Overview

This trial is active, not recruiting.

Conditions hiv, hepatitis c
Treatments motivational interviewing, educational intervention
Phase phase 3
Sponsor National Institute on Drug Abuse (NIDA)
Start date September 2003
End date November 2006
Trial size 851 participants
Trial identifier NCT00596843, DESPR DA013763, RO1 DA13763-01-A2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Motivational intervention
motivational interviewing
6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
(Active Comparator)
Educational intervention
educational intervention
6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos

Primary Outcomes

Measure
Reduction/cessation of alcohol use
time frame: 6-months and 12-months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Chronic Hepatitis Intervention Project for Drug Users
Principal investigator William A. Zule, Dr.P.H.
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).