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Trial record 1 of 1 for:    NCT03155906
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Integrated Treatment of Hepatitis C Virus Infection (INTRO-HCV)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155906
Recruitment Status : Active, not recruiting
First Posted : May 16, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
Helse Stavanger HF
Forskningsrådet
Helse Vest
University of Bergen
Folkehelseinstituttet
Bergen kommune
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST) compared to standard treatment. The trial will recruit approximately 250 HCV infected in Bergen and Stavanger and about 1000 in a linked observational study.

Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and treatment evaluation and treatment delivery.

Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger (intervention arm) with standard treatment provided after referral to infectious disease clinics among patients who receive OST having HCV Secondary objectives: Compare treatment adherence between the intervention and control arms, and assess changes in quality of life, fatigue and psychological well-being before and after HCV treatment, as well as changes in drug use, infection related risk behavior, and risk of reinfection among those with sustained virological response.

Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study population: The target group will be patients receiving care with MAR from involved outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and eligible for treatment according to national guidelines.

Study duration: Participants will be included and followed up at least annually for the total study duration between 2017 and 2021.

Expected outcome: This study will inform on the relative advantages and disadvantages of an integrated treatment program for HCV into MAR compared to standard care aiming to increase access to treatment and improved treatment adherence. If the integrated treatment structure is found to be safe and efficacious, it can be considered for further scale-up.


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Opioid Dependence, on Agonist Therapy Other: Health care delivery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicentre, randomised controlled clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Even though complete blinding is regarded as difficult, there will be some degree of blinding/masking. Randomisation will be disclosed to physician and other health care staff providing OST treatment, but not to research nurses conducting data collection for outcomes. Patients will be informed of the follow-up they will receive, but not on other follow-up alternatives that are used or the exact hypotheses for the study.
Primary Purpose: Health Services Research
Official Title: Integrated Treatment of Hepatitis C Virus Infection Among Patients With Injecting Drug Abuse:a Randomised Controlled Trial (INTRO-HCV)
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : May 8, 2020
Estimated Study Completion Date : August 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Integrated treatment
Patients randomised to receive integrated treatment will be counselled on treatment by physician working at MAR outpatient clinic where patient receive OST care, and will receive medication and follow-up at the same MAR outpatient clinic. Treatment medication will be given in line with national guidelines with a close and integrated follow-up.
Other: Health care delivery
Integrated HCV treatment within the OST clinics will compared to standard treatment. Those who are eligible to receiving treatment in line with national guidelines, have no exclusion criteria and consent to study participation, will be randomised to either standard or integrated treatment. For the integrated treatment, treatment initiation, follow-up and delivery of medication will be given at a MAR outpatient clinic where they already receive care including OST. Those randomised to standard treatment will be referred to a medical ward clinic for assessment of treatment initiation and follow-up. Assessment of outcomes will be done 12 weeks after completed treatment and adherence will be assessed at 4, 8 and 12 weeks after initiation of treatment.
Other Name: Integrated health care

Active Comparator: Standard treatment
Those randomised to receive standard treatment will be offered referral for standard HCV treatment at a medical ward hospital clinic. Treatment medication will be given in line with national guidelines.
Other: Health care delivery
Integrated HCV treatment within the OST clinics will compared to standard treatment. Those who are eligible to receiving treatment in line with national guidelines, have no exclusion criteria and consent to study participation, will be randomised to either standard or integrated treatment. For the integrated treatment, treatment initiation, follow-up and delivery of medication will be given at a MAR outpatient clinic where they already receive care including OST. Those randomised to standard treatment will be referred to a medical ward clinic for assessment of treatment initiation and follow-up. Assessment of outcomes will be done 12 weeks after completed treatment and adherence will be assessed at 4, 8 and 12 weeks after initiation of treatment.
Other Name: Integrated health care




Primary Outcome Measures :
  1. Sustained virological response of HCV at 12 [ Time Frame: At 12 (10 - 14) weeks after completed treatment ]
    Sustained virological response of HCV will be assessed by HCV RNA at 12 (range 10 - 14) weeks after completed treatment

  2. Treatment initiation [ Time Frame: 6 months after diagnosing HCV in need of treatment ]
    Treatment initiation within 6 months after diagnosing HCV in need of treatment (in line with national guidelines). This will be assessed through observation in intervention and in reported obtainment from pharmacies of the prescribed drugs


Secondary Outcome Measures :
  1. Treatment adherence [ Time Frame: At 4, 8 (and 12 for treatment recommended beyond 8 weeks) weeks after treatment initiation ]
    Treatment adherence will be assessed by proportion of doses observed being taken in intervention group and reported obtainment from pharmacies of the prescribed drugs combined with self-reported questions on adherence collected at 4, 8 (and 12 for treatment recommended beyond 8 weeks) weeks after treatment initiation. The self-reported question categorises adherence during last four weeks into rarely, sometimes but less than half of the doses, between 50 and 80% of the doses, more than 80% of the doses, and always (95% of doses or more)

  2. Changes in quality of life [ Time Frame: At 12 weeks after treatment compared to before treatment ]
    Changes in quality of life will be assessed with EQ-5D-5L at 12 weeks after treatment compared to before treatment

  3. Changes in fatigue [ Time Frame: At 12 weeks after treatment compared to before treatment ]
    Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS) at 12 weeks after treatment compared to before treatment

  4. Changes in psychological well-being [ Time Frame: At 12 weeks after treatment compared to before treatment ]
    Changes in psychological well-being will be assessed with the Norwegian validated translation ten time version of Hopkins Symptom Checklist (SCL-10) at 12 weeks after treatment compared to before treatment

  5. Changes in drug use [ Time Frame: At 12 weeks after treatment compared to before treatment ]
    Assessment of changes in drug use will be assessed with self-reported use of the following drug categories the last 30 days, the last 12 months and ever: Alcohol, tobacco, cannabis, amphetamines, cocaine, heroin, other opioids not prescribed by physician, benzodiazepines or z-hypnotics, hallusinogens, solvents and gamma hydroxybutyrate (GHB), anabole steroids and other drugs at 12 weeks after treatment compared to before treatment

  6. Changes in drug infection related risk behaviour [ Time Frame: At 12 weeks after treatment compared to before treatment ]
    Assessment of changes in infection related risk behaviour will be assessed with questions assessing sharing of needles and other user equipment before and after HCV treatment at 12 weeks after treatment compared to before treatment

  7. Changes in incidence of HCV [ Time Frame: Assessed annually at follow-up assessments, up to 3 years ]
    Changes in incidence of HCV at the OST outpatient clinics in Bergen, Stavanger, Sandnes during the follow-up periode (2017-2019). Re-infections will also be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving OST from included outpatient clinic
  • Chronically infected with HCV (HCV RNA positive and also HCV RNA positive or anti-HCV at least 6 months before inclusion)
  • Eligible for treatment according to national guidelines (criteria specified below)
  • Obtaining informed consent

At the time of study initiation , eligibility for treatment according to national guidelines was defined as follows:

  • Genotype 1 and 4 independent of degree of fibrosis
  • Genotype 2 and 3, dependent on significant fibrosis.

Significant fibrosis will be assessed with FibroScan indicating elastography of above 7 kPa. Where elastography cannot be obtained, significant fibrosis will be assessed with AST to platelet ratio index (APRI score) of > 0.7 (http://www.hepatitisc.uw.edu/page/clinical-calculators/apri), i.e.

APRI = ASAT levels (in IU/L) / 40 (upper normal levels of ASAT in IU/L) / platelet count (109/L). An APRI score greater than 0.7 had a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.

Exclusion Criteria:

  • Co-infection with HIV
  • Severe extrahepatic HCV associated diseases (e.g. cerebral vasculitis, cryoglobulinemia/membranoprolifereative glomerulonephritis (MPGN), renal failure (eGFR <30), polyarthritis)
  • Decompensated liver failure assessed with Child-Pugh (CP) score (>6 points, class B and C)
  • Currently receiving treatment for HCV

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): NCT03155906


Locations
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Norway
Department of Addiction Medicine, Haukeland University Hospital
Bergen, Hordaland, Norway, 5020
LAR Helse Stavanger HF
Stavanger, Rogaland, Norway, 4010
Sponsors and Collaborators
Haukeland University Hospital
Helse Stavanger HF
Forskningsrådet
Helse Vest
University of Bergen
Folkehelseinstituttet
Bergen kommune
Investigators
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Principal Investigator: Lars T Fadnes, MD, PhD Department of Addiction Medicine, Haukeland University Hospital
Study Chair: Else-Marie Løberg, MA, PhD Department of Addiction Medicine, Haukeland University Hospital
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03155906    
Other Study ID Numbers: 2017/51/REK vest
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Chronic hepatitis C
Opiate Substitution Treatment
Integrated Delivery of Health Care
Substance Abuse Treatment Centers
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Opioid-Related Disorders
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders