Hepatitis CNCT00241943
A Video-Based HCV Curriculum for Active Injection Drug Users
A study testing Hepatitis C educational video in people with Hepatitis C and Opiate Dependence, run by Organization to Achieve Solutions in Substance Abuse (OASIS) at 1 site in United States.
Trial summary
The investigators hypothesize that a well-designed hepatitis C (HCV) video education curriculum for active drug injectors will lead to measurable improvements in HCV testing rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Opiate Dependence
- What is being tested?
- Hepatitis C educational video
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Attendance at syringe exchange program
Who cannot join
- Unable to provide informed consent
- Not interested in study
- Not able to speak or understand English
Trial locations and contacts
1 site in 1 country.
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 active drug injectors will lead to measurable improvements in HCV testing rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this condition. The investigators will use a short 10 minute video designed for active drug users to and assess its impact vs. a usual-care counseling intervention. The investigators will measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after intervention.
Read the detailed description
Active drug injectors are at high risk for contracting and transmitting HCV. Very few culturally-specific tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing rates, hepatitis A and B vaccination rates, and knowledge, attitudes, and motivations toward behavior change may be elicited by such a curriculum.
In this study, we will investigate the impact of a short HCV education video on active drug injectors at a syringe exchange program. Subjects will be enrolled in one of two cohorts: a usual-care cohort, which will receive the program's standard HCV counseling; vs an intervention cohort, which will view the education video. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, immediately after 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 end of the 12 week time point in both cohorts.
- Conditions
- Hepatitis C, Opiate Dependence
- Being tested
- Hepatitis C educational 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 videoProcedure or surgery
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 motivations 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 completionAug 2007
- Study completionAug 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
- 103 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
- NCT00241943
- Sponsor's protocol ID
- U50/CCU923257-2
- 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
- NCT00241943
- Acronym / sponsor ID
- U50/CCU923257-2
- Conditions
- Hepatitis C, Opiate Dependence
- Keywords
- Hepatitis C, Heroin, Populations at risk, testing, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 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
- Aug 2007 (actual)
- Study completion
- Aug 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 active drug injectors will lead to measurable improvements in HCV testing rates, HAV and HBV vaccination rates, as well as knowledge and attitudes about this condition. The investigators will use a short 10 minute video designed for active drug users to and assess its impact vs. a usual-care counseling intervention. The investigators will measure and compare its impact at baseline, 4 weeks after video viewing, and 12 weeks after intervention.
Detailed description
Active drug injectors are at high risk for contracting and transmitting HCV. Very few culturally-specific tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing rates, hepatitis A and B vaccination rates, and knowledge, attitudes, and motivations toward behavior change may be elicited by such a curriculum.
In this study, we will investigate the impact of a short HCV education video on active drug injectors at a syringe exchange program. Subjects will be enrolled in one of two cohorts: a usual-care cohort, which will receive the program's standard HCV counseling; vs an intervention cohort, which will view the education video. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, immediately after 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 end of the 12 week time point in both cohorts.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and older
- Attendance at syringe exchange program
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 | Procedure or surgery | – |
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 motivations 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)
1 site 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 in people with Hepatitis C and Opiate Dependence, run by Organization to Achieve Solutions in Substance Abuse (OASIS) at 1 site 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 1 site 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.