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Direct-acting Antiviral

HCV care provided by hospitalist during acute psychiatric admission for Hepatitis C

Phase 4
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test whether treating HCV during a psychiatric admission, rather than referring to specialty care, is feasible and beneficial.

Eligible Conditions
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SVR12 by intention to treat (ITT) in each arm
Secondary outcome measures
Adherence to HCV treatment, by HCV regimen
Adherence with out-patient follow-up visits
Adverse events while on HCV treatment
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Receive HCV care during inpatient admission by a hospitalistExperimental Treatment1 Intervention
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 II: Referral to outpatient specialty for HCV careActive Control1 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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,745 Total Patients Enrolled
15 Trials studying Hepatitis C
1,120 Patients Enrolled for Hepatitis C
Centre for Addiction and Mental HealthOTHER
351 Previous Clinical Trials
81,312 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks may be associated with hepatitis C care administered by hospitalists during an acute psychiatric visit?

"HCV care provided by hospitalists in the setting of acute psychiatric admissions has been deemed safe and is thus assigned a score of 3 on our scale. This is due to this intervention having achieved Phase 4 trial status, indicating its approval for use as a medical treatment."

Answered by AI

Are there opportunities for new participants in this trial?

"Affirmative. The clinical trial's webpage on clinicaltrials.gov corroborates that enrolment is still ongoing, with the experiment first listed on April 19th 2022 and last updated a few days later, on April 28th of the same year. Only 54 individuals are required to be recruited at 1 specific medical site."

Answered by AI

Does the admission criteria for this trial include individuals aged sixty and over?

"This medical experiment is open to potential participants of legal age, with the upper limit set at 80 years old."

Answered by AI

To what extent is participation in this experiment widespread?

"Affirmative. Clinicaltrials.gov hosts information that clearly demonstrates this clinical trial is actively recruiting patients, having been posted on April 19th and edited most recently on April 28th 2022. Only 54 participants are necessary at a single site to fulfil the requirements of this medical study."

Answered by AI

Could I be accepted as a participant for this experiment?

"To be considered for this study, candidates must possess hepatitis c and be in the age range of 18 - 80. A total of 54 individuals are needed to participate."

Answered by AI
~19 spots leftby Mar 2025