Expanded PrEP Implementation in Communities in NSW

HIV Clinical Trial

— EPIC-NSW  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870790
• Other study ID #: HEPP1511
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: October 2020

Study information

• Verified date: February 2021
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9733
• Est. completion date: October 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• STI

Intervention

Drug:
• TDF/FTC
one pill daily

Locations

Country	Name	City	State
Australia	Albury Sexual Health Service	Albury	New South Wales
Australia	Fountain Street General Practice	Alexandria	New South Wales
Australia	Holdsworth House Byron Bay	Byron Bay	New South Wales
Australia	RPA Sexual Health	Camperdown	New South Wales
Australia	Canberra Sexual Health Centre	Canberra	Australian Capital Territory
Australia	Interchange General Practice	Canberra	Australian Capital Territory
Australia	Coffs Harbour Sexual Health Clinic	Coffs harbour	New South Wales
Australia	St Vincent's Hospital HIV, Immunology and Infectious Disease Unit	Darlinghurst	New South Wales
Australia	Dubbo Sexual Health	Dubbo	New South Wales
Australia	Dr Doong's Surgery	Enfield	New South Wales
Australia	Holden Street Gosford	Gosford	New South Wales
Australia	Illawarra Shoalhaven Sexual Health	Illawarra	New South Wales
Australia	Short Street Clinic	Kogarah	New South Wales
Australia	Lismore Sexual Health Clinic - Northen Rivers Area Health Service	Lismore	New South Wales
Australia	Liverpool Sexual Health Clinic	Liverpool	New South Wales
Australia	Hunter New England Sexual Health Services	Newcastle	New South Wales
Australia	St Leonards Medical Centre	North Sydney	New South Wales
Australia	Orange Sexual Health	Orange	New South Wales
Australia	Western Sydney Sexual Health Centre	Parramatta	New South Wales
Australia	Macleay Street Medical Practice	Potts Point	New South Wales
Australia	Crown Street Medical Centre	Surry Hills	New South Wales
Australia	The Albion Centre	Surry Hills	New South Wales
Australia	Clinic 16, Royal North Shore Hospital	Sydney	New South Wales
Australia	East Sydney Doctors	Sydney	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Kirketon Road Centre	Sydney	New South Wales
Australia	Nepean Sexual Health and HIV Clinic	Sydney	New South Wales
Australia	Sydney Sexual Health Centre	Sydney	New South Wales
Australia	Taylor Square Private Clinic	Sydney	New South Wales
Australia	Brookong Centre Sexual Health Centre	Wagga Wagga	New South Wales
Australia	Green Square Health	Waterloo	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HIV infection per 100 person years among study participants		24 months of follow-up
Primary	Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.		24 months of follow-up
Secondary	Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants		24 months of follow-up