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| Sponsors and Collaborators: |
Organization to Achieve Solutions in Substance Abuse (OASIS) Centers for Disease Control and Prevention |
| Information provided by: | Organization to Achieve Solutions in Substance Abuse (OASIS) |
| ClinicalTrials.gov Identifier: | NCT00241917 |
Purpose
We 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. We 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 |
| MedlinePlus related topics: | Hepatitis Hepatitis C |
| ChemIDplus related topics: | Diacetylmorphine Diacetylmorphine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training |
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | May 2007 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Diana L Sylvestre, MD | 510-834-5442 | dsylves@itsa.ucsf.edu |
| Contact: Laphyne Barrett | 510-834-5442 | oasisclinic@sbcglobal.net |
| United States, California | |||||
| BAART/Market Methadone Clinic | Not yet recruiting | ||||
| San Francisco, California, United States, 94103 | |||||
| Principal Investigator: Audrey Sellers, MD | |||||
| BAART/Richmond Methadone Clinic | Not yet recruiting | ||||
| Richmond, California, United States, 94804 | |||||
| Contact: Kyle Moore, MD | |||||
| Principal Investigator: Kyle Moore, MD | |||||
| BAART/Antioch Methadone Clinic | Not yet recruiting | ||||
| Antioch, California, United States, 94565 | |||||
| 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) |
More Information
| Study ID Numbers: | U50/CCU923257, U50/CCU923257 |
| First Received: | October 18, 2005 |
| Last Updated: | October 18, 2005 |
| ClinicalTrials.gov Identifier: | NCT00241917 |
| Health Authority: | United States: Institutional Review Board |
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