Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
2020年12月10日 更新者：Boston Medical Center
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.
研究概览
研究类型
介入性
注册 (实际的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02118
- Boston Medical Center
-
-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Individuals unable to provide informed consent
- Individuals with a known history of HCV and/or HIV
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 |
|---|---|
|
实验性的：Rapid finger stick
HIV and HCV testing through rapid finger stick.
Behavioral questionnaires will also be administered.
|
Behavioral questionnaires
HIV and HCV testing through rapid finger stick
|
|
实验性的：Standard venipuncture
HIV and HCV testing through venipuncture.
Behavioral questionnaires will also be administered.
|
Behavioral questionnaires
HIV and HCV testing through venipuncture
|
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 |
|---|---|---|
|
Number of participants who receive HCV test results
大体时间：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
|
within 5 days (by the time of discharge from the detoxification center)
|
|
Number of participants who receive HIV test results
大体时间：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
|
within 5 days (by the time of discharge from the detoxification center)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants who link to HCV care
大体时间：by three months
|
The number of participants who are seen for an HCV visit
|
by three months
|
|
Number of participants who have HCV RNA testing
大体时间：by three months
|
The number of participants who have HCV RNA testing performed
|
by three months
|
|
Number of participants who have fibrosis staging performed
大体时间：by three months
|
The number participants who have fibrosis staging performed
|
by three months
|
|
Number of participants who have HCV treatment initiated
大体时间：by six months
|
The number participants who have HCV treatment initiated
|
by six months
|
|
Number of participants who reach sustained virologic response
大体时间：by twelve months
|
The number participants who reach sustained virologic response
|
by twelve months
|
|
Number of participants who link to HIV care
大体时间：by 3 months
|
The number participants who are seen for an HIV visit
|
by 3 months
|
|
Number of participants who HIV RNA testing
大体时间：by 3 months
|
The number participants who have HIV RNA testing
|
by 3 months
|
|
Number of participants who have CD4 testing
大体时间：by 3 months
|
The number participants who have CD4 testing
|
by 3 months
|
|
Number of participants who have antiretroviral treatment initiated
大体时间：by 3 months
|
The number participants who initiated antiretroviral treatment
|
by 3 months
|
|
Number of participants who achieve HIV viral suppression
大体时间：by 6 months
|
The number participants who achieve HIV viral suppression
|
by 6 months
|
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。
调查人员
- 首席研究员：Sabrina Assoumou, MD, MPH、Boston Medical Center
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
- Assoumou SA, Paniagua SM, Gonzalez P, Wang J, Beckwith CG, White LF, Taylor JL, Coogan K, Samet JH, Linas BP. HIV Pre-exposure Prophylaxis and Buprenorphine at a Drug Detoxification Center During the Opioid Epidemic: Opportunities and Challenges. AIDS Behav. 2021 Aug;25(8):2591-2598. doi: 10.1007/s10461-021-03220-0. Epub 2021 Mar 22.
- Assoumou SA, Paniagua SM, Linas BP, Wang J, Samet JH, Hall J, White LF, Beckwith CG. Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial. J Infect Dis. 2020 Sep 2;222(Suppl 5):S376-S383. doi: 10.1093/infdis/jiaa162.
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 (实际的)
2016年9月1日
初级完成 (实际的)
2017年7月26日
研究完成 (实际的)
2017年7月26日
研究注册日期
首次提交
2016年8月10日
首先提交符合 QC 标准的
2016年8月16日
首次发布 (估计)
2016年8月17日
研究记录更新
最后更新发布 (实际的)
2020年12月11日
上次提交的符合 QC 标准的更新
2020年12月10日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.