PrEP has been approved in several jurisdictions around the world for use by high-risk populations and was recently approved for HIV prevention in Australia by the Australian Government Department of Health Therapeutic Goods Administration. This clinic is only available to people with Medicare or visitors from countries with reciprocal healthcare agreements. Our online tool to find the lucky number from name will accurately calculate your lucky number and list the same.
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While PrEP is highly effective at reducing HIV transmission it confers no protective effect against sexually transmissible infections (STIs) with the exception of HSV2 infections (15, 16). Concerns have been raised that PrEP use would increase condomless peno-anal or peno-vaginal sex, number of sex partners and in turn incidence of STIs, however there is mixed evidence of such changes occurring (11, 14, 17). In 2015 the World Health Organisation recommended PrEP as an HIV prevention option for all key populations (18). As at November 2017, PrEP is approved for use by the regulatory authorities of at least 20 countries, including Australia. Although approximately 30 countries currently run or plan to implement PrEP demonstration projects (19), there are as yet no publications which confirm the population level impact of PrEP.
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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.
Registration and Waitlist Data Collection
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.
Test results are maintained at both the remote GP and Alfred Hospital PrEPX sites; results are discussed between practitioners (PrEPX investigator and shared care site GP) as required. Study drug can be dispensed by a participating PrEPX community pharmacy site or the hospital pharmacy can dispense and send the study drug to the participant via registered mail. For participants receiving study drug at the baseline visit via mail, the investigator provides a follow-up phone call to the participant, reaffirming dispensing information and receipt of study drug. The PrEPX shared care model is based on existing models of clinical shared care in Victoria. These models ensure individuals are able to access services across outer metropolitan Melbourne, regional and rural Victoria.
Personal Care
The study opened on 26 July 2016 and data collection among enrolled participants is scheduled until July 2019. Within the outreach clinic model a clinician from the Alfred Hospital attends a rural or regional clinic in Victoria. Study participants are enrolled at the remote clinic into the PrEPX study as an Alfred Hospital patient and assigned an Alfred Hospital unique reference number. PrEP randomized controlled trials and PrEP demonstration projects have shown that the use of tenofovir and emtricitabine is safe, highly efficacious and effective in the prevention of HIV infection (3, 6, 9, 11). Based on this current knowledge of PrEP we are introducing this HIV intervention tool at a population level in Victoria to people at high risk of HIV infection to help reduce new HIV infections in the State.
Participants' Baseline and Follow-Up Data Collection
In Australia, more than three quarters of new HIV diagnoses are made among gay and bisexual men (GBM). HIV pre-exposure prophylaxis (PrEP), the use of HIV treatment medication by people at risk of HIV to reduce their risk of acquisition, has emerged over recent years as a highly-effective HIV prevention tool. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). 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.
- 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.
- 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).
- 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.
- 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.
- 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.
In some studies, including VicPrEP, STIs have increased and condom use has declined (11, 17). However interpretation of these findings is not straightforward and requires further follow-up combined with the planning and implementation of innovative STI prevention strategies. PrEP is the use of tenofovir and emtricitabine on a daily or on demand schedule to prevent HIV transmission (3, 4). 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). 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).
The PrEPX Study
Participants are required to pay a co-payment to simulate the co-payment costs that Australian residents pay for medications listed on the PBS (26). The investigators approached five community pharmacies to determine if they would dispense PrEPX study medication. All community pharmacies approached by investigators agreed to participate in the study and received appropriate facilities and training to conform with good clinical research practice. While efforts were made to emulate real world setting the exclusion criteria, limited number of study spaces, and compensation of clinics for each enrollee introduce aspects to the study that will not be present when PrEP is listed on the PBS.
- Recent changes to the guidelines also permit clinicians' discretionary prescription of PrEP (20).
- 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.
- 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.
- For participants receiving study drug at the baseline visit via mail, the investigator provides a follow-up phone call to the participant, reaffirming dispensing information and receipt of study drug.
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.
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 chicken road 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).
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. The primary aim of this study is to determine if the provision of PrEP for 36 months to 2,600 people at high risk of HIV infection in Victoria will result in a 30% decline in new HIV infections in GBM and a 25% state wide decline in new HIV infections. The VicPrEP study showed that during a period of 12 months of PrEP use, adherence to drug schedule was high.
People interested in participating in PrEPX may register their interest in the registration or waitlists or directly approach participating clinics to enquire about the study. Participating clinicians may recommend PrEP, and participation in PrEPX, to their clients. Participants will be provided with daily co-formulated generic tenofovir with emtricitabine purchased from Mylan Pharmaceuticals, Australian Sponsor- Alphapharm (38). GRHANITETM data extraction software removes all patient identifying details before data extraction from the clinics or pathology services. Patients are assigned a unique identifier, which allows longitudinal analysis of a patient within a clinic.
This survey provides more detailed information on sexual behavior, adherence, attitudes to PrEP and acceptability of the study. An in-depth, face-to-face interview at baseline and month 21 was completed by up to 30 participants, purposively selected from those completing the in-depth online survey (Table 4). Each participant's study visit attracts a Medicare rebate for consultations and pathology requests because regular clinical, HIV, STI and laboratory monitoring are standard-of-care for GBM at high risk of HIV infection in Australia (45, 46). In addition, participants who enrol at one of the participating general practice clinics will be billed for their visits in accordance with the existing billing policies of those clinics. Details of the participant's enrolment are entered into the participant's local medical records at the outreach clinic. The Alfred Hospital PrEPX clinician will have access to the study participants medical records at the outreach clinic.