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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014