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A Video-Based HCV Curriculum for Drug Users
This study has been completed.
Study NCT00241917   Information provided by Organization to Achieve Solutions in Substance Abuse (OASIS)
First Received: October 18, 2005   Last Updated: December 5, 2008   History of Changes

October 18, 2005
December 5, 2008
November 2005
May 2007   (final data collection date for primary outcome measure)
  • HCV testing rates, intervention vs. usual care
  • HAV vaccination rates, intervention vs. usual care
  • HBV vaccination rates, intervention vs. usual care
  • 1. HCV testing rates, intervention vs. usual care
  • 2. HAV vaccination rates, intervention vs. usual care
  • 3. HBV vaccination rates, intervention vs. usual care
Complete list of historical versions of study NCT00241917 on ClinicalTrials.gov Archive Site
  • Improvement in knowledge, intervention vs. usual care
  • Improvement in attitudes toward behavior change, intervention vs. usual care
  • Improvement in motivation toward behavior change, intervention vs. usual care
  • 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
 
A Video-Based HCV Curriculum for Drug Users
Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training

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.

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.

 
Interventional
Other, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
  • Hepatitis C
  • Opiate Dependence
  • Behavioral: Hepatitis C educational video
  • Other: Video
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
450
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00241917
Diana Sylvestre, MD, OASIS
U50/CCU923257, U50/CCU923257
Organization to Achieve Solutions in Substance Abuse (OASIS)
Centers for Disease Control and Prevention
Principal Investigator: Diana L Sylvestre, MD Organization to Achieve Solutions in Substance Abuse (OASIS)
Organization to Achieve Solutions in Substance Abuse (OASIS)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP