Hepatitis CNCT02648022
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
A study testing Brief mental health interventions and case management in people with Hepatitis C and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C, Depression, PTSD
- What is being tested?
- Brief mental health interventions and case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
- All patients 18 and 75 years old with confirmed HCV infection
- Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate
- Screening measures and cutoffs for inclusion were depression:
- Beck Depression Inventory: (BDI) > 10
- Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
- PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
- Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen
Who cannot join
- Lacked a confirmed test of HCV RNA
- Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
- Had Hepatitis B (HBV) co-infection
- Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
- Had other significant near term life-threatening diseases
- Were treatment non-responders with pegylated Interferon plus ribavirin
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
Read the detailed description
Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).
Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.
- Conditions
- Hepatitis C, Depression, PTSD, Substance Use Disorder, Fibrosis
- Being tested
- Brief mental health interventions and case management
- Keywords
- Care Integration, Hepatitis C, Substance Use Disorder, PTSD
- Medical subject headings
- Hepatitis C, Depression, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mental health interventions and case managementBehavioural
The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Care | Experimental | Consisted of brief mental health interventions and case management provided in a collaborative treatment environment. Receives: Behavioral: Brief mental health interventions and case management |
| Usual Care | No intervention | The usual care group received "standard of care" required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (SVR)
The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
Measured: up to 24 weeks
Secondary outcomes (2)
Percentage of Participants With Treatment Initiation and Completion
The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
Measured: up to 24 weeks
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Samuel B Ho, MD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648022
- Sponsor's protocol ID
- IIR 07-101-A
- Status last verified
- May 2016
- First submitted
- 21 Dec 2015
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
- ClinicalTrials.gov ID
- NCT02648022
- Acronym / sponsor ID
- IIR 07-101-A
- Conditions
- Hepatitis C, Depression, PTSD, Substance Use Disorder, Fibrosis
- Keywords
- Care Integration, Hepatitis C, Substance Use Disorder, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 20 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
Detailed description
Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).
Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Care | Experimental | Behavioral: Brief mental health interventions and case managementConsisted of brief mental health interventions and case management provided in a collaborative treatment environment. |
| Usual Care | No intervention | –The usual care group received "standard of care" required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
- All patients 18 and 75 years old with confirmed HCV infection
- Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate
- Screening measures and cutoffs for inclusion were depression:
Key exclusion criteria (6 listed)
- Lacked a confirmed test of HCV RNA
- Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
- Had Hepatitis B (HBV) co-infection
- Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
- Had other significant near term life-threatening diseases
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 |
|---|---|---|
| Brief mental health interventions and case managementThe mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians. | Behavioural | Integrated Care |
Primary outcome
Sustained Viral Response (SVR)
Time frame: up to 24 weeks
The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
2 secondary outcomes
Percentage of Participants With Treatment Initiation and Completion
Time frame: up to 24 weeks
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
Time frame: up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samuel B Ho, MD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mental health interventions and case management in people with Hepatitis C and Depression, run by VA Office of Research and Development 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 8 inclusion and 6 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 20 May 2016. 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?
Yes. Results are posted in the registry (first posted 20 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Viral Response (SVR) (time frame: up to 24 weeks). 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 20 May 2016.