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临床试验/NCT06870019
NCT06870019招募中不适用

Effects of GPS Tracking on Patient Adherence to Hepatitis C Treatment Among People Experiencing Unsheltered Homelessness

University of Southern California4 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年8月8日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
4
主要终点
Medication Adherence Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Medication Adherence Rate

时间窗: 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

时间窗: 8-12 weeks

Number of weeks patient engaged in HCV medication treatment

次要结局

  • Sustained virologic response(through study completion, an average of 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camillo Zaks

Associate Professor

University of Southern California

研究点 (4)

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