Chronic Hepatitis Intervention Project for Drug Users
2 other identifiers
interventional
851
1 country
1
Brief Summary
The purpose of this study is to determine if a 6-session motivational interviewing intervention is more effective than a 6-session educational intervention at reducing behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C among out of treatment injecting drug users.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv
Started Sep 2003
Typical duration for phase_3 hiv
1 active site
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
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedMarch 1, 2017
November 1, 2008
3.2 years
January 7, 2008
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction/cessation of alcohol use
6-months and 12-months
Secondary Outcomes (2)
Reductions in direct and indirect needle and syringe sharing
6-months and 12-months
Reductions in unprotected sexual behavior
6-months and 12-months
Study Arms (2)
1
EXPERIMENTALMotivational intervention
2
ACTIVE COMPARATOREducational intervention
Interventions
6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
Eligibility Criteria
You may qualify if:
- minimum age of 18 years injected illicit drugs within last 30 days
You may not qualify if:
- participated in formal substance treatment in last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RTI International Field Site
Durham, North Carolina, United States
Related Publications (1)
Zule WA, Costenbader EC, Coomes CM, Wechsberg WM. Effects of a hepatitis C virus educational intervention or a motivational intervention on alcohol use, injection drug use, and sexual risk behaviors among injection drug users. Am J Public Health. 2009 Apr;99 Suppl 1(Suppl 1):S180-6. doi: 10.2105/AJPH.2007.126854. Epub 2009 Feb 12.
PMID: 19218179RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William A. Zule, Dr.P.H.
RTI International
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 17, 2008
Study Start
September 1, 2003
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
March 1, 2017
Record last verified: 2008-11