Hepatitis C Tracker Study

Not Applicable

Not yet recruiting

• Conditions: Hepatitis C Virus Infection

• Registration Number: NCT06870019
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2025-02-07
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Adherence Rate	12 weeks	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
Length of treatment course	12 weeks	Number of weeks patient engaged in HCV medication treatment

Secondary Outcome Measures

Name	Time	Method
Sustained virologic response	through study completion, an average of 24 weeks	"Undetectable" quantitative HCV RNA blood value 12-weeks post conclusion of HCV treatment course

Trial Locations

Locations (2)

USC Street Medicine; 🇺🇸 Alhambra, California, United States

Ventura County Medical Center; 🇺🇸 Ventura, California, United States