Chronic Hepatitis CNCT01717560
Hepatitis C Treatment in Underserved Populations
A study testing Collaborative, multidisciplinary, integrated care in people with Chronic Hepatitis C and Illicit Drug Use, run by Brian Edlin at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Illicit Drug Use
- What is being tested?
- Collaborative, multidisciplinary, integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2020
- 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 years or older
- Used heroin, cocaine, or injected other drugs for at least 1 year
- Have used heroin, cocaine and/or methamphetamine within the last 30 days
- Test positive for HCV antibody
- Are interested in being evaluated for HCV treatment
Who cannot join
- Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Study of Hepatitis C, Weill Medical College, Cornell University
New York, New York, 10021
About this study
The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.
Read the detailed description
This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.
- Conditions
- Chronic Hepatitis C, Illicit Drug Use
- Being tested
- Collaborative, multidisciplinary, integrated care
- Keywords
- chronic hepatitis C, illicit drug use, Substance-Related Disorders, multidisciplinary care, integrated care, mental health care, intensive case management
- Medical subject headings
- Hepatitis C, Chronic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative, multidisciplinary, integrated careOther
Collaborative, multidisciplinary, integrated care for hepatitis C
multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative multidisciplinary integrated care | Experimental | Collaborative, multidisciplinary, integrated care for hepatitis C Receives: Other: Collaborative, multidisciplinary, integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
SVR is measured 24 weeks after completion of antiviral treatment
Measured: 24 weeks after completion of antiviral treatment
Secondary outcomes (11)
completion of medical and psychiatric evaluation for antiviral therapy
Measured: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.
initiation of antiviral therapy
Measured: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.
adherence to antiviral therapy
Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)
Measured: Weekly up to 48 weeks
completion of antiviral therapy
Measured: Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)
levels of alcohol and illicit drug use
Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up
Measured: Weekly up to 96 weeks
entry into treatment for substance use
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
Measured: Monthly up to 24 months
entry into treatment for another unaddressed medical or psychiatric condition
Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy
Measured: Monthly up to 24 months
neuropsychiatric side effects, including depression and hostility/irritability
Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter
Measured: Monthly up to 72 weeks
treatment-limiting systemic, hematologic, or other side effects
Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)
Measured: Weekly up to 72 weeks
other adverse events or adverse effects
Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff
Measured: Monthly up to 72 weeks
reinfection
Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.
Measured: Quarterly up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startFeb 2005
- Primary completionDec 2012 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Edlin
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, State University of New York - Downstate Medical Center
- Responsible party
- Sponsor-investigator, Brian Edlin, Weill Medical College of Cornell University
- Investigators
- Brian R. Edlin, MD, Principal investigator, Weill Medical College, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717560
- Sponsor's protocol ID
- 0308006281
- Status last verified
- Oct 2012
- First submitted
- 29 Apr 2008
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Treatment in Underserved Populations
- ClinicalTrials.gov ID
- NCT01717560
- Acronym / sponsor ID
- 0308006281
- Conditions
- Chronic Hepatitis C, Illicit Drug Use
- Keywords
- chronic hepatitis C, illicit drug use, Substance-Related Disorders, multidisciplinary care, integrated care, mental health care, intensive case management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brian EdlinUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, State University of New York - Downstate Medical Center
- Study start
- Feb 2005
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Oct 2012 (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 feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.
Detailed description
This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collaborative multidisciplinary integrated care | Experimental | Other: Collaborative, multidisciplinary, integrated careCollaborative, multidisciplinary, integrated care for hepatitis C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Used heroin, cocaine, or injected other drugs for at least 1 year
- Have used heroin, cocaine and/or methamphetamine within the last 30 days
- Test positive for HCV antibody
- Are interested in being evaluated for HCV treatment
Key exclusion criteria (1 listed)
- Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.
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 |
|---|---|---|
| Collaborative, multidisciplinary, integrated careCollaborative, multidisciplinary, integrated care for hepatitis C multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. | Other | Collaborative multidisciplinary integrated care |
Primary outcome
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
Time frame: 24 weeks after completion of antiviral treatment
SVR is measured 24 weeks after completion of antiviral treatment
11 secondary outcomes
completion of medical and psychiatric evaluation for antiviral therapy
Time frame: Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.
initiation of antiviral therapy
Time frame: Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.
adherence to antiviral therapy
Time frame: Weekly up to 48 weeks
completion of antiviral therapy
Time frame: Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)
levels of alcohol and illicit drug use
Time frame: Weekly up to 96 weeks
entry into treatment for substance use
Time frame: Monthly up to 24 months
entry into treatment for another unaddressed medical or psychiatric condition
Time frame: Monthly up to 24 months
neuropsychiatric side effects, including depression and hostility/irritability
Time frame: Monthly up to 72 weeks
treatment-limiting systemic, hematologic, or other side effects
Time frame: Weekly up to 72 weeks
other adverse events or adverse effects
Time frame: Monthly up to 72 weeks
reinfection
Time frame: Quarterly up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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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.
Brian R. Edlin, MD principal investigator
Weill Medical College, Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative, multidisciplinary, integrated care in people with Chronic Hepatitis C and Illicit Drug Use, run by Brian Edlin 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 5 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: status not confirmed, as of the sponsor's last update on 30 Oct 2012. 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?
Results are not available in the source record.
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?
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy. (time frame: 24 weeks after completion of antiviral treatment). 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 30 Oct 2012.