CClinicalTrials.gg
CompletedNCT00241917Updated Dec 9, 2008

A Video-Based HCV Curriculum for Drug Users

An interventional study of Hepatitis C educational video and Video in Hepatitis C and Opiate Dependence, sponsored by Organization to Achieve Solutions in Substance Abuse (OASIS). Completed at 3 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-12-09.

Sponsored by Organization to Achieve Solutions in Substance Abuse (OASIS) · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis C
  • Opiate Dependence

Keywords

  • hepatitis C
  • heroin
  • populations at risk
  • testing
  • vaccination
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 450 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Organization to Achieve Solutions in Substance Abuse (OASIS) is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 or older
  • Enrolled on methadone maintenance within last 30 days

Exclusion criteria

Exclusion Criteria:

  • Unable to provide informed consent
  • Not interested in study
  • Not able to speak or understand English
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Video

    Behavioral: Hepatitis C educational video · Other: Video

  • No intervention
    Control

Interventions

  • BehavioralHepatitis C educational video
  • OtherVideo

    Prevention education video about hepatitis C

06

What researchers measure

Primary outcomes

  1. HCV testing rates, intervention vs. usual care

  2. HAV vaccination rates, intervention vs. usual care

  3. HBV vaccination rates, intervention vs. usual care

Secondary outcomes

  1. Improvement in knowledge, intervention vs. usual care

  2. Improvement in attitudes toward behavior change, intervention vs. usual care

  3. Improvement in motivation toward behavior change, intervention vs. usual care

07

Study locations

3 sites
  • BAART/Antioch Methadone Clinic
    Antioch, California 94565, United States
  • BAART/Richmond Methadone Clinic
    Richmond, California 94804, United States
  • BAART/Market Methadone Clinic
    San Francisco, California 94103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00241917
Lead sponsor
Organization to Achieve Solutions in Substance Abuse (OASIS)
Collaborators
Centers for Disease Control and Prevention
First posted
Oct 19, 2005
Start date
Nov 2005
Primary completion
May 2007
Completion
May 2007
Last update
Dec 9, 2008

Study contacts

Diana L Sylvestre, MD
principal investigator · Organization to Achieve Solutions in Substance Abuse (OASIS)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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