Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital (EZ-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03441542
Recruitment Status : Not yet recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Grady Health System
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. David Rein, National Opinion Research Center

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Behavioral: Data-assisted Case Navigation Behavioral: Standard of Care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized, Parallel Design Study to Assess the Effectiveness of Patient Registry Directed Patient Navigation in Improving Attainment of Hepatitis C Virus (HCV) Care Management and Treatment Outcomes Among Two HCV Antibody Positive Sub-populations, Patients Using Opioid Substitution Therapy and Patients Who Currently Inject Drugs
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Data-assisted Case Navigation
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.
Behavioral: Data-assisted Case Navigation

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.

Active Comparator: Standard of Care
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.
Behavioral: Standard of Care
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.

Primary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Achievement of HCV sustained viral response (SVR) [ Time Frame: Within 12 months of enrollment ]
    Dichotomous (yes/no) variable of achieving SVR

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Criterion 1: 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.

Criterion 2: 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

Criterion 3: 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

Criterion 4: 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03441542

Contact: Farah Ahmed, B.S. 404-680-7275

Sponsors and Collaborators
National Opinion Research Center
Grady Health System
Merck Sharp & Dohme Corp.
Principal Investigator: David Rein, Ph.D. NORC at the University of Chicago

Responsible Party: Dr. David Rein, Program Area Director, Public Health, National Opinion Research Center Identifier: NCT03441542     History of Changes
Other Study ID Numbers: 8223
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. David Rein, National Opinion Research Center:
Care cascade
Patient navigation services
Injection drug users
Opioid substitution therapy

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections