIV incidence, adherence
KW - HIV risk
KW - implementation research
KW - pre-exposure prophylaxis
KW - PrEP eligibility
UR - http://www.scopus.com/inward/record.url?scp=85041625097&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/record.url?scp=85042748273&partnerID=8YFLogxK
U2 - 10.1186/s12889-017-5018-9
DO - 10.1186/s12889-017-5018-9
M3 - Article
VL - 18
SP - 1
EP - 10
JO - BMC Public Health
JF - BMC Public Health
SN - 1471-2458
IS - 1
M1 - 210
ER -