A Video-Based HCV Curriculum for Drug Users

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training

Conditions
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Hepatitis C, Opiate Dependence

Intervention / Treatment
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* Behavioral: Hepatitis C educational video
* Other: Video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video<br> | Behavioral: Hepatitis C educational video<br> <br> Other: Video<br>* Prevention education video about hepatitis C<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV testing rates, intervention vs. usual care |  |  | 
| HAV vaccination rates, intervention vs. usual care |  |  | 
| HBV vaccination rates, intervention vs. usual care |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C, heroin, populations at risk, testing, vaccination