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Combating Related Epidemics in HCV (CREST)

2026年4月30日 更新者:Duke University

Combating Related Epidemics in HCV Through Simplified Testing and Treatment. A Cluster Randomized Trial of Point-of-care Hepatitis C Testing and Treatment Among Key Populations

This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.

研究概览

研究类型

介入性

注册 (估计的)

1280

阶段

  • 第四阶段

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Can provide written informed consent or assent
  2. Minimum of 16 years of age
  3. Willing to undergo HIV, HCV, HBV testing
  4. Willing to undergo treatment for HCV and complete study activities

Exclusion Criteria:

  1. History of HCV treatment for current infection
  2. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI
  3. Contraindication for treatment with sofosbuvir/velpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
  4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
  5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.

Retreatment Inclusion Criteria:

  1. Completion of sofosbuvir/velpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 & CTP score available within 90-days of retreatment initiation.
  2. Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA <LLOQ/D (TD or TND) during and/or at end of treatment followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA >LLOQ/D at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection

Retreatment Exclusion Criteria:

  1. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7.
  2. Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir.
  3. Contraindication for treatment with sofosbuvir/velpatasvir (reinfection) or sofosbuvir/velpatasvir/voxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
  4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
  5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent.). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Standard of Care (control arm)
Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.
Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.
其他名称:
  • Direct acting antiviral
实验性的:Single-visit POC test & treat (intervention arm)
Sites randomized to the single-visit point-of-care test (POC) & treat arm will undergo fingerstick POC HCV RNA, HIV antibody/antigen, and HBsAg and for those with detectable HCV RNA, HCV treatment will be initiated.
Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.
其他名称:
  • Direct acting antiviral
Cepheid Xpert HCV Test, performed on the GeneXpert Xpress system, in an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hep C (HCV) RNA in human fingerstick.
Abbott Determine HIV - 1/2 Ag/Ab combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus type-1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type-1 and type-2 in fingerstick. Intended use is point-of-care test to aid in the diagnosis of infection.
Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human fingerstick. The test is intended as an aid to detect HBAg from infected individuals.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants who complete the Hepatitis C Virus (HCV) care cascade within 24 weeks of study entry in intervention versus Standard of Care (SOC) arm.
大体时间:24 weeks from study enrollment
Proportion of participants in the primary analysis population (as defined as detectable HCV RNA on dried blood spot testing at screening) who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm. Completion of the care cascade will be defined as HCV RNA<lower limit of quantification/detection (LLOQ/D) at a minimum of 4 weeks post-cessation of direct-acting antiviral (DAA) therapy sustained virologic response (SVR4+).
24 weeks from study enrollment

次要结果测量

结果测量
措施说明
大体时间
Time from enrollment to treatment initiation
大体时间:up to 24 weeks
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 24 weeks
Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60
大体时间:Week 24 and 60
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
Week 24 and 60
Proportion of participants who have received any HIV test result within 24 weeks of entry
大体时间:24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Proportion of participants who initiate PrEP within 24 weeks of entry
大体时间:24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Time from enrollment to PrEP initiation
大体时间:up to 60 weeks
HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 60 weeks
All cause and liver specific hospitalizations through week 60
大体时间:60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
60 weeks
All cause and liver specific mortality through week 60
大体时间:Week 60
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
Week 60
Adverse device effects related to study devices
大体时间:up to 60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 60 weeks
Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only)
大体时间:Day 1
Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only)
Day 1
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry
大体时间:12 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
12 weeks
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry
大体时间:24
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
24
Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry
大体时间:24 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks
Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry
大体时间:60 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
60 weeks
Cumulative incidence of HCV reinfection following sustained virologic response (SVR4+) within 60 weeks of entry
大体时间:within 60 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
within 60 weeks
Cumulative retreatment following sustained virologic response (SVR4+) or relapse within 60 weeks of entry
大体时间:within 60 weeks
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. This analysis for retreatment is limited to participants 18 years old and older.
within 60 weeks
Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry
大体时间:24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Proportion of participants with HIV not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry
大体时间:24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Proportion of participants with HIV on antiretroviral therapy (ART) at screening who remain on ART at week 24 and week 60
大体时间:Week 24 and 60
HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
Week 24 and 60
On direct-acting antiviral (DAA) treatment serious suspected adverse events leading to discontinuation of sofosbuvir/velpatasvir
大体时间:60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
60 weeks
Adverse maternal and fetal outcomes for those on direct-acting antiviral (DAA) at any time during pregnancy
大体时间:up to 60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 60 weeks

其他结果措施

结果测量
大体时间
Health-related quality of life (EQ5D) and social functioning through week 60
大体时间:Week 60
Week 60
Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60
大体时间:from baseline to Week 24 and 60
from baseline to Week 24 and 60
Among participants pregnant at time of enrollment: Proportion of participants completing DAA therapy within 24 weeks of entry and achieving SVR4+ within 60 weeks of entry
大体时间:Week 24 and 60
Week 24 and 60
Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report
大体时间:12 and 24 weeks
12 and 24 weeks
Among participants pregnant at time of enrollment: Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 and 24 weeks of entry
大体时间:Weeks 12 and 24
Weeks 12 and 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2030年11月30日

研究完成 (估计的)

2030年12月30日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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