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HCV Treatment Initiation During Acute Psychiatric Admission

28 april 2022 bijgewerkt door: University Health Network, Toronto

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

54

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H3
        • Werving
        • Centre for Addiction and Mental Health
        • Contact:
          • Renee Logan, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
SVR12 by intention to treat (ITT) in each arm
Tijdsspanne: 24 months
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
SVR12 by modified intention to treat (mITT) in each arm
Tijdsspanne: 24 months
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
HCV relapse rate
Tijdsspanne: 24 months
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
HCV seroprevalence rates
Tijdsspanne: 12 months
To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.
12 months
HCV RNA positivity rates
Tijdsspanne: 12 months
To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.
12 months
CAMH staff acceptability of POC antibody and RNA testing
Tijdsspanne: 12 months
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
Concordance of POC HCV RNA with HCV RNA by phlebotomy
Tijdsspanne: 12 months
To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).
12 months
Minimum and mean times from diagnosis to treatment initiation
Tijdsspanne: 24 months
Evaluate the mean and minimum times to treatment initiation in both arms, and compare.
24 months
Adherence with out-patient follow-up visits
Tijdsspanne: 24 months.
Evaluate and compare out-patient follow-up visit adherence in both arms.
24 months.
Adherence to HCV treatment, by HCV regimen
Tijdsspanne: 24 months.
Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.
24 months.
Adverse events while on HCV treatment
Tijdsspanne: 18 months.
To determine and compare adverse events in both arms while patients are on treatment.
18 months.
HCV Reinfection
Tijdsspanne: 24 months.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Health Network, Toronto

Medewerkers

Centre for Addiction and Mental Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 april 2022

Primaire voltooiing (Verwacht)

1 april 2023

Studie voltooiing (Verwacht)

1 april 2023

Studieregistratiedata

Eerst ingediend

29 september 2020

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2020

Eerst geplaatst (Werkelijk)

12 november 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

28 april 2022

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20-5188

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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