- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01128920
Reducing Health Problems Associated With Injection Drug Use
Reduction of Medical Complications Associated With Injection Drug Use
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80506
- Project Safe, University of Colorado
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- injection of heroin on at least three different days in the last week
- injection of heroin for at least three months
- visible track marks/puncture wounds from needles
- positive urine screen for heroin
Exclusion Criteria:
- currently exhibiting active psychotic symptoms
- cannot complete study assessments or the intervention
- cannot provide informed consent
- unable to provide names and contact information for at least two verifiable locator persons who will know where to find client
- plans to relocate from area or be jail over next six months
- have been in a Project Safe study in the last year
- report being pregnant or attempting to become pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Skin and Needle Hygiene Intervention
|
Intervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices
|
Experimental: Assessment-Only Condition
|
No intervention is assigned in this condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
Time Frame: 1 month
|
1 month
|
Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
Time Frame: 6 months
|
6 months
|
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Time Frame: 1 month
|
1 month
|
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Time Frame: 1 month
|
1 month
|
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Time Frame: 1 month
|
1 month
|
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Time Frame: 6 months
|
6 months
|
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristina T Phillips, Ph.D., University Of Northern Colorado
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA026773-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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