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Hepatitis C Tracker Study

Effects of GPS Tracking on Patient Adherence to Hepatitis C Treatment Among People Experiencing Unsheltered Homelessness

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06870019
Enrollment
124
Registered
2025-03-11
Start date
2025-08-08
Completion date
2027-12-31
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus Infection

Keywords

Street medicine, Unsheltered homelessness, Hepatitis C, GPS tracker, Mixed-methods, Ill-housed person

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.

Interventions

BEHAVIORALGPS tracker device

GPS tracker device

Sponsors

Ventura County Medical Center
CollaboratorOTHER_GOV
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Masking at the participant and provider levels is not possible because participants will be randomized to receive a physical GPS tracker device or to not receive a GPS tracker device. Street medicine team providers need to know the randomization assignment to ping the tracker for scheduled medical encounters to locate the participant.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence Rate8-12 weeksNumber of prescribed HCV pills taken (missing from pill organizer) versus number of HCV pills prescribed (present in pill organizer) per week, for each week of the 12-week treatment regimen
Length of treatment course8-12 weeksNumber of weeks patient engaged in HCV medication treatment

Secondary

MeasureTime frameDescription
Sustained virologic responsethrough study completion, an average of 24 weeksUndetectable quantitative HCV RNA blood value 12-weeks post conclusion of HCV treatment course

Countries

United States

Contacts

Primary ContactAlexis Coulourides Kogan, PhD
acoulour@usc.edu626-457-4207

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026