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临床试验/NCT02869776
NCT02869776已完成不适用

Integrating HCV and HIV Screening During the Era of HIV Antigen Testing

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Number of participants who receive HIV test results

研究概览

简要总结

The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in high prevalence settings, such as detoxification centers with a large proportion of young injection drug users. The latest venipuncture testing will be compared to rapid finger stick testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a short-term drug detoxification center will be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age greater or equal to 18
  • •All clients admitted to BTC with a history of drug or alcohol use
  • •Individuals who self-report as being HIV and HCV non-infected within the past 6 months or having unknown status
  • •Participants providing contact information of two family members or friends
  • •Individuals signing a medical records release form for the referral site (Boston Medical Center)
  • •English speaking

排除标准

  • •Individuals unable to provide informed consent
  • •Individuals with a known history of HCV and/or HIV

研究组 & 干预措施

Rapid finger stick

Experimental

HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered.

干预措施: Questionnaire (Behavioral)

Rapid finger stick

Experimental

HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered.

干预措施: Rapid finger stick (Procedure)

Standard venipuncture

Experimental

HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered.

干预措施: Questionnaire (Behavioral)

Standard venipuncture

Experimental

HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered.

干预措施: Venipuncture (Procedure)

结局指标

主要结局

Number of participants who receive HIV test results

时间窗: within 5 days (by the time of discharge from the detoxification center)

The number of participants who receive HIV test results by the time they are discharged from the detoxification center

Number of participants who receive HCV test results

时间窗: within 5 days (by the time of discharge from the detoxification center)

The number of participants who receive HCV test results by the time they are discharged from the detoxification center

次要结局

  • Number of participants who link to HIV care(by 3 months)
  • Number of participants who link to HCV care(by three months)
  • Number of participants who have fibrosis staging performed(by three months)
  • Number of participants who have HCV treatment initiated(by six months)
  • Number of participants who reach sustained virologic response(by twelve months)
  • Number of participants who HIV RNA testing(by 3 months)
  • Number of participants who achieve HIV viral suppression(by 6 months)
  • Number of participants who have antiretroviral treatment initiated(by 3 months)
  • Number of participants who have HCV RNA testing(by three months)
  • Number of participants who have CD4 testing(by 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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