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.
研究概览
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Mia Biondi, NP-PHC, PhD
- 电话号码：6476286461
- 邮箱：mia.biondi@mail.mcgill.ca
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M6J 1H3
- 招聘中
- Centre for Addiction and Mental Health
-
接触：
- Renee Logan, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：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.
|
|
|
实验性的：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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SVR12 by intention to treat (ITT) in each arm
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SVR12 by modified intention to treat (mITT) in each arm
大体时间：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
大体时间：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
大体时间：12 months
|
To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.
|
12 months
|
|
HCV RNA positivity rates
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：24 months.
|
Evaluate and compare out-patient follow-up visit adherence in both arms.
|
24 months.
|
|
Adherence to HCV treatment, by HCV regimen
大体时间：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
大体时间：18 months.
|
To determine and compare adverse events in both arms while patients are on treatment.
|
18 months.
|
|
HCV Reinfection
大体时间：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
|
24 months.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
丙型肝炎的临床试验
-
Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
-
University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的