Clinical trial NCT01128920: Reducing Health Problems Associated With Injection Drug Use
Official title: Reduction of Medical Complications Associated With Injection Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Drug Abuse
HIV Infections
Keywords: bacterial infections
skin infections
HIV
Hepatitis C
risk reduction intervention
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Butler Hospital
First posted: 2010-05-24
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
timeFrame: 1 month
measure: Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
timeFrame: 6 months
measure: Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
timeFrame: 1 month
measure: Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
timeFrame: 1 month
measure: Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
timeFrame: 1 month
measure: Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)
timeFrame: 6 months
measure: Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Project Safe, University of Colorado
state: Colorado
Study officials:
affiliation: University of Northern Colorado
name: Kristina T Phillips, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: