Hepatitis C Virus InfectionNCT06870019
Hepatitis C Tracker Study
A study testing GPS tracker device in people with Hepatitis C Virus Infection, run by University of Southern California at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- GPS tracker device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior engagement in HCV treatment
- Decompensated cirrhosis; HBsAg positive
- Current pregnancy; Known or suspended hepatocellular carcinoma
- Prior liver transplantation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
USC Street Medicine
Alhambra, California, 91803
Alexis Coulourides Kogan, PhD, 626-457-4204, acoulour@usc.edu
Alexis Coulourides Kogan, PhD
- Recruiting
Ventura County Medical Center
Ventura, California, 93003
Matthew Lamon, DO, 805-652-6100, Matthew.Lamon@ventura.org
Matthew Lamon, DO
About this study
Official title: Effects of GPS Tracking on Patient Adherence to Hepatitis C Treatment Among People Experiencing Unsheltered Homelessness
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.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- GPS tracker device
- Keywords
- Street medicine, Unsheltered homelessness, Hepatitis C, GPS tracker, Mixed-methods, Ill-housed person
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS tracker deviceBehavioural
GPS tracker device
| Study group | Role | What they receive |
|---|---|---|
| Standard HCV treatment | No intervention | Participants randomized to this study arm will receive the standard medical care for Hepatitis C. |
| Standard HCV treatment + GPS tracker device | Active comparator | Participants randomized to this study arm will receive the standard medical care for Hepatitis C and a GPS tracker device. Receives: Behavioral: GPS tracker device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8-12 weeks
Length of treatment course
Number of weeks patient engaged in HCV medication treatment
Measured: 8-12 weeks
Secondary outcomes (1)
Sustained virologic response
"Undetectable" quantitative HCV RNA blood value 12-weeks post conclusion of HCV treatment course
Measured: through study completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start8 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Ventura County Medical Center
- Responsible party
- Principal investigator, Camillo Zaks, University of Southern California
- Investigators
- Camilo Zaks, MD, Principal investigator, University of Southern California, Keck School of Medicine of USC, Department of Family Medicine, USC Street MedicineTipu Kahn, MD, Principal investigator, Ventura County Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870019
- Sponsor's protocol ID
- ISHF-62320
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GPS Tracking on Patient Adherence to Hepatitis C Treatment Among People Experiencing Unsheltered Homelessness
- ClinicalTrials.gov ID
- NCT06870019
- Acronym / sponsor ID
- ISHF-62320
- Conditions
- Hepatitis C Virus Infection
- Keywords
- Street medicine, Unsheltered homelessness, Hepatitis C, GPS tracker, Mixed-methods, Ill-housed person
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Ventura County Medical Center
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard HCV treatment | No intervention | –Participants randomized to this study arm will receive the standard medical care for Hepatitis C. |
| Standard HCV treatment + GPS tracker device | Active comparator | Behavioral: GPS tracker deviceParticipants randomized to this study arm will receive the standard medical care for Hepatitis C and a GPS tracker device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Prior engagement in HCV treatment
- Decompensated cirrhosis; HBsAg positive
- Current pregnancy; Known or suspended hepatocellular carcinoma
- Prior liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPS tracker deviceGPS tracker device | Behavioural | Standard HCV treatment + GPS tracker device |
Primary outcome
Medication Adherence Rate
Time frame: 8-12 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
Time frame: 8-12 weeks
Number of weeks patient engaged in HCV medication treatment
1 secondary outcome
Sustained virologic response
Time frame: through study completion, an average of 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPS tracker device in people with Hepatitis C Virus Infection, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Coulourides Kogan, PhD (626-457-4207, acoulour@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Rate (time frame: 8-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.