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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03327155




Registration number
NCT03327155
Ethics application status
Date submitted
8/09/2017
Date registered
31/10/2017
Date last updated
4/09/2020

Titles & IDs
Public title
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
Scientific title
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
Secondary ID [1] 0 0
HEPP1701
Universal Trial Number (UTN)
Trial acronym
PrEPIT-WA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Prevention 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)

Experimental: TDF/FTC (300mg/200mg) once daily - Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) (300mg/200mg) on tablet once daily with food.


Treatment: Drugs: Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)
One tablet, containing 300mg of TDF and 200mg of FTC once daily with food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of HIV infection per 100 person years among study participants
Timepoint [1] 0 0
24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
Primary outcome [2] 0 0
Number of HIV diagnoses among gay and bisexual men notified to Western Australian Department of Health
Timepoint [2] 0 0
number of HIV diagnoses in the 12 month period prior to the date of first recruitment will be compared to the annual number of HIV diagnoses in the 12 month period after the study is fully recruited
Secondary outcome [1] 0 0
Trends in test positivity of Sexually Transmitted Infections (STIs, gonorrhoea, chlamydia and infectious syphilis) among study participants
Timepoint [1] 0 0
24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
Secondary outcome [2] 0 0
Number of enrollment to the study by clinic type
Timepoint [2] 0 0
up to 6 months

Eligibility
Key inclusion criteria
1. HIV negative at enrolment, with a negative HIV test result conducted at the enrolment clinic within seven days of initiating PrEP
2. At high and ongoing risk for acquiring HIV infection [as defined by Behavioural Eligibility criteria in the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) HIV PrEP Clinical Guidelines]
3. Aged 18 years or over
4. Live in WA or visit WA enough to attend clinics for follow-up assessments
5. Willing and able to provide informed consent
6. Medicare ineligible individuals may be enrolled if the clinical service is able to cover the costs of monitoring of the patient
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. HIV-1 infected or has symptoms consistent with acute viral infection (If HIV positive status is not confirmed by testing, delay starting PrEP for at least one month and reconfirm negative HIV-1 status)
2. Having an estimated creatinine clearance (glomerular filtration rate [eGFR]) <60ml/min
3. Having or developing clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness)
4. Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs)
5. Allergic to TDF and/or FTC (based on self-report or recorded)
6. Concurrently taking prescribed products containing FTC or TDF including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD, TAF (tenofovir alafenamide), GENVOYA, DESCOVY; other drugs containing lamivudine; HEPSERA
7. Factors or conditions that may compromise a participant's access to health services for follow-up (incarceration or planned relocation and potential absence from Western Australia)

Study design
Purpose of the study
Prevention
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2020
Sample size
Target
Accrual to date
Final
900
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
South Terrace Sexual Health Clinic - Fremantle
Recruitment hospital [2] 0 0
GP on Beaufort - Mount Lawley
Recruitment hospital [3] 0 0
Royal Perth Hospital Sexual Health Clinic - Perth
Recruitment hospital [4] 0 0
M Clinic - Perth
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
6050 - Mount Lawley
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
6005 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Government of Western Australia, Department of Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Western Australia AIDS Council
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
David Cooper, MD
Address 0 0
The Kirby Institute, UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03327155