NCT06870019

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

February 7, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

August 8, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

February 7, 2025

Last Update Submit

August 22, 2025

Conditions

Hepatitis C Virus Infection

Keywords

Street medicineUnsheltered homelessnessHepatitis CGPS trackerMixed-methodsIll-housed person

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Sustained virologic response

    through study completion, an average of 24 weeks

Study Arms (2)

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.

Behavioral: GPS tracker device

Interventions

GPS tracker deviceBEHAVIORAL

GPS tracker device

Standard HCV treatment + GPS tracker device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior engagement in HCV treatment
  • Decompensated cirrhosis; HBsAg positive
  • Current pregnancy; Known or suspended hepatocellular carcinoma
  • Prior liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

USC Street Medicine

Alhambra, California, 91803, United States

RECRUITING

Ventura County Medical Center

Ventura, California, 93003, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • 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

Central Study Contacts

Alexis Coulourides Kogan, PhD

CONTACT

626-457-4207acoulour@usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2025

First Posted

March 11, 2025

Study Start

August 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

US(2)