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HCV Treatment Initiation During Acute Psychiatric Admission

Primary Purpose

Hepatitis C

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
HCV care provided by hospitalist during acute psychiatric admission
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Psychiatric, Hospital, Treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Chronic HCV infection, positive HCV RNA
  2. Aged 18 to 80
  3. Willingness and capacity to provide informed consent, or consent is provided by a substitute decision maker

Exclusion Criteria:

  1. Presence of or history of decompensated cirrhosis (evidence of decompensation with history of either ascites, variceal hemorrhage, or hepatic encephalopathy)
  2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin >34 μmol/L, INR >1.5
  3. History of current or past hepatocellular carcinoma.
  4. HBV (HBsAg +ve) co-infection or untreated HIV co-infection
  5. Prior HCV antiviral therapy with DAA with or without peginterferon/ribavirin
  6. Chronic liver disease other than mild nonalcoholic or alcoholic fatty liver disease from a cause other than HCV
  7. Pregnancy/breastfeeding/inability to use contraception
  8. Use of concomitant contraindicated medications

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Referral to outpatient specialty for HCV care

Receive HCV care during inpatient admission by a hospitalist

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SVR12 by intention to treat (ITT) in each arm
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).

Secondary Outcome Measures

SVR12 by modified intention to treat (mITT) in each arm
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).
HCV relapse rate
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).
HCV seroprevalence rates
To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.
HCV RNA positivity rates
To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.
CAMH staff acceptability of POC antibody and RNA testing
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.
Concordance of POC HCV RNA with HCV RNA by phlebotomy
To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).
Minimum and mean times from diagnosis to treatment initiation
Evaluate the mean and minimum times to treatment initiation in both arms, and compare.
Adherence with out-patient follow-up visits
Evaluate and compare out-patient follow-up visit adherence in both arms.
Adherence to HCV treatment, by HCV regimen
Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.
Adverse events while on HCV treatment
To determine and compare adverse events in both arms while patients are on treatment.
HCV Reinfection
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

Full Information

First Posted
September 29, 2020
Last Updated
April 28, 2022
Sponsor
University Health Network, Toronto
Collaborators
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04625322
Brief Title
HCV Treatment Initiation During Acute Psychiatric Admission
Official Title
INSPIRE: Interventions for Screening and Treatment of Psychiatric Inpatients With HCV Resulting in Elimination
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, Psychiatric, Hospital, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Models of Care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Referral to outpatient specialty for HCV care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Receive HCV care during inpatient admission by a hospitalist
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HCV care provided by hospitalist during acute psychiatric admission
Intervention Description
HCV diagnosis and treatment will be conducted by a hospitalist during an acute psychiatric admission at CAMH
Primary Outcome Measure Information:
Title
SVR12 by intention to treat (ITT) in each arm
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
SVR12 by modified intention to treat (mITT) in each arm
Description
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).
Time Frame
24 months
Title
HCV relapse rate
Description
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).
Time Frame
24 months
Title
HCV seroprevalence rates
Description
To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.
Time Frame
12 months
Title
HCV RNA positivity rates
Description
To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.
Time Frame
12 months
Title
CAMH staff acceptability of POC antibody and RNA testing
Description
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.
Time Frame
12 months
Title
Concordance of POC HCV RNA with HCV RNA by phlebotomy
Description
To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).
Time Frame
12 months
Title
Minimum and mean times from diagnosis to treatment initiation
Description
Evaluate the mean and minimum times to treatment initiation in both arms, and compare.
Time Frame
24 months
Title
Adherence with out-patient follow-up visits
Description
Evaluate and compare out-patient follow-up visit adherence in both arms.
Time Frame
24 months.
Title
Adherence to HCV treatment, by HCV regimen
Description
Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.
Time Frame
24 months.
Title
Adverse events while on HCV treatment
Description
To determine and compare adverse events in both arms while patients are on treatment.
Time Frame
18 months.
Title
HCV Reinfection
Description
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
Time Frame
24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mia Biondi, NP-PHC, PhD
Phone
6476286461
Email
mia.biondi@mail.mcgill.ca
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Logan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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HCV Treatment Initiation During Acute Psychiatric Admission

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