HCV Treatment Initiation During Acute Psychiatric Admission

NCT ID: NCT04625322

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2023-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

HCV care provided by hospitalist during acute psychiatric admission

Intervention Type: OTHER

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

Interventions

HCV care provided by hospitalist during acute psychiatric admission

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mia Biondi, NP-PHC, PhD

Role: CONTACT

mia.biondi@mail.mcgill.ca

6476286461

Facility Contacts

Renee Logan, MD

Role: primary

Other Identifiers

20-5188

Identifier Type: -

Identifier Source: org_study_id