A Video-Based HCV Curriculum for Drug Users

Not Applicable

Completed

• Conditions: Hepatitis C; Opiate Dependence
• Interventions: Behavioral: Hepatitis C educational video; Other: Video

• Registration Number: NCT00241917
• Lead Sponsor: Organization to Achieve Solutions in Substance Abuse (OASIS)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Study Start: 2005-11
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-05
• Last Update Posted: 2008-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video	Hepatitis C educational video	-
Video	Video	-

Primary Outcome Measures

Name	Time	Method
HCV testing rates, intervention vs. usual care
HAV vaccination rates, intervention vs. usual care
HBV vaccination rates, intervention vs. usual care

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

BAART/Market Methadone Clinic; 🇺🇸 San Francisco, California, United States

BAART/Richmond Methadone Clinic; 🇺🇸 Richmond, California, United States

BAART/Antioch Methadone Clinic; 🇺🇸 Antioch, California, United States