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Chronic Hepatitis Intervention Project for Drug Users

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596843
First Posted: January 17, 2008
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
January 7, 2008
January 17, 2008
March 1, 2017
September 2003
November 2006   (Final data collection date for primary outcome measure)
Reduction/cessation of alcohol use [ Time Frame: 6-months and 12-months ]
Same as current
Complete list of historical versions of study NCT00596843 on ClinicalTrials.gov Archive Site
  • Reductions in direct and indirect needle and syringe sharing [ Time Frame: 6-months and 12-months ]
  • Reductions in unprotected sexual behavior [ Time Frame: 6-months and 12-months ]
Same as current
Not Provided
Not Provided
 
Chronic Hepatitis Intervention Project for Drug Users
Chronic Hepatitis Intervention Project for Drug Users
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.

This 4.5-year community-based study is a randomized field experiment that uses a two-group design. Participants are randomized into either an Educational intervention group or a Motivational intervention group. We are comparing the effectiveness of the Motivational intervention with the Educational intervention. We are also estimating the costs and evaluating the cost-effectiveness of the Motivational intervention relative to the Educational intervention.

We have the following aims and related hypotheses:

Aim 1: To compare the effectiveness of a 6-session personalized motivational intervention to a 6-session educational intervention in terms of injection risk, sexual behavior, alcohol use, and knowledge and perception related to HBV and HCV; H1. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no injection risk at 6- and 12-month follow-up interviews. No injection risk is operationally defined as either no injections in the past 30 days, or no direct or indirect sharing of syringes and other injection equipment in the past 30 days.

H2. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no sexual risk at 6- and 12-month follow-up interviews. No sexual risk is operationally defined as either no sex (oral, vaginal, or anal) in the past 30 days, or no unprotected oral, vaginal, or anal sex in the past 30 days.

H3. Relative to the Educational intervention group, the Motivational intervention group will report greater decreases in frequency of alcohol consumption and quantity of alcohol consumed. Frequency of alcohol consumption is defined as "number of days drank alcohol in the past 30 days," and quantity of alcohol consumed is defined as "the average number of drinks per drinking day during the past 30 days." H4. Relative to the Educational intervention group, participants in the Motivational intervention group will report greater increases in knowledge and more accurate perceptions of severity of disease and efficacy of protective actions regarding hepatitis B and C at Session 3.

Aim 2: To estimate the cost and cost-effectiveness of a 6-session personalized motivational intervention relative to a 6-session educational intervention.

H5. The Motivational Intervention will cost more than the Educational Intervention, but will be cost-effective at eliminating injection risk behavior and sexual risk behavior and at reducing alcohol use

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HIV
  • Hepatitis C
  • Behavioral: Motivational interviewing
    6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
  • Behavioral: Educational intervention
    6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
  • Experimental: 1
    Motivational intervention
    Intervention: Behavioral: Motivational interviewing
  • Active Comparator: 2
    Educational intervention
    Intervention: Behavioral: Educational intervention
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:S180-6. doi: 10.2105/AJPH.2007.126854. Epub 2009 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
851
November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • minimum age of 18 years injected illicit drugs within last 30 days

Exclusion Criteria:

  • participated in formal substance treatment in last 30 days
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00596843
DESPR DA013763
R01DA013763-01A2 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: William A. Zule, Dr.P.H. RTI International
National Institute on Drug Abuse (NIDA)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP