A Video-Based HCV Curriculum for Active Injection Drug Users

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Organization to Achieve Solutions in Substance Abuse (OASIS)
ClinicalTrials.gov Identifier:
NCT00241943
First received: October 18, 2005
Last updated: December 8, 2008
Last verified: December 2008

October 18, 2005
December 8, 2008
November 2005
August 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 NCT00241943 on ClinicalTrials.gov Archive Site
  • Improvement in knowledge, intervention vs. usual care
  • Improvement in attitudes toward behavior change, intervention vs. usual care
  • Improvement in motivations 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 motivations toward behavior change, intervention vs. usual care
Not Provided
Not Provided
 
A Video-Based HCV Curriculum for Active Injection 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 active drug injectors will lead to measurable improvements in HCV testing rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this condition. The investigators will use a short 10 minute video designed for active drug users to and assess its impact vs. a usual-care counseling intervention. The investigators will measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after intervention.

Active drug injectors are at high risk for contracting and transmitting HCV. Very few culturally-specific tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing rates, hepatitis A and B vaccination rates, and knowledge, attitudes, and motivations toward behavior change may be elicited by such a curriculum.

In this study, we will investigate the impact of a short HCV education video on active drug injectors at a syringe exchange program. Subjects will be enrolled in one of two cohorts: a usual-care cohort, which will receive the program's standard HCV counseling; vs an intervention cohort, which will view the education video. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, immediately after 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 end of the 12 week time point in both cohorts.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Hepatitis C
  • Opiate Dependence
Procedure: Hepatitis C educational video
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 and older
  • Attendance at syringe exchange program

Exclusion Criteria:

  • Unable to provide informed consent
  • Not interested in study
  • Not able to speak or understand English
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00241943
U50/CCU923257-2, U50/CCU923257
No
Diana Sylvestre, MD, OASIS
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