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RecruitingNCT06870019Updated Aug 29, 2025

Hepatitis C Tracker Study

An interventional study of GPS tracker device in Hepatitis C Virus Infection, sponsored by University of Southern California. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by University of Southern California · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis C Virus Infection

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Keywords

  • Street medicine
  • Unsheltered homelessness
  • Hepatitis C
  • GPS tracker
  • Mixed-methods
  • Ill-housed person
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Prior engagement in HCV treatment
  • Decompensated cirrhosis; HBsAg positive
  • Current pregnancy; Known or suspended hepatocellular carcinoma
  • Prior liver transplantation
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • No intervention
    Standard HCV treatment

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

  • Active comparator
    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.

    Behavioral: GPS tracker device

Interventions

  • BehavioralGPS tracker device

    GPS tracker device

05

What researchers measure

Primary outcomes

  1. Medication Adherence Rate

    Number 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

    Time frame: 8-12 weeks

  2. Length of treatment course

    Number of weeks patient engaged in HCV medication treatment

    Time frame: 8-12 weeks

Secondary outcomes

  1. Sustained virologic response

    "Undetectable" quantitative HCV RNA blood value 12-weeks post conclusion of HCV treatment course

    Time frame: through study completion, an average of 24 weeks

06

Study locations

2 of 2 sites recruiting
  • USC Street Medicine
    Alhambra, California 91803, United States
    • Alexis Coulourides Kogan, PhD · Contact · acoulour@usc.edu · 626-457-4204
    • Alexis Coulourides Kogan, PhD · Sub investigator
    • Camilo Zaks, MD · Principal investigator
    Recruiting
  • Ventura County Medical Center
    Ventura, California 93003, United States
    • Matthew Lamon, DO · Contact · Matthew.Lamon@ventura.org · 805-652-6100
    • Matthew Lamon, DO · Sub investigator
    • Tipu Kahn, MD · Principal investigator
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 24, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — The condition of interest for this study (HCV) is a sensitive one and thus, individual participant data will not be shared. However, de-identified data and/or data in aggregate may be shared as long as it cannot be traced back to an individual. GPS location data will not be shared; instead, data associated with the GPS device such as lost device, device used to locate participant, device refusal, etc. may be shared.

08

Registry details

Key details

Study ID
NCT06870019
Lead sponsor
University of Southern California
Collaborators
Ventura County Medical Center
Responsible party
Camillo Zaks (Associate Professor, University of Southern California) — Principal investigator
First posted
Mar 11, 2025
Start date
Aug 8, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 29, 2025

Study contacts

Alexis Coulourides Kogan, PhD
Contact
acoulour@usc.edu
626-457-4207
Camilo Zaks, MD
principal investigator · University of Southern California, Keck School of Medicine of USC, Department of Family Medicine, USC Street Medicine
Tipu Kahn, MD
principal investigator · Ventura County Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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