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A Video-Based HCV Curriculum for Active Injection Drug Users

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
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
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training

Resource links provided by NLM:

U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • 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

Enrollment: 103
Study Start Date: November 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241943

Locations
United States, California
HEPPAC
Oakland, California, United States, 94601
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

No publications provided

Responsible Party: Diana Sylvestre, MD, OASIS
ClinicalTrials.gov Identifier: NCT00241943     History of Changes
Other Study ID Numbers: U50/CCU923257-2, U50/CCU923257
Study First Received: October 18, 2005
Last Updated: December 8, 2008
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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013