A Video-Based HCV Curriculum for Drug Users

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Organization to Achieve Solutions in Substance Abuse (OASIS)
ClinicalTrials.gov Identifier:
NCT00241917
First received: October 18, 2005
Last updated: December 5, 2008
Last verified: December 2008
  Purpose

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.


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


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 motivation toward behavior change, intervention vs. usual care

Enrollment: 450
Study Start Date: November 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Video Behavioral: Hepatitis C educational video Other: Video
Prevention education video about hepatitis C
No Intervention: Control

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

Locations
United States, California
BAART/Antioch Methadone Clinic
Antioch, California, United States, 94565
BAART/Richmond Methadone Clinic
Richmond, California, United States, 94804
BAART/Market Methadone Clinic
San Francisco, California, United States, 94103
Sponsors and Collaborators
Organization to Achieve Solutions in Substance Abuse (OASIS)
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: NCT00241917     History of Changes
Other Study ID Numbers: U50/CCU923257, U50/CCU923257
Study First Received: October 18, 2005
Last Updated: December 5, 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 April 21, 2014