HCV Treatment Initiation During Acute Psychiatric Admission

Hepatitis C Clinical Trial

Official title:

INSPIRE: Interventions for Screening and Treatment of Psychiatric Inpatients With HCV Resulting in Elimination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625322
• Other study ID #: 20-5188
• Status: Recruiting
• Phase: Phase 4
• Start date: April 19, 2022
• Est. completion date: April 2023

Study information

• Verified date: December 2021
• Source: University Health Network, Toronto
• Contact: Mia Biondi, NP-PHC, PhD
• Phone: 6476286461
• Email: mia.biondi[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	24 months
Secondary	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).	24 months
Secondary	HCV seroprevalence rates	To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.	12 months
Secondary	HCV RNA positivity rates	To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.	12 months
Secondary	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.	12 months
Secondary	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).	12 months
Secondary	Minimum and mean times from diagnosis to treatment initiation	Evaluate the mean and minimum times to treatment initiation in both arms, and compare.	24 months
Secondary	Adherence with out-patient follow-up visits	Evaluate and compare out-patient follow-up visit adherence in both arms.	24 months.
Secondary	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.	24 months.
Secondary	Adverse events while on HCV treatment	To determine and compare adverse events in both arms while patients are on treatment.	18 months.
Secondary	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	24 months.