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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02870790
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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


Condition or disease Intervention/treatment Phase
HIV STI Drug: TDF/FTC Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9733 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of HIV infection per 100 person years among study participants [ Time Frame: 24 months of follow-up ]
  2. Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health. [ Time Frame: 24 months of follow-up ]

Secondary Outcome Measures :
  1. Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants [ Time Frame: 24 months of follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870790


Locations
Show Show 31 study locations
Sponsors and Collaborators
Kirby Institute
Investigators
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Study Chair: David Cooper, MD, PhD The Kirby Institute, UNSW Sydney
Study Chair: Andrew Grulich, MD, PhD The Kirby Institute, UNSW Sydney

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02870790    
Other Study ID Numbers: HEPP1511
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020