Re-linking People With Diagnosed But Untreated HCV to Care in a Community-based Substance-use Telemedicine Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- number of patients identified as having diagnosed but untreated HCV
研究概览
简要总结
This is an observational, retrospective & prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion & cure rates of these HCV clients achieved through this chart review and re-linking approach.
详细描述
The study, led by trueNorth medical center in Ontario, focuses on re-linking people diagnosed with untreated Hepatitis C (HCV) to care through a community-based substance-use telemedicine program. HCV is a significant health concern in Canada, especially among people who inject drugs (PWID), who face barriers to accessing treatment. Integrating HCV treatment with substance use care may improve treatment uptake.
This observational study includes both retrospective and prospective cohorts. The retrospective aspect involves chart reviews to identify untreated HCV patients for re-linking, while the prospective cohort examines treatment outcomes such as linkage to care and cure rates. Participants include individuals over 18 with a positive HCV RNA result who have not completed a course of Direct-Acting Antiviral (DAA) treatment. Excluded are those unable to consent or with restricted access to their health records.
Study procedures involve identifying untreated HCV patients, attempting re-linkage via telecommunication, and offering treatment through the program. Outcome measures include the number of patients re-linked to care and their treatment outcomes. Data analysis will utilize IBM SPSS for logistic regression and descriptive statistics, aiming to evaluate the efficacy of this telemedicine approach in improving HCV care among PWID.
Ethical considerations include informed consent and data privacy, with oversight by the ADVARRA Canadian Institutional Review Board. The study seeks to address HCV care gaps in PWID populations by leveraging telemedicine for improved access and treatment outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the retrospective chart review element of the study, inclusion criteria includes anyone who had a telemedicine visit at the community based substance use telemedicine program between January 1st 2023 and December 31st
- •For the prospective cohort element of the study, the inclusion criteria are listed below:
- •Ability and willingness of the participant to provide informed consent. Having a positive HCV RNA laboratory result and lacking a sufficient previous course of DAA treatment.
排除标准
- •For the retrospective chart review element of the study, exclusion criteria is: a consent directive to restrict access to their OLIS record.
- •For the prospective cohort study, exclusion criteria is an inability or unwillingness of the participant to provide informed consent.
结局指标
主要结局
number of patients identified as having diagnosed but untreated HCV
时间窗: March 2024 - August 2024
number of patients identified as having diagnosed but untreated HCV
percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care
时间窗: March 2024 - December 2024
percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care
次要结局
- cure rates(March 2024 - December 2024)
- treatment completion dates(March 2024 - December 2024)
- treatment initiation rates(March 2024 - December 2024)