Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ventura County Medical Center | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GPS tracker device | Behavioral | GPS tracker device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8-12 weeks |
| Length of treatment course | Number of weeks patient engaged in HCV medication treatment | 8-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response | "Undetectable" quantitative HCV RNA blood value 12-weeks post conclusion of HCV treatment course | through study completion, an average of 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexis Coulourides Kogan, PhD | Contact | 626-457-4207 | acoulour@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Camilo Zaks, MD | University of Southern California, Keck School of Medicine of USC, Department of Family Medicine, USC Street Medicine | Principal Investigator |
| Tipu Kahn, MD | Ventura County Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Street Medicine | Recruiting | Alhambra | California | 91803 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2025 | Feb 24, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Randomized controlled trial
Not provided
Not provided
Masking at the participant and provider levels is not possible because participants will be randomized to receive a physical GPS tracker device or to not receive a GPS tracker device. Street medicine team providers need to know the randomization assignment to ping the tracker for scheduled medical encounters to locate the participant.
Not provided
| Ventura County Medical Center | Recruiting | Ventura | California | 93003 | United States |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |