Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164372
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-09-09
Brief Title:
Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Collaborative Injection Drug Users Study IIIDrug Users Intervention Trial CIDUS IIIDUIT
Status:
COMPLETED
Status Verified Date:
2012-09
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 test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection
Detailed Description:
CIDUS IIIDUIT is a five-city Baltimore Chicago Los Angeles New York and Seattle randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years The primary goals of the intervention are to
1 decrease the shared use of syringes and other injection paraphernalia
2 decrease sexual risk behaviors associated with HIV and HCV infection and
3 decrease the incidence of hepatitis C virus HCV infection
The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection In the fifth session participants practice peer education around sex or injection risk behaviors within their community The control arm consists of six video and discussion sessions to control for attention Prior to study enrollment all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information Behavioral assessments by audio computer assisted self interviewing and blood draws for serologic testing occur at baseline 3 and 6 month follow-up 3285 participants completed the baseline visit of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial Of the eligible participants 854 were randomized into the trial 606 and 591 returned for 3 and 6 month follow-up assessments respectively and 712 participants completed at least one follow-up visit
1 decrease the shared use of syringes and other injection paraphernalia
2 decrease sexual risk behaviors associated with HIV and HCV infection and
3 decrease the incidence of hepatitis C virus HCV infection
The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection In the fifth session participants practice peer education around sex or injection risk behaviors within their community The control arm consists of six video and discussion sessions to control for attention Prior to study enrollment all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information Behavioral assessments by audio computer assisted self interviewing and blood draws for serologic testing occur at baseline 3 and 6 month follow-up 3285 participants completed the baseline visit of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial Of the eligible participants 854 were randomized into the trial 606 and 591 returned for 3 and 6 month follow-up assessments respectively and 712 participants completed at least one follow-up visit
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 |
|---|---|---|---|
| U64CCU071615 | None | None | None |
| U64CCU317662 | None | None | None |
| U64CCU517656 | None | None | None |
| U64CCU917655 | None | None | None |
| U64 CCU217659 | None | None | None |