Frontiers in Public Health (May 2018)
Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study
- Kathleen E. Ryan,
- Kathleen E. Ryan,
- Anne Mak,
- Mark Stoove,
- Mark Stoove,
- Brian Price,
- Christopher K. Fairley,
- Christopher K. Fairley,
- Simon Ruth,
- Luxshimi Lal,
- Luxshimi Lal,
- Jason Asselin,
- Carol El-Hayek,
- Long Nguyen,
- Colin Batrouney,
- David Wilson,
- John Lockwood,
- Dean Murphy,
- Vincent J. Cornelisse,
- Vincent J. Cornelisse,
- Norman Roth,
- Jeff Willcox,
- Christina C. Chang,
- Judy Armishaw,
- Ban K. Tee,
- Ban K. Tee,
- Matthew Penn,
- George Forgan-Smith,
- Christopher Williams,
- Jeff Montgomery,
- Kat Byron,
- Alison Coelho,
- Brent Allen,
- Jeremy Wiggins,
- Jeremy Wiggins,
- Jenny Kelsall,
- Olga Vujovic,
- Michael West,
- Anna B. Pierce,
- Daniel Gallant,
- Charlotte Bell,
- John B. F. de Wit,
- Jennifer F. Hoy,
- Steve L. Wesselingh,
- Robert M. Grant,
- Edwina J. Wright,
- Edwina J. Wright,
- Edwina J. Wright
Affiliations
- Kathleen E. Ryan
- The Burnet Institute, Melbourne, VIC, Australia
- Kathleen E. Ryan
- Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia
- Anne Mak
- Alfred Health Pharmacy, Melbourne, VIC, Australia
- Mark Stoove
- The Burnet Institute, Melbourne, VIC, Australia
- Mark Stoove
- Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia
- Brian Price
- Alfred Health, Melbourne, VIC, Australia
- Christopher K. Fairley
- Melbourne Sexual Health Centre, Melbourne, VIC, Australia
- Christopher K. Fairley
- Central Clinical School, Monash University, Melbourne, VIC, Australia
- Simon Ruth
- Victorian AIDS Council, Melbourne, VIC, Australia
- Luxshimi Lal
- The Burnet Institute, Melbourne, VIC, Australia
- Luxshimi Lal
- Alfred Health, Melbourne, VIC, Australia
- Jason Asselin
- The Burnet Institute, Melbourne, VIC, Australia
- Carol El-Hayek
- The Burnet Institute, Melbourne, VIC, Australia
- Long Nguyen
- The Burnet Institute, Melbourne, VIC, Australia
- Colin Batrouney
- Victorian AIDS Council, Melbourne, VIC, Australia
- David Wilson
- The Burnet Institute, Melbourne, VIC, Australia
- John Lockwood
- Alfred Health, Melbourne, VIC, Australia
- Dean Murphy
- Centre for Social Research in Health, University of New South Wales, Sydney, NSW, Australia
- Vincent J. Cornelisse
- Melbourne Sexual Health Centre, Melbourne, VIC, Australia
- Vincent J. Cornelisse
- Central Clinical School, Monash University, Melbourne, VIC, Australia
- Norman Roth
- Prahran Market Clinic, Melbourne, VIC, Australia
- Jeff Willcox
- 0Northside Clinic, Melbourne, VIC, Australia
- Christina C. Chang
- 1Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia
- Judy Armishaw
- Alfred Health, Melbourne, VIC, Australia
- Ban K. Tee
- 2The Centre Clinic, Melbourne, VIC, Australia
- Ban K. Tee
- 3Access Health and Community Richmond, Melbourne, VIC, Australia
- Matthew Penn
- 4PRONTO! Community Health Centre, Melbourne, VIC, Australia
- George Forgan-Smith
- 5ERA Health, Melbourne, VIC, Australia
- Christopher Williams
- 6PrEP'DForChange, Melbourne, VIC, Australia
- Jeff Montgomery
- 7PrEPaccessNOW, Melbourne, VIC, Australia
- Kat Byron
- 8Victorian Aboriginal Community Controlled Health Organisation Inc., Melbourne, VIC, Australia
- Alison Coelho
- 9Centre for Culture, Ethnicity and Health, Melbourne, VIC, Australia
- Brent Allen
- 0Living Positive Victoria, Melbourne, VIC, Australia
- Jeremy Wiggins
- Victorian AIDS Council, Melbourne, VIC, Australia
- Jeremy Wiggins
- 1Peer Advocacy Network for the Sexual Health of Trans Masculinities, Melbourne, VIC, Australia
- Jenny Kelsall
- 2Harm Reduction Victoria, Melbourne, VIC, Australia
- Olga Vujovic
- 1Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia
- Michael West
- 3Sexual Health and Viral Hepatitis Service Department of Health and Human Services, Government of Victoria, Melbourne, VIC, Australia
- Anna B. Pierce
- 1Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia
- Daniel Gallant
- 4Sexually Transmissible Infection and Blood Borne Virus Section, Communicable Disease Control Branch, Department of Health and Ageing, Government of South Australia, Adelaide, SA, Australia
- Charlotte Bell
- 5Clinic 275, Royal Adelaide Hospital, Adelaide, SA, Australia
- John B. F. de Wit
- Centre for Social Research in Health, University of New South Wales, Sydney, NSW, Australia
- Jennifer F. Hoy
- 1Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia
- Steve L. Wesselingh
- 6South Australian Health and Medical Research Institute, Adelaide, SA, Australia
- Robert M. Grant
- 7School of Medicine, University of California San Francisco, Gladstone Institutes, San Francisco, CA, United States
- Edwina J. Wright
- The Burnet Institute, Melbourne, VIC, Australia
- Edwina J. Wright
- 2The Centre Clinic, Melbourne, VIC, Australia
- Edwina J. Wright
- 8Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
- DOI
- https://doi.org/10.3389/fpubh.2018.00151
- Journal volume & issue
-
Vol. 6
Abstract
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)
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