Hepatitis C Tracker Study

NCT ID: NCT06870019

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-08
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this study is to determine if GPS tracking can enhance adherence to hepatitis C treatment among patients diagnosed with hepatitis C infection who are also experiencing unsheltered homelessness and receiving street medicine. Research will compare medication adherence among participants randomly assigned to receive standard medical care for Hepatitis C versus the standard medical care for Hepatitis C along with GPS tracking assistance.

Detailed Description

Previous research on Hepatitis C infection (HCV) has found positivity rates between 12% and 27% among people experiencing homelessness; far exceeding typical rates found among a general housed population (1%). The usual course of HCV care in the healthcare system is screening and diagnosis in primary care, then referral to specialty care (such as Hepatology or Gastroenterology) for treatment. All of this takes place within the confines of traditional "brick and mortar" clinics. This screen, refer, and treat model presents a multitude of person- and systems-level barriers for individuals experiencing homelessness.

Street Medicine was developed as an alternative healthcare delivery model to better account for the unique circumstances of the unsheltered homeless population and better meet their healthcare needs. It is defined as the delivery of individually tailored health and social services to people experiencing unsheltered homelessness directly in their own environment. Street Medicine clinicians are ideally positioned to screen, diagnose, and treat patients for HCV. Treatment of uncomplicated HCV requires daily medication for 8 to 12 weeks. Our pilot data show that USC Street Medicine can successfully engage patients in HCV treatment on the street (93% successful follow-up rate), however, adequate longitudinal follow-up for effective treatment has been a problem for other programs.

Innovative, practical, and ethical solutions to help locate patients experiencing homelessness who require follow-up for medical treatment are needed. One such potential solution is the use of discreet GPS tracking devices that may be activated when providers are in the field to locate and provide care to patients. GPS tracking devices have been used by other Street Medicine programs caring for patients experiencing homelessness. However, no research has used GPS devices for the treatment of HCV amongst people experiencing unsheltered homelessness or formally elicited the patient perspective.

This study seeks to evaluate the impact of using a GPS tracker among patients engaged in street-based treatment for HCV on medication adherence. This is a multi-site randomized controlled study to test the impact of using a GPS tracker vs. usual care (no tracker) on HCV medication adherence, along with individual interviews to explore the perspective of unsheltered homeless patients engaged in both study arms.

In this study, the use of the GPS tracker constitutes the experimental research; not the treatment for HCV. Initial screening for HCV will have already occurred as part of usual street medicine healthcare prior to this study and will not be conducted as part of this research.

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard HCV treatment

Participants randomized to this study arm will receive the standard medical care for Hepatitis C.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard HCV treatment + GPS tracker device

Participants randomized to this study arm will receive the standard medical care for Hepatitis C and a GPS tracker device.

Group Type: ACTIVE_COMPARATOR

GPS tracker device

Intervention Type: BEHAVIORAL

GPS tracker device

Interventions

GPS tracker device

GPS tracker device

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Hepatitis C infection
• Experiencing unsheltered homelessness at study initiation
• Speaks English or Spanish
• Receiving street medicine care
• Meet the American Association for the Study of Liver Diseases (AASLD) criteria for simplified treatment of Hepatitis C

Exclusion Criteria

• Prior engagement in HCV treatment
• Decompensated cirrhosis; HBsAg positive
• Current pregnancy; Known or suspended hepatocellular carcinoma
• Prior liver transplantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ventura County Medical Center

OTHER_GOV

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Camillo Zaks

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camilo Zaks, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Keck School of Medicine of USC, Department of Family Medicine, USC Street Medicine

Tipu Kahn, MD

Role: PRINCIPAL_INVESTIGATOR

Ventura County Medical Center

Locations

USC Street Medicine

Alhambra, California, United States

Site Status: RECRUITING

Ventura County Medical Center

Ventura, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexis Coulourides Kogan, PhD

Role: CONTACT

acoulour@usc.edu

626-457-4207

Facility Contacts

Alexis Coulourides Kogan, PhD

Role: primary

acoulour@usc.edu

626-457-4204

Matthew Lamon, DO

Role: primary

Matthew.Lamon@ventura.org

805-652-6100

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ISHF-62320

Identifier Type: -

Identifier Source: org_study_id