Intervention to Reduce Injection Drug Use

Study Overview
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Brief Summary
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This is a five-year prospective randomized trial comparing two intervention conditions designed to facilitate substance abuse treatment entry and enhance retention in order to reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and to improve client overall functioning. The overall goal of this project is to compare strengths-based case-management (CM) to an enhanced version of CM that uses case managers to facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.

Official Title
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Intervention to Reduce Injection Drug Use

Conditions
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Substance Abuse

Intervention / Treatment
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* Behavioral: Strengths-based case management
* Behavioral: Case management plus facilitated treatment alliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: opiate injection at least 3 times a week during the last 6-months 18 years of age or older no drug abuse treatment in the 30-days prior to the interview not transient no known reason (e.g. pending jail time) why they will not be available for follow-up interviews not involved in Project Safe research activities in the previous 12 months willing to meet with an Addiction Research and Treatment Services (methadone clinic) counselor eligible to be treated at ARTS Exclusion Criteria: too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview

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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No

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: Case Management<br> | Behavioral: Strengths-based case management<br>* Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline.<br>|
| Experimental: Facilitated Treatment Alliance<br> | Behavioral: Case management plus facilitated treatment alliance<br>* Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline. They will also receive a facilitated treatment alliance, which consists of meetings with methadone counselors to aid in treatment entry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment entry and retention |  | Baseline, 6 months after baseline, 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug injection and HIV/HCV risk behaviors |  | Baseline, 6 months after baseline, 12 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug treatment entry and retention, Drug injection frequency, HIV risk behaviors, Hepatitis C risk behaviors