search
Back to results

Intensive Models of HCV Care for Injection Drug Users

Primary Purpose

Hepatitis C, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Models (mDOT and CGT) of HCV Care
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring 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, Group Therapy, Health Care Costs, Health Personnel, Healthcare Systems, Hepatitis C, Hepatitis C Prevalence, Hepatitis C Transmission, Hepatitis C virus, HIV, Homelessness, improved, Incidence, Infection, Injecting drug user, Injection of therapeutic agent, Intensive Care, Interferons, Intervention, Knowledge, Life, Liver diseases, Liver Failure, liver transplantation, Living Costs, Mental disorders, Methadone, methadone clinic/center, Modeling, Mortality Vital Statistics, Motivation, multidisciplinary, Opiates, Oral, Outcome, Patients, Persons, Pharmaceutical Preparations, Physicians, pill (pharmacologic), Play, Poverty, Primary Health Care, programs, Psychiatric therapeutic procedure, psychosocial, Publishing, Quality-Adjusted Life Years, Randomized, Randomized Controlled Trials, randomized trial, Recruitment Activity, Regimen, Resistance, Resistance development, response, Risk, risk perception, Role, Site, skills, Social support, standard care, substance abuse treatment, success, Time, Treatment outcome, Treatment Protocols, treatment site, Trust, United States, Viral, Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Greenville Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Modified Directly Observed Therapy (mDOT)

Concurrent Group Treatment (CGT)

Treatment as Usual

Arm Description

In our mDOT 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 social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.

In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.

Outcomes

Primary Outcome Measures

Electronically monitored medication adherence
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.

Secondary Outcome Measures

Hepatitis C viral load.

Full Information

First Posted
May 16, 2013
Last Updated
March 26, 2021
Sponsor
Prisma Health-Upstate
Collaborators
Clemson University, Albert Einstein College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01857245
Brief Title
Intensive Models of HCV Care for Injection Drug Users
Official Title
Intensive Models of HCV Care for Injection Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
Clemson University, Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Medication Adherence
Keywords
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, Group Therapy, Health Care Costs, Health Personnel, Healthcare Systems, Hepatitis C, Hepatitis C Prevalence, Hepatitis C Transmission, Hepatitis C virus, HIV, Homelessness, improved, Incidence, Infection, Injecting drug user, Injection of therapeutic agent, Intensive Care, Interferons, Intervention, Knowledge, Life, Liver diseases, Liver Failure, liver transplantation, Living Costs, Mental disorders, Methadone, methadone clinic/center, Modeling, Mortality Vital Statistics, Motivation, multidisciplinary, Opiates, Oral, Outcome, Patients, Persons, Pharmaceutical Preparations, Physicians, pill (pharmacologic), Play, Poverty, Primary Health Care, programs, Psychiatric therapeutic procedure, psychosocial, Publishing, Quality-Adjusted Life Years, Randomized, Randomized Controlled Trials, randomized trial, Recruitment Activity, Regimen, Resistance, Resistance development, response, Risk, risk perception, Role, Site, skills, Social support, standard care, substance abuse treatment, success, Time, Treatment outcome, Treatment Protocols, treatment site, Trust, United States, Viral, Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Directly Observed Therapy (mDOT)
Arm Type
Experimental
Arm Description
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Arm Title
Concurrent Group Treatment (CGT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intervention Type
Other
Intervention Name(s)
Intensive Models (mDOT and CGT) of HCV Care
Intervention Description
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
Primary Outcome Measure Information:
Title
Electronically monitored medication adherence
Description
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
Time Frame
12-24 weeks
Secondary Outcome Measure Information:
Title
Hepatitis C viral load.
Time Frame
12 weeks after treatment completion
Other Pre-specified Outcome Measures:
Title
Hepatitis C resistance
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garland Gudger, MD, MPH
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33876230
Citation
Heo M, Pericot-Valverde I, Rennert L, Akiyama MJ, Norton BL, Gormley M, Agyemang L, Arnsten JH, Litwin AH. Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs. Clin Infect Dis. 2021 Dec 6;73(11):2093-2100. doi: 10.1093/cid/ciab334.
Results Reference
derived
PubMed Identifier
33276738
Citation
Pericot-Valverde I, Heo M, Akiyama MJ, Norton BL, Agyemang L, Niu J, Litwin AH. Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial. BMC Infect Dis. 2020 Dec 4;20(1):928. doi: 10.1186/s12879-020-05667-3.
Results Reference
derived
PubMed Identifier
30959528
Citation
Akiyama MJ, Norton BL, Arnsten JH, Agyemang L, Heo M, Litwin AH. Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial. Ann Intern Med. 2019 May 7;170(9):594-603. doi: 10.7326/M18-1715. Epub 2019 Apr 9.
Results Reference
derived
PubMed Identifier
29426304
Citation
Akiyama MJ, Agyemang L, Arnsten JH, Heo M, Norton BL, Schackman BR, Linas BP, Litwin AH. Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy. BMC Infect Dis. 2018 Feb 9;18(1):74. doi: 10.1186/s12879-018-2964-5.
Results Reference
derived

Learn more about this trial

Intensive Models of HCV Care for Injection Drug Users

We'll reach out to this number within 24 hrs