Reducing Health Problems Associated With Injection Drug Use

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

Detailed Description
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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.

Official Title
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Reduction of Medical Complications Associated With Injection Drug Use

Conditions
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Intravenous Drug Abuse, HIV Infections

Intervention / Treatment
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* Behavioral: Skin and Needle Hygiene Intervention
* Other: No intervention - assessment-only condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin and Needle Hygiene Intervention<br> | Behavioral: Skin and Needle Hygiene Intervention<br>* Intervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices<br>|
| Experimental: Assessment-Only Condition<br> | Other: No intervention - assessment-only condition<br>* No intervention is assigned in this condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors) |  | 1 month | 
| Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors) |  | 6 months | 
| Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery) |  | 1 month | 
| Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning) |  | 1 month | 
| Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall. |  | 1 month | 
| Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning) |  | 6 months | 
| Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial infections, skin infections, HIV, Hepatitis C, risk reduction intervention