Reducing Health Problems Associated With Injection Drug Use

NCT ID: NCT01128920

Last Updated: 2012-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Intravenous Drug Abuse; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Skin and Needle Hygiene Intervention

Group Type: EXPERIMENTAL

Skin and Needle Hygiene Intervention

Intervention Type: BEHAVIORAL

Intervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices

Assessment-Only Condition

Group Type: EXPERIMENTAL

No intervention - assessment-only condition

Intervention Type: OTHER

No intervention is assigned in this condition

Interventions

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

Intervention Type: BEHAVIORAL

No intervention - assessment-only condition

No intervention is assigned in this condition

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: collaborator

University of Northern Colorado

OTHER

Sponsor Role: lead

Responsible Party

Kristina Phillips

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristina T Phillips, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Northern Colorado

Locations

Project Safe, University of Colorado

Denver, Colorado, United States

Countries

United States

Other Identifiers

DA026773-01

Identifier Type: -

Identifier Source: org_study_id