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Case Management in HCV Infected PWID (CM-HCV)

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ClinicalTrials.gov Identifier: NCT03106194
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborators:
Ziekenhuis Oost-Limburg
CAD Limburg
Information provided by (Responsible Party):
Geert Robaeys, Hasselt University

Brief Summary:
To study the impact of case management on the outcome of the care of chronic hepatitis C in people who inject drugs (PWID). By creating the function of case manager, the investigators will target all the barriers to care of the HCV care continuum. Partial objectives are to measure the impact of case management on the uptake for screening, the uptake and outcome of treatment, and the rate of reinfection.

Condition or disease Intervention/treatment Phase
Drug Abuse, Intravenous Other: case management Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Case Management in Hepatitis C Virus Infected People Who Inject Drugs in Belgium
Study Start Date : July 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
history of injection drug use

Men and women ≥ 18 years old with a history of injection drug use, enrolled in the opiate substitution program of CAD Limburg.

Case management

Other: case management



Primary Outcome Measures :
  1. Uptake for screening (%) [ Time Frame: screening ]
    percentage of clients screened in relation to number of clients in follow-up at CAD

  2. Uptake for treatment assessment (%) [ Time Frame: day 1 ]
    percentage of HCV positive clients who attented a hepatology consultation in relation of total of HCV positive clients

  3. Uptake for treatment (%) [ Time Frame: day 1 ]
    percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment

  4. Compliance to therapy (%) [ Time Frame: up to three years ]
    percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment

  5. Rate of sustained viral response (SVR) (%) [ Time Frame: up to three years ]
    percentage of patients who clear the hepatitis C virus in relation to total patients treated

  6. Rate of reinfection (%) [ Time Frame: up to three years ]
    percentage of patients who get reinfected with HCV in relation to total cured patients



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

Inclusion criteria

  • ≥ 18 years of age
  • History of injection drug use with substitution program
  • Written informed consent obtained

Exclusion criteria

  • Possible acute HCV infection within the previous 6 months defined by one of the following: acute hepatitis symptoms, ALT ≥ 10x ULN, negative or unknown HCV antibody status

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): NCT03106194


Contacts
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Contact: Geert Robaeys, prof. dr. geert.robaeys@zol.be
Contact: Rob Bielen, drs. rob.bielen@uhasselt.be

Locations
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Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3590
Contact: Geert Robaeys       rob.bielen@uhasselt.be   
Contact: Rob Bielen, drs.       rob.bielen@uhasselt.be   
Sponsors and Collaborators
Hasselt University
Ziekenhuis Oost-Limburg
CAD Limburg
Investigators
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Principal Investigator: Geert Robaeys, prof. dr. Hasselt University
Study Chair: Rob Bielen, drs. Hasselt University

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Responsible Party: Geert Robaeys, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03106194     History of Changes
Other Study ID Numbers: ZOL-CM-HCV
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Substance-Related Disorders
Substance Abuse, Intravenous
Chemically-Induced Disorders
Mental Disorders