Expanded PrEP Implementation in Communities in NSW (EPIC-NSW)
2021年2月15日 更新者：Kirby Institute
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
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
研究概览
研究类型
介入性
注册 (实际的)
9733
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Australian Capital Territory
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Canberra、Australian Capital Territory、澳大利亚、2601
- Interchange General Practice
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Canberra、Australian Capital Territory、澳大利亚、2605
- Canberra Sexual Health Centre
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New South Wales
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Albury、New South Wales、澳大利亚、2640
- Albury Sexual Health Service
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Alexandria、New South Wales、澳大利亚、2015
- Fountain Street General Practice
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Byron Bay、New South Wales、澳大利亚、2481
- Holdsworth House Byron Bay
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Camperdown、New South Wales、澳大利亚、2050
- RPA Sexual Health
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Coffs harbour、New South Wales、澳大利亚、2450
- Coffs Harbour Sexual Health Clinic
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Darlinghurst、New South Wales、澳大利亚、2010
- St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
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Dubbo、New South Wales、澳大利亚、2830
- Dubbo Sexual Health
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Enfield、New South Wales、澳大利亚、2136
- Dr Doong's Surgery
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Gosford、New South Wales、澳大利亚、2250
- Holden Street Gosford
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Illawarra、New South Wales、澳大利亚、2502
- Illawarra Shoalhaven Sexual Health
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Kogarah、New South Wales、澳大利亚、2217
- Short Street Clinic
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Lismore、New South Wales、澳大利亚、2480
- Lismore Sexual Health Clinic - Northen Rivers Area Health Service
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Liverpool、New South Wales、澳大利亚、2217
- Liverpool Sexual Health Clinic
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Newcastle、New South Wales、澳大利亚、2300
- Hunter New England Sexual Health Services
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North Sydney、New South Wales、澳大利亚、2065
- St Leonards Medical Centre
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Orange、New South Wales、澳大利亚、2800
- Orange Sexual Health
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Parramatta、New South Wales、澳大利亚、2150
- Western Sydney Sexual Health Centre
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Potts Point、New South Wales、澳大利亚、2011
- Macleay Street Medical Practice
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Surry Hills、New South Wales、澳大利亚、2010
- Crown Street Medical Centre
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Surry Hills、New South Wales、澳大利亚、2010
- The Albion Centre
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Sydney、New South Wales、澳大利亚、2010
- Holdsworth House Medical Practice
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Sydney、New South Wales、澳大利亚、2010
- Taylor Square Private Clinic
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Sydney、New South Wales、澳大利亚、1340
- Kirketon Road Centre
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Sydney、New South Wales、澳大利亚、2010
- East Sydney Doctors
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Sydney、New South Wales、澳大利亚、2000
- Sydney Sexual Health Centre
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Sydney、New South Wales、澳大利亚、2747
- Nepean Sexual Health and HIV Clinic
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Sydney、New South Wales、澳大利亚、2065
- Clinic 16, Royal North Shore Hospital
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Wagga Wagga、New South Wales、澳大利亚、2650
- Brookong Centre Sexual Health Centre
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Waterloo、New South Wales、澳大利亚
- Green Square Health
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
男性
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：treatment
A single open-label arm.
All participants receive daily oral pill containing TDF/FTC
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one pill daily
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of HIV infection per 100 person years among study participants
大体时间：24 months of follow-up
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24 months of follow-up
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Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.
大体时间：24 months of follow-up
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24 months of follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
大体时间：24 months of follow-up
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24 months of follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：David Cooper, MD, PhD、The Kirby Institute, UNSW Sydney
- 学习椅：Andrew Grulich, MD, PhD、The Kirby Institute, UNSW Sydney
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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. Erratum In: BMC Public Health. 2018 Feb 28;18(1):297.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年3月1日
初级完成 (实际的)
2019年3月1日
研究完成 (实际的)
2020年10月1日
研究注册日期
首次提交
2016年8月14日
首先提交符合 QC 标准的
2016年8月14日
首次发布 (估计)
2016年8月17日
研究记录更新
最后更新发布 (实际的)
2021年2月17日
上次提交的符合 QC 标准的更新
2021年2月15日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.