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临床试验/NCT06533319
NCT06533319尚未招募不适用

Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting

Eastern Idaho Public Health0 个研究点目标入组 100 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Sustained Virologic Response

研究概览

简要总结

To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including;

  1. incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and
  2. incarcerated persons positive for HCV in jails less than the duration of 12 weeks of treatment who receive remaining supply of study drug on discharge with appropriate linkage to care.

Assess quality of life measures in participants being treated for their HCV through the validated questionnaire EuroQol-5D at baseline and post-treatment.

详细描述

Aligning with the World Health Organization (WHO) global guidance and recommendation to eliminate viral hepatitis by 2030 will require designated focus on priority populations who are disproportionately impacted by viral hepatitis. Addressing chronic hepatitis C virus (HCV) with the justice involved population is crucial in reducing HCV within the greater population. Inmate populations bear a disproportionate share of the burden of HCV infection. HCV prevalence is 10-20 fold greater in the incarcerated population than the general population, although wider uptake among people who are incarcerated remains limited. Addressing HCV in the incarcerated population is a strategy to bring the US closer to successfully eradicating the HCV epidemic. Additionally, previous qualitative research has suggested that justice involved individuals felt incarceration is an apt time to initiate treatment and is a missed opportunity to not do so, and that waiting and initiating treatment upon release faces multiple challenges, including insurance or Medicaid enrollment, making appointments, transportation and work commitments.

HCV in the jail setting is a public health issue that needs to be addressed. Extensive modelling has shown that HCV testing in people who are incarcerated prevents community spread of HCV and is cost effective. Furthermore, there is guidance and recommendations for HCV testing in the prison system where a vast majority of research is being conducted. However, there is limited guidance for HCV testing within jails. Thus, county jails are critical partners, and potentially may serve as an important setting for HCV screening, diagnosis and treatment, although data is scarce in this realm. We therefore aim to explore whether county jails are a practical and feasible setting for HCV screening, and initiating HCV treatment, including whether an incarcerated person resides in the county jail for the duration of treatment (group 1), or is released to the community in the midst of treatment with a supply of remaining study drug and linked to appropriate care (group 2).

研究设计

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

盲法说明

All study components will be blind to individuals in charge of the study, with the exception of the prescribing clinician and primary investigator.

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

  • All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
  • All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
  • Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis.

排除标准

  • All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
  • All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
  • Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis

研究组 & 干预措施

Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail

Other

Patients infected with chronic hepatitis C who are also incarcerated will be enrolled into the study and provided FDA approved Epclusa (sofosbuvir/velpatasvir) for treatment of chronic hepatitis C. Epclusa (sofosbuvir/velpatasvir) is currently used as a first line treatment for chronic hepatitis C. This study will focus on effectiveness of treatment in the county jai setting.

干预措施: sofosbuvir/velpatasvir (Drug)

结局指标

主要结局

Sustained Virologic Response

时间窗: 12 weeks after treatment

Undetectable hepatitis C RNA

次要结局

  • Quality of life improvement(At study enrollment and 12 weeks after treatment)

研究者

发起方
Eastern Idaho Public Health
申办方类型
Other Gov
责任方
Sponsor

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