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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT01448915

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

828

Enrollment

Location

Study Details

Study Description

Brief Summary

The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. Research procedures will focus on determining liver disease prevalence and severity within this population. This is an observational study without study specific interventions.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection Hepatitis C

Detailed Description

The principal goal of this research project is to evaluate the natural history of HCV and liver disease and its treatment in HIV-infected persons who use drugs. 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.

Study Design

Study Type:

Observational

Actual Enrollment :

828 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Management of Hepatitis C in HIV Infected IDUs

Actual Study Start Date :

Mar 31, 2021

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Persons with HIV and HCV coinfection Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital

Outcome Measures

Primary Outcome Measures

Hepatitis C Treatment Uptake and HCV cure [5 years]
The proportion of persons with HIV and HCV coinfection who achieve HCV cure

Secondary Outcome Measures

Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure [5 years]
Clinical events including liver failure and liver cancer
Liver stiffness measurement by elastography in persons with HIV infection [5 years]
Change in liver stiffness following HCV cure