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Reducing Health Problems Associated With Injection Drug Use

This study has been completed.
Sponsor:
Collaborators:
University of Colorado, Denver
Butler Hospital
Information provided by (Responsible Party):
Kristina Phillips, University of Northern Colorado
ClinicalTrials.gov Identifier:
NCT01128920
First received: May 19, 2010
Last updated: December 30, 2011
Last verified: December 2011

May 19, 2010
December 30, 2011
June 2009
May 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01128920 on ClinicalTrials.gov Archive Site
  • Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reducing Health Problems Associated With Injection Drug Use
Reduction of Medical Complications Associated With Injection Drug Use

The purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intravenous Drug Abuse
  • HIV Infections
  • Behavioral: 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
  • Other: No intervention - assessment-only condition
    No intervention is assigned in this condition
  • Experimental: Skin and Needle Hygiene Intervention
    Intervention: Behavioral: Skin and Needle Hygiene Intervention
  • Experimental: Assessment-Only Condition
    Intervention: Other: No intervention - assessment-only condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128920
DA026773-01
No
Kristina Phillips, University of Northern Colorado
University of Northern Colorado
  • University of Colorado, Denver
  • Butler Hospital
Principal Investigator: Kristina T Phillips, Ph.D. University of Northern Colorado
University of Northern Colorado
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP