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Trial registered on ANZCTR


Registration number
ACTRN12616001215415
Ethics application status
Approved
Date submitted
12/08/2016
Date registered
2/09/2016
Date last updated
2/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of pre-exposure prophylaxis for Human Immunodeficiency Virus (HIV) in high-risk individuals in Victoria, Australia
Scientific title
The evaluation of pre-exposure prophylaxis expanded across 2600 individuals at risk of HIV infection in Victoria, Australia.
Secondary ID [1] 289922 0
The PrEPX study
Universal Trial Number (UTN)
U1111-1186-3722
Trial acronym
PrEPX
Linked study record
None - This study is in fact NOT an expansion of VicPrEP but an independent, stand-alone trial.

Health condition
Health condition(s) or problem(s) studied:
HIV 299892 0
Anxiety 299893 0
Condition category
Condition code
Infection 299796 299796 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Mental Health 299797 299797 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295606 0
Prevention
Comparator / control treatment
We will compare to historical data collected from the Victorian HIV surveillance dataset that is overseen by the Burnet Institute.
We will compare to the time period July 2013 and June 2016
Control group
Historical

Outcomes
Primary outcome [1] 299264 0
The primary outcome of the study is the number of new HIV infections in Victoria during the 36 months from the time that the PrEPX study opens, as reported by the Victorian HIV Surveillance registry.

Study participants who are attending clinics that participate in the ACCESS surveillance system will have their results collected by ACCESS, using the software GRHANITE. GRHANITE is able to access the clinics' patient management systems to retrieve study participants' HIV and STI test results.
Study participants who are not attending clinics that participate in the ACCESS surveillance system will have their test result data collected manually.
Timepoint [1] 299264 0
We will monitor new HIV infections in Victoria from July 2016 until July 2019.
This outcome is not for study participants only: the outcome reflects new infections across all populations in Victoria.
Secondary outcome [1] 326685 0
Concern about HIV infection will be measured in a subset of 200 individuals who complete six monthly online surveys. Individuals will rate their concern on a Likert scale from 1-5. Individuals will also be asked about anxiety in qualitative face-to-face interviews at baseline and at the end of the study.
Timepoint [1] 326685 0
Face to face interview will take place at baseline and month 21.

Online surveys will be completed 6 monthly for 21 months post enrolment.
Secondary outcome [2] 326686 0
Change in condom usage during the intervention period measured by ACCESS study self reported surveys completed at each 3 monthly visit and in online PrEPX study specific 6 monthly surveys in a subset of 260 people.
Timepoint [2] 326686 0
Every 3 months for 21 months for ACCESS survey and 6 monthly surveys for month 21 for PrEPX study specific online surveys in a subset of 260 people.
Secondary outcome [3] 326687 0
Change during the intervention period for concurrent sexually transmitted infections evaluated by urine and rectal swabs tested for chlamydia and Neisseria gonorrhoea PCR, throat swab Neisseria gonorrhoea PCR and chlamydia and blood tests for syphilis serology
Timepoint [3] 326687 0
STI tests are done a minimum of every 3 months for 21 months post enrolment.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size estimate for the PrEPX study was undertaken as follows. There are an estimated 300 new HIV infections per year in Victoria; this is based on back-calculation methods which have used available surveillance data and a modelling framework to estimate these levels for recent years and demonstrated that in the Australian context, with high and fairly stable testing rates, numbers and trends in HIV notifications are a strong surrogate marker for the actual number of and trend in new infections. Approximately 75% of all new HIV diagnoses in Victoria occur in MSM, which is 300 new HIV infections x 75% = 225 new infections occur in MSM annually in Victoria.

We determined that a thirty percent reduction in new HIV infections in MSM, which would represent an overall 23% (=75%x30%) decline across Victoria, would be a meaningful outcome at a population level, of scaling up PrEP through the PrEPX study.

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.

We did not perform power calculations

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/07/2016
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
2600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6480 0
The Alfred - Prahran
Recruitment postcode(s) [1] 14036 0
3004 - Prahran
Recruitment postcode(s) [2] 14038 0
3182 - St Kilda
Recruitment postcode(s) [3] 14039 0
3000 - Melbourne
Recruitment postcode(s) [4] 14040 0
3053 - Carlton
Recruitment postcode(s) [5] 14041 0
3066 - Collingwood
Recruitment postcode(s) [6] 14042 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 294288 0
Government body
Name [1] 294288 0
Victoria State Government, health and Human Services
Country [1] 294288 0
Australia
Funding source category [2] 294289 0
Hospital
Name [2] 294289 0
The Alfred
Country [2] 294289 0
Australia
Funding source category [3] 294290 0
Charities/Societies/Foundations
Name [3] 294290 0
Victorian AIDS Council
Country [3] 294290 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 293139 0
None
Name [1] 293139 0
Address [1] 293139 0
Country [1] 293139 0
Other collaborator category [1] 279159 0
Charities/Societies/Foundations
Name [1] 279159 0
Burnet Institute
Address [1] 279159 0
85 Commercial Rd, Melbourne VIC 3004
Country [1] 279159 0
Australia
Other collaborator category [2] 279160 0
University
Name [2] 279160 0
Centre for Social Research in Health, University of New South Wales
Address [2] 279160 0
University of New South Wales, Australia
Sydney NSW 2052
Country [2] 279160 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295726 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 295726 0
Ethics committee country [1] 295726 0
Australia
Date submitted for ethics approval [1] 295726 0
28/04/2016
Approval date [1] 295726 0
02/05/2016
Ethics approval number [1] 295726 0
HREC/16/Alfred/16 (Local Reference: Project 100/16)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1019 1019 0 0
/AnzctrAttachments/371290-PrEPX Protocol V2.0 April 19.pdf (Protocol)
Attachments [2] 1020 1020 0 0
/AnzctrAttachments/371290-100-16 Certificate of Approval_Jul16.pdf (Ethics approval)
Attachments [3] 1021 1021 0 0
/AnzctrAttachments/371290-PrEPX FAQ version 1 FINAL July 25 2016.pdf (Supplementary information)
Attachments [4] 1022 1022 0 0
/AnzctrAttachments/371290-100-16 PICF V 4.0 (with withdrawal form) Master Copy.pdf (Participant information/consent)

Contacts
Principal investigator
Name 68218 0
A/Prof Edwina Wright
Address 68218 0
Alfred Health, Monash University
Department of Infectious Diseases
85 Commercial Rd, Melbourne VIC 3004
Country 68218 0
Australia
Phone 68218 0
+61 3 9076 6078
Fax 68218 0
+61 3 9076 2431
Email 68218 0
Edwina.wright@monash.edu
Contact person for public queries
Name 68219 0
Timmy Lockwood
Address 68219 0
Alfred Health
Department of Infectious Diseases
85 Commercial Rd, Melbourne VIC 3004
Country 68219 0
Australia
Phone 68219 0
+61 429 473 138
Fax 68219 0
+61 3 9076 2431
Email 68219 0
J.Lockwood2@alfred.org.au
Contact person for scientific queries
Name 68220 0
Timmy Lockwood
Address 68220 0
Alfred Health
Department of Infectious Diseases
85 Commercial Rd, Melbourne VIC 3004
Country 68220 0
Australia
Phone 68220 0
+61 429 473 138
Fax 68220 0
+61 3 9076 2431
Email 68220 0
J.Lockwood2@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTransformation of Australian community pharmacies into good clinical practice compliant trial pharmacies for HIV pre-exposure prophylaxis.2019https://dx.doi.org/10.3389/fphar.2019.01269
N.B. These documents automatically identified may not have been verified by the study sponsor.