HCV Treatment Initiation During Acute Psychiatric Admission

NCT04625322 | Unknown Phase 4 DMC

• 1 other identifier: 20-5188
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; Psychiatric; Hospital; Treatment

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Secondary Outcomes (11)

• SVR12 by modified intention to treat (mITT) in each arm

  24 months

• HCV relapse rate

  24 months

• HCV seroprevalence rates

  12 months

• HCV RNA positivity rates

  12 months

• CAMH staff acceptability of POC antibody and RNA testing

  12 months

Study Arms (2)

Referral to outpatient specialty for HCV care

NO INTERVENTION

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.

Receive HCV care during inpatient admission by a hospitalist

EXPERIMENTAL

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.

Other: HCV care provided by hospitalist during acute psychiatric admission

Interventions

HCV care provided by hospitalist during acute psychiatric admission OTHER

HCV diagnosis and treatment will be conducted by a hospitalist during an acute psychiatric admission at CAMH

Receive HCV care during inpatient admission by a hospitalist

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H3, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Mia Biondi, NP-PHC, PhD

CONTACT

6476286461; mia.biondi@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Models of Care

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 12, 2020
• Study Start: April 19, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)