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

May 16, 2013
April 28, 2014
July 2013
June 2016   (final data collection date for primary outcome measure)
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.
Electronically monitored medication adherence [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
Complete list of historical versions of study NCT01857245 on ClinicalTrials.gov Archive Site
Hepatitis C viral load. [ Time Frame: 12 weeks after treatment completion ] [ Designated as safety issue: No ]
Hepatitis C viral load. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Hepatitis C resistance [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
Same as current
 
Intensive Models of HCV Care for Injection Drug Users
Intensive Models of HCV Care for Injection Drug Users

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Medication Adherence
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: 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.
    Intervention: Other: Intensive Models (mDOT and CGT) of HCV Care
  • 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.
    Intervention: Other: Intensive Models (mDOT and CGT) of HCV Care
  • Active Comparator: Treatment as Usual
    In the TAU arm, subjects will receive all medications monthly at the clinic from the clinic nurse.
    Intervention: Other: Intensive Models (mDOT and CGT) of HCV Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2017
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Alain Litwin, MD, MPH 718-944-3862 alitwin@montefiore.org
Contact: Kimberly K Yu, MPH 718-944-3859 kyu@montefiore.org
United States
 
NCT01857245
1R01DA034086-01, 2011-555
Yes
Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
Not Provided
Not Provided
Albert Einstein College of Medicine of Yeshiva University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP