A Video-Based HCV Curriculum for Drug Users

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241917
• Other study ID #: U50/CCU923257
• Secondary ID: U50/CCU923257
• Status: Completed
• Phase: N/A
• First received: October 18, 2005
• Last updated: December 5, 2008
• Start date: November 2005
• Est. completion date: May 2007

Study information

• Verified date: December 2008
• Source: Organization to Achieve Solutions in Substance Abuse (OASIS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Opiate Dependence

Intervention

Behavioral:
• Hepatitis C educational video

Other:
• Video
Prevention education video about hepatitis C

Locations

Country	Name	City	State
United States	BAART/Antioch Methadone Clinic	Antioch	California
United States	BAART/Richmond Methadone Clinic	Richmond	California
United States	BAART/Market Methadone Clinic	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Organization to Achieve Solutions in Substance Abuse (OASIS)	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV testing rates, intervention vs. usual care
Primary	HAV vaccination rates, intervention vs. usual care
Primary	HBV vaccination rates, intervention vs. usual care
Secondary	Improvement in knowledge, intervention vs. usual care
Secondary	Improvement in attitudes toward behavior change, intervention vs. usual care
Secondary	Improvement in motivation toward behavior change, intervention vs. usual care