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Trial registered on ANZCTR


Registration number
ACTRN12617000196347
Ethics application status
Approved
Date submitted
11/11/2016
Date registered
6/02/2017
Date last updated
14/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Victorian Pre-Exposure Prophylaxis Demonstration Project- VicPrEP
HIV prevention trial for people at risk of HIV
Scientific title
The Victorian HIV Pre-Exposure Prophylaxis Demonstration Project- To determine in HIV negative individuals at risk of HIV infection whether the uptake of PrEP is associated with decreased HIV risk behaviour and a decreased likelihood of future HIV and STI infections.
Secondary ID [1] 290527 0
None
Universal Trial Number (UTN)
U1111-1189-7522
Trial acronym
VicPrEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV prophylaxis 300947 0
Pre exposure prophylaxis (PrEP) 300948 0
Condition category
Condition code
Infection 300744 300744 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 300745 300745 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multi-site, prospective, open-label PrEP demonstration project that aims to assess the uptake, acceptability, safety, and feasibility of a single tablet of emtricitabine 200mg and tenofovir disoproxil fumarate 300mg as PrEP, administered orally, once daily to enrolled participants who engage in high risk sexual practices over a period of 30 months. Refill based assessment and dried blood spot testing will be utilised to monitor adherence.
Intervention code [1] 296377 0
Prevention
Intervention code [2] 296386 0
Treatment: Drugs
Comparator / control treatment
Comparator group with no treatment
Control group
Active

Outcomes
Primary outcome [1] 300161 0
To determine the relationship between the use of PrEP and change in HIV risk behaviour (assessed using a questionnaire designed for this study).
Timepoint [1] 300161 0
12, 24, and 30 months on PrEP,
Primary outcome [2] 300873 0
To determine the relationship between the use of PrEP and the frequency of HIV/STI infections (assessed by serum immunoassays and nucleic acid amplification for HIV/STI's)
Timepoint [2] 300873 0
12, 24 and 30 months on PrEP and 12 months after cessation of PrEP
Primary outcome [3] 300874 0
To determine adherence to PrEP in HIV negative individuals at risk of HIV infection who choose to use PrEP medication, using dried blood spot testing
Timepoint [3] 300874 0
12, 24 and 30 months on PrEP
Secondary outcome [1] 329216 0
To determine from the healthcare providers involved in the Victorian PrEP Demonstration Project the feasibility of providing a PrEP service in Victoria. Staff at study sites will complete questionnaires (designed for this study and not validated) and interviewed.
Timepoint [1] 329216 0
After all participants have completed their final study visit
Secondary outcome [2] 331246 0
To determine in HIV negative individuals at risk of HIV infection who are not using PrEP and are enrolled in VPCNSS (Non-PrEP comparator group) the incidence of HIV/STI infection (by review of medical records)
Timepoint [2] 331246 0
12, 18, 30 and 42 months after study commencement

Eligibility
Key inclusion criteria
HIV negative people at risk of HIV infection, including MSM and HIV serodiscordant couples.
1. Age 18 years and older
2. Willing and able to provide written informed consent
3. Documentation of an HIV negative test performed at both screening visit and enrolment
4. Have a creatinine clearance of > 60mL per minute (via Cockroft-Gault formula)
5. Evidence of risk for acquiring HIV-1 infection including any one of the following:
a. Unprotected receptive or insertive intercourse (anal and/or vaginal) with an HIV seropositive partner and/or
b. RUAI with casual partners whose HIV status is unknown (MSM and transgender)
c. Uncircumcised male and IUAI with casual partners whose HIV status is unknown (MSM only)
d. HIV serodiscordant couples wishing to conceive without the use of assisted reproduction
6. Able to provide street address and/or telephone number and/or email address to be contacted during the period of the demonstration project
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. HIV as confirmed by HIV antibody and western blot testing
2. Signs of symptoms of acute HIV infection
3. Signs of intercurrent sexually transmitted infection
4. Unable to attend scheduled follow-up assessments
5. Unwilling to provide consent to follow-up
6. A creatinine clearance of < 60 mL per minute (via Cockroft-Gault formula)
7. Active, clinically significant medical problems including active tuberculosis, poorly controlled cardiac disease, previous or currently diagnosed malignancy requiring further treatment
8. Hepatitis B surface antigen (HBsAg) positive
9. Current use of any of the following: ART, including nucleoside analogs, non nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta or gamma) or interleukin (e.g. IL-2) therapy, any investigational agents which may interact or affect PrEP medication and any nephrotoxic agents
10. Severe inter-current illness
11. Concomitant participation in another clinical trial using investigational agents, including placebo-controlled agents, with the exception of The Pre Exposure Prophylaxis Expanded Study- The PrEPX Study [Alfred Ethics Approved Project 100/16]. Participants may be allowed to transfer from The VicPrEP Study to The PrEPX Study.
12. At enrolment, has any other condition that, based on the opinion of the treating physician, would make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a demonstration project with a comparator arm who do not receive treatment
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed in accordance with the protocol using SPSS software, and statistical significance will be defined as a p-value <0.05. All statistical tests will be two-tailed. Continuous variables will be expressed as median and interquartile range and categorical variables as proportions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/06/2014
Date of last participant enrolment
Anticipated
Actual
28/08/2015
Date of last data collection
Anticipated
30/06/2017
Actual
30/06/2017
Sample size
Target
100
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6921 0
The Alfred - Prahran
Recruitment postcode(s) [1] 14594 0
3004 - Prahran
Recruitment postcode(s) [2] 14595 0
3181 - Prahran
Recruitment postcode(s) [3] 14596 0
3182 - St Kilda
Recruitment postcode(s) [4] 14597 0
3053 - Carlton
Recruitment postcode(s) [5] 14598 0
3068 - Fitzroy North

Funding & Sponsors
Funding source category [1] 294944 0
Government body
Name [1] 294944 0
Victorian Department of Health
Country [1] 294944 0
Australia
Funding source category [2] 294945 0
Other Collaborative groups
Name [2] 294945 0
Victorian AIDS Council
Country [2] 294945 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Commercial Road
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 293774 0
Government body
Name [1] 293774 0
Victorian Department of Health
Address [1] 293774 0
50 Lonsdale Street
Melbourne 3000
Victoria
Country [1] 293774 0
Australia
Secondary sponsor category [2] 293775 0
Government body
Name [2] 293775 0
Victorian AIDS Council
Address [2] 293775 0
6 Claremont Street
South Yarra, VIC 3141
Victoria
Country [2] 293775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296313 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 296313 0
Ethics committee country [1] 296313 0
Australia
Date submitted for ethics approval [1] 296313 0
19/12/2013
Approval date [1] 296313 0
26/02/2014
Ethics approval number [1] 296313 0
564/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70414 0
A/Prof Edwina J Wright
Address 70414 0
Alfred Hospital
Infectious Diseases
Commercial Road
Melbourne
VIC 3004
Country 70414 0
Australia
Phone 70414 0
+61 3 9076 6078
Fax 70414 0
+61 3 9076 2431
Email 70414 0
[email protected]
Contact person for public queries
Name 70415 0
Brian Price
Address 70415 0
Alfred Hospital
Infectious Diseases
Commercial Road
Melbourne
VIC 3004
Country 70415 0
Australia
Phone 70415 0
+61 3 9076 3981
Fax 70415 0
+61 3 9076 2431
Email 70415 0
[email protected]
Contact person for scientific queries
Name 70416 0
Edwina Wright
Address 70416 0
Alfred Hospital
Infectious Diseases
Commercial Road
Melbourne
VIC 3004
Country 70416 0
Australia
Phone 70416 0
+61 3 9076 6078
Fax 70416 0
Email 70416 0
[email protected]

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

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