Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146445
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-09-02
Brief Title:
Behavioral Intervention Trial for HIV-infected Injection Drug Users
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Intervention for Seropositive Injection Drug Users - Research and Evaluation INSPIRE
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 ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection increasing access to or utilization of HIV primary health care and increasing adherence to HIV medications
Detailed Description:
INSPIRE is a four-site Baltimore Miami New York and San Francisco randomized control trial to develop and evaluate the efficacy of a ten-session intervention for HIV-positive injection drug users The primary goals of the intervention are to
1 decrease sex and injection risk behaviors that put others at risk for HIV infection
2 increase access to or utilization of HIV primary health care and
3 increase adherence to HIV medications
The intervention arm consists of 7 group sessions 2 individual sessions and one community experience The control arm consists of 8 group sessions aiming at controlling for demand 1st session and attention 8 group sessions Behavioral assessments and blood draws for viral load and CD4 testing occur at baseline 6 and 12 month follow-up a 3 month assessment involves behavioral assessment only 1161 participants took baseline Of these 966 were randomized into the study and 840 807 and 821 participants took 3 6 and 12 month follow-up assessments respectively
1 decrease sex and injection risk behaviors that put others at risk for HIV infection
2 increase access to or utilization of HIV primary health care and
3 increase adherence to HIV medications
The intervention arm consists of 7 group sessions 2 individual sessions and one community experience The control arm consists of 8 group sessions aiming at controlling for demand 1st session and attention 8 group sessions Behavioral assessments and blood draws for viral load and CD4 testing occur at baseline 6 and 12 month follow-up a 3 month assessment involves behavioral assessment only 1161 participants took baseline Of these 966 were randomized into the study and 840 807 and 821 participants took 3 6 and 12 month follow-up assessments respectively
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 |
|---|---|---|---|
| U22CCU918003 | None | None | None |
| U22CCU217990 | None | None | None |
| U22CCU317999 | None | None | None |
| U22CCU417998 | None | None | None |