Chronic Hepatitis Intervention Project for Drug Users

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00596843
First received: January 7, 2008
Last updated: November 13, 2008
Last verified: November 2008
  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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Reduction/cessation of alcohol use [ Time Frame: 6-months and 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596843

Locations
United States, North Carolina
RTI International Field Site
Durham, North Carolina, United States
Sponsors and Collaborators
Investigators
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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 31, 2014