Expanded PrEP Implementation in Communities in NSW (EPIC-NSW)
15 februari 2021 uppdaterad av: Kirby Institute
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
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
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
9733
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Australian Capital Territory
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Canberra, Australian Capital Territory, Australien, 2601
- Interchange General Practice
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Canberra, Australian Capital Territory, Australien, 2605
- Canberra Sexual Health Centre
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New South Wales
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Albury, New South Wales, Australien, 2640
- Albury Sexual Health Service
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Alexandria, New South Wales, Australien, 2015
- Fountain Street General Practice
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Byron Bay, New South Wales, Australien, 2481
- Holdsworth House Byron Bay
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Camperdown, New South Wales, Australien, 2050
- RPA Sexual Health
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Coffs harbour, New South Wales, Australien, 2450
- Coffs Harbour Sexual Health Clinic
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Darlinghurst, New South Wales, Australien, 2010
- St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
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Dubbo, New South Wales, Australien, 2830
- Dubbo Sexual Health
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Enfield, New South Wales, Australien, 2136
- Dr Doong's Surgery
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Gosford, New South Wales, Australien, 2250
- Holden Street Gosford
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Illawarra, New South Wales, Australien, 2502
- Illawarra Shoalhaven Sexual Health
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Kogarah, New South Wales, Australien, 2217
- Short Street Clinic
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Lismore, New South Wales, Australien, 2480
- Lismore Sexual Health Clinic - Northen Rivers Area Health Service
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Liverpool, New South Wales, Australien, 2217
- Liverpool Sexual Health Clinic
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Newcastle, New South Wales, Australien, 2300
- Hunter New England Sexual Health Services
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North Sydney, New South Wales, Australien, 2065
- St Leonards Medical Centre
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Orange, New South Wales, Australien, 2800
- Orange Sexual Health
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Parramatta, New South Wales, Australien, 2150
- Western Sydney Sexual Health Centre
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Potts Point, New South Wales, Australien, 2011
- Macleay Street Medical Practice
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Surry Hills, New South Wales, Australien, 2010
- Crown Street Medical Centre
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Surry Hills, New South Wales, Australien, 2010
- The Albion Centre
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Sydney, New South Wales, Australien, 2010
- Holdsworth House Medical Practice
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Sydney, New South Wales, Australien, 2010
- Taylor Square Private Clinic
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Sydney, New South Wales, Australien, 1340
- Kirketon Road Centre
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Sydney, New South Wales, Australien, 2010
- East Sydney Doctors
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Sydney, New South Wales, Australien, 2000
- Sydney Sexual Health Centre
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Sydney, New South Wales, Australien, 2747
- Nepean Sexual Health and HIV Clinic
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Sydney, New South Wales, Australien, 2065
- Clinic 16, Royal North Shore Hospital
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Wagga Wagga, New South Wales, Australien, 2650
- Brookong Centre Sexual Health Centre
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Waterloo, New South Wales, Australien
- Green Square Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: treatment
A single open-label arm.
All participants receive daily oral pill containing TDF/FTC
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one pill daily
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Incidence of HIV infection per 100 person years among study participants
Tidsram: 24 months of follow-up
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24 months of follow-up
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Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.
Tidsram: 24 months of follow-up
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24 months of follow-up
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
Tidsram: 24 months of follow-up
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24 months of follow-up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: David Cooper, MD, PhD, The Kirby Institute, UNSW Sydney
- Studiestol: Andrew Grulich, MD, PhD, The Kirby Institute, UNSW Sydney
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2016
Primärt slutförande (Faktisk)
1 mars 2019
Avslutad studie (Faktisk)
1 oktober 2020
Studieregistreringsdatum
Först inskickad
14 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2016
Första postat (Uppskatta)
17 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 februari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 februari 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HEPP1511
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .