Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000032550
Ethics application status
Approved
Date submitted
12/12/2014
Date registered
19/01/2015
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Date results information initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis with antiretroviral medications amongst men at high risk for HIV infection; a demonstration project
Scientific title
Implementation of HIV pre-exposure prophylaxis with antiretroviral medications amongst men at high risk for HIV infection; a demonstration project to evaluate feasibility, acceptability and adherence
Secondary ID [1] 285841 0
Nil known
Universal Trial Number (UTN)
Trial acronym
QPrEP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV prevention 293758 0
Condition category
Condition code
Infection 294057 294057 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 294104 294104 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention model: single group assignment
Masking: Open label
Primary Purpose: prevention
Drug: emtricitabine/tenofovir disoproxil fumarate
a) Name of intervention: emtricitabine (200mg)/tenofovir disoproxil fumarate(300mg) (Truvada)
b) Dose administered: One tablet once a day
c) Duration of administration: Up to 12 months
d) Mode of administration - oral tablet

Strategies to monitor adherence: follow up at 1,3,6,9 and 12 months including tablet count and client surveys at 1,6 and 12 months
Intervention code [1] 290820 0
Prevention
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293836 0
Feasibility of PrEP provision through sexual health clinics and general practice services in Queensland
This will be assessed by the Implementation processes and feedback from all sites
Timepoint [1] 293836 0
12 Months
Primary outcome [2] 293837 0
Acceptability of this model of PrEP provision
This will be assessed by the proportion of clients eligible to participate but decline to do so. Participant self discontinuation of PrEP, product experience and likelihood of future PrEP use post study
Timepoint [2] 293837 0
12 Months
Primary outcome [3] 293838 0
Adherence to PrEP
This will be assessed by percentage and patterns of prescribed doses taken estimated from self report. Percentage of prescribed doses taken estimated by tablet count.
Timepoint [3] 293838 0
12 Months
Secondary outcome [1] 311964 0
safety and side effects. Possible side effects include renal impairment this will be monitored at 3 and 9 months by checking creatinine clearance. Surveys will be conducted at 3, 6 , 9 and 12 months.
Timepoint [1] 311964 0
12 months

Eligibility
Key inclusion criteria
Men who have sex with men at risk of acquiring HIV due to high risk sexual practices. Willing and able to provide written informed consent. HIV negative at enrolment, medicare eligible, willing and able to partake in study procedures, fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
HIV infected or signs or symptoms of acute HIV infection, creatinine clearance <60ml/min, active clinically significant medical problems including active TB, poorly controlled cardiac disease, previous or currently diagnosed malignancy requiring further treatment. Hepatitis B surface antigen positive, current use of ART, including nucleoside analogues, non-neucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon or interleukein therapy any investigational agents that may interact or affect PrEP medication and any nephrotoxic agents. Mental health issues, memory loss or other cognitive impairment or intellectual disability that may compromise participant safety and/or regimen adherence. Factors/conditions that may compromise a participant's retention in the study. Unwilling to adhere to any of the required study procedures

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/02/2015
Actual
2/02/2015
Date of last participant enrolment
Anticipated
Actual
30/03/2018
Date of last data collection
Anticipated
7/12/2018
Actual
Sample size
Target
3000
Accrual to date
Final
2400
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290414 0
Government body
Name [1] 290414 0
State of Queensland
Country [1] 290414 0
Australia
Primary sponsor type
Hospital
Name
Cairns and Hinterland Hospital and Health Service
Address
PO box 902
Cairns
Qld
4870
Country
Australia
Secondary sponsor category [1] 289130 0
None
Name [1] 289130 0
Address [1] 289130 0
Country [1] 289130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292104 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 292104 0
Level 2 E Block
1 Hospital Blvd
Southport
QLD
4215
Ethics committee country [1] 292104 0
Australia
Date submitted for ethics approval [1] 292104 0
Approval date [1] 292104 0
27/11/2014
Ethics approval number [1] 292104 0
HREC/14/QGC/182

Summary
Brief summary
Medications, drugs and devices have to be approved for use by the Australian Federal Government. Truvada (tenofovir and emtricitabine) is approved in Australia for HIV management in people who are HIV-positive. Truvada has been recently approved by the FDA in the United States for PrEP in people who are HIV-negative, however it has not yet been approved in Australia for use as PrEP.
New HIV prevention strategies are necessary in Australia because HIV infection rates continue to rise. HIV pre-exposure prophylaxis (PrEP), when given as a daily pill and coupled with the consistent use of condoms and regular checks for sexually transmitted infections including HIV, is effective in preventing HIV infection. Several overseas studies have shown that daily tenofovir, or daily Truvada (tenofovir and emtricitabine) reduces HIV transmission by about 44% in men who have sex with men (MSM) and by about 70% in heterosexual people at risk of becoming HIV positive. There has been further evidence to show that in MSM who take their Truvada PrEP medication in the prescribed manner, that is one pill every day, that their risk of HIV infection is reduced by 96%. So taking PrEP every day according to the instructions along with using other HIV prevention measures like condoms and regular HIV and sexually transmitted infection (STI) screening is the best way to reduce your chances of becoming infected with HIV.
It is now important to examine the results of these PrEP clinical trials in the “real world” setting to show that PrEP is a feasible, safe and effective method for reducing the risk of HIV acquisition in the Queensland community. The QPrEP demonstration project will address this need.
Trial website
Trial related presentations / publications
Public notes
The decision to cease the trial early is based on the view that the primary research objective (that the provision of PrEP though public sexual health services and general practices is an appropriate model within Queensland), has already been demonstrated, and in recognition that PrEP is now listed on the PBS and widely available through routine care from any medical practitioner and some nurse practitioners.

Contacts
Principal investigator
Name 53506 0
A/Prof Darren Russell
Address 53506 0
Cairns Sexual Health Service,
Cairns and Hinterland Hospital and Health Service
PO Box 902
Cairns
Qld
4870
Country 53506 0
Australia
Phone 53506 0
+61742264769
Fax 53506 0
Email 53506 0
[email protected]
Contact person for public queries
Name 53507 0
Mr Simon Doyle-Adams
Address 53507 0
Cairns Sexual Health Service,
Cairns and Hinterland Hospital and Health Service
PO Box 902
Cairns
Qld
4870
Country 53507 0
Australia
Phone 53507 0
+61742264769
Fax 53507 0
Email 53507 0
[email protected]
Contact person for scientific queries
Name 53508 0
A/Prof Darren Russell
Address 53508 0
Cairns Sexual Health Service,
Cairns and Hinterland Hospital and Health Service
PO Box 902
Cairns
Qld
4870
Country 53508 0
Australia
Phone 53508 0
+61742264769
Fax 53508 0
Email 53508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.