Clinical trial NCT04625322: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C
Psychiatric
Hospital
Treatment
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2020-11-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Models of Care
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: SVR12 by intention to treat (ITT) in each arm
timeFrame: 24 months
Secondary outcomes:
measure: SVR12 by modified intention to treat (mITT) in each arm
timeFrame: 24 months
measure: HCV relapse rate
timeFrame: 24 months
measure: HCV seroprevalence rates
timeFrame: 12 months
measure: HCV RNA positivity rates
timeFrame: 12 months
measure: CAMH staff acceptability of POC antibody and RNA testing
timeFrame: 12 months
measure: Concordance of POC HCV RNA with HCV RNA by phlebotomy
timeFrame: 12 months
measure: Minimum and mean times from diagnosis to treatment initiation
timeFrame: 24 months
measure: Adherence with out-patient follow-up visits
timeFrame: 24 months.
measure: Adherence to HCV treatment, by HCV regimen
timeFrame: 24 months.
measure: Adverse events while on HCV treatment
timeFrame: 18 months.
measure: HCV Reinfection
timeFrame: 24 months.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References: