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Chronic Hepatitis Intervention Project for Drug Users

Primary Purpose

HIV, Hepatitis C

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Educational intervention
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • RTI International Field Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Motivational intervention

Educational intervention

Outcomes

Primary Outcome Measures

Reduction/cessation of alcohol use

Secondary Outcome Measures

Reductions in direct and indirect needle and syringe sharing
Reductions in unprotected sexual behavior

Full Information

First Posted
January 7, 2008
Last Updated
February 28, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00596843
Brief Title
Chronic Hepatitis Intervention Project for Drug Users
Official Title
Chronic Hepatitis Intervention Project for Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis C

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
851 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Motivational intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Educational intervention
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
Primary Outcome Measure Information:
Title
Reduction/cessation of alcohol use
Time Frame
6-months and 12-months
Secondary Outcome Measure Information:
Title
Reductions in direct and indirect needle and syringe sharing
Time Frame
6-months and 12-months
Title
Reductions in unprotected sexual behavior
Time Frame
6-months and 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William A. Zule, Dr.P.H.
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
RTI International Field Site
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19218179
Citation
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.
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Chronic Hepatitis Intervention Project for Drug Users

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