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

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)

Characteristics of recently arrived Asian men who have sex with men diagnosed with HIV through sexual health services in Melbourne and Sydney

“…During the latter part of the study period, PrEP uptake increased among MSM in Victoria and New South Wales through the PrEPX and EPIC‐NSW studies, respectively 7,8 . In Victoria, men were required to have Medicare to access PrEPX while in New South Wales individuals without Medicare could enter EPIC‐NSW.…”

“…These suggest that health promotion aimed © 2019 The Authors During the latter part of the study period, PrEP uptake increased among MSM in Victoria and New South Wales through the PrEPX and EPIC-NSW studies, respectively. 7,8 In Victoria, men were required to have Medicare to access PrEPX while in New South Wales individuals without Medicare could enter EPIC-NSW. PrEP was listed on the Australian Pharmaceutical Benefits Scheme in April 2018, after the period of this study, allowing patients with Medicare to obtain subsidised PrEP from pharmacies.…”

HIV pre‐exposure prophylaxis and the ‘problems’ of reduced condom use and sexually transmitted infections in Australia: a critical analysis from an evidence‐making intervention perspective

“…, Ryan et al . ). The rapid scale‐up of PrEP in 2016 in New South Wales, Australia's most populous state, was associated with a 25% decline in annual HIV infections among gay and bisexual men in the following year (Grulich et al .…”

“…If users maintain detectable drug levels, PrEP has been shown to be highly effective in reducing the risk of HIV acquisition in multiple studies and populations (Fonner et al 2016). PrEP has been embraced in Australia, making PrEP available to gay and bisexual men in particular in large, state-funded demonstration projects administered by specialist providers and clinics, before it became available nationally through general prescribing (Grulich et al 2018, Ryan et al 2018. The rapid scaleup of PrEP in 2016 in New South Wales, Australia's most populous state, was associated with a 25% decline in annual HIV infections among gay and bisexual men in the following year (Grulich et al 2018), the first major decline in that state for over a decade.…”

Aktueller Forschungsstand zur HIV-PrEP: HIV-Prävention und Verbreitung anderer STI

“…einigen Ländern wie den USA, Australien und Frankreich wurden PrEP-Programme aufgelegt (CDC 2011;Chen et al 2016;Noret et al 2018;Ryan et al 2018;Zablotska et al 2018b).…”