None listed
Conditions
Brief summary
Pre Exposure Prophylaxis eXpanded (PrEPX) is a new study that will expand the provision of PrEP to 2,600 Victorians who have a high chance of acquiring HIV. Alfred Health is responsible for conducting the study. Associate Professor Edwina Wright from the Department of Infectious Diseases Alfred Health, Monash University and The Burnet Institute will be the Chief Investigator of this study. The study is sponsored by the Victorian Department of Health and Human Services and, co-sponsored by Alfred Health and the Victorian AIDS Council. The chief research partners are The Burnet Institute and the Centre for Social Research in Health, UNSW. The aims of PrEPX are to: -Reduce the incidence of new HIV infections in Victoria, -Expand access to PrEP in Victoria, including rural and regional locations -Build capacity in the Victorian Health Service system so that the use of PrEP will become a routine option for preventing HIV infection PrEPX will start enrolling people on 26th July 2016 and run for 21 months. We will monitor the rate of new HIV infections in Victoria for a period of 36 months after the PrEPX study commences.
Interventions
Pre-Exposure Prophylaxis (PrEP) is a medication used to HIV prevention in people who do not have HIV to reduce their risk of becoming infected with HIV. Current literature recommends that PrEP is taken orally every day to minimise the risk of HIV. All participants in the PrEPX trial will be given PrEP as an intervention. The intervention used in this trial is a single pill, taken daily containing two antiretroviral medicines: Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg tablets. The
Pre-Exposure Prophylaxis (PrEP) is a medication used to HIV prevention in people who do not have HIV to reduce their risk of becoming infected with HIV. Current literature recommends that PrEP is taken orally every day to minimise the risk of HIV. All participants in the PrEPX trial will be given PrEP as an intervention. The intervention used in this trial is a single pill, taken daily containing two antiretroviral medicines: Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg tablets. There is evidence that if individuals take PrEP daily that they may reduce their chance of HIV infection by up to 99%.PrEP is recommended in individuals as long as they are at a high risk of HIV infection. Intervention adherence will be assessed by self report surveys and script collection intervals. The study duration is a maximum of 21 months, beginning July 2016 until April 2018.
Sponsors
The Alfred
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Age greater than or equal to 18 years old Willing and able to provide informed consent Documentation of an HIV negative test performed at enrolment Have a creatinine clearance of > 60mL per minute eGFR Will to provide an email address Have a high risk of HIV infection as per the Australian PrEP Guidelines
Exclusion criteria
HIV infection confirmed by HIV antibody and western blot testing Signs and symptoms of acute HIV infection Unwilling to provide consent for follow up An eGFR of <60 Mls per minute Ues of any investigational agents which may interact or affect PrEP medication use of any nephrotoxic agents Concomitant participation in another clinical trial using investigational agents, including placebo-controlled agents At enrolment an individual that has any other condition that, based on the opinion of the treating physician, would make participation in the project unsafe
Outcome results
None listed