National Australian HCV Point-of-Care Testing Program - 最小データセット
National Australian HCV Point-of-Care Testing Program: HCV 感染の診断と治療を強化するための指刺しポイントオブケア C 型肝炎検査の使用を評価するための観察コホート研究 - 最小限のデータセット
The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
調査の概要
詳細な説明
The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4
Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6
The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.
The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program.
An observational cohort study will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection.
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Simon Comben, BSc, MN
- 電話番号：+6193480777
- メール：scomben@kirby.unsw.edu.au
研究連絡先のバックアップ
- 名前：David Silk, BSc
- 電話番号：+61293850900
- メール：dsilk@kirby.unsw.edu.au
研究場所
-
-
New South Wales
-
Sydney、New South Wales、オーストラリア
- 積極的、募集していない
- Justice Health and Forensic Mental Health Network
-
-
Queensland
-
Aldershot、Queensland、オーストラリア、4650
- 募集
- Maryborough Correctional Centre
-
コンタクト：
- Ashley Willman
- 電話番号：(07) 4123 7600
- メール：ashley.willmann@health.qld.gov.au
-
Brisbane、Queensland、オーストラリア、4000
- 募集
- QuIHN
-
コンタクト：
- Nicholas Alexander
- 電話番号：3620 8111
- メール：nalexander@quihn.org
-
Cairns、Queensland、オーストラリア
- 募集
- Lotus Glen Correctional Centre
-
コンタクト：
- Darren Russell
-
主任研究者：
- Darren Russell
-
Coorparoo、Queensland、オーストラリア、4151
- 完了
- Hepatitis Queensland
-
Ipswich、Queensland、オーストラリア
- 募集
- West Moreton Hospital and Health Service
-
コンタクト：
- Blake Ponting
-
主任研究者：
- Blake Ponting
-
Rathdowney、Queensland、オーストラリア、4287
- まだ募集していません
- Palen Creek Correctional Centre
-
コンタクト：
- Mike Hurley
- 電話番号：(07) 5544 3700
- メール：mike.hurley@corrections.qld.gov.au
-
Townsville、Queensland、オーストラリア
- 募集
- Townsville Correctional Centre
-
コンタクト：
- John Morey
-
主任研究者：
- John Morey
-
Woodford、Queensland、オーストラリア
- 募集
- Woodford Correctional Centre
-
コンタクト：
- Rajendra Prakash
-
主任研究者：
- Rajendra Prakash
-
-
South Australia
-
Hackney、South Australia、オーストラリア、5069
- 募集
- Hepatitis SA
-
コンタクト：
- Lisa Carter
- 電話番号：(08) 8362 8443
- メール：lisa@hepatitissa.asn.au
-
Marden、South Australia、オーストラリア、5070
- まだ募集していません
- South Australian Prison Health Service
-
コンタクト：
- Tom Turnbull
-
主任研究者：
- Tom Turnbull
-
Mount Gambier、South Australia、オーストラリア、5290
- 募集
- Mount Gambier Priosn
-
コンタクト：
- William Galloway
-
主任研究者：
- William Galloway
-
-
Victoria
-
Fitzroy、Victoria、オーストラリア、3065
- 積極的、募集していない
- St Vincent's Correctional Health Services
-
Melbourne、Victoria、オーストラリア、3000
- 募集
- Medically Supervised Injecting Room
-
コンタクト：
- Nathan Stam
-
主任研究者：
- Nathan Stam
-
Ravenhall、Victoria、オーストラリア、3023
- 募集
- Dame Phyllis Frost Centre
-
コンタクト：
- Katelyn Mannix
- 電話番号：1300 492 202
- メール：katelyn.mannix@wh.org.au
-
Ravenhall、Victoria、オーストラリア、3023
- 募集
- Geo Healthcare - The Geo Group Australia Pty Ltd
-
コンタクト：
- David Grace
-
主任研究者：
- David Grace
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
説明
Inclusion Criteria:
- ≥ 18 years of age.
- Received point-of-care HCV testing.
Exclusion Criteria:
- Nil
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
People at risk of HCV acquisition
Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing. |
Participants will be offered finger-stick point-of-care testing for HCV |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
時間枠：12 Weeks from enrolment
|
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing. |
12 Weeks from enrolment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of participants who accept point-of-care testing
時間枠：2 years from recruitment commencement
|
To evaluate the proportion of people who accept point-of-care testing among those offered testing. |
2 years from recruitment commencement
|
|
The prevalence of HCV infection amongst study participants tested
時間枠：2 years from recruitment commencement
|
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. |
2 years from recruitment commencement
|
|
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
時間枠：52 weeks
|
To evaluate the length of time participants take to initiate HCV treatment after diagnosis |
52 weeks
|
|
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
時間枠：52 weeks
|
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. |
52 weeks
|
|
To evaluate the proportion of participants who complete HCV (DAA) treatment
時間枠：52 weeks
|
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment. |
52 weeks
|
|
To evaluate the proportion of participants who achieve an SVR
時間枠：12 weeks
|
To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12). |
12 weeks
|
|
To evaluate the proportion of participants who are HCV RNA negative at 12 months
時間枠：52 weeks
|
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. |
52 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- VHCRP2104
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Request to share IPD will be considered by the protocol steering committee on individual basis
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。