Clinical trial NCT00241943: A Video-Based HCV Curriculum for Active Injection Drug Users
Official title: Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Opiate Dependence
Keywords: Hepatitis C
Heroin
Populations at risk
testing
vaccination
Lead sponsor: Organization to Achieve Solutions in Substance Abuse (OASIS)
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-10-19
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: HCV testing rates, intervention vs. usual care
measure: HAV vaccination rates, intervention vs. usual care
measure: HBV vaccination rates, intervention vs. usual care
Secondary outcomes:
measure: Improvement in knowledge, intervention vs. usual care
measure: Improvement in attitudes toward behavior change, intervention vs. usual care
measure: Improvement in motivations toward behavior change, intervention vs. usual care
Other outcomes:
Locations:
city: Oakland
country: United States
facility: HEPPAC
state: California
Study officials:
affiliation: Organization to Achieve Solutions in Substance Abuse (OASIS)
name: Diana L. Sylvestre, MD
role: PRINCIPAL_INVESTIGATOR
References: