Chronic Hepatitis Intervention Project for Drug Users

HIV Clinical Trial

Official title:

Chronic Hepatitis Intervention Project for Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596843
• Other study ID #: DESPR DA013763
• Secondary ID: R01DA013763-01A2
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2008
• Last updated: February 28, 2017
• Start date: September 2003
• Est. completion date: November 2006

Study information

• Verified date: November 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 851
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis, Chronic
• HIV

Intervention

Behavioral:
• Motivational interviewing
6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
• Educational intervention
6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos

Locations

Country	Name	City	State
United States	RTI International Field Site	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction/cessation of alcohol use		6-months and 12-months
Secondary	Reductions in direct and indirect needle and syringe sharing		6-months and 12-months
Secondary	Reductions in unprotected sexual behavior		6-months and 12-months