Clinical trial NCT06870019: Hepatitis C Tracker Study
Official title: Effects of GPS Tracking on Patient Adherence to Hepatitis C Treatment Among People Experiencing Unsheltered Homelessness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatitis C Virus Infection
Keywords: Street medicine
Unsheltered homelessness
Hepatitis C
GPS tracker
Mixed-methods
Ill-housed person
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Ventura County Medical Center
First posted: 2025-03-11
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Medication Adherence Rate
timeFrame: 12 weeks
measure: Length of treatment course
timeFrame: 12 weeks
Secondary outcomes:
measure: Sustained virologic response
timeFrame: through study completion, an average of 24 weeks
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: USC Street Medicine
state: California
city: Ventura
country: United States
facility: Ventura County Medical Center
state: California
Study officials:
affiliation: University of Southern California, Keck School of Medicine of USC, Department of Family Medicine, USC Street Medicine
name: Camilo Zaks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ventura County Medical Center
name: Tipu Kahn, MD
role: PRINCIPAL_INVESTIGATOR
References: