Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01128920
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.
Study:
NCT01128920
Study Brief:
Protocol Section:
NCT01128920