Expanded PrEP Implementation in Communities in NSW

NCT02870790 | Completed Phase 3 DMC

• 1 other identifier: HEPP1511
• Study Type: interventional
• Target: 9,733
• Locations: 1 country
• Sites: 31

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

Conditions

HIV; STI

Outcome Measures

Primary Outcomes (2)

• Incidence of HIV infection per 100 person years among study participants

  24 months of follow-up

• Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.

  24 months of follow-up

Secondary Outcomes (1)

• Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants

  24 months of follow-up

Study Arms (1)

treatment

EXPERIMENTAL

A single open-label arm. All participants receive daily oral pill containing TDF/FTC

Drug: TDF/FTC

Interventions

TDF/FTC DRUG

one pill daily

Also known as: Truvada, generic TDF/FTC

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (31)

Interchange General Practice

Canberra, Australian Capital Territory, 2601, Australia

Location

Canberra Sexual Health Centre

Canberra, Australian Capital Territory, 2605, Australia

Location

Albury Sexual Health Service

Albury, New South Wales, 2640, Australia

Location

Fountain Street General Practice

Alexandria, New South Wales, 2015, Australia

Location

Holdsworth House Byron Bay

Byron Bay, New South Wales, 2481, Australia

Location

RPA Sexual Health

Camperdown, New South Wales, 2050, Australia

Location

Coffs Harbour Sexual Health Clinic

Coffs Harbour, New South Wales, 2450, Australia

Location

St Vincent's Hospital HIV, Immunology and Infectious Disease Unit

Darlinghurst, New South Wales, 2010, Australia

Location

Dubbo Sexual Health

Dubbo, New South Wales, 2830, Australia

Location

Dr Doong's Surgery

Enfield, New South Wales, 2136, Australia

Location

Holden Street Gosford

Gosford, New South Wales, 2250, Australia

Location

Illawarra Shoalhaven Sexual Health

Illawarra, New South Wales, 2502, Australia

Location

Short Street Clinic

Kogarah, New South Wales, 2217, Australia

Location

Lismore Sexual Health Clinic - Northen Rivers Area Health Service

Lismore, New South Wales, 2480, Australia

Location

Liverpool Sexual Health Clinic

Liverpool, New South Wales, 2217, Australia

Location

Hunter New England Sexual Health Services

Newcastle, New South Wales, 2300, Australia

Location

St Leonards Medical Centre

North Sydney, New South Wales, 2065, Australia

Location

Orange Sexual Health

Orange, New South Wales, 2800, Australia

Location

Western Sydney Sexual Health Centre

Parramatta, New South Wales, 2150, Australia

Location

Macleay Street Medical Practice

Potts Point, New South Wales, 2011, Australia

Location

Crown Street Medical Centre

Surry Hills, New South Wales, 2010, Australia

Location

The Albion Centre

Surry Hills, New South Wales, 2010, Australia

Location

Kirketon Road Centre

Sydney, New South Wales, 1340, Australia

Location

Sydney Sexual Health Centre

Sydney, New South Wales, 2000, Australia

Location

East Sydney Doctors

Sydney, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Taylor Square Private Clinic

Sydney, New South Wales, 2010, Australia

Location

Clinic 16, Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Nepean Sexual Health and HIV Clinic

Sydney, New South Wales, 2747, Australia

Location

Brookong Centre Sexual Health Centre

Wagga Wagga, New South Wales, 2650, Australia

Location

Green Square Health

Waterloo, New South Wales, Australia

Location

Related Publications (4)

• 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.

  PMID: 35352102 DERIVED

• 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.

  PMID: 34217426 DERIVED

• 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.

  PMID: 30343026 DERIVED

• 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.

  PMID: 29394918 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• David Cooper, MD, PhD

  The Kirby Institute, UNSW Sydney

  STUDY CHAIR

• Andrew Grulich, MD, PhD

  The Kirby Institute, UNSW Sydney

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 17, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: October 1, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

AU (31)