PrEP clinics

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.

Data Collection

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 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.

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.

Participants’ Baseline and Follow-Up Data Collection

• 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.
• PrEPX received funding from the Victorian Department of Health and Human Services (DHHS) on 29 January 2016 for 2,600 study places.
• However interpretation of these findings is not straightforward and requires further follow-up combined with the planning and implementation of innovative STI prevention strategies.
• 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.
• 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 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 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.

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).

Rationale for This Study

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.

Registration and Waitlist Data Collection

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).

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.

• This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY).
• This clinic is only available to people with Medicare or visitors from countries with reciprocal healthcare agreements.
• Participants will be provided with daily co-formulated generic tenofovir with emtricitabine purchased from Mylan Pharmaceuticals, Australian Sponsor- Alphapharm (38).
• The register collects participants’ contact details, previous PrEP use and which study site participants would prefer to attend.
• 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.

Access to Document

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.

Study Design

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.

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.

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.

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).

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.

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 chicken road 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.