Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

The Australian seventh National HIV strategy (2014-2017) aims to reduce the incidence of HIV and to work towards the virtual elimination of HIV transmission in Australia by 2020. This extraordinary goal relies on two anti-retroviral therapy (ARV)-related interventions, in addition to traditional behavioural prevention. The first of these interventions, HIV treatment as prevention targeted at HIV positive people, has been ramped up over the last few years, and is approaching maximal levels of population impact. Despite this, new HIV diagnoses in Australia have been approximately constant over the last four years. Critical to the new strategy's success is the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). TDF/FTC has been extensively used in millions of people with HIV for more than 15 years.

This large-scale study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will comprise mostly gay and bisexual men (GBM) but will also include small numbers of heterosexuals, people who inject drugs, and transgender men and women. The drug will be used according to existing Australasian Society for HIV, Viral Hepatitis and Sexual Health (ASHM) HIV PrEP Clinical Guidelines.

By rapidly rolling out this new intervention as rapidly as feasible, and following participants for up to two years on treatments, we expect a reduction in new HIV diagnoses in WA due to decreased infection in the on-treatment cohort, and to the interruption of chains of transmission to others not receiving PrEP. The rapid and large-scale roll-out of PrEP is a critical component of working towards the virtual elimination of HIV transmission by 2020.

Inclusion criteria

• HIV negative at enrolment, with a negative HIV test result conducted at the enrolment clinic within seven days of initiating PrEP
• At high and ongoing risk for acquiring HIV infection [as defined by Behavioural Eligibility criteria in the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) HIV PrEP Clinical Guidelines]
• Aged 18 years or over
• Live in WA or visit WA enough to attend clinics for follow-up assessments
• Willing and able to provide informed consent
• Medicare ineligible individuals may be enrolled if the clinical service is able to cover the costs of monitoring of the patient

Exclusion criteria

• HIV-1 infected or has symptoms consistent with acute viral infection (If HIV positive status is not confirmed by testing, delay starting PrEP for at least one month and reconfirm negative HIV-1 status)
• Having an estimated creatinine clearance (glomerular filtration rate [eGFR]) <60ml/min
• Having or developing clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness)
• Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs)
• Allergic to TDF and/or FTC (based on self-report or recorded)
• Concurrently taking prescribed products containing FTC or TDF including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD, TAF (tenofovir alafenamide), GENVOYA, DESCOVY; other drugs containing lamivudine; HEPSERA
• Factors or conditions that may compromise a participant's access to health services for follow-up (incarceration or planned relocation and potential absence from Western Australia)