Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148031
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2005-09-02
Brief Title:
Improving Hepatitis C Treatment in Injection Drug Users
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
Improving Hepatitis C Treatment in Injection Drug Users
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of the research project is to improve the outcome of medical care for injection drug users IDUs with Hepatitis C viral HCV infection
Hypothesis An intervention designed to improve the rate of HCV treatment completion and sustained virologic response SVR in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program
Hypothesis An intervention designed to improve the rate of HCV treatment completion and sustained virologic response SVR in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program
Detailed Description:
The overall goal of the proposed health services research project is to improve the outcome of medical care for injection drug users IDUs with Hepatitis C viral HCV infection This will be done by testing an intervention designed to improve the rate of HCV treatment completion and sustained virologic response SVR in IDUs This intervention will increase access by integrating HCV medical care into a substance abuse treatment program HCV infection is endemic among IDUs and is associated with significant medical morbidity While antiviral treatments are improving rapidly providing HCV medical care for IDUs remains problematic for a number of reasons IDUs often do not have adequate access to HCV diagnosis and treatment services and they may have co-morbid psychiatric diagnoses that affect the ability to withstand the demands of HCV treatment Therefore this study will also examine psychiatric disorders and psychiatric symptoms in IDUs who are infected with Hepatitis C virus
The proposed project is a five-year program consisting of a controlled clinical trial studying 220 patients with HCV infection enrolled in methadone maintenance treatment MMT The HCV Medical Care Study is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the Gastroenterology GI Clinic HCV antibody positive MMT patients N220 will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic or through usual off-site referral to the GI Clinic The main outcomes will be the rates of attaining SVR and completion of HCV treatment as well as other measures of HCV-related health outcomes and quality of life Participants will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study Psychiatric diagnosis will be made using the Structured Psychiatric Interview for the DSM-IV SCID and psychiatric symptom severity will be assessed for depression mania anxiety and psychosis Drug use measures and quality of life measures will also be obtained These data are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs They will provide a comparison of psychiatric diagnoses and psychiatric symptom presentation in HCV positive IDUs who choose to receive HCV treatment and those who do not choose to follow through with HCV treatment and will describe changes in psychiatric symptoms before during and after HCV medical care Finally the studies will also provide information about the influence of psychiatric symptoms and drug and alcohol use on HCV medical outcomes such as treatment completion and SVR
The proposed project is a five-year program consisting of a controlled clinical trial studying 220 patients with HCV infection enrolled in methadone maintenance treatment MMT The HCV Medical Care Study is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the Gastroenterology GI Clinic HCV antibody positive MMT patients N220 will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic or through usual off-site referral to the GI Clinic The main outcomes will be the rates of attaining SVR and completion of HCV treatment as well as other measures of HCV-related health outcomes and quality of life Participants will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study Psychiatric diagnosis will be made using the Structured Psychiatric Interview for the DSM-IV SCID and psychiatric symptom severity will be assessed for depression mania anxiety and psychosis Drug use measures and quality of life measures will also be obtained These data are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs They will provide a comparison of psychiatric diagnoses and psychiatric symptom presentation in HCV positive IDUs who choose to receive HCV treatment and those who do not choose to follow through with HCV treatment and will describe changes in psychiatric symptoms before during and after HCV medical care Finally the studies will also provide information about the influence of psychiatric symptoms and drug and alcohol use on HCV medical outcomes such as treatment completion and SVR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA016764 | NIH | None | httpsreporternihgovquickSearchR01DA016764 |