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A Video-Based HCV Curriculum for Drug Users

This study is not yet open for participant recruitment.
Verified by Organization to Achieve Solutions in Substance Abuse (OASIS), October 2005

Sponsors and Collaborators: Organization to Achieve Solutions in Substance Abuse (OASIS)
Centers for Disease Control and Prevention
Information provided by: Organization to Achieve Solutions in Substance Abuse (OASIS)
ClinicalTrials.gov Identifier: NCT00241917
  Purpose

We 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. We 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.


Condition Intervention
Hepatitis C
Opiate Dependence
Behavioral: Hepatitis C educational video

MedlinePlus related topics:   Hepatitis    Hepatitis C   

ChemIDplus related topics:   Diacetylmorphine    Diacetylmorphine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training

Further study details as provided by Organization to Achieve Solutions in Substance Abuse (OASIS):

Primary Outcome Measures:
  • 1. HCV testing rates, intervention vs. usual care
  • 2. HAV vaccination rates, intervention vs. usual care
  • 3. HBV vaccination rates, intervention vs. usual care

Secondary Outcome Measures:
  • 1. Improvement in knowledge, intervention vs. usual care
  • 2. Improvement in attitudes toward behavior change, intervention vs. usual care
  • 3. Improvement in motivation toward behavior change, intervention vs. usual care

Estimated Enrollment:   450
Study Start Date:   November 2005
Estimated Study Completion Date:   May 2007

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241917

Contacts
Contact: Diana L Sylvestre, MD     510-834-5442     dsylves@itsa.ucsf.edu    
Contact: Laphyne Barrett     510-834-5442     oasisclinic@sbcglobal.net    

Locations
United States, California
BAART/Market Methadone Clinic     Not yet recruiting
      San Francisco, California, United States, 94103
      Principal Investigator: Audrey Sellers, MD            
BAART/Richmond Methadone Clinic     Not yet recruiting
      Richmond, California, United States, 94804
      Contact: Kyle Moore, MD            
      Principal Investigator: Kyle Moore, MD            
BAART/Antioch Methadone Clinic     Not yet recruiting
      Antioch, California, United States, 94565

Sponsors and Collaborators
Organization to Achieve Solutions in Substance Abuse (OASIS)
Centers for Disease Control and Prevention

Investigators
Principal Investigator:     Diana L Sylvestre, MD     Organization to Achieve Solutions in Substance Abuse (OASIS)    
  More Information

Study ID Numbers:   U50/CCU923257, U50/CCU923257
First Received:   October 18, 2005
Last Updated:   October 18, 2005
ClinicalTrials.gov Identifier:   NCT00241917
Health Authority:   United States: Institutional Review Board

Keywords provided by Organization to Achieve Solutions in Substance Abuse (OASIS):
hepatitis C  
heroin  
populations at risk  
testing  
vaccination  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Heroin
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Hepatitis, Viral, Human
Hepatitis C
Opioid-Related Disorders

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 05, 2008




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