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Reducing Health Problems Associated With Injection Drug Use

Primary Purpose

Intravenous Drug Abuse, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin and Needle Hygiene Intervention
No intervention - assessment-only condition
Sponsored by
University of Northern Colorado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intravenous Drug Abuse focused on measuring bacterial infections, skin infections, HIV, Hepatitis C, risk reduction intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Project Safe, University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Skin and Needle Hygiene Intervention

Assessment-Only Condition

Arm Description

Outcomes

Primary Outcome Measures

Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)

Secondary Outcome Measures

Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.

Full Information

First Posted
May 19, 2010
Last Updated
December 30, 2011
Sponsor
University of Northern Colorado
Collaborators
University of Colorado, Denver, Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01128920
Brief Title
Reducing Health Problems Associated With Injection Drug Use
Official Title
Reduction of Medical Complications Associated With Injection Drug Use
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Northern Colorado
Collaborators
University of Colorado, Denver, Butler Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravenous Drug Abuse, HIV Infections
Keywords
bacterial infections, skin infections, HIV, Hepatitis C, risk reduction intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin and Needle Hygiene Intervention
Arm Type
Experimental
Arm Title
Assessment-Only Condition
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Skin and Needle Hygiene Intervention
Intervention Description
Intervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices
Intervention Type
Other
Intervention Name(s)
No intervention - assessment-only condition
Intervention Description
No intervention is assigned in this condition
Primary Outcome Measure Information:
Title
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
Title
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
Title
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Time Frame
1 month
Title
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Time Frame
1 month
Title
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Time Frame
1 month
Title
Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
Time Frame
6 months
Title
Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina T Phillips, Ph.D.
Organizational Affiliation
University of Northern Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Safe, University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80506
Country
United States

12. IPD Sharing Statement

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Reducing Health Problems Associated With Injection Drug Use

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