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

February 15, 2021 updated by: 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9733

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
A single open-label arm. All participants receive daily oral pill containing TDF/FTC
Drug: TDF/FTC
one pill daily
Other Names:
  • Truvada
  • generic TDF/FTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of HIV infection per 100 person years among study participants
Time Frame: 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.
Time Frame: 24 months of follow-up
24 months of follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

August 14, 2016

First Submitted That Met QC Criteria

August 14, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPP1511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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