Chronic Hepatitis Intervention Project for Drug Users
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Hepatitis C |
Behavioral: Motivational interviewing Behavioral: Educational intervention |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Chronic Hepatitis Intervention Project for Drug Users |
- Reduction/cessation of alcohol use [ Time Frame: 6-months and 12-months ] [ Designated as safety issue: No ]
- Reductions in direct and indirect needle and syringe sharing [ Time Frame: 6-months and 12-months ] [ Designated as safety issue: No ]
- Reductions in unprotected sexual behavior [ Time Frame: 6-months and 12-months ] [ Designated as safety issue: No ]
| Enrollment: | 851 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | February 2008 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Motivational intervention
|
Behavioral: Motivational interviewing
6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
|
|
Active Comparator: 2
Educational intervention
|
Behavioral: Educational intervention
6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00596843
| United States, North Carolina | |
| RTI International Field Site | |
| Durham, North Carolina, United States | |
| Principal Investigator: | William A. Zule, Dr.P.H. | RTI International |
More Information
No publications provided
| Responsible Party: | Elizabeth Lambert, PO, NIDA |
| ClinicalTrials.gov Identifier: | NCT00596843 History of Changes |
| Other Study ID Numbers: | DESPR DA013763, RO1 DA13763-01-A2 |
| Study First Received: | January 7, 2008 |
| Last Updated: | November 13, 2008 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on March 03, 2015