Pharmacist-led Hepatitis C Management (PHARM-C)
2022年4月19日 更新者:University Health Network, Toronto
Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community
Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada.
During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use.
In addition to the tolerability and efficacy of all-oral direct acting antivirals (DAAs), novel diagnostic strategies have also increased engagement in the care cascade.
Point-of care and/or dried blood spot antibody as well as RNA testing allow for diagnosis without the need for phlebotomy, a major barrier for those with a history of past or current injection drug use.
Despite these advances in diagnostic streamlining and increased cure rates, engagement post-diagnosis continues to be a major gap.
Although the exact mechanism of HCV acquisition may not be clear - people who inject drugs, persons who are street-involved or low-income, or persons who are difficult-to-reach for other reasons, often experience both structural and geographic challenges to obtaining care.
Community pharmacists may be the first point of contact for higher risk populations and may avoid testing and/or treatment for fear of judgement or poor treatment in hospital/specialist settings.
While studies have demonstrated the feasibility of treating people receiving opioid against therapy (OAT), it remains unclear whether Canadian pharmacists can safely and effectively screen, and/or confirm HCV, work-up patients for HCV treatment, and prescribe with minimal oversight.
If this model proves successful, it may have global utility especially in areas of the world where pharmacists are the initial point of contact for healthcare issues.
The aim of this study is to determine whether being tested and linked care and treatment will be more effective in a community pharmacy than a referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.
調査の概要
研究の種類
介入
入学 (予想される)
108
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Mia Biondi, PhD, NP-PHC
- 電話番号:6476286471
- メール:mia.biondi@mail.mcgill.ca
研究連絡先のバックアップ
- 名前:Jordan Feld, MD, MPH
- 電話番号:4163404584
- メール:jordan.feld@uhn.ca
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M4Y 1G7
- 募集
- Specialty Rx Solutions
-
コンタクト:
- Jordan Feld, MD, MPH
- 電話番号:4163404584
- メール:jordan.feld@uhn.ca
-
コンタクト:
- Mia Biondi, NP-PHC, PhD
- 電話番号:6476276461
- メール:mbiondi@yorku.ca
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- HCV infection
- HCV RNA > 1,000 IU/mL
- Aged 18 to 80
- Willingness and capacity to provide informed consent
Exclusion Criteria:
- Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
- Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
- History of current or past hepatocellular carcinoma
- Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
- Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
- Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
- Significant co-morbid illness that precludes inclusion in the opinion of the investigator
- Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
- Pregnancy/breast-feeding/inability to use contraception
- Use of concomitant contraindicated drugs
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
|
実験的:Community Pharmacist-Led
Patients in Arm 1 will receive care and treatment at their home pharmacy and be evaluated and treated by a community pharmacist under medical directives and with study oversight.
|
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
|
|
アクティブコンパレータ:Academic hepatology
Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.
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Rapid testing in a community pharmacy, with standard of care referral to academic hepatology
|
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 |
|---|---|---|
|
Intention to treat by Completion Rates
時間枠:24 months
|
Intention to treat direct acting antiviral (DAA) completion rates in non-cirrhotic or compensated cirrhotic patients treated with DAAs in pharmacist-led programs in community pharmacies, compared to treatment completion rates with referral and treatment in tertiary care hepatology (Toronto Centre for Liver Disease).
|
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sustained Virologic Response by Intention-to-Treat
時間枠:24 months
|
Compare Sustained Virologic Response rates by Intention to treat in both sites.
|
24 months
|
|
Sustained Virologic Response by modified Intention-to-Treat
時間枠:24 months
|
Compare the rates of Sustained Virologic Response by modified Intention to treat (including all participants who take at least one dose of medication)
|
24 months
|
|
Sustained Virologic Response by Per Protocol analysis
時間枠:24 months
|
Compare the rates of Sustained Virologic Response by per protocol analysis including all individuals who complete treatment in both groups.
|
24 months
|
|
Hepatitis C Community seroprevalence in downtown Toronto
時間枠:18 months
|
Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
|
18 months
|
|
Community Pharmacist Fibrosis Identification
時間枠:18 months
|
Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
|
18 months
|
|
Community Pharmacist Decompensation Identification
時間枠:18 months
|
Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
|
18 months
|
|
Minimum Mean Time-to-Treatment
時間枠:18 months
|
Determine the minimum mean time-to-treatment initiation in both groups
|
18 months
|
|
Community Appointment Adherence
時間枠:24 months
|
Assess appointment adherence in both arms
|
24 months
|
|
Medication Adherence
時間枠:18 months
|
Assess self-reported medication adherence at both sites
|
18 months
|
|
Quality of Life and Substance Use
時間枠:24 months
|
Evaluate quality of life for patients with chronic liver disease (CLDQ-HCV) before and after treatment (endpoint and SV12) at both sites.
|
24 months
|
|
Substance Use
時間枠:24 months
|
Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
|
24 months
|
|
Patient Understanding and Satisfaction
時間枠:24 months
|
Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
|
24 months
|
|
Reinfection
時間枠:24 months
|
Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
|
24 months
|
|
Patient empowerment
時間枠:24 months
|
Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
|
24 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年4月13日
一次修了 (予想される)
2023年6月1日
研究の完了 (予想される)
2023年12月1日
試験登録日
最初に提出
2020年2月20日
QC基準を満たした最初の提出物
2020年3月24日
最初の投稿 (実際)
2020年3月26日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月27日
QC基準を満たした最後の更新が送信されました
2022年4月19日
最終確認日
2021年12月1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
- 20-5265
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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