Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study

Kathleen E Ryan^{1

2}, Anne Mak³, Mark Stoove^{1

2}, Brian Price⁴, Christopher K Fairley^{5

6}, Simon Ruth⁷, Luxshimi Lal^{1

4}, Jason Asselin¹, Carol El-Hayek¹, Long Nguyen¹, Colin Batrouney⁷, David Wilson¹, John Lockwood⁴, Dean Murphy⁸, Vincent J Cornelisse^{5

6}, Norman Roth⁹, Jeff Willcox¹⁰, Christina C Chang¹¹, Judy Armishaw⁴, Ban K Tee^{12

13}, Matthew Penn¹⁴, George Forgan-Smith¹⁵, Christopher Williams¹⁶, Jeff Montgomery¹⁷, Kat Byron¹⁸, Alison Coelho¹⁹, Brent Allen²⁰, Jeremy Wiggins^{7

21}, Jenny Kelsall²², Olga Vujovic¹¹, Michael West²³, Anna B Pierce¹¹, Daniel Gallant²⁴, Charlotte Bell²⁵, John B F de Wit⁸, Jennifer F Hoy¹¹, Steve L Wesselingh²⁶, Robert M Grant²⁷, Edwina J Wright^{1

12

28}

Affiliations

¹ The Burnet Institute, Melbourne, VIC, Australia.
² Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
³ Alfred Health Pharmacy, Melbourne, VIC, Australia.
⁴ Alfred Health, Melbourne, VIC, Australia.
⁵ Melbourne Sexual Health Centre, Melbourne, VIC, Australia.
⁶ Central Clinical School, Monash University, Melbourne, VIC, Australia.
⁷ Victorian AIDS Council, Melbourne, VIC, Australia.
⁸ Centre for Social Research in Health, University of New South Wales, Sydney, NSW, Australia.
⁹ Prahran Market Clinic, Melbourne, VIC, Australia.
¹⁰ Northside Clinic, Melbourne, VIC, Australia.
¹¹ Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia.
¹² The Centre Clinic, Melbourne, VIC, Australia.
¹³ Access Health and Community Richmond, Melbourne, VIC, Australia.
¹⁴ PRONTO! Community Health Centre, Melbourne, VIC, Australia.
¹⁵ ERA Health, Melbourne, VIC, Australia.
¹⁶ PrEP'DForChange, Melbourne, VIC, Australia.
¹⁷ PrEPaccessNOW, Melbourne, VIC, Australia.
¹⁸ Victorian Aboriginal Community Controlled Health Organisation Inc., Melbourne, VIC, Australia.
¹⁹ Centre for Culture, Ethnicity and Health, Melbourne, VIC, Australia.
²⁰ Living Positive Victoria, Melbourne, VIC, Australia.
²¹ Peer Advocacy Network for the Sexual Health of Trans Masculinities, Melbourne, VIC, Australia.
²² Harm Reduction Victoria, Melbourne, VIC, Australia.
²³ Sexual Health and Viral Hepatitis Service Department of Health and Human Services, Government of Victoria, Melbourne, VIC, Australia.
²⁴ Sexually Transmissible Infection and Blood Borne Virus Section, Communicable Disease Control Branch, Department of Health and Ageing, Government of South Australia, Adelaide, SA, Australia.
²⁵ Clinic 275, Royal Adelaide Hospital, Adelaide, SA, Australia.
²⁶ South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
²⁷ School of Medicine, University of California San Francisco, Gladstone Institutes, San Francisco, CA, United States.
²⁸ Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.

PMID: 29896468
PMCID: PMC5987055
DOI: 10.3389/fpubh.2018.00151

Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study

Kathleen E Ryan et al. Front Public Health. 2018.

. 2018 May 29:6:151.

doi: 10.3389/fpubh.2018.00151. eCollection 2018.

Authors

Affiliations

¹ The Burnet Institute, Melbourne, VIC, Australia.
² Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
³ Alfred Health Pharmacy, Melbourne, VIC, Australia.
⁴ Alfred Health, Melbourne, VIC, Australia.
⁵ Melbourne Sexual Health Centre, Melbourne, VIC, Australia.
⁶ Central Clinical School, Monash University, Melbourne, VIC, Australia.
⁷ Victorian AIDS Council, Melbourne, VIC, Australia.
⁸ Centre for Social Research in Health, University of New South Wales, Sydney, NSW, Australia.
⁹ Prahran Market Clinic, Melbourne, VIC, Australia.
¹⁰ Northside Clinic, Melbourne, VIC, Australia.
¹¹ Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, VIC, Australia.
¹² The Centre Clinic, Melbourne, VIC, Australia.
¹³ Access Health and Community Richmond, Melbourne, VIC, Australia.
¹⁴ PRONTO! Community Health Centre, Melbourne, VIC, Australia.
¹⁵ ERA Health, Melbourne, VIC, Australia.
¹⁶ PrEP'DForChange, Melbourne, VIC, Australia.
¹⁷ PrEPaccessNOW, Melbourne, VIC, Australia.
¹⁸ Victorian Aboriginal Community Controlled Health Organisation Inc., Melbourne, VIC, Australia.
¹⁹ Centre for Culture, Ethnicity and Health, Melbourne, VIC, Australia.
²⁰ Living Positive Victoria, Melbourne, VIC, Australia.
²¹ Peer Advocacy Network for the Sexual Health of Trans Masculinities, Melbourne, VIC, Australia.
²² Harm Reduction Victoria, Melbourne, VIC, Australia.
²³ Sexual Health and Viral Hepatitis Service Department of Health and Human Services, Government of Victoria, Melbourne, VIC, Australia.
²⁴ Sexually Transmissible Infection and Blood Borne Virus Section, Communicable Disease Control Branch, Department of Health and Ageing, Government of South Australia, Adelaide, SA, Australia.
²⁵ Clinic 275, Royal Adelaide Hospital, Adelaide, SA, Australia.
²⁶ South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
²⁷ School of Medicine, University of California San Francisco, Gladstone Institutes, San Francisco, CA, United States.
²⁸ Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.

PMID: 29896468
PMCID: PMC5987055
DOI: 10.3389/fpubh.2018.00151

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).

Keywords: HIV; MSM; PrEP; prevention; protocol.

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References

1. The Kirby InstituteHIV , Viral, Hepatitis Sexually Transmissible Infections in Australia. Annual Surveillance Reports 2016 [Internet]. Sydney, NSW: (2016). Available online at: http://www.kirby.unsw.edu.au/surveillance/Annual-Surveillance-Reports
1. Australian Bureau of Statistics 3101.0 - Australian Demographic Statistics, Sep 2016 [Internet]. (2017) Available online at: http://www.abs.gov.au/AUSSTATS/abs@.nsf/mf/3101.0
1. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. (2010) 363:2587–99. 10.1056/NEJMoa1011205 - DOI - PMC - PubMed
1. Molina J-M, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. (2015) 373:2237–46. 10.1056/NEJMoa1506273 - DOI - PubMed
1. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in botswana. N Engl J Med. (2012) 367:423–34. 10.1056/NEJMoa1110711 - DOI - PubMed

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Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study

Affiliations

Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study

Authors

Affiliations

Abstract

References

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