HIV Clinical Trial
— EPIC-NSWOfficial 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
NCT number | NCT02870790 |
Other study ID # | HEPP1511 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | October 2020 |
Verified date | February 2021 |
Source | Kirby Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Kirby Institute |
Australia,
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 |
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