Hepatitis CNCT00241917
A Video-Based HCV Curriculum for Drug Users
A study testing Hepatitis C educational video and Video in people with Hepatitis C and Opiate Dependence, run by Organization to Achieve Solutions in Substance Abuse (OASIS) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatitis C, Opiate Dependence
- What is being tested?
- Hepatitis C educational video and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Enrolled on methadone maintenance within last 30 days
Who cannot join
- Unable to provide informed consent
- Not interested in study
- Not able to speak or understand English
Trial locations and contacts
3 sites in 1 country.
United States3 sites
BAART/Antioch Methadone Clinic
Antioch, California, 94565
BAART/Richmond Methadone Clinic
Richmond, California, 94804
BAART/Market Methadone Clinic
San Francisco, California, 94103
About this study
Official title: Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training
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.
- Conditions
- Hepatitis C, Opiate Dependence
- Being tested
- Hepatitis C educational video, Video
- Keywords
- hepatitis C, heroin, populations at risk, testing, vaccination
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C educational videoBehavioural
VideoOther
Prevention education video about hepatitis C
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Not described Receives: Behavioral: Hepatitis C educational video; Other: Video |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organization to Achieve Solutions in Substance Abuse (OASIS)
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Diana L Sylvestre, MD, Principal investigator, Organization to Achieve Solutions in Substance Abuse (OASIS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241917
- Sponsor's protocol ID
- U50/CCU923257
- Other IDs
- U50/CCU923257
- Status last verified
- Dec 2008
- First submitted
- 18 Oct 2005
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Agreement to Develop, Implement, and Evaluate Viral Hepatitis and Training
- ClinicalTrials.gov ID
- NCT00241917
- Acronym / sponsor ID
- U50/CCU923257
- Conditions
- Hepatitis C, Opiate Dependence
- Keywords
- hepatitis C, heroin, populations at risk, testing, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Organization to Achieve Solutions in Substance Abuse (OASIS)University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: Hepatitis C educational video, Other: Video |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Enrolled on methadone maintenance within last 30 days
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Not interested in study
- Not able to speak or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis C educational video | Behavioural | Video |
| VideoPrevention education video about hepatitis C | Other | Video |
Primary outcome
HCV testing rates, intervention vs. usual care
HAV vaccination rates, intervention vs. usual care
HBV vaccination rates, intervention vs. usual care
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana L Sylvestre, MD principal investigator
Organization to Achieve Solutions in Substance Abuse (OASIS)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis C educational video and Video in people with Hepatitis C and Opiate Dependence, run by Organization to Achieve Solutions in Substance Abuse (OASIS) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV testing rates, intervention vs. usual care. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.