We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of an Accelerated Pre-treatment Evaluation on Linkage-to-care and Linkage-to-treatment for HCV Infected Persons Who Inject Drugs

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: NCT02755402
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : January 20, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population.

The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is a potential occasion for disengagement and loss to follow-up. This is especially true with hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial situation can change rapidly.

By using new technologies that can quickly provide clinical results, like Xpert HCV Viral Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a patient needs treatment rapidly or not on the day of the initial visit.

The aim of this study is to explore whether an accelerated pre-treatment evaluation can result in an improved linkage-to-care (defined as linkage to health care, addiction or social services) and, eventually, linkage-to-treatment among PWID.


Condition or disease Intervention/treatment
Hepatitis C Intravenous Drug Users Device: Xpert HCV Viral load Device: Transient elastography

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rapid evaluation Device: Xpert HCV Viral load Device: Transient elastography


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients who initiate treatment after first visit [ Time Frame: 1 year ]
    Proportion of patients who initiate treatment among those who are treatment-eligible based on Quebec's treatment reimbursement guidelines following the accelerated intervention and comparison with historical controls


Secondary Outcome Measures :
  1. Proportion of patients who attend at least two visits in one year [ Time Frame: 1 year ]
    To compare linkage-to-care proportion at one year of treated PWID with untreated PWID at one year.

  2. Proportion of patients who initiate opioid substitution therapy during follow-up [ Time Frame: 1 year ]
    To compare opioid substitution therapy initiation rates at one year of treated and untreated PWID.

  3. Difference in number of injection between the month prior to study entry and the last month of follow-up [ Time Frame: 1 year ]
    To compare drug use reduction during the study period of treated PWID with untreated PWID at one year.

  4. Sustained virological response (undetectable HCV viral load 12 weeks post-end-of-treatment [ Time Frame: 12 weeks post-treatment ]
    To compare proportion of treated patients who achieved SVR12 with historical controls treated in phase III trials.

  5. Proportion of patients with a re-infection within six months of end-of-treatment [ Time Frame: 6 months post-treatment ]
    To evaluate rapid re-infection rates (<6 months) of patients who achieve end-of-treatment undetectability.

  6. Difference in HCV viral load results between techniques [ Time Frame: At enrollment ]
    To compare Xpert HCV Viral Load® (Cepheid) viral loads results to HCV RealTime® (Abbott) results.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person who inject drugs, defined as having injected in the past year
  • Able to give an informed consent
  • Unknown treatment eligibility status
  • Naïve to HCV treatment.

Exclusion Criteria:

  • Patients actively engaged in HCV follow up
  • Patients visibly intoxicated at initial study visit
  • Pregnant or breastfeeding women
  • Pacemaker.
Contacts and Locations

Information from the National Library of Medicine

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): NCT02755402


Contacts
Contact: Valérie Martel-Laferrière, MD, MSc 514-890-8000 ext 24720 valerie.martel-laferriere.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3J4
Contact: Claire Casavant, RN    514-890-8000 ext 26588      
Principal Investigator: Valérie Martel-Laferrière, MD, MSc         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Gilead Sciences
Cepheid
More Information

Responsible Party: Valérie Martel-Laferrière, Medical microbiologist, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02755402     History of Changes
Other Study ID Numbers: IN-CA-337-2100
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases