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Expanded PrEP Implementation in Communities in NSW (EPIC-NSW)

15. februar 2021 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9733

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australien, 2601
        • Interchange General Practice
      • Canberra, Australian Capital Territory, Australien, 2605
        • Canberra Sexual Health Centre
    • New South Wales
      • Albury, New South Wales, Australien, 2640
        • Albury Sexual Health Service
      • Alexandria, New South Wales, Australien, 2015
        • Fountain Street General Practice
      • Byron Bay, New South Wales, Australien, 2481
        • Holdsworth House Byron Bay
      • Camperdown, New South Wales, Australien, 2050
        • RPA Sexual Health
      • Coffs harbour, New South Wales, Australien, 2450
        • Coffs Harbour Sexual Health Clinic
      • Darlinghurst, New South Wales, Australien, 2010
        • St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
      • Dubbo, New South Wales, Australien, 2830
        • Dubbo Sexual Health
      • Enfield, New South Wales, Australien, 2136
        • Dr Doong's Surgery
      • Gosford, New South Wales, Australien, 2250
        • Holden Street Gosford
      • Illawarra, New South Wales, Australien, 2502
        • Illawarra Shoalhaven Sexual Health
      • Kogarah, New South Wales, Australien, 2217
        • Short Street Clinic
      • Lismore, New South Wales, Australien, 2480
        • Lismore Sexual Health Clinic - Northen Rivers Area Health Service
      • Liverpool, New South Wales, Australien, 2217
        • Liverpool Sexual Health Clinic
      • Newcastle, New South Wales, Australien, 2300
        • Hunter New England Sexual Health Services
      • North Sydney, New South Wales, Australien, 2065
        • St Leonards Medical Centre
      • Orange, New South Wales, Australien, 2800
        • Orange Sexual Health
      • Parramatta, New South Wales, Australien, 2150
        • Western Sydney Sexual Health Centre
      • Potts Point, New South Wales, Australien, 2011
        • Macleay Street Medical Practice
      • Surry Hills, New South Wales, Australien, 2010
        • Crown Street Medical Centre
      • Surry Hills, New South Wales, Australien, 2010
        • The Albion Centre
      • Sydney, New South Wales, Australien, 2010
        • Holdsworth House Medical Practice
      • Sydney, New South Wales, Australien, 2010
        • Taylor Square Private Clinic
      • Sydney, New South Wales, Australien, 1340
        • Kirketon Road Centre
      • Sydney, New South Wales, Australien, 2010
        • East Sydney Doctors
      • Sydney, New South Wales, Australien, 2000
        • Sydney Sexual Health Centre
      • Sydney, New South Wales, Australien, 2747
        • Nepean Sexual Health and HIV Clinic
      • Sydney, New South Wales, Australien, 2065
        • Clinic 16, Royal North Shore Hospital
      • Wagga Wagga, New South Wales, Australien, 2650
        • Brookong Centre Sexual Health Centre
      • Waterloo, New South Wales, Australien
        • Green Square Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: treatment
A single open-label arm. All participants receive daily oral pill containing TDF/FTC
Medicin: TDF/FTC
one pill daily
Andre navne:
  • Truvada
  • generic TDF/FTC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of HIV infection per 100 person years among study participants
Tidsramme: 24 months of follow-up
24 months of follow-up
Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.
Tidsramme: 24 months of follow-up
24 months of follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
Tidsramme: 24 months of follow-up
24 months of follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kirby Institute

Efterforskere

  • Studiestol: David Cooper, MD, PhD, The Kirby Institute, UNSW Sydney
  • Studiestol: Andrew Grulich, MD, PhD, The Kirby Institute, UNSW Sydney

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2016

Primær færdiggørelse (Faktiske)

1. marts 2019

Studieafslutning (Faktiske)

1. oktober 2020

Datoer for studieregistrering

Først indsendt

14. august 2016

Først indsendt, der opfyldte QC-kriterier

14. august 2016

Først opslået (Skøn)

17. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HEPP1511

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV

Kliniske forsøg med TDF/FTC

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner