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A Video-Based HCV Curriculum for Drug Users

NCT ID: NCT00241917

Last Updated: 2008-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-05-31

Brief Summary

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The investigators hypothesize that a well-designed hepatitis C (HCV)video education curriculum for high-risk drug users will show measurable benefits in improving HCV testing, hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward transmission behavior change. The investigators will use a 4-part modular video series designed for at-risk drug users, and in this 12 week study will assess its impact on testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained drug users as compared to a usual-care intervention.

Detailed Description

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Injection drug users are at high risk for contracting hepatitis C (HCV). Very few culturally-specific educational tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing, hepatitis A and B vaccinations, and testable knowledge, attitudes, and motivations may be elicited by such a curriculum.

In this study, we will investigate the impact of a 4-module short video educational series on these measures in in-treatment drug users maintained on methadone. Subjects will be enrolled in 3 sequential cohorts of 150 each: usual care, a 4 weekly sequential video cohort, and a single-session intervention in which the 4 videos are viewed at once. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, 4 weeks after the intervention, and 12 weeks after the intervention. Additionally, we will measure and compare the rates of HCV testing and HAV/HBV vaccinations before and at the 12-week time point in all cohorts.

Conditions

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Hepatitis C Opiate Dependence

Keywords

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hepatitis C heroin populations at risk testing vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Video

Group Type EXPERIMENTAL

Hepatitis C educational video

Intervention Type BEHAVIORAL

Video

Intervention Type OTHER

Prevention education video about hepatitis C

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hepatitis C educational video

Intervention Type BEHAVIORAL

Video

Prevention education video about hepatitis C

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Enrolled on methadone maintenance within last 30 days

Exclusion Criteria

* Unable to provide informed consent
* Not interested in study
* Not able to speak or understand English
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Organization to Achieve Solutions in Substance Abuse (OASIS)

OTHER

Sponsor Role lead

Responsible Party

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OASIS

Principal Investigators

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Diana L Sylvestre, MD

Role: PRINCIPAL_INVESTIGATOR

Organization to Achieve Solutions in Substance Abuse (OASIS)

Locations

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BAART/Antioch Methadone Clinic

Antioch, California, United States

Site Status

BAART/Richmond Methadone Clinic

Richmond, California, United States

Site Status

BAART/Market Methadone Clinic

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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U50/CCU923257

Identifier Type: -

Identifier Source: secondary_id

U50/CCU923257

Identifier Type: -

Identifier Source: org_study_id