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
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.
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.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 124 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this study arm will receive the standard medical care for Hepatitis C.
Participants randomized to this study arm will receive the standard medical care for Hepatitis C and a GPS tracker device.
Behavioral: GPS tracker device
GPS tracker device
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
Length of treatment course
Number of weeks patient engaged in HCV medication treatment
Time frame: 8-12 weeks
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
PDFs hosted by the registry, ClinicalTrials.gov.
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.
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