NCT00241917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 9, 2008

Status Verified

December 1, 2008

Enrollment Period

1.5 years

First QC Date

October 18, 2005

Last Update Submit

December 5, 2008

Conditions

Keywords

hepatitis Cheroinpopulations at risktestingvaccination

Outcome Measures

Primary Outcomes (3)

  • HCV testing rates, intervention vs. usual care

  • HAV vaccination rates, intervention vs. usual care

  • HBV vaccination rates, intervention vs. usual care

Secondary Outcomes (3)

  • Improvement in knowledge, intervention vs. usual care

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

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

Study Arms (2)

Video

EXPERIMENTAL
Behavioral: Hepatitis C educational videoOther: Video

Control

NO INTERVENTION

Interventions

VideoOTHER

Prevention education video about hepatitis C

Video

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

BAART/Antioch Methadone Clinic

Antioch, California, 94565, United States

Location

BAART/Richmond Methadone Clinic

Richmond, California, 94804, United States

Location

BAART/Market Methadone Clinic

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Hepatitis COpioid-Related Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Diana L Sylvestre, MD

    Organization to Achieve Solutions in Substance Abuse (OASIS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Study Start

November 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

December 9, 2008

Record last verified: 2008-12

Locations