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Intensive Models of HCV Care for Injection Drug Users

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT01857245
First received: May 16, 2013
Last updated: January 22, 2017
Last verified: March 2016

May 16, 2013
January 22, 2017
July 2013
June 2017   (Final data collection date for primary outcome measure)
Electronically monitored medication adherence [ Time Frame: 12-24 weeks ]
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
Electronically monitored medication adherence [ Time Frame: 48 weeks ]
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 ]
Hepatitis C viral load. [ Time Frame: 72 weeks ]
Hepatitis C resistance [ Time Frame: Up to 48 weeks ]
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, if applicable, 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, if applicable. 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) 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, 60 IDUs with chronic HCV (genotypes 1 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.

PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 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 oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.

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 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, 60 IDUs with chronic HCV (genotypes 1 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.

PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 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 oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 (or more often as needed) at the clinic.
    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.
 
Active, not recruiting
150
June 2017
June 2017   (Final data collection date for primary outcome measure)

Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both

PREVAIL 1:

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or sofosbuvir
  • Pregnant or breast-feeding

PREVAIL 3:

Inclusion Criteria:

  • HCV-infected, Genotype-1 or 4
  • Willing to receive HCV treatment on-site at an opiate agonist treatment program.
  • Initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir.
  • 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)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to sofosbuvir, simprevir or ledipasvir.
  • Pregnant or breast-feeding

PREVAIL 4

Inclusion Criteria:

  • 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
  • Age 18 or older
  • Able to provide informed consent
  • Psychiatrically stable
  • English or Spanish speaking

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or DAA
  • Psychiatrically unstable
  • Pregnant or breast-feeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01857245
1R01DA034086-01, 2011-555
1R01DA034086-01 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Not Provided
Not Provided
Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
Not Provided
Principal Investigator: Alain Litwin, MD, MPH Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
March 2016

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