Clinical Trials Directory

Trials / Completed

CompletedNCT01128920

Reducing Health Problems Associated With Injection Drug Use

Reduction of Medical Complications Associated With Injection Drug Use

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
87 (actual)
Sponsor
University of Northern Colorado · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALSkin and Needle Hygiene InterventionIntervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices
OTHERNo intervention - assessment-only conditionNo intervention is assigned in this condition

Timeline

Start date
2009-06-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2010-05-24
Last updated
2012-01-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01128920. Inclusion in this directory is not an endorsement.