HCV Treatment Initiation During Acute Psychiatric Admission
INSPIRE: Interventions for Screening and Treatment of Psychiatric Inpatients With HCV Resulting in Elimination
Hepatitis C virus (HCV) disproportionally affects certain populations, including those facing substance use and mental health challenges. In the past, many individuals with mental illness were not treated due to the psychiatric side-effects of interferon. However, the development of highly effective, direct-acting antivirals (DAA) has revolutionized HCV treatment such that cure rates are >95% with 8-12 weeks of simple, safe, and well-tolerated therapy.
A recent systematic review reported that across 13 North American studies, HCV prevalence among people admitted to psychiatric hospitals was a staggering 17.4% (13.2-22.6%). Despite these concerning figures, mental health facilities have not been a focus of HCV elimination efforts to date. The Centre for Addiction and Mental Health (CAMH) in Toronto is the largest mental health facility in Canada, with a psychiatric emergency department seeing ~35 patients per day with many admitted to the acute psychiatric units for safety and stabilization. Currently, psychiatric patients screened for HCV at CAMH have a 75% 'no show' rate at the Toronto Centre for Liver Disease (TCLD), which is located less than 5km away, suggesting that referral upon discharge is ineffective.
This study will be the first trial to evaluate whether it would be feasible and beneficial to initiate treatment during an acute psychiatric admission rather than referring to specialty upon discharge. The combination of broad HCV screening with rapid linkage to treatment has led to successful elimination of HCV within defined populations, so-called micro-elimination. The investigators hypothesize that HCV treatment can be effectively delivered by providers in psychiatric care facilities, which will improve treatment uptake over traditional referral models.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Mia Biondi, NP-PHC, PhD
- 電話番号：6476286461
- メール：mia.biondi@mail.mcgill.ca
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M6J 1H3
- 募集
- Centre for Addiction and Mental Health
-
コンタクト：
- Renee Logan, MD
-
-
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
説明
Inclusion Criteria:
- Chronic HCV infection, positive HCV RNA
- Aged 18 to 80
- Willingness and capacity to provide informed consent, or consent is provided by a substitute decision maker
Exclusion Criteria:
- Presence of or history of decompensated cirrhosis (evidence of decompensation with history of either ascites, variceal hemorrhage, or hepatic encephalopathy)
- Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin >34 μmol/L, INR >1.5
- History of current or past hepatocellular carcinoma.
- HBV (HBsAg +ve) co-infection or untreated HIV co-infection
- Prior HCV antiviral therapy with DAA with or without peginterferon/ribavirin
- Chronic liver disease other than mild nonalcoholic or alcoholic fatty liver disease from a cause other than HCV
- Pregnancy/breastfeeding/inability to use contraception
- Use of concomitant contraindicated medications
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：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 |
|---|---|
|
介入なし：Referral to outpatient specialty for HCV care
Acute psychiatric patients who test HCV RNA positive by OraQuick HCV Antibody Test will be referred for outpatient specialty follow-up at the Toronto Centre for Liver Disease (TCLD) where they will be assessed and offered treatment as per standard of care.
TCLD referrals are triaged by clinicians unaware of the trial and prioritized based on urgency of treatment.
Patients who do not attend the initial visit will be rescheduled.
After 3 'no-show' visits, the person will not be scheduled again at TCLD and will be deemed a 'treatment failure' for the trial with subsequent HCV follow-up at the discretion of the CAMH provider, consistent with current practice.
|
|
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実験的：Receive HCV care during inpatient admission by a hospitalist
CAMH hospitalists covering the inpatient units will undergo a training designed for non-specialist providers, used in the ASCEND trial, which has already occurred.
An algorithm-based work-up which has been used for non-specialist treaters in ECHO Liver, a Ministry-of-Health supported tele-mentoring program, will then be completed for all who test HCV RNA positive.
Labs will be drawn by the hospital phlebotomist following a positive HCV RNA result from the Gene Xpert Viral Load Assay.
At this time, a sample will also be obtained to send to for conventional HCV RNA quantification and genotyping.
|
HCV diagnosis and treatment will be conducted by a hospitalist during an acute psychiatric admission at CAMH
|
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 |
|---|---|---|
|
SVR12 by intention to treat (ITT) in each arm
時間枠：24 months
|
To determine whether screening for HCV using rapid diagnostics during an acute psychiatric admission with inpatient initiation of HCV treatment is superior to standard post-discharge referral and treatment by intention to treat (ITT).
|
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SVR12 by modified intention to treat (mITT) in each arm
時間枠：24 months
|
To determine whether screening for HCV using rapid diagnostics during an acute psychiatric admission with inpatient initiation of HCV treatment is superior to standard post-discharge referral and treatment by modified intention to treat (mITT).
|
24 months
|
|
HCV relapse rate
時間枠：24 months
|
To compare the HCV viral relapse rate in both arms (re-appearance of HCV RNA in those undetectable at end of treatment; relapse distinguished from reinfection by sequencing of the recurrent HCV RNA and comparing to baseline).
|
24 months
|
|
HCV seroprevalence rates
時間枠：12 months
|
To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.
|
12 months
|
|
HCV RNA positivity rates
時間枠：12 months
|
To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.
|
12 months
|
|
CAMH staff acceptability of POC antibody and RNA testing
時間枠：12 months
|
CAMH staff involved in the trial will be asked to particiapte in an acceptibility survey regarding rapid POC antibody and RNA testing on the acute units.
|
12 months
|
|
Concordance of POC HCV RNA with HCV RNA by phlebotomy
時間枠：12 months
|
To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).
|
12 months
|
|
Minimum and mean times from diagnosis to treatment initiation
時間枠：24 months
|
Evaluate the mean and minimum times to treatment initiation in both arms, and compare.
|
24 months
|
|
Adherence with out-patient follow-up visits
時間枠：24 months.
|
Evaluate and compare out-patient follow-up visit adherence in both arms.
|
24 months.
|
|
Adherence to HCV treatment, by HCV regimen
時間枠：24 months.
|
Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.
|
24 months.
|
|
Adverse events while on HCV treatment
時間枠：18 months.
|
To determine and compare adverse events in both arms while patients are on treatment.
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18 months.
|
|
HCV Reinfection
時間枠：24 months.
|
Reinfection rates by the end of the defined as HCV RNA detectability after prior SVR with demonstration of distinct viral sequence from baseline sample to distinguish
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24 months.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 20-5188
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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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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