NCT00786630

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
726

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

5.1 years

First QC Date

November 4, 2008

Last Update Submit

December 19, 2014

Conditions

Substance Abuse

Keywords

Drug treatment entry and retentionDrug injection frequencyHIV risk behaviorsHepatitis C risk behaviors

Outcome Measures

Primary Outcomes (1)

  • Treatment entry and retention

    Baseline, 6 months after baseline, 12 months after baseline

Secondary Outcomes (1)

  • Drug injection and HIV/HCV risk behaviors

    Baseline, 6 months after baseline, 12 months after baseline

Study Arms (2)

Case Management

EXPERIMENTAL
Behavioral: Strengths-based case management

Facilitated Treatment Alliance

EXPERIMENTAL
Behavioral: Case management plus facilitated treatment alliance

Interventions

Strengths-based case managementBEHAVIORAL

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.

Case Management
Case management plus facilitated treatment allianceBEHAVIORAL

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.

Facilitated Treatment Alliance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opiate injection at least 3 times a week during the last 6-months
  • 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

You may not qualify if:

  • too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Safe

Denver, Colorado, 80205, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Robert E. Booth, Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 6, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

US(1)