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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
History of Changes
  Purpose

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


Condition Intervention
Intravenous Drug Abuse
HIV Infections
 Behavioral: Skin and Needle Hygiene Intervention
Other: No intervention - assessment-only condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of Medical Complications Associated With Injection Drug Use

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Northern Colorado:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Skin and Needle Hygiene Intervention 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
Experimental: Assessment-Only Condition Other: No intervention - assessment-only condition
No intervention is assigned in this condition

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128920

Locations
United States, Colorado
Project Safe, University of Colorado
Denver, Colorado, United States, 80506
Sponsors and Collaborators
University of Northern Colorado
University of Colorado, Denver
Butler Hospital
Investigators
Principal Investigator: Kristina T Phillips, Ph.D. University of Northern Colorado
  More Information

No publications provided

Responsible Party: Kristina Phillips, Associate Professor, University of Northern Colorado
ClinicalTrials.gov Identifier: NCT01128920     History of Changes
Other Study ID Numbers: DA026773-01
Study First Received: May 19, 2010
Last Updated: December 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Northern Colorado:
bacterial infections
skin infections
HIV
Hepatitis C
risk reduction intervention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Substance Abuse, Intravenous
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mental Disorders

ClinicalTrials.gov processed this record on March 03, 2013