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临床试验/NCT05413785
NCT05413785已完成不适用

Prospective Cohort Study to Determine Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office

Jens Rosenau2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Jens Rosenau
入组人数
77
试验地点
2
主要终点
HCV treatment uptake rate of HCV RNA positive participants

研究概览

简要总结

This prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (P&P office) setting and compare the results with a historic control with referral to care. Research participants will be followed in the P&P office when they report to their officer during regularly scheduled appointments. Participants will receive treatment without having to travel to a specialist's office. The telemedicine visit will include a consultation with an experienced HCV provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor HCV treatment. The UK specialty pharmacy will be available to participants and the HCV management team through a 24-hour support line. Participants will be treated per HCV guidelines and insurance preference.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clients who will be supervised in the probation and parole office for at least 5 months
  • History of hepatitis C
  • Able to obtain health insurance
  • Capacity to provide written, informed consent
  • Life expectancy >1 year

排除标准

  • Negative HCV RNA
  • Pregnant or breast-feeding
  • HIV or HBV co-infection
  • Liver cirrhosis with Child-Turcotte-Pugh score 6 or greater at baseline lab work
  • Subjects with impaired capacity to provide informed consent

结局指标

主要结局

HCV treatment uptake rate of HCV RNA positive participants

时间窗: 6 months

Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.

次要结局

  • HCV treatment uptake rate(6 months)
  • Determine visit adherence(6 months)

研究者

发起方
Jens Rosenau
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jens Rosenau

Associate Professor

University of Kentucky

研究点 (2)

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