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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA034086-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Clemson University | OTHER |
| Albert Einstein College of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Experimental | In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window. |
|
| Concurrent Group Treatment (CGT) | Experimental | 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. |
|
| Treatment as Usual | Active Comparator | In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Models (mDOT and CGT) of HCV Care | Other | Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electronically Monitored Medication Adherence | Hepatitis C medication adherence will be measured using electronic blister pack monitoring. | 1-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response | Undetectable HCV RNA at posttreatment week 12. | 12 weeks after treatment completion |
| HCV Treatment Completion | Completion of ≥80% of the planned treatment course. For example, ≥10 wk of a 12-wk course, or ≥20 wk of a 24-wk course. |
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Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both
PREVAIL 1:
Inclusion Criteria:
Exclusion Criteria:
PREVAIL 2:
Inclusion Criteria:
Exclusion Criteria:
PREVAIL 3:
Inclusion Criteria:
Exclusion Criteria:
PREVAIL 4
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garland Gudger, MD, MPH | Prisma Health-Upstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33876230 | Derived | 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. | |
| 33276738 | Derived | 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. |
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Hepatitis C virus-infected PWID from 3 OAT programs in Bronx, New York, were enrolled beginning in October 2013, and participants were followed until April 2017. Potential participants were referred by clinicians if they were eligible for HCV treatment on the basis of guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America (AASLD/IDSA). Eligibility was assessed by an oral screener and a confirmatory chart review.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
| FG001 | 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. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
| FG002 | Treatment as Usual | In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Electronically Monitored Medication Adherence | Hepatitis C medication adherence will be measured using electronic blister pack monitoring. | Posted | Mean | 95% Confidence Interval | Percentage of medication taken | 1-12 weeks |
|
8 months / 36 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Virologic Failure (HCV) | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Claire Stam - Director, Addiction Medicine Center | Prisma Health | (864) 979-6749 | claire.stam@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2012 | Jan 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D055118 | Medication Adherence |
| D016739 | Behavior, Addictive |
| D019698 | Hepatitis C, Chronic |
| D023801 | Directly Observed Therapy |
| D004194 | Disease |
| D007239 | Infections |
| D008107 | Liver Diseases |
| D017093 | Liver Failure |
| D001523 | Mental Disorders |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
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| Up to 48 weeks |
| 30959528 | Derived | 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. |
| 29426304 | Derived | 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. |
| BG001 |
| 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. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
| BG002 | Treatment as Usual | In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Homelessness | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Urine Drug Screen (6 mo before baseline) | Urine drug screen results for participants within 6 months of baseline visit. Participant count indicates those who tested positive for the indicated substance. | Number | Number of participants |
|
| Self-Reported Durg Use (30 days before baseline) | Measure Description: Urine drug screen results for participants within 30 days of baseline visit. Participant count indicates those who tested positive for the indicated substance. | Number | Participants |
|
| Alcohol use to intoxication (30 days before baseline) | Count of Participants | Participants |
|
| Injection drug use | Count of Participants | Participants |
|
| Comorbid psychiatric conditions | Number | participants |
|
| Depression (PHQ-9) | Count of Participants | Participants |
|
| HIV/HCV co-infection | Count of Participants | Participants |
|
| HCV subtype | Subtype determined by medical chart review | Number | participants |
|
| Cirrhosis | Count of Participants | Participants |
|
| Treatment experienced | Count of Participants | Participants |
|
| DAA regimen | Direct acting antivirals (DAA) are medication for treating HCV. Several drug combinations were used to treat participants in this study and are listed here. | Count of Participants | Participants |
|
| Opioid agonist therapy | Number | participants |
|
| Opioid agonist pick-up schedule | Count of Participants | Participants |
|
| Urine drug screen (at baseline) | Measure Description: Urine drug screen results for participants at baseline visit. Participant count indicates those who tested positive for the indicated substance. | Number | participants |
|
| IL28B Genotype | Genotype was determined through medical record chart review. | Count of Participants | Participants |
|
| OG002 | Treatment as Usual | In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. |
|
|
| Secondary | Sustained Virologic Response | Undetectable HCV RNA at posttreatment week 12. | Posted | Count of Participants | Participants | 12 weeks after treatment completion |
|
|
|
| Secondary | HCV Treatment Completion | Completion of ≥80% of the planned treatment course. For example, ≥10 wk of a 12-wk course, or ≥20 wk of a 24-wk course. | Posted | Count of Participants | Participants | Up to 48 weeks |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 1 |
| 51 |
| EG001 | 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. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. | 1 | 48 | 0 | 48 | 3 | 48 |
| EG002 | Treatment as Usual | In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. | 1 | 51 | 0 | 51 | 5 | 51 |
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| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |