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Completed

NCT Number: NCT00241917

A Video-Based HCV Curriculum for Drug Users

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Opiate Dependence Opioid-Related Disorders RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BAART/Antioch Methadone Clinic, Antioch, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatitis C educational video

Behavioral

video

Other

Prevention education video about hepatitis C

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

Sponsors and collaborators

Lead sponsor

Organization to Achieve Solutions in Substance Abuse (OASIS)

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 19, 2005
Registry last updated
Dec 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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