HCV Negative StatusPhase 3NCT00218192
A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
A Phase 3 study testing Behavior Therapy in people with HCV Negative Status and HCV Risk Behavior, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCV Negative Status, HCV Risk Behavior
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Nov 2006
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current opiate or cocaine use
- HCV seronegative
- able to complete the study procedures in English
Who cannot join
- current enrollment in a formal substance abuse treatment program
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Trial to Reduce Hepatitis C Among Injection Drug Users
The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.
Read the detailed description
Injection drug users are at high risk for blood-borne viral infections during their first years of injecting when they are least likely to seek formal substance abuse treatment, and are likely to be practicing risky drug-use behaviors. Research has demonstrated that a brief motivational intervention that includes booster sessions and addresses drug and sex risks is effective in reducing HIV risk behaviors among injection drug users.
Because Hepatitis C Virus is a bloodborne pathogen like HIV, and transmission occurs via similar behaviors, successful HIV prevention strategies should be robust in preventing HCV but need to be tested. Motivational interventions, which aim to elicit a goal and plan from the patient to reduce injection and sexual risk taking, are particularly suited to address behaviorally-based changes. Motivational interventions are individualized and tailored to the risks and concerns of the participant, but can be standardized and evaluated to make this technique applicable in a variety of settings. The occurrence of injection drug use in a population with traditionally poor linkage to primary care, an enormous burden of illness, and high HCV and other blood-borne pathogen transmission risk, supports the use of motivational interventions in this group.
Comparison(s): Participants are assigned, in this 24 month longitudinal study, to an assessment-only condition or an assessment plus motivational intervention condition. Participants in the intervention condition receive up to 4 sessions of motivational interviewing during the first 6 months of the study.
- Conditions
- HCV Negative Status, HCV Risk Behavior
- Being tested
- Behavior Therapy
- Keywords
- hepatitis c, injection drug use
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis C seroconversion
Secondary outcomes (1)
Substance use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2000
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCV Negative StatusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Stein, MD, National Institute on Drug Abuse (NIDA)
- Investigators
- Michael Stein, M.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218192
- Sponsor's protocol ID
- NIDA-13759-1
- Other IDs
- R01DA013759, R01-13759-1
- Status last verified
- Apr 2013
- First submitted
- 16 Sep 2005
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein MD, Herman DS, Anderson BJ. A trial to reduce hepatitis C seroincidence in drug users. J Addict Dis. 2009 Oct;28(4):389-98. doi: 10.1080/10550880903183034.
PubMed 20155608
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Reduce Hepatitis C Among Injection Drug Users
- ClinicalTrials.gov ID
- NCT00218192
- Acronym / sponsor ID
- NIDA-13759-1
- Conditions
- HCV Negative Status, HCV Risk Behavior
- Keywords
- hepatitis c, injection drug use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2000
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Sep 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 purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.
Detailed description
Injection drug users are at high risk for blood-borne viral infections during their first years of injecting when they are least likely to seek formal substance abuse treatment, and are likely to be practicing risky drug-use behaviors. Research has demonstrated that a brief motivational intervention that includes booster sessions and addresses drug and sex risks is effective in reducing HIV risk behaviors among injection drug users.
Because Hepatitis C Virus is a bloodborne pathogen like HIV, and transmission occurs via similar behaviors, successful HIV prevention strategies should be robust in preventing HCV but need to be tested. Motivational interventions, which aim to elicit a goal and plan from the patient to reduce injection and sexual risk taking, are particularly suited to address behaviorally-based changes. Motivational interventions are individualized and tailored to the risks and concerns of the participant, but can be standardized and evaluated to make this technique applicable in a variety of settings. The occurrence of injection drug use in a population with traditionally poor linkage to primary care, an enormous burden of illness, and high HCV and other blood-borne pathogen transmission risk, supports the use of motivational interventions in this group.
Comparison(s): Participants are assigned, in this 24 month longitudinal study, to an assessment-only condition or an assessment plus motivational intervention condition. Participants in the intervention condition receive up to 4 sessions of motivational interviewing during the first 6 months of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current opiate or cocaine use
- HCV seronegative
- able to complete the study procedures in English
Key exclusion criteria (1 listed)
- current enrollment in a formal substance abuse treatment program
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
Hepatitis C seroconversion
1 secondary outcome
Substance use
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 22 May 2015.
- Derived from this study: PubMed 20155608Stein MD, Herman DS, Anderson BJ. A trial to reduce hepatitis C seroincidence in drug users. J Addict Dis. 2009 Oct;28(4):389-98. doi: 10.1080/10550880903183034.
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.
Michael Stein, M.D. principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavior Therapy in people with HCV Negative Status and HCV Risk Behavior, run by Butler Hospital 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 3 inclusion and 1 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 22 May 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hepatitis C seroconversion. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218192, which also lists 1 linked publication.
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 22 May 2015.