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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
HEPP1511
Universal Trial Number (UTN)
Trial acronym
EPIC-NSW
Linked study record

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

Intervention/exposure
Study type
Interventional
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
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 months of follow-up
Primary outcome [2] 0 0
Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.
Timepoint [2] 0 0
24 months of follow-up
Secondary outcome [1] 0 0
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
Timepoint [1] 0 0
24 months of follow-up

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
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
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2020
Sample size
Target
Accrual to date
Final
9733
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
Interchange General Practice - Canberra
Recruitment hospital [2] 0 0
Canberra Sexual Health Centre - Canberra
Recruitment hospital [3] 0 0
Albury Sexual Health Service - Albury
Recruitment hospital [4] 0 0
Fountain Street General Practice - Alexandria
Recruitment hospital [5] 0 0
Holdsworth House Byron Bay - Byron Bay
Recruitment hospital [6] 0 0
RPA Sexual Health - Camperdown
Recruitment hospital [7] 0 0
Coffs Harbour Sexual Health Clinic - Coffs harbour
Recruitment hospital [8] 0 0
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit - Darlinghurst
Recruitment hospital [9] 0 0
Dubbo Sexual Health - Dubbo
Recruitment hospital [10] 0 0
Dr Doong's Surgery - Enfield
Recruitment hospital [11] 0 0
Holden Street Gosford - Gosford
Recruitment hospital [12] 0 0
Illawarra Shoalhaven Sexual Health - Illawarra
Recruitment hospital [13] 0 0
Short Street Clinic - Kogarah
Recruitment hospital [14] 0 0
Lismore Sexual Health Clinic - Northen Rivers Area Health Service - Lismore
Recruitment hospital [15] 0 0
Liverpool Sexual Health Clinic - Liverpool
Recruitment hospital [16] 0 0
Hunter New England Sexual Health Services - Newcastle
Recruitment hospital [17] 0 0
St Leonards Medical Centre - North Sydney
Recruitment hospital [18] 0 0
Orange Sexual Health - Orange
Recruitment hospital [19] 0 0
Western Sydney Sexual Health Centre - Parramatta
Recruitment hospital [20] 0 0
Macleay Street Medical Practice - Potts Point
Recruitment hospital [21] 0 0
Crown Street Medical Centre - Surry Hills
Recruitment hospital [22] 0 0
The Albion Centre - Surry Hills
Recruitment hospital [23] 0 0
Kirketon Road Centre - Sydney
Recruitment hospital [24] 0 0
Sydney Sexual Health Centre - Sydney
Recruitment hospital [25] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [26] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [27] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [28] 0 0
Clinic 16, Royal North Shore Hospital - Sydney
Recruitment hospital [29] 0 0
Nepean Sexual Health and HIV Clinic - Sydney
Recruitment hospital [30] 0 0
Brookong Centre Sexual Health Centre - Wagga Wagga
Recruitment hospital [31] 0 0
Green Square Health - Waterloo
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2605 - Canberra
Recruitment postcode(s) [3] 0 0
2640 - Albury
Recruitment postcode(s) [4] 0 0
2015 - Alexandria
Recruitment postcode(s) [5] 0 0
2481 - Byron Bay
Recruitment postcode(s) [6] 0 0
2050 - Camperdown
Recruitment postcode(s) [7] 0 0
2450 - Coffs harbour
Recruitment postcode(s) [8] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [9] 0 0
2830 - Dubbo
Recruitment postcode(s) [10] 0 0
2136 - Enfield
Recruitment postcode(s) [11] 0 0
2250 - Gosford
Recruitment postcode(s) [12] 0 0
2502 - Illawarra
Recruitment postcode(s) [13] 0 0
2217 - Kogarah
Recruitment postcode(s) [14] 0 0
2480 - Lismore
Recruitment postcode(s) [15] 0 0
2217 - Liverpool
Recruitment postcode(s) [16] 0 0
2300 - Newcastle
Recruitment postcode(s) [17] 0 0
2065 - North Sydney
Recruitment postcode(s) [18] 0 0
2800 - Orange
Recruitment postcode(s) [19] 0 0
2150 - Parramatta
Recruitment postcode(s) [20] 0 0
2011 - Potts Point
Recruitment postcode(s) [21] 0 0
2010 - Surry Hills
Recruitment postcode(s) [22] 0 0
1340 - Sydney
Recruitment postcode(s) [23] 0 0
2000 - Sydney
Recruitment postcode(s) [24] 0 0
2010 - Sydney
Recruitment postcode(s) [25] 0 0
2065 - Sydney
Recruitment postcode(s) [26] 0 0
2747 - Sydney
Recruitment postcode(s) [27] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [28] 0 0
- Waterloo

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02870790
Trial related presentations / publications
Amin J, Vaccher S, Templeton DJ, Bavinton B, Jin F, Zablotska I, Matthews G, Ogilvie E, Yeung B, Ooi C, Dharan N, Baker DA, Read P, Guy R, Grulich AE. Low Prior Exposure and Incidence of Hepatitis C in Human Immunodeficiency Virus-Negative Gay and Bisexual Men Taking Preexposure Prophylaxis (PrEP): Findings From the Expanded PrEP Implementation in Communities-New South Wales Prospective Implementation Study. Clin Infect Dis. 2022 Oct 29;75(9):1497-1502. doi: 10.1093/cid/ciac231.
Grulich AE, Jin F, Bavinton BR, Yeung B, Hammoud MA, Amin J, Cabrera G, Clackett S, Ogilvie E, Vaccher S, Vickers T, McNulty A, Smith DJ, Dharan NJ, Selvey C, Power C, Price K, Zablotska I, Baker DA, Bloch M, Brown K, Carmody CJ, Carr A, Chanisheff D, Doong N, Finlayson R, Lewis DA, Lusk J, Martin S, Ooi C, Read P, Ryder N, Smith D, Tuck Meng Soo C, Templeton DJ, Vlahakis E, Guy R; Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group. Long-term protection from HIV infection with oral HIV pre-exposure prophylaxis in gay and bisexual men: findings from the expanded and extended EPIC-NSW prospective implementation study. Lancet HIV. 2021 Aug;8(8):e486-e494. doi: 10.1016/S2352-3018(21)00074-6. Epub 2021 Jul 1.
Grulich AE, Guy R, Amin J, Jin F, Selvey C, Holden J, Schmidt HA, Zablotska I, Price K, Whittaker B, Chant K, Cooper C, McGill S, Telfer B, Yeung B, Levitt G, Ogilvie EE, Dharan NJ, Hammoud MA, Vaccher S, Watchirs-Smith L, McNulty A, Smith DJ, Allen DM, Baker D, Bloch M, Bopage RI, Brown K, Carr A, Carmody CJ, Collins KL, Finlayson R, Foster R, Jackson EY, Lewis DA, Lusk J, O'Connor CC, Ryder N, Vlahakis E, Read P, Cooper DA; Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group. Population-level effectiveness of rapid, targeted, high-coverage roll-out of HIV pre-exposure prophylaxis in men who have sex with men: the EPIC-NSW prospective cohort study. Lancet HIV. 2018 Nov;5(11):e629-e637. doi: 10.1016/S2352-3018(18)30215-7. Epub 2018 Oct 17.
Zablotska IB, Selvey C, Guy R, Price K, Holden J, Schmidt HM, McNulty A, Smith D, Jin F, Amin J, Cooper DA, Grulich AE; EPIC-NSW study group. Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial. BMC Public Health. 2018 Feb 2;18(1):210. doi: 10.1186/s12889-017-5018-9. Erratum In: BMC Public Health. 2018 Feb 28;18(1):297. doi: 10.1186/s12889-018-5173-7.
Public notes

Contacts
Principal investigator
Name 0 0
David Cooper, MD, PhD
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02870790