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Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)

This study is ongoing, but not recruiting participants.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Sulkowski, Johns Hopkins University Identifier:
First received: September 27, 2011
Last updated: August 10, 2016
Last verified: August 2016
The principal goal of this research project is to evaluate the extent of HCV disease and its treatment in coinfected IDUs. Research procedures will focus on determining liver disease prevalence and grade of disease within this population. The investigators will also evaluate if behavioral reinforcement interventions increase the rate of treatment participation and completion.

Condition Intervention Phase
HIV Infection Hepatitis C Behavioral: Contigent voucher incentive Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Hepatitis C in HIV Infected IDUs

Resource links provided by NLM:

Further study details as provided by Mark Sulkowski, Johns Hopkins University:

Primary Outcome Measures:
  • Hepatitis C Treatment Eligibility and Uptake [ Time Frame: one year ]
    The proportion of IDUs who have no evidence of contraindications to HCV treatment with peginterferon/ribavirin and initial HCV treatment with the regimen treatment eligibility).

Secondary Outcome Measures:
  • Liver stiffness [ Time Frame: one year ]
    Liver stiffness, derived from liver elastography

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
HCV treatment in a standard-of-care setting
Experimental: Contingent Voucher Incentive (CVI)
HCV treatment with Contingent Voucher Incentive (CVI): At timed intervals during HCV treatment, subjects receive vouchers based on behavioral objectives.
Behavioral: Contigent voucher incentive
Subjects receive vouchers based on adherence to clinical visits and HCV medication.

Detailed Description:
The principal goal of this research project remains focused on hepatitis C virus (HCV) infection in HIV-infected injection drug users (IDUs). The recent availability of a novel, non-invasive method of measuring HCV disease stage makes it possible to test the relationship of HCV disease stage and the management of coinfected IDUs with adequate precision. The investigators will apply the innovative technology, elastography (FibroScan®) to ask whether the marked differences in the final disease outcome, end-stage liver disease (ESLD), can be explained by a measure of liver stiffness as assessed by elastography (FibroScan®). While advances in non-invasive disease assessment are critical to HCV management, the greatest challenge to improving HCV treatment effectiveness in coinfected persons remains low rates of treatment uptake and adherence, even when freely accessible. In response to this glaring disparity, the investigators will test potent behavioral reinforcement interventions to improve the management of HCV disease by adapting a rigorously studied contingent behavioral incentives program to the treatment to coinfected IDUs. Hepatitis C Treatment Eligibility: To determine the population prevalence of significant liver disease in coinfected IDUs using an innovative, non-invasive methodology (transient elastography, FibroScan®) to measure liver stiffness. Liver Disease Staging: To test the hypothesis that liver stiffness, assessed by a novel, non-invasive methodology, is predictive of the development of ESLD, defined as hepatic decompensation, hepatocellular cancer, and liver-related death, in coinfected IDUs. Hepatitis C Treatment Incentives: To test the hypothesis that a contingent behavioral reinforcement intervention will effectively increase the proportion of coinfected IDUs who initiate, attend, and complete HCV treatment.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of substance abuse
  • Reactive HCV antibody
  • Reactive HIV antibody

Exclusion Criteria:

For the treatment arm, HCV treatment eligible defined by the absence of an absolute contraindication to HCV treatment:

  • HCV RNA not detected by PCR
  • Pregnant or not willing to use birth control
  • Life expectancy < 2 years
  • Severe depression with suicidal ideation Allergy to interferon and/or ribavirin Severe hematologic abnormality Renal insufficiency Women may not undergo FibroScan while pregnant Persons with implanted cardiac devices may not undergo FibroScan
  Contacts and Locations
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Please refer to this study by its identifier: NCT01448915

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mark S. Sulkowski, MD Johns Hopkins University
  More Information

Responsible Party: Mark Sulkowski, Professor of Medicine, Johns Hopkins University Identifier: NCT01448915     History of Changes
Obsolete Identifiers: NCT00496912
Other Study ID Numbers: NA00029706
R01DA016065 ( U.S. NIH Grant/Contract )
Study First Received: September 27, 2011
Last Updated: August 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mark Sulkowski, Johns Hopkins University:
Human immunodeficiency virus
Acquired Immune Deficiency Syndrome Virus
AIDS virus
Immunodeficiency Virus, Human
Virus, Human Immunodeficiency
Hepatitis C
Hepatitis C, chronic
Hepatitis C virus
Hepatitis C antibodies
Hepatitis C antigens

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on August 16, 2017