Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391482
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2006-10-20
Brief Title:
Study to Reduce Intravenous Exposures STRIVE
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Behavioral Intervention Trial to Reduce Transmission Risks and Improve HCV Treatment Access Among HCV-infected Injection Drug Users
Status:
COMPLETED
Status Verified Date:
2008-11
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 purpose of this study is to determine whether a six-session small group behavioral intervention based on peer-volunteer activism is effective in 1 decreasing distributive sharing of syringes and other injection paraphernalia and 2 increasing utilization of HCV-related healthcare services among HCV-infected injection drug users
Detailed Description:
The purpose of this study is to determine the efficacy of a peer-volunteer intervention to reduce high-risk transmission behaviors among hepatitis C virus HCV-infected young adult injection drug users IDUs and to identify the proportion of these individuals who would be eligible and willing to undergo treatment to eradicate HCV infection HCV is one of the most frequently occurring human viral infections having an estimated worldwide prevalence of 3 In many regions of the United States between 65 and 95 of IDUs are HCV-seropositive and capable of transmitting the infection To date research studies targeting infected individuals to prevent secondary transmission of chronic blood-borne viral infection have generally been limited to post-test counseling and case management In addition recent data suggest that medical treatment of HCV infection may be most effective when offered soon after HCV seroconversion However the proportion of HCV-infected IDUs who meet strict national guidelines for HCV treatment is likely to be small because treatment is usually postponed while drug use continues Determining the proportion of infected individuals who may be both eligible and willing to undergo HCV therapy is highly important for guiding national standards and objectives to achieve greater numbers of IDUs in HCV therapy We have previously reported that fewer than 1 of HCV-infected IDUs in Baltimore are currently receiving such therapy Early initiation of HCV treatment among young IDUs in conjunction with a reduction in HCV transmission risk behaviors may ultimately lead to a reduction in incident HCV infection at the individual and the community levels
This study is a randomized controlled trial to determine the efficacy of a peer-volunteer activism intervention to reduce distributive syringe and injection paraphernalia sharing behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment If proven effective this intervention would substantially decrease the risk of HCV infection in the community To address these aims we plan to recruit screen and randomly assign 750 IDUs age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore New York and Seattle to a behavioral intervention 250 per site and prospectively monitor participants behavior at 3- and 6-month follow-up visits
This study is a randomized controlled trial to determine the efficacy of a peer-volunteer activism intervention to reduce distributive syringe and injection paraphernalia sharing behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment If proven effective this intervention would substantially decrease the risk of HCV infection in the community To address these aims we plan to recruit screen and randomly assign 750 IDUs age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore New York and Seattle to a behavioral intervention 250 per site and prospectively monitor participants behavior at 3- and 6-month follow-up visits
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 |
|---|---|---|---|
| 1R01DA014499 | NIH | None | httpsreporternihgovquickSearch1R01DA014499 |