| October 18, 2005 |
| December 5, 2008 |
| November 2005 |
| May 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
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- 1. HCV testing rates, intervention vs. usual care
- 2. HAV vaccination rates, intervention vs. usual care
- 3. HBV vaccination rates, intervention vs. usual care
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| Complete list of historical versions of study NCT00241917 on ClinicalTrials.gov Archive Site |
- 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
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- 1. Improvement in knowledge, intervention vs. usual care
- 2. Improvement in attitudes toward behavior change, intervention vs. usual care
- 3. Improvement in motivation toward behavior change, intervention vs. usual care
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| A Video-Based HCV Curriculum for 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 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. |
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. |
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| Interventional |
| Other, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
- Hepatitis C
- Opiate Dependence
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- Behavioral: Hepatitis C educational video
- Other: Video
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| Completed |
| 450 |
| May 2007 |
| May 2007 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00241917 |
| Diana Sylvestre, MD, OASIS |
| U50/CCU923257, U50/CCU923257 |
| 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) |
|
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| Organization to Achieve Solutions in Substance Abuse (OASIS) |
| December 2008 |