An interventional study of Collaborative, multidisciplinary, integrated care in Chronic Hepatitis C and Illicit Drug Use, sponsored by Brian Edlin. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-30.
Sponsored by Brian Edlin · Not applicable, Interventional, and Treatment
The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.
This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →This is the only study on the registry with Brian Edlin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Collaborative, multidisciplinary, integrated care for hepatitis C
Other: Collaborative, multidisciplinary, integrated care
Collaborative, multidisciplinary, integrated care for hepatitis C multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
SVR is measured 24 weeks after completion of antiviral treatment
Time frame: 24 weeks after completion of antiviral treatment
completion of medical and psychiatric evaluation for antiviral therapy
Time frame: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.
initiation of antiviral therapy
Time frame: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.
adherence to antiviral therapy
Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)
Time frame: Weekly up to 48 weeks
completion of antiviral therapy
Time frame: Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)
levels of alcohol and illicit drug use
Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
Time frame: Weekly up to 96 weeks
entry into treatment for substance use
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
Time frame: Monthly up to 24 months
entry into treatment for another unaddressed medical or psychiatric condition
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
Time frame: Monthly up to 24 months
neuropsychiatric side effects, including depression and hostility/irritability
Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
Time frame: Monthly up to 72 weeks
treatment-limiting systemic, hematologic, or other side effects
Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)
Time frame: Weekly up to 72 weeks
other adverse events or adverse effects
Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff
Time frame: Monthly up to 72 weeks
reinfection
Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.
Time frame: Quarterly up to 10 years
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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