TY - JOUR
T1 - Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia
T2 - The PrEPX Study
AU - Ryan, Kathleen
AU - Mak, Anne
AU - Stoove, Mark
AU - Price, Brian
AU - Fairley, Christopher K
AU - Ruth, Simon
AU - Lal, Luxshimi
AU - Asselin, Jason
AU - El-Hayek, Carol
AU - Nguyen, Long
AU - Batrouney, Colin
AU - Wilson, David
AU - Lockwood, John
AU - Murphy, Dean Anthony
AU - Cornelisse, Vincent
AU - Roth, Norman J
AU - Willcox, Jeff
AU - Chang, Christina
AU - Armishaw, Judy
AU - Tee, Ban Kiem
AU - Penn, Matthew
AU - Smith, George
AU - Williams, Christopher
AU - Montgomery, Jeff
AU - Byron, Kat
AU - Coelho, Alison
AU - Allen, Brent
AU - Wiggins, Jeremy
AU - Kelsall, Jenny
AU - Vujovic, Olga Vera
AU - West, Michael J
AU - Pierce, Anna
AU - Gallant, Daniel
AU - Bell, Charlotte
AU - de Wit, John
AU - Hoy, Jennifer Frances
AU - Wesselingh, Steven Lodewyk
AU - Grant, Robert M.
AU - Wright, Edwina Jane
N1 - Funding Information:
We would like to acknowledge The PrEPX study participants, the researchers and participants from previous PrEP studies, the non-human primates and other animals who have contributed to our current understanding of the science of PrEP. Funding. This project was funded by the Victorian Department of Health and Human Services, the Alfred Hospital and the Victorian AIDS Council.
Publisher Copyright:
Copyright © 2018 Ryan, Mak, Stoove, Price, Fairley, Ruth, Lal, Asselin, El-Hayek, Nguyen, Batrouney, Wilson, Lockwood, Murphy, Cornelisse, Roth, Willcox, Chang, Armishaw, Tee, Penn, Forgan-Smith, Williams, Montgomery, Byron, Coelho, Allen, Wiggins, Kelsall, Vujovic, West, Pierce, Gallant, Bell, Wit, Hoy, Wesselingh, Grant and Wright.
PY - 2018/5/29
Y1 - 2018/5/29
N2 - Background: Pre-exposure prophylaxis (PrEP) is the use of HIV anti-retroviral therapy to prevent HIV transmission in people at high risk of HIV acquisition. PrEP is highly efficacious when taken either daily, or in an on-demand schedule. In Australia co-formulated tenofovir-emtricitabine is registered for daily use for PrEP, however, this co-formulation is not listed yet on the national subsidized medicines list. We describe a study protocol that aims to demonstrate if the provision of PrEP to up to 3800 individuals at risk of HIV in Victoria, Australia reduces HIV incidence locally by 25% generally and 30% among GBM. Methods: PrEPX is a population level intervention study in Victoria, Australia in which generic PrEP will be delivered to 3800 individuals for up to 36 months. Study eligibility is consistent with the recently updated 2017 Australian PrEP guidelines. Participants will attend study clinics, shared care clinics, or outreach clinics for quarterly HIV/STI screening, biannual renal function tests and other clinical care as required. Study visits and STI diagnoses will be recorded electronically through the ACCESS surveillance system. At each study visit participants will be invited to complete behavioral surveys that collect demographics and sexual risk data. Diagnosis and behavioral data will be compared between PrEPX participants and other individuals testing within the ACCESS surveillance system. A subset of participants will complete in depth surveys and interviews to collect attitudes, beliefs and acceptability data. Participating clinics will provide clinic level data on implementation and management of PrEPX participants. The population level impact on HIV incidence will be assessed using Victorian HIV notification data. Discussion: This study will collect evidence on the real world impact of delivery of PrEP to 3800 individuals at risk of acquiring HIV in Victoria. This study will provide important information for the broader implementation of PrEP planning upon listing of the tenofovir-emtricitabine on the national subsidized list of medicines. The study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001215415)
AB - Background: Pre-exposure prophylaxis (PrEP) is the use of HIV anti-retroviral therapy to prevent HIV transmission in people at high risk of HIV acquisition. PrEP is highly efficacious when taken either daily, or in an on-demand schedule. In Australia co-formulated tenofovir-emtricitabine is registered for daily use for PrEP, however, this co-formulation is not listed yet on the national subsidized medicines list. We describe a study protocol that aims to demonstrate if the provision of PrEP to up to 3800 individuals at risk of HIV in Victoria, Australia reduces HIV incidence locally by 25% generally and 30% among GBM. Methods: PrEPX is a population level intervention study in Victoria, Australia in which generic PrEP will be delivered to 3800 individuals for up to 36 months. Study eligibility is consistent with the recently updated 2017 Australian PrEP guidelines. Participants will attend study clinics, shared care clinics, or outreach clinics for quarterly HIV/STI screening, biannual renal function tests and other clinical care as required. Study visits and STI diagnoses will be recorded electronically through the ACCESS surveillance system. At each study visit participants will be invited to complete behavioral surveys that collect demographics and sexual risk data. Diagnosis and behavioral data will be compared between PrEPX participants and other individuals testing within the ACCESS surveillance system. A subset of participants will complete in depth surveys and interviews to collect attitudes, beliefs and acceptability data. Participating clinics will provide clinic level data on implementation and management of PrEPX participants. The population level impact on HIV incidence will be assessed using Victorian HIV notification data. Discussion: This study will collect evidence on the real world impact of delivery of PrEP to 3800 individuals at risk of acquiring HIV in Victoria. This study will provide important information for the broader implementation of PrEP planning upon listing of the tenofovir-emtricitabine on the national subsidized list of medicines. The study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001215415)
KW - HIV
KW - MSM
KW - PrEP
KW - prevention
KW - protocol
UR - http://www.scopus.com/inward/record.url?scp=85052872130&partnerID=8YFLogxK
U2 - 10.3389/fpubh.2018.00151
DO - 10.3389/fpubh.2018.00151
M3 - Article
AN - SCOPUS:85052872130
SN - 2296-2565
VL - 6
JO - Frontiers in Public Health
JF - Frontiers in Public Health
M1 - 151
ER -
