A Video-Based HCV Curriculum for Drug Users
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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 |
- HCV testing rates, intervention vs. usual care
- HAV vaccination rates, intervention vs. usual care
- HBV vaccination rates, intervention vs. usual care
- 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 |
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| 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 | |
| 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 May 23, 2013