About The Study

CTN 337 aims to improve engagement in hepatitis C virus (HCV) testing and treatment for people who are incarcerated in Saskatchewan correctional facilities. They will trial a ‘Fast-Track’ intervention using a combination of rapid testing, assessment, and treatment initiation. The study will determine if this approach is acceptable, effective, and safe among people who are incarcerated and if it improves treatment uptake compared with the current standard of care.

Background

Saskatchewan has high rates of HCV, thought to be driven by injection drug use. While treatment with direct-acting antiviral (DAA) therapy has been available in the province for several years, uptake has been modest to date.

People who are incarcerated are disproportionately affected by HCV, with 15–30 per cent of this population being currently or previously infected. There is a lack of evidence behind how best to optimize HCV testing and treatment for people who are incarcerated, but it is hoped that new, evidence-based, proactive approaches within correctional facilities could help. Specifically, new technologies to diagnose HCV infection such as rapid fingerstick HCV antibody and RNA tests may improve engagement and linkage to care.

Study Approach

Everyone incarcerated at Regina Correctional Centre (RCC) will be invited to participate in this study. Following informed consent, participants will be randomized to either the ‘Fast-Track’ intervention or standard of care.

The ‘Fast-Track’ arm will begin with a nurse-led clinical assessment to determine any history of HCV infection. People with no history of HCV infection will receive an HCV antibody fingerstick test and, if positive, an RNA fingerstick test and blood test to confirm the results. People with a history of HCV infection will receive an RNA fingerstick test and blood test. Participants with confirmed HCV infection will receive a nurse-led clinical assessment and non-invasive liver fibrosis assessment, and begin HCV treatment. Participants with confirmed HCV infection who are incarcerated for more than 6 weeks will begin treatment on the same day or the next day. People with confirmed HCV infection who are incarcerated for less than 6 weeks will begin treatment upon release.

The standard-of-care arm will involve a nursing assessment visit along with collection of dried-blood spot samples to perform HCV RNA testing at the end of the study, blood draws as per facility protocol, and nurse-led review of laboratory results once available. These participants will then undergo a non-invasive liver fibrosis assessment and HCV treatment initiation, if eligible. Any participant who is found to have HCV, but is not initiated on HCV therapy, will be offered an in-person or virtual follow-up appointment with the ID Clinic at Regina General Hospital, as per usual standard of care.

All participants will be followed through treatment completion until HCV is no longer detectable or they are lost to follow-up.

All participants will also receive rapid HIV and syphilis testing. Any participant with a positive HIV or syphilis test will be referred for immediate follow-up with the ID Clinic, as per usual standard of care.

Eligibility Requirements

Required

Inclusion Criteria:

  1. Male and ≥18 years of age at time of enrolment
  2. Currently incarcerated at RPCC
  3. Has provided written informed consent to participate

For persons determined to have HCV and commencing treatment:

  1. Is treatment-naïve for any NS5A inhibitor (e.g., daclatasvir) against HCV (previous treatment with any other antiviral therapy against HCV including 1st-generation protease inhibitors, sofosbuvir, pegylated interferon, ribavirin, or any combination of these, is allowed)

Not Allowed

Exclusion Criteria:

  1. Is unable or unwilling to provide written informed consent or abide by the requirements of the study
  2. Anyone posing a security risk to the research team, as determined by correctional officers

For persons determined to have HCV RNA positive and commencing treatment:

  1. Any clinically relevant condition, history, or medication that would contraindicate DAA therapy for HCV or would make HCV management in a correctional-based setting inappropriate or unsafe
  2. Known clinical or laboratory evidence of decompensated cirrhosis as determined by the study investigator

Principal Investigator

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@ctnplus.ca.

Participating Site

Here’s where this study is being conducted.

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