Testing and Treating Hepatitis C in Community Pharmacies (SuperDOT-C)
A Cluster Randomised Trial of Pharmacy Led HCV Therapy Versus Conventional Treatment Pathways for HCV Positive Patients Receiving Daily OST in Pharmacies in Health Boards Within NHS Scotland
Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers.
The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff.
Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy.
The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Aberdeen、イギリス、AB25 2ZN
- NHS Grampian
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Dundee、イギリス、DD1 9SY
- NHS Tayside
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Glasgow、イギリス、G$ 0SF
- NHS Greater Glasgow and Clyde
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- HCV PCR positive,
- Stable OST dose for greater than 12 weeks prior to study enrolment
Exclusion Criteria:
- Evidence of current or previous decompensated liver disease,
- Currently receiving HCV eradication treatment
- HIV infection,
- HBsAg positive with detectable HBV DNA,
- Pregnancy
- Cirrhosis or high fibrosis score
- Genotype deemed unsuitable for treatment with available study drugs
- Unable or unwilling to provide informed consent
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
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Pharmacist Led
This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists
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Trial of administering established, licensed treatments by a novel pathway, ie Community Pharmacists, which is hypothesized to improve treatment and retention in treatment of difficult to engage subjects
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実験的:Nurse Led
This arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses
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Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses
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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 |
|---|---|---|
|
Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy
時間枠:12 week SVR, (12 weeks post completion of HCV treatment)
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Blood test result; PCR - based measurement of levels of hepatitis C virus.
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12 week SVR, (12 weeks post completion of HCV treatment)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway
時間枠:Span of study ie 24 months
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Health economics analysis
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Span of study ie 24 months
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To determine whether the Pharmacist-led pathway compared with the Conventional Pathway leads to more people on OST being tested and initiating treatment
時間枠:Span of study ie 24 months
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Comparison of rate of HCV testing rates in pharmacist pathway compared with current pathway
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Span of study ie 24 months
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To explore whether adherence and persistence to HCV therapy in the pharmacy setting is at least similar to that in the Conventional pathway
時間枠:Span of study ie 24 months
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Comparison of compliance rates of antiviral medications between pharmacist and conventional pathway.
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Span of study ie 24 months
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To compare the acceptability of the Pharmacist-led pathway versus the conventional treatment pathway for OST clients
時間枠:Span of study ie 24 months
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Compare the acceptability of the pharmacist pathway as compare to conventional pathway of care
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Span of study ie 24 months
|
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To measure re-infection rate at 1 year after end of treatment in patients with SVR
時間枠:Span of study ie 24 months
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Comparison of the rate of reinfections with HCV between pharmacist and conventional pathways
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Span of study ie 24 months
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To compare the number of patients who drop out of the study between the two pathways
時間枠:Span of study ie 24 months
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Comparison of subject drop out rates between pharmacist and conventional pathways
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Span of study ie 24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:John F Dillon, MD、University of Dundee
出版物と役立つリンク
一般刊行物
- Radley A, de Bruin M, Inglis SK, Donnan PT, Hapca A, Barclay ST, Fraser A, Dillon JF. Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):809-818. doi: 10.1016/S2468-1253(20)30120-5. Epub 2020 Jun 8.
- Hickman M, Dillon JF, Elliott L, De Angelis D, Vickerman P, Foster G, Donnan P, Eriksen A, Flowers P, Goldberg D, Hollingworth W, Ijaz S, Liddell D, Mandal S, Martin N, Beer LJZ, Drysdale K, Fraser H, Glass R, Graham L, Gunson RN, Hamilton E, Harris H, Harris M, Harris R, Heinsbroek E, Hope V, Horwood J, Inglis SK, Innes H, Lane A, Meadows J, McAuley A, Metcalfe C, Migchelsen S, Murray A, Myring G, Palmateer NE, Presanis A, Radley A, Ramsay M, Samartsidis P, Simmons R, Sinka K, Vojt G, Ward Z, Whiteley D, Yeung A, Hutchinson SJ. Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol). BMJ Open. 2019 Sep 24;9(9):e029538. doi: 10.1136/bmjopen-2019-029538.
- Radley A, de Bruin M, Inglis SK, Donnan PT, Dillon JF. Clinical effectiveness of pharmacy-led versus conventionally delivered antiviral treatment for hepatitis C in patients receiving opioid substitution therapy: a study protocol for a pragmatic cluster randomised trial. BMJ Open. 2018 Dec 14;8(12):e021443. doi: 10.1136/bmjopen-2017-021443.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2014GA07
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?
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