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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02870790
Registration number
NCT02870790
Ethics application status
Date submitted
14/08/2016
Date registered
17/08/2016
Date last updated
17/02/2021
Titles & IDs
Public title
Expanded PrEP Implementation in Communities in NSW
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Scientific title
Impact of the Rapid Expansion of Pre-exposure Prophylaxis (PrEP) on HIV Incidence, in a Setting With High HIV Testing and Antiretroviral Treatment Coverage, to Achieve the Virtual Elimination of HIV Transmission by 2020: a NSW HIV Strategy Implementation Project
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Secondary ID [1]
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HEPP1511
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Universal Trial Number (UTN)
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Trial acronym
EPIC-NSW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV
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STI
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TDF/FTC
Experimental: treatment - A single open-label arm. All participants receive daily oral pill containing TDF/FTC
Treatment: Drugs: TDF/FTC
one pill daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of HIV infection per 100 person years among study participants
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Assessment method [1]
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Timepoint [1]
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24 months of follow-up
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Primary outcome [2]
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Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.
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Assessment method [2]
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Timepoint [2]
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24 months of follow-up
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Secondary outcome [1]
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Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
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Assessment method [1]
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Timepoint [1]
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24 months of follow-up
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Eligibility
Key inclusion criteria
- HIV negative at enrolment, with a negative HIV test result documented within seven
days of initiating PrEP
- At high and ongoing risk for acquiring HIV infection through sexual exposure (as
defined by Behavioural Eligibility criteria presented in Appendix II and online Risk
Assessment Questionnaire in Appendix III), OR previously a PrELUDE study participant
- Aged 18 years or over
- Live in NSW or ACT or visit NSW or ACT enough to attend clinics for follow-up
assessments
- Willing and able to provide informed consent
- Medicare ineligible individuals may be enrolled if the clinical service is able to
cover the costs of monitoring of the patient
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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).
- Having an estimated creatinine clearance (glomerular filtration rate [GFR]) <60ml/min
- Having or developing clinical symptoms suggestive of lactic acidosis or pronounced
hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort,
and weakness)
- Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal
anti-inflammatory drugs / NSAIDs)
- Allergic to TDF and/or FTC (based on self-report or recorded)
- Concurrently taking prescribed products containing FTC or TDF including ATRIPLA®,
COMPLERA®, EMTRIVA, STRIBILD®, VIREAD, TAF (tenofovir alafenamide), GENVOYA, DESCOVY;
other drugs containing lamivudine; HEPSERA
- Factors or conditions that may compromise a participant's access to health services
for follow-up (incarceration or planned relocation and potential absence from NSW or
ACT).
Behavioural eligibility criteria as per NSW PrEP guidelines.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2020
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Sample size
Target
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Accrual to date
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Final
9733
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Recruitment in Australia
Recruitment state(s)
ACT,NSW
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Recruitment hospital [1]
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Interchange General Practice - Canberra
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Recruitment hospital [2]
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Canberra Sexual Health Centre - Canberra
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Recruitment hospital [3]
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Albury Sexual Health Service - Albury
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Recruitment hospital [4]
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Fountain Street General Practice - Alexandria
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Recruitment hospital [5]
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Holdsworth House Byron Bay - Byron Bay
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Recruitment hospital [6]
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RPA Sexual Health - Camperdown
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Recruitment hospital [7]
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Coffs Harbour Sexual Health Clinic - Coffs harbour
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Recruitment hospital [8]
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St Vincent's Hospital HIV, Immunology and Infectious Disease Unit - Darlinghurst
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Recruitment hospital [9]
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Dubbo Sexual Health - Dubbo
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Recruitment hospital [10]
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Dr Doong's Surgery - Enfield
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Recruitment hospital [11]
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Holden Street Gosford - Gosford
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Recruitment hospital [12]
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Illawarra Shoalhaven Sexual Health - Illawarra
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Recruitment hospital [13]
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Short Street Clinic - Kogarah
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Recruitment hospital [14]
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Lismore Sexual Health Clinic - Northen Rivers Area Health Service - Lismore
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Recruitment hospital [15]
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Liverpool Sexual Health Clinic - Liverpool
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Recruitment hospital [16]
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Hunter New England Sexual Health Services - Newcastle
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Recruitment hospital [17]
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St Leonards Medical Centre - North Sydney
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Recruitment hospital [18]
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Orange Sexual Health - Orange
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Recruitment hospital [19]
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Western Sydney Sexual Health Centre - Parramatta
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Recruitment hospital [20]
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Macleay Street Medical Practice - Potts Point
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Recruitment hospital [21]
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Crown Street Medical Centre - Surry Hills
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Recruitment hospital [22]
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The Albion Centre - Surry Hills
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Recruitment hospital [23]
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Kirketon Road Centre - Sydney
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Recruitment hospital [24]
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Sydney Sexual Health Centre - Sydney
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Recruitment hospital [25]
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East Sydney Doctors - Sydney
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Recruitment hospital [26]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [27]
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Taylor Square Private Clinic - Sydney
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Recruitment hospital [28]
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Clinic 16, Royal North Shore Hospital - Sydney
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Recruitment hospital [29]
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Nepean Sexual Health and HIV Clinic - Sydney
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Recruitment hospital [30]
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Brookong Centre Sexual Health Centre - Wagga Wagga
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Recruitment hospital [31]
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Green Square Health - Waterloo
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Recruitment postcode(s) [1]
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2601 - Canberra
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Recruitment postcode(s) [2]
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2605 - Canberra
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Recruitment postcode(s) [3]
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2640 - Albury
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Recruitment postcode(s) [4]
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2015 - Alexandria
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Recruitment postcode(s) [5]
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2481 - Byron Bay
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Recruitment postcode(s) [6]
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2050 - Camperdown
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Recruitment postcode(s) [7]
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2450 - Coffs harbour
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Recruitment postcode(s) [8]
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2010 - Darlinghurst
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Recruitment postcode(s) [9]
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2830 - Dubbo
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Recruitment postcode(s) [10]
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2136 - Enfield
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Recruitment postcode(s) [11]
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2250 - Gosford
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Recruitment postcode(s) [12]
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2502 - Illawarra
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Recruitment postcode(s) [13]
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2217 - Kogarah
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Recruitment postcode(s) [14]
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2480 - Lismore
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Recruitment postcode(s) [15]
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2217 - Liverpool
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Recruitment postcode(s) [16]
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2300 - Newcastle
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Recruitment postcode(s) [17]
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2065 - North Sydney
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Recruitment postcode(s) [18]
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2800 - Orange
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Recruitment postcode(s) [19]
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2150 - Parramatta
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Recruitment postcode(s) [20]
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2011 - Potts Point
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Recruitment postcode(s) [21]
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2010 - Surry Hills
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Recruitment postcode(s) [22]
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1340 - Sydney
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Recruitment postcode(s) [23]
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2000 - Sydney
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Recruitment postcode(s) [24]
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2010 - Sydney
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Recruitment postcode(s) [25]
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2065 - Sydney
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Recruitment postcode(s) [26]
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2747 - Sydney
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Recruitment postcode(s) [27]
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2650 - Wagga Wagga
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Recruitment postcode(s) [28]
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- Waterloo
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual
elimination of HIV transmission in NSW by 2020. Critical to the new strategy's success is the
population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of
co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). This large-scale
study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will
comprise mostly gay and bisexual men (GBM) but will also include small numbers of
heterosexuals, injecting drug users, and transgender men and women. The drug will be used
according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new
intervention over a 12 month period, and following participants for two years on treatments,
a reduction of about 50% in new HIV diagnoses in NSW is expected.
The study aims to assess the incidence of HIV among PrEP study participants and measure the
population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over
a two-year period.
It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the
incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP
and measure the effect of the rapid roll-out of PrEP on the overall number of notifications
of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of PrEP use and
medication adherence, and monitor behavioural risk practices among PrEP users.
The main population group will be more than 3700 gay men at high risk of HIV infection. All
procedures of this study are guided by the NSW Guidelines on PrEP.
Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Project Manager: Barbara
Yeung
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02870790
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Cooper, MD, PhD
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Address
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The Kirby Institute, UNSW Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02870790
Download to PDF