Reducing Health Problems Associated With Injection Drug Use

HIV Infections Clinical Trial

Official title:

Reduction of Medical Complications Associated With Injection Drug Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128920
• Other study ID #: DA026773-01
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: December 30, 2011
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: December 2011
• Source: University of Northern Colorado
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Intravenous Drug Abuse
• Substance Abuse, Intravenous

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

Other:
• No intervention - assessment-only condition
No intervention is assigned in this condition

Locations

Country	Name	City	State
United States	Project Safe, University of Colorado	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Northern Colorado	Butler Hospital, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)		1 month	No
Primary	Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)		6 months	No
Primary	Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)		1 month	No
Primary	Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)		6 months	No
Secondary	Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)		1 month	No
Secondary	Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.		1 month	No
Secondary	Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)		6 months	No
Secondary	Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.		6 months	No