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临床试验/NCT05369507
NCT05369507已完成不适用

Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics

Prisma Health-Upstate2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
HCV Treatment Initiation Rates

研究概览

简要总结

Up to 150 individuals with current hepatitis C (HCV) will be recruited from mobile health clinics in rural South Carolina - sites will be selected based on HCV prevalence rates and lack of current HCV screening/treatment resources. NPs will provide HCV care through mobile health units. Participants will be randomized (1:1) to either mobile health clinic treatment as usual or virtual care coordination. Virtual care coordination designed to move people along HCV care cascade will be conducted by the Emocha smartphone platform - an adaptable platform designed by emocha to link patients to care. Using quantitative methods, associations between psychosocial factors such as homelessness, mental illness, provider mistrust, poor social support, high levels of shame and stigma with HCV outcomes including SVR will be examined. Investigators hypothesize that SVR rate among the HCV-infected individuals treated (and with follow-up SVR determination) will be 90% with the Clopper-Pearson 95% CI having a width of 13%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

At time of randomization, participant is informed of study group assignment and provided instructions on use of app. Care provider is aware of group assignment as the provider is also using the platform to communicate with participants during course of treatment.

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

  • Not previously treated with HCV direct-acting antiviral medications OR treatment-experienced and eligible for treatment with sofosbuvir/velpatasvir
  • Willing to be randomized to either emocha versus TAU arms
  • Able to provide informed consent

排除标准

  • Pregnant or breastfeeding

结局指标

主要结局

HCV Treatment Initiation Rates

时间窗: 27 months

To determine whether treatment initiation rates are higher among patients randomized to Emocha virtual care coordination versus treatment as usual (TAU), among HCV-infected patients enrolled in a NP-led mobile clinic

次要结局

  • HCV Treatment Completion(12 weeks)
  • Rate of Sustained Virologic Response(6 months)
  • HCV Treatment Adherence(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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