Hepatitis CEZ-CNCT03441542
Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital
A study testing Data-assisted Case Navigation in people with Hepatitis C, run by National Opinion Research Center at 1 site in United States.
Trial summary
This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Data-assisted Case Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 15 Feb 2019
- 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
- Patient is antibody positivity for HCV, defined as;
- Patients identified in the Grady Memorial Hospital Hepatitis C registry who have tested antibody positive for HCV and have not received additional RNA confirmatory or genotype testing; or
- Patients who tested antibody positive for HCV through Grady Liver Clinics allied community-based testing organizations.
- Patient is a member of one of two sub-population groups of interest, people on opioid substitution therapy (OST) or people who currently inject drugs, defined as;
- A pharmaceutical or diagnostic indicator of OST or morbidity resulting from injecting drug use identified in the patient's electronic health record (EHR), or
- Referral for HCV care from an Atlanta area syringe exchange program
Show all 15Show fewer
- Eligible for treatment. To be eligible for treatment, patients must
- Meet the above criteria,
- Complete care milestones of viral load/RNA confirmation, viral genotyping, clinical evaluation, and non-invasive fibrosis stages;
- Exhibit a detectable viral load, and an HCV genotypes of 1 or 4
- Note: Enrolled patients infected with genotypes other than 1 or 4 will be treated according to usual care practices of the Grady Liver Clinic.
- Exclusion criteria. Patients who meet criteria 1 and 2 will be excluded from the study if
- They have already received confirmatory RNA or genotype testing
- Have been offered treatment by the Grady Liver Clinic and refused
- Have a comorbidity that the Grady Liver Clinic determines would contraindicate treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Effectiveness of Patient Registry Directed Patient Navigation in Improving Attainment of Hepatitis C Virus (HCV) Care Among Patients Using Opioid Substitution Therapy and Patients Who Currently Inject Drugs
This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). The study will use data from a previously developed patient registry system to identify patients for study recruitment, and use monthly updates of registry data to organize and direct patient navigation services for those individuals assigned to the treatment group. Patients assigned to the control group will also be eligible to receive HCV treatment, but will otherwise receive usual care.
This study has a parallel, randomized unblinded, case/control design in which eligible patients are assigned at baseline to either a registry-directed patient navigation system (case) or to usual care (control), characterized in terms of demographic and sub-population variables, and then compared after 12 months on two categories of outcomes; (1) attainment of care cascade milestones; and (2) treatment initiation, adherence, and virologic response. The study is designed and powered to answer two primary hypotheses (H1 \& H2):
- H1: As compared to those randomized to usual care (control), those randomized to the registry directed patient navigation arm (case) will be more likely to complete all pretreatment HCV care milestones as defined by a higher proportion completing all four pre-treatment care cascade outcomes.
- H2: As compared to the control group, a significantly higher proportion of those randomized to the case group will achieve a sustained viral response.
Read the detailed description
EZ-C's purpose is to determine the effectiveness of patient navigation services during treatment of hepatitis C compared to usual care among opioid substitution therapy (OST) and active injecting drug use (IDU) individuals.
To recruit OST and active IDU patients, customized queries will be created to identify pharmaceutical (methadone, buprenorphine, buprenorphine/naltrexone, naloxone) and diagnostic (ICD-10 codes for heroin poisoning, history of heroin abuse, long term current use of opiate analgesic, opioid dependence, and potentially others) indicators of OST or active injecting drug use. These codes will be implemented into the Grady HCV registry to flag and identify OST or possible active injecting drug use individuals that are HCV positive at Grady Health Systems.
Recruitment will consist of an initial letter describing the study and informing patients of their possible eligibility as well as informed consent documentation. This letter will be followed by up to three phone calls per patient from the patient navigator until a full sample of OST and active injecting drug users have been recruited. Once enrolled, patients will be randomly assigned into either the control or intervention group. Although there is no compensation for participating in the study, all patients that are recruited will receive treatment at no cost.
Once the study begins enrolling, the researchers will create spreadsheet reports of patients in the intervention group (those who are receiving patient navigation services) containing their HCV care information, such as antibody results, viral load test results and prescription refill information. Based on this spreadsheet, the researchers will develop a monthly task list for the patient navigator with patient by patient care cascade and treatment milestones that need to be accomplished per patient in the intervention group. The researchers will then deliver the spreadsheet and the task list to the Grady Liver Clinic Director who will use it to direct and supervise the activities of the patient navigator. The patient navigator will actively engage with those in the intervention group throughout the study and send reminders of their next steps in the treatment process/care cascade. The patient navigator will not engage with those in the control group as they will receive only usual care.
The intervention will last 12 months for each patient in both the case and control groups. After collecting data for the 80 patients at the end of the study, the researchers will analyze the data to determine the effectiveness of patient navigation services compared to those receiving usual care among IDU and OST individuals.
- Conditions
- Hepatitis C
- Being tested
- Data-assisted Case Navigation, Standard of Care
- Keywords
- Care cascade, Patient navigation services, Injection drug users, Opioid substitution therapy
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-assisted Case NavigationBehavioural
The researchers will develop a monthly task list for the patient navigator with patient by patient care cascade and treatment milestones that need to be accomplished per patient in the case group. The researchers will deliver the spreadsheet and the task list to the Grady Liver Clinic Director who will use it to direct and supervise the activities of the patient navigator.
Patient navigators will be responsible for reaching out to patients in only the intervention arm about their next step in the HCV care cascade.
Standard of CareBehavioural
Patients will be recruited into the study by the patient navigator, be provided information about HCV infection, and will be informed that treatment is freely available should they seek it. Patients will also be provided contact and address information for the treatment clinic.
| Study group | Role | What they receive |
|---|---|---|
| Data-assisted Case Navigation | Experimental | Patients are recruited and consented into the study by the patient navigator after which the navigator provides assistance with scheduling, reminders, and transportation. The navigator is also charged with responding to patient questions, and monitoring and documenting if and when patients achieve HCV care milestones. Each month, the project will update the Grady Liver Clinic HCV patient registry, to generate information about the patient's HCV care progress and use this information to develop instructions sheets regarding the expected care milestones to be achieved that month for each patient. During the month, the navigator will participate in project meetings and report on milestone achievement and barriers for patients assigned to the experimental arm of the study. Receives: Behavioral: Data-assisted Case Navigation |
| Standard of Care | Active comparator | Patients are recruited and consented into the study by the patient navigator at which time they will be reminded of their infection, consequences of untreated disease, and the availability of study sponsored antiviral treatment should they seek it. Patients will not be subsequently contacted by the study. Patients who seek treatment without patient navigation services will receive the same study provided HCV pre-treatment care and study provided treatment drugs when indicated. Self-referral to care and antiviral therapy when indicated are known to be effective in curing HCV among some patients, this arm is classified as an active comparator. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of HCV care milestones in HCV cure cascade
Variable indicating which step in the cure cascade patient last completed
Measured: Within 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start23 Jul 2018
- Primary completion15 Dec 2018
- Study completion15 Feb 2019
Why it stopped: Insufficient enrollment. Reasons for low enrollment were low eligibility, and difficulty contacting patients.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Opinion Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Grady Health System, Merck Sharp & Dohme LLC, Emory University
- Responsible party
- Principal investigator, Dr. David Rein, National Opinion Research Center
- Investigators
- David Rein, Ph.D., Principal investigator, NORC at the University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441542
- Sponsor's protocol ID
- 8223
- Acronym
- EZ-C
- Status last verified
- May 2022
- First submitted
- 9 Feb 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Effectiveness of Patient Registry Directed Patient Navigation in Improving Attainment of Hepatitis C Virus (HCV) Care Among Patients Using Opioid Substitution Therapy and Patients Who Currently Inject Drugs
- ClinicalTrials.gov ID
- NCT03441542
- Acronym / sponsor ID
- EZ-C / 8223
- Conditions
- Hepatitis C
- Keywords
- Care cascade, Patient navigation services, Injection drug users, Opioid substitution therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment. Reasons for low enrollment were low eligibility, and difficulty contacting patients.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Opinion Research CenterUniversity, hospital or other
- Collaborators
- Grady Health System, Merck Sharp & Dohme LLC, Emory University
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). The study will use data from a previously developed patient registry system to identify patients for study recruitment, and use monthly updates of registry data to organize and direct patient navigation services for those individuals assigned to the treatment group. Patients assigned to the control group will also be eligible to receive HCV treatment, but will otherwise receive usual care.
This study has a parallel, randomized unblinded, case/control design in which eligible patients are assigned at baseline to either a registry-directed patient navigation system (case) or to usual care (control), characterized in terms of demographic and sub-population variables, and then compared after 12 months on two categories of outcomes; (1) attainment of care cascade milestones; and (2) treatment initiation, adherence, and virologic response. The study is designed and powered to answer two primary hypotheses (H1 \& H2):
- H1: As compared to those randomized to usual care (control), those randomized to the registry directed patient navigation arm (case) will be more likely to complete all pretreatment HCV care milestones as defined by a higher proportion completing all four pre-treatment care cascade outcomes.
- H2: As compared to the control group, a significantly higher proportion of those randomized to the case group will achieve a sustained viral response.
Detailed description
EZ-C's purpose is to determine the effectiveness of patient navigation services during treatment of hepatitis C compared to usual care among opioid substitution therapy (OST) and active injecting drug use (IDU) individuals.
To recruit OST and active IDU patients, customized queries will be created to identify pharmaceutical (methadone, buprenorphine, buprenorphine/naltrexone, naloxone) and diagnostic (ICD-10 codes for heroin poisoning, history of heroin abuse, long term current use of opiate analgesic, opioid dependence, and potentially others) indicators of OST or active injecting drug use. These codes will be implemented into the Grady HCV registry to flag and identify OST or possible active injecting drug use individuals that are HCV positive at Grady Health Systems.
Recruitment will consist of an initial letter describing the study and informing patients of their possible eligibility as well as informed consent documentation. This letter will be followed by up to three phone calls per patient from the patient navigator until a full sample of OST and active injecting drug users have been recruited. Once enrolled, patients will be randomly assigned into either the control or intervention group. Although there is no compensation for participating in the study, all patients that are recruited will receive treatment at no cost.
Once the study begins enrolling, the researchers will create spreadsheet reports of patients in the intervention group (those who are receiving patient navigation services) containing their HCV care information, such as antibody results, viral load test results and prescription refill information. Based on this spreadsheet, the researchers will develop a monthly task list for the patient navigator with patient by patient care cascade and treatment milestones that need to be accomplished per patient in the intervention group. The researchers will then deliver the spreadsheet and the task list to the Grady Liver Clinic Director who will use it to direct and supervise the activities of the patient navigator. The patient navigator will actively engage with those in the intervention group throughout the study and send reminders of their next steps in the treatment process/care cascade. The patient navigator will not engage with those in the control group as they will receive only usual care.
The intervention will last 12 months for each patient in both the case and control groups. After collecting data for the 80 patients at the end of the study, the researchers will analyze the data to determine the effectiveness of patient navigation services compared to those receiving usual care among IDU and OST individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data-assisted Case Navigation | Experimental | Behavioral: Data-assisted Case NavigationPatients are recruited and consented into the study by the patient navigator after which the navigator provides assistance with scheduling, reminders, and transportation. The navigator is also charged with responding to patient questions, and monitoring and documenting if and when patients achieve HCV care milestones. Each month, the project will update the Grady Liver Clinic HCV patient registry, to generate information about the patient's HCV care progress and use this information to develop instructions sheets regarding the expected care milestones to be achieved that month for each patient. During the month, the navigator will participate in project meetings and report on milestone achievement and barriers for patients assigned to the experimental arm of the study. |
| Standard of Care | Active comparator | Behavioral: Standard of CarePatients are recruited and consented into the study by the patient navigator at which time they will be reminded of their infection, consequences of untreated disease, and the availability of study sponsored antiviral treatment should they seek it. Patients will not be subsequently contacted by the study. Patients who seek treatment without patient navigation services will receive the same study provided HCV pre-treatment care and study provided treatment drugs when indicated. Self-referral to care and antiviral therapy when indicated are known to be effective in curing HCV among some patients, this arm is classified as an active comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient is antibody positivity for HCV, defined as;
- Patient is a member of one of two sub-population groups of interest, people on opioid substitution therapy (OST) or people who currently inject drugs, defined as;
- Eligible for treatment. To be eligible for treatment, patients must
- Exclusion criteria. Patients who meet criteria 1 and 2 will be excluded from the study if
- They have already received confirmatory RNA or genotype testing
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Data-assisted Case NavigationThe researchers will develop a monthly task list for the patient navigator with patient by patient care cascade and treatment milestones that need to be accomplished per patient in the case group. The researchers will deliver the spreadsheet and the task list to the Grady Liver Clinic Director who will use it to direct and supervise the activities of the patient navigator. Patient navigators will be responsible for reaching out to patients in only the intervention arm about their next step in the HCV care cascade. | Behavioural | Data-assisted Case Navigation |
| Standard of CarePatients will be recruited into the study by the patient navigator, be provided information about HCV infection, and will be informed that treatment is freely available should they seek it. Patients will also be provided contact and address information for the treatment clinic. | Behavioural | Standard of Care |
Primary outcome
Completion of HCV care milestones in HCV cure cascade
Time frame: Within 6 months of enrollment
Variable indicating which step in the cure cascade patient last completed
Results and safety
The study was stopped early (reason given: Insufficient enrollment. Reasons for low enrollment were low eligibility, and difficulty contacting patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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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.
David Rein, Ph.D. principal investigator
NORC at the University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-assisted Case Navigation in people with Hepatitis C, run by National Opinion Research Center 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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 25 May 2022. 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 was stopped early (reason given: Insufficient enrollment. Reasons for low enrollment were low eligibility, and difficulty contacting patients.). 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?
Completion of HCV care milestones in HCV cure cascade (time frame: Within 6 months of enrollment). 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 25 May 2022.