HCV Treatment Initiation During Acute Psychiatric Admission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04625322|
Recruitment Status : Not yet recruiting
First Posted : November 12, 2020
Last Update Posted : December 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Other: HCV care provided by hospitalist during acute psychiatric admission||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Models of Care|
|Masking:||None (Open Label)|
|Official Title:||INSPIRE: Interventions for Screening and Treatment of Psychiatric Inpatients With HCV Resulting in Elimination|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
No Intervention: 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.
Experimental: 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.
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
- SVR12 by intention to treat (ITT) in each arm [ Time Frame: 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).
- SVR12 by modified intention to treat (mITT) in each arm [ Time Frame: 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).
- HCV relapse rate [ Time Frame: 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).
- HCV seroprevalence rates [ Time Frame: 12 months ]To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.
- HCV RNA positivity rates [ Time Frame: 12 months ]To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.
- CAMH staff acceptability of POC antibody and RNA testing [ Time Frame: 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.
- Concordance of POC HCV RNA with HCV RNA by phlebotomy [ Time Frame: 12 months ]To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).
- Minimum and mean times from diagnosis to treatment initiation [ Time Frame: 24 months ]Evaluate the mean and minimum times to treatment initiation in both arms, and compare.
- Adherence with out-patient follow-up visits [ Time Frame: 24 months. ]Evaluate and compare out-patient follow-up visit adherence in both arms.
- Adherence to HCV treatment, by HCV regimen [ Time Frame: 24 months. ]Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.
- Adverse events while on HCV treatment [ Time Frame: 18 months. ]To determine and compare adverse events in both arms while patients are on treatment.
- HCV Reinfection [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625322
|Contact: Brett Wolfson-Stofko, PhD||4163404800 ext firstname.lastname@example.org|
|Contact: Mia J Biondi, NP-PHC, PhDemail@example.com|