Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01128920
Status:
COMPLETED
Last Update Posted:
2012-01-04
First Post:
2010-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Health Problems Associated With Injection Drug Use
Sponsor:
University of Northern Colorado
Organization:
Study Overview
Official Title:
Reduction of Medical Complications Associated With Injection Drug Use
Status:
COMPLETED
Status Verified Date:
2011-12
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 develop and test an intervention to reduce bacterial and viral infections among injection drug users.
Detailed Description:
Injection drug use (IDU) is a major public health problem that is associated with a host of medical complications, including blood-borne viral disease (e.g., HIV, Hepatitis C) and bacterial infections (e.g., skin abscesses, endocarditis), that often result from high-risk drug injection practices. There are no current interventions designed to reduce bacterial infections among IDUs, despite high rates of infection.
The objective of this study is to develop and test the efficacy of a skin and needle hygiene intervention for IDUs to reduce practices associated with bacterial and viral infections. In the first phase of the study, focus group interviews were conducted to determine key areas of emphasis for an intervention with this population. An initial intervention was developed, pilot tested, and refined. The final 2-session intervention combines psychoeducation, skill-building, and motivational interviewing.
Following refinement of the intervention, a small randomized controlled trial (n = 60; 30 in each group) to examine the efficacy of the intervention compared to an assessment-only condition will be conducted. The goals of this two-year study are to: 1) reduce high-risk injection practices among active IDUs that lead to bacterial and viral infections, 2) improve skin and needle cleaning behavioral skills, and 3) increase skin cleaning prior to injection and reduce subcutaneous/intramuscular injection.
In addition to examining these goals over a six-month period, the acceptability and feasibility of the intervention will be examined.
The objective of this study is to develop and test the efficacy of a skin and needle hygiene intervention for IDUs to reduce practices associated with bacterial and viral infections. In the first phase of the study, focus group interviews were conducted to determine key areas of emphasis for an intervention with this population. An initial intervention was developed, pilot tested, and refined. The final 2-session intervention combines psychoeducation, skill-building, and motivational interviewing.
Following refinement of the intervention, a small randomized controlled trial (n = 60; 30 in each group) to examine the efficacy of the intervention compared to an assessment-only condition will be conducted. The goals of this two-year study are to: 1) reduce high-risk injection practices among active IDUs that lead to bacterial and viral infections, 2) improve skin and needle cleaning behavioral skills, and 3) increase skin cleaning prior to injection and reduce subcutaneous/intramuscular injection.
In addition to examining these goals over a six-month period, the acceptability and feasibility of the intervention will be examined.
Study Oversight
Has Oversight DMC:
False
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?: