Clinicians are advised to provide a prescription for 3 months of PrEP at the baseline visit unless they are concerned the participant is HIV positive, or has renal impairment. At each study visit participants undergo scheduled HIV and STI testing and received a 3-month PrEP prescription (Table 3). Within this shared care model the participant is enrolled as a study participant at the Alfred Hospital while receiving care with their general practitioner at a remote site (remote GP). The PrEPX investigator (based at the Alfred hospital) is responsible for confirming study eligibility, for enrolling the participant, providing clinical monitoring, PrEPX study drug prescription and oversight of the shared care remote GP.

Study Design

PrEP is recommended for people reporting high or moderate risk for acquiring HIV through male to male sex, heterosexual sex, and/or injecting drug use. Recent changes to the guidelines also permit clinicians’ discretionary prescription of chicken road PrEP (20). Behavioural data collected at baseline and three-monthly clinic visits will help explore the potential prevention impact of PrEP. Preceding the anticipated public subsidisation of PrEP through Medicare, the Victorian government has funded a program (PrEPX) to rapidly scale-up PrEP access to GBM through high-caseload clinics.

The cost of personally importing PrEP ranges between $70–230 USD (approximately $90–300 AUD) for a 3 month supply (28, 29); delays in customs and shipping have been reported (30). Finally, PrEP can be accessed through jurisdiction-level PrEP implementation projects, which either provide participants free study medication, or require that participants pay costs commensurate with current PBS prices. Six of the eight Australian jurisdictions offer PrEP via population intervention studies, with the size and number of studies increasing significantly since the first PrEP demonstration project, VicPrEP, began enrolment in Victoria in June 2014 (Table 1) (17, 31–36). VicPrEP demonstrated that PrEP could be successfully prescribed and managed in general practice in Victoria, providing preliminary evidence for the current, larger demonstration study, PrEPX (17). PrEPX will provide important evidence on an approach that emulates the real world when implementing PrEP on a large scale at a time when much of the world is transitioning to the use of this new HIV prevention tool.

Pelaa online-kaninopelejä

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. AM, BP, CF, SR, LL, CoB, DW, JL, DM, VC, NR, JWillcox, CC, JAr, BT, MP, GS, CW, JM, KB, AC, BA, JWiggins, JK, OV, MW, AP, DG, ChB, JdeW, JH, SW, RG, and EW contributed to the design of the project. KR, MS, JAs, CE-H, LN, DM, VC, NR, JWillcox, CC, JAr, BT, MP, G-FS, and EW contributed to data collection.

• The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner are credited and that the original publication in this journal is cited, in accordance with accepted academic practice.
• The efficacy of PrEP is directly correlated with medication adherence (12, 13) with recent open label trials reporting high adherence and greater reduction in risk of HIV acquisition compared to earlier, blinded studies (13, 14).
• Clinicians are advised to provide a prescription for 3 months of PrEP at the baseline visit unless they are concerned the participant is HIV positive, or has renal impairment.
• We hypothesize that the provision of PrEP to individuals at high risk of HIV would be both justified and feasible and could achieve a population level reduction in HIV incidence.

Pathology tests are collected at a local Pathology Service provider and the results are sent to the Alfred Hospital and to the outreach clinic. Study drug is dispensed and sent to the participant via registered mail from the Alfred Hospital Clinical Trials pharmacy. PrEPX is a prospective, population-level intervention study, designed to emulate “real world” conditions to reflect the likely clinical scenario were tenofovir and emtricitabine to become subsided by the PBS for use as HIV PrEP in Australia.

• The PrEPX study design will allow researchers to determine if provision of PrEP to people at risk of HIV in Victoria reduces HIV transmission.
• There is substantial evidence of the safety, efficacy and effectiveness of PrEP at reducing HIV transmission in GBM, trans-women, heterosexual men and women and people who inject drugs (3, 5–11).
• Behavioural data collected at baseline and three-monthly clinic visits will help explore the potential prevention impact of PrEP.

Study Participants

Also, while there is significant data collected in this study, the restriction of behavioral and test data is only collected from sites participating in the ACCESS surveillance system, however we anticipate that the vast majority of clients will be enrolled at these sites. Finally, HIV diagnoses are being used as a proxy for HIV incidence and may not accurately reflect incidence. However, we aim to triangulate HIV notification in Victoria, with diagnoses and testing at ACCESS surveillance sites to improve estimates of the impact of PrEPX. A few days prior to commencement of study enrolment, registered individuals were emailed information on how to book a PrEPX appointment at their preferred study site and information on whether co-payment would likely be required by the clinic at study enrolment.

PrEP is currently registered for use in Australia, and will be listed on the national list of medicines the Pharmaceutical Benefits Scheme (PBS) on 01 April 2018. In 2016, three pharmaceutical companies had their co-formulated tenofovir and emtricitabine products approved by Australia’s Therapeutic Goods Administration (TGA) for use in HIV prevention (21–23). Generic PrEP can be imported from overseas through the TGA personal importation scheme, wherein registered medical practitioners provide individuals with clinical monitoring and 3-monthly prescriptions for PrEP (27).

Medical specialist clinic

The study will determine if the provision of PrEP to 2,600 people at high risk of HIV infection in Victoria results in a 30% decline in new HIV infections among GBM over the 36 months of the study. In addition, the study will monitor the rate of new HIV infections in Victoria for a period of 36 months after the PrEPX study commences. Analyses of changes in the rates of HIV infection will be undertaken using Mann-Whitney U and chi-square tests to determine whether there has been a significant decline in new HIV infections during this 36-month period, compared to the 36 months prior to PrEPX commencing.

Participants attending one of the seven clinics will be able to attend a linked community pharmacy and will be required to pay the PBS co-payment ($7 or $39 AUD) as per usual practice in Australia. Participants attending Melbourne Sexual Health Centre or the Alfred Hospital will be invoiced for the co-payment. PrEPX received funding from the Victorian Department of Health and Human Services (DHHS) on 29 January 2016 for 2,600 study places. An additional 600 places were funded by the Victorian AIDS Council (announced on 19 January 2017) and a further 600 places were funded by the Victorian DHHS (announced on 28 March 2017). We will also monitor the background incidence of HIV among gay men attending PrEP implementation clinics, undertaking world-leading research to measure the impact of rapid PrEP scale-up on background rates of HIV transmission.

Access to Document

The shared care model aims to improve geographic access, equity and convenience and the model was used to provide PrEP sites outside of metropolitan Melbourne. In Australia clinical trial medications are conventionally free of charge and are dispensed by hospital-based pharmacies. However, to mimic real world conditions, PrEPX participants can have their PrEP medication dispensed by community pharmacies located close to the study clinics.

The PrEPX study design will allow researchers to determine if provision of PrEP to people at risk of HIV in Victoria reduces HIV transmission. In addition, it will provide important information on behavioral change and STI rates, attitudes toward PrEP, ancillary health benefits of quarterly clinical visits and the health service requirements for providing PrEP on a large scale. PrEPX will deliver implementation and population level results that will be transferrable to other Australian jurisdictions and international settings.

We will use ACCESS test data, pharmacy data and in-depth online surveys to explore PrEP adherence. Monthly aggregate data from the state NPEP service will be descriptively analyzed to explore state wide use of clinic survey and ACCESS test data will be used to explore the capacity of study clinics to prescribe PrEP. The laboratory investigations and surveys that participants undergo at baseline are outlined in Tables 3, 4. All study participants are evaluated with baseline laboratory tests and the baseline enrolment form survey (Tables 3, 4, respectively). An in-depth, online survey performed at baseline then 6-monthly thereafter was completed by 1,200 participants at enrolment.

Community groups have representatives as co-investigators on the study and provide information to their communities and to the study team, contributing to iterative refinement of the study. Consultation with clinics allowed clinics to plan for study enrolment and to provide feedback to the study team when they reached capacity. Electronic data collection, including study enrolment, behavioral data and test data collection decrease the clinical trial burden placed on clinics and with the exception of enrolment, utilize the existing ACCESS sentinel surveillance system at most clinic sites. This design provides long term, high quality clinical and behavioral data among GBM testing for HIV and STIs, allowing for population level estimates of the impact of PrEP while maintaining standard practice at participating sites. To answer the study secondary aims a range of datasets and analyses will be employed, as required. The in-depth online survey and interviews will be used to explore attitudes to PrEP, reasons for taking PrEP and attitudes around sexual behavior since the availability of PrEP.

PrEPX participants are re-identified within ACCESS study sites through matching a numerical identifier, year of birth and enrolment clinic within the enrolment survey and the ACCESS dataset. At baseline, written informed consent is obtained and clinicians complete and submit an online enrolment survey through the Research Electronic Data Capture system (REDCap) (44). REDCap immediately generates the participant’s study number and sends it via email to the participant along with the contact details of study personnel (Table 3).

Clinics were provided with a list of individuals planning to attend their clinic, including contact details, if currently using PrEP and if currently a client at that clinic. When study funding was announced in January 2016, a database (study registry) was established so that individuals could register their interest in the study thereby assisting the study team’s plans for study implementation (Table 1). The register collects participants’ contact details, previous PrEP use and which study site participants would prefer to attend. In Victoria, three quarters of new HIV diagnoses are among GBM and the knowledge of, interest and willingness to use PrEP is high amongst GBM at higher risk of HIV acquisition (37).