Clinical trial NCT00241917: A Video-Based HCV Curriculum for 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: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 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.

Eligibility criteria: 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

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 motivation toward behavior change, intervention vs. usual care
Other outcomes:
Locations:
city: Antioch
country: United States
facility: BAART/Antioch Methadone Clinic
state: California
city: Richmond
country: United States
facility: BAART/Richmond Methadone Clinic
state: California
city: San Francisco
country: United States
facility: BAART/Market Methadone Clinic
state: California
Study officials:
affiliation: Organization to Achieve Solutions in Substance Abuse (OASIS)
name: Diana L Sylvestre, MD
role: PRINCIPAL_INVESTIGATOR
References: