Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital

NCT03441542 | Terminated

• 1 other identifier: 8223
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Care cascade; Patient navigation services; Injection drug users; Opioid substitution therapy

Outcome Measures

Primary Outcomes (1)

• Completion of HCV care milestones in HCV cure cascade

  Variable indicating which step in the cure cascade patient last completed

  Within 6 months of enrollment

Other Outcomes (1)

• Achievement of HCV sustained viral response (SVR)

  Within 12 months of enrollment

Study Arms (2)

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.

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.

Behavioral: Standard of Care

Interventions

Data-assisted Case Navigation BEHAVIORAL

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.

Data-assisted Case Navigation

Standard of Care BEHAVIORAL

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify 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

Sponsors & Collaborators

• National Opinion Research Center: lead
• Grady Health System: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Emory University: collaborator

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30315, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David Rein, Ph.D.

  NORC at the University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Area Director, Public Health

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: July 23, 2018
• Primary Completion: December 15, 2018
• Study Completion: February 15, 2019
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)