ANZCTR - Registration

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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

QPrEP Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

HIV prevention

Condition category

Condition code

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Public Health

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]

Prevention

Comparator / control treatment

none

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

12 Months

Primary outcome [2]

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]

12 Months

Primary outcome [3]

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]

12 Months

Secondary outcome [1]

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]

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]

Government body

Name [1]

State of Queensland

Address [1]

Level 1 725 Ann Street Fortitude Valley Brisbane, QLD, 4006

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Hospital and Health Service HREC

Ethics committee address [1]

Level 2 E Block
1 Hospital Blvd
Southport
QLD 
4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/11/2014

Ethics approval number [1]

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

A/Prof Darren Russell

Address

Cairns Sexual Health Service,
Cairns and Hinterland Hospital and Health Service
PO Box 902
Cairns
Qld
4870

Country

Australia

Phone

+61742264769

Fax

darren.russell@health.qld.gov.au

Contact person for public queries

Name

Simon Doyle-Adams

Address

Cairns Sexual Health Service,
Cairns and Hinterland Hospital and Health Service
PO Box 902
Cairns
Qld
4870

Country

Australia

Phone

+61742264769

Fax

simon.doyle-adams@health.qld.gov.au

Contact person for scientific queries

Name

Darren Russell

Address

Cairns Sexual Health Service,
Cairns and Hinterland Hospital and Health Service
PO Box 902
Cairns
Qld
4870

Country

Australia

Phone

+61742264769

Fax

darren.russell@health.qld.gov.au

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.

Trial Review

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