Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intensive Models of HCV Care for Injection Drug Users

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01857245
First received: May 16, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections. It is unknown whether either model is better or more cost-effective than standard on-site care.

PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1 treatment naive) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.

PREVAIL 2: In the proposed study, 50 IDUs with chronic HCV (genotype 1 treatment experienced, genotype 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.


Condition Intervention
Hepatitis C
Medication Adherence
Other: Intensive Models (mDOT and CGT) of HCV Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Models of HCV Care for Injection Drug Users

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Electronically monitored medication adherence [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
    Hepatitis C medication adherence will be measured using electronic blister pack monitoring.


Secondary Outcome Measures:
  • Hepatitis C viral load. [ Time Frame: 12 weeks after treatment completion ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Hepatitis C resistance [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Directly Observed Therapy (mDOT)
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Other: Intensive Models (mDOT and CGT) of HCV Care
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
Experimental: Concurrent Group Treatment (CGT)
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Other: Intensive Models (mDOT and CGT) of HCV Care
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
Active Comparator: Treatment as Usual
In the TAU arm, subjects will receive all medications monthly at the clinic from the clinic nurse.
Other: Intensive Models (mDOT and CGT) of HCV Care
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PREVAIL 1:

Inclusion Criteria:

  • HCV-infected, Genotype-1
  • Not previously treated with HCV medications
  • Willing to receive HCV treatment on-site
  • Initiating treatment with direct-acting antiviral agent (DAA) and ribavirin +/- pegylated interferon alfa-2a
  • Receiving methadone in clinic at least three times per week
  • Age 18 or older
  • Able to provide informed consent
  • Psychiatrically stable
  • English or Spanish speaking
  • Currently enrolled in a methadone treatment program in the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or DAA
  • Psychiatrically unstable
  • Pregnant or breast-feeding

PREVAIL 2:

Inclusion Criteria:

  • HCV-infected, Genotype-1 (treatment experienced), 2, 3, or 4
  • Willing to receive HCV treatment on-site
  • Initiating treatment with sofosbuvir and ribavirin +/- pegylated interferon alfa-2a
  • Receiving either methadone or buprenorphine
  • Age 18 or older
  • Able to provide informed consent
  • Psychiatrically stable
  • English or Spanish speaking
  • Currently a patient in one of the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or sofosbuvir
  • Psychiatrically unstable
  • Pregnant or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857245

Contacts
Contact: Alain Litwin, MD, MPH 718-944-3862 alitwin@montefiore.org
Contact: Kimberly K Yu, MPH 718-944-3859 kyu@montefiore.org

Locations
United States, New York
Albert Einstein College of Medicine Division of Substance Abuse Recruiting
Bronx, New York, United States, 10461
Contact: Alain Litwin, MD, MPH    718-944-3862    alitwin@montefiore.org   
Contact: Kimberly K Yu, MPH    718-944-3859    kyu@montefiore.org   
Principal Investigator: Alain Litwin, MD, MPH         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01857245     History of Changes
Other Study ID Numbers: 1R01DA034086-01, 2011-555
Study First Received: May 16, 2013
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
addiction
Adherence (attribute)
Adverse effects
Agonist
Antiviral Agents
arm
base
care delivery
Caring
Chronic Hepatitis C
Clinic
Clinical Trials
Complex
Computer Simulation
cost
cost effective
cost effectiveness
Data
Development
Directly Observed Therapy
Disease
Dose
Drug resistance
drug resistant virus
Educational aspects
Epidemic
experience
Frequencies (time pattern)
Fright
Genotype

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014