Clinical trial NCT03441542: Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatitis C
Keywords: Care cascade
Patient navigation services
Injection drug users
Opioid substitution therapy
Lead sponsor: National Opinion Research Center
Sponsor class: OTHER
Collaborators: name: Grady Health System
name: Merck Sharp & Dohme LLC
name: Emory University
First posted: 2018-02-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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.
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
3. 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

Primary outcomes:
measure: Completion of HCV care milestones in HCV cure cascade
timeFrame: Within 6 months of enrollment
Secondary outcomes:
Other outcomes:
measure: Achievement of HCV sustained viral response (SVR)
timeFrame: Within 12 months of enrollment
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: NORC at the University of Chicago
name: David Rein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: