Clinical trial NCT02870790: Expanded PrEP Implementation in Communities in 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
STI
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2016-08-17
Enrollment: 9733
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Incidence of HIV infection per 100 person years among study participants
timeFrame: 24 months of follow-up
measure: Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.
timeFrame: 24 months of follow-up
Secondary outcomes:
measure: Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
timeFrame: 24 months of follow-up
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Interchange General Practice
state: Australian Capital Territory
city: Canberra
country: Australia
facility: Canberra Sexual Health Centre
state: Australian Capital Territory
city: Albury
country: Australia
facility: Albury Sexual Health Service
state: New South Wales
city: Alexandria
country: Australia
facility: Fountain Street General Practice
state: New South Wales
city: Byron Bay
country: Australia
facility: Holdsworth House Byron Bay
state: New South Wales
city: Camperdown
country: Australia
facility: RPA Sexual Health
state: New South Wales
city: Coffs harbour
country: Australia
facility: Coffs Harbour Sexual Health Clinic
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
state: New South Wales
city: Dubbo
country: Australia
facility: Dubbo Sexual Health
state: New South Wales
city: Enfield
country: Australia
facility: Dr Doong's Surgery
state: New South Wales
city: Gosford
country: Australia
facility: Holden Street Gosford
state: New South Wales
city: Illawarra
country: Australia
facility: Illawarra Shoalhaven Sexual Health
state: New South Wales
city: Kogarah
country: Australia
facility: Short Street Clinic
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Sexual Health Clinic - Northen Rivers Area Health Service
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Sexual Health Clinic
state: New South Wales
city: Newcastle
country: Australia
facility: Hunter New England Sexual Health Services
state: New South Wales
city: North Sydney
country: Australia
facility: St Leonards Medical Centre
state: New South Wales
city: Orange
country: Australia
facility: Orange Sexual Health
state: New South Wales
city: Parramatta
country: Australia
facility: Western Sydney Sexual Health Centre
state: New South Wales
city: Potts Point
country: Australia
facility: Macleay Street Medical Practice
state: New South Wales
city: Surry Hills
country: Australia
facility: Crown Street Medical Centre
state: New South Wales
city: Surry Hills
country: Australia
facility: The Albion Centre
state: New South Wales
city: Sydney
country: Australia
facility: Kirketon Road Centre
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Sexual Health Centre
state: New South Wales
city: Sydney
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Clinic 16, Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Nepean Sexual Health and HIV Clinic
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Brookong Centre Sexual Health Centre
state: New South Wales
city: Waterloo
country: Australia
facility: Green Square Health
state: New South Wales
Study officials:
affiliation: The Kirby Institute, UNSW Sydney
name: David Cooper, MD, PhD
role: STUDY_CHAIR
affiliation: The Kirby Institute, UNSW Sydney
name: Andrew Grulich, MD, PhD
role: STUDY_CHAIR
References:
citation: Amin J, Vaccher S, Templeton DJ, Bavinton B, Jin F, Zablotska I, Matthews G, Ogilvie E, Yeung B, Ooi C, Dharan N, Baker DA, Read P, Guy R, Grulich AE. Low Prior Exposure and Incidence of Hepatitis C in Human Immunodeficiency Virus-Negative Gay and Bisexual Men Taking Preexposure Prophylaxis (PrEP): Findings From the Expanded PrEP Implementation in Communities-New South Wales Prospective Implementation Study. Clin Infect Dis. 2022 Oct 29;75(9):1497-1502. doi: 10.1093/cid/ciac231.
citation: Grulich AE, Jin F, Bavinton BR, Yeung B, Hammoud MA, Amin J, Cabrera G, Clackett S, Ogilvie E, Vaccher S, Vickers T, McNulty A, Smith DJ, Dharan NJ, Selvey C, Power C, Price K, Zablotska I, Baker DA, Bloch M, Brown K, Carmody CJ, Carr A, Chanisheff D, Doong N, Finlayson R, Lewis DA, Lusk J, Martin S, Ooi C, Read P, Ryder N, Smith D, Tuck Meng Soo C, Templeton DJ, Vlahakis E, Guy R; Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group. Long-term protection from HIV infection with oral HIV pre-exposure prophylaxis in gay and bisexual men: findings from the expanded and extended EPIC-NSW prospective implementation study. Lancet HIV. 2021 Aug;8(8):e486-e494. doi: 10.1016/S2352-3018(21)00074-6. Epub 2021 Jul 1.
citation: Grulich AE, Guy R, Amin J, Jin F, Selvey C, Holden J, Schmidt HA, Zablotska I, Price K, Whittaker B, Chant K, Cooper C, McGill S, Telfer B, Yeung B, Levitt G, Ogilvie EE, Dharan NJ, Hammoud MA, Vaccher S, Watchirs-Smith L, McNulty A, Smith DJ, Allen DM, Baker D, Bloch M, Bopage RI, Brown K, Carr A, Carmody CJ, Collins KL, Finlayson R, Foster R, Jackson EY, Lewis DA, Lusk J, O'Connor CC, Ryder N, Vlahakis E, Read P, Cooper DA; Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group. Population-level effectiveness of rapid, targeted, high-coverage roll-out of HIV pre-exposure prophylaxis in men who have sex with men: the EPIC-NSW prospective cohort study. Lancet HIV. 2018 Nov;5(11):e629-e637. doi: 10.1016/S2352-3018(18)30215-7. Epub 2018 Oct 17.
citation: Zablotska IB, Selvey C, Guy R, Price K, Holden J, Schmidt HM, McNulty A, Smith D, Jin F, Amin J, Cooper DA, Grulich AE; EPIC-NSW study group. Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial. BMC Public Health. 2018 Feb 2;18(1):210. doi: 10.1186/s12889-017-5018-9.