Status:
COMPLETED
Intensive Models of HCV Care for Injection Drug Users
Lead Sponsor:
Prisma Health-Upstate
Collaborating Sponsors:
Clemson University
Albert Einstein College of Medicine
Conditions:
Hepatitis C
Medication Adherence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associate...
Detailed Description
PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or sta...
Eligibility Criteria
Inclusion
- Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both
- PREVAIL 1:
- HCV-infected, Genotype-1
- Treatment naïve or treatment experienced patients
- Willing to receive HCV treatment on-site
- Initiating treatment with direct-acting antiviral agents (DAA) with or without ribavirin +/- pegylated interferon alfa-2a
- Receiving methadone or buprenorphine in clinic at least one time per week
- Age 18 or older
- Able to provide informed consent
- Psychiatrically stable
- English or Spanish speaking
- Currently enrolled in a methadone or buprenorphine treatment program in the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)
Exclusion
- Known hypersensitivity (allergy) to interferon, ribavirin or DAA
- Psychiatrically unstable
- Pregnant or breast-feeding
- PREVAIL 2:
- Inclusion Criteria:
- HCV-infected, Genotype-1, , 2, 3, or 4
- Willing to receive HCV treatment on-site at an opiate agonist treatment program.
- Initiating treatment with sofosbuvir and ribavirin +/- pegylated interferon alfa-2a
- Age 18 or older
- Able to provide informed consent
- English or Spanish speaking
- Currently a patient in one of the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01857245
Start Date
October 1 2013
End Date
April 30 2017
Last Update
February 3 2025
Active Locations (1)
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1
Greenville Health System
Greenville, South Carolina, United States, 29605