Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)
Recruitment status was Recruiting
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.
Behavioral: Contigent voucher incentive (CVI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Management of Hepatitis C in HIV Infected IDUs|
- Hepatitis C Treatment Eligibility [ Time Frame: one year ] [ Designated as safety issue: No ]The proportion of IDUs who have clear medical contraindications to HCV treatment (i.e., HCV treatment eligibility).
- Liver Disease Staging [ Time Frame: one year ] [ Designated as safety issue: No ]The prevalence of significant hepatic fibrosis (≥ modified HAI stage 2) among treatment eligible IDUs randomly selected from clinical settings (i.e., the histopathologic disease stage ).
- Hepatitis C Treatment Incentives [ Time Frame: one year ] [ Designated as safety issue: No ]The proportion of treatment-eligible IDUs who initiate PEG/RBV therapy after enrolling into the Standard of Care (SOC) or Contingent Voucher Incentive (CVI) treatment arms.
- Liver stiffness [ Time Frame: one year ] [ Designated as safety issue: No ]Liver stiffness, derived from liver elastography
- Body mass index [ Time Frame: one year ] [ Designated as safety issue: No ]Body mass index, derived from height and weight
- Serum markers [ Time Frame: one year ] [ Designated as safety issue: No ]Serum levels of various chemical markers
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
No Intervention: Standard of Care
HCV treatment in a standard-of-care setting (without voucher intervention)
Experimental: Contingent Voucher Incentive
Contingent voucher incentive: At timed intervals during HCV treatment, subjects receive vouchers based on behavioral objectives.
Behavioral: Contigent voucher incentive (CVI)
Subjects receive vouchers based on adherence to clinical visits and HCV medication.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448915
|Contact: Yvonne M Higgins, MSemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Yvonne M Higgins, MS 410-614-0440 firstname.lastname@example.org|
|Principal Investigator: Mark S. Sulkowski, MD|
|Principal Investigator:||Mark S. Sulkowski, MD||Johns Hopkins University|