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