A Video-Based HCV Curriculum for Active Injection 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: NCT00241943
• Other study ID #: U50/CCU923257-2
• Secondary ID: U50/CCU923257
• Status: Completed
• Phase: N/A
• First received: October 18, 2005
• Last updated: December 8, 2008
• Start date: November 2005
• Est. completion date: August 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 active drug injectors will lead to measurable improvements in HCV testing rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this condition. The investigators will use a short 10 minute video designed for active drug users to and assess its impact vs. a usual-care counseling intervention. The investigators will measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after intervention.

Description:

Active drug injectors are at high risk for contracting and transmitting HCV. Very few culturally-specific tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing rates, hepatitis A and B vaccination rates, and knowledge, attitudes, and motivations toward behavior change may be elicited by such a curriculum.

In this study, we will investigate the impact of a short HCV education video on active drug injectors at a syringe exchange program. Subjects will be enrolled in one of two cohorts: a usual-care cohort, which will receive the program's standard HCV counseling; vs an intervention cohort, which will view the education video. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, immediately after 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 end of the 12 week time point in both cohorts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Attendance at syringe exchange program

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

Procedure:
• Hepatitis C educational video

Locations

Country	Name	City	State
United States	HEPPAC	Oakland	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 motivations toward behavior change, intervention vs. usual care