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CCTG 593: Testing and Linkage to Care

2021年5月10日 更新者：Jill Blumenthal、University of California, San Diego

CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group

This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an option to be linked into care.

If they accept, tested individuals will be in contact with an ALERT specialist that will help facilitate their linkage. The study's primary analysis will analyze how many HIV screened individuals accept the ALERT specialist assistance.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Design: CCTG 593 is a project to evaluate the uptake and effectiveness of an ALERT specialist serving to

  1. link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and
  2. link confirmed HIV antibody negative persons with continued high risk behaviors to PrEP centers

Duration: Each subject who agrees to linkage will receive ALERT follow-up until successful linkage or 60 days following enrollment for linkage to care or 90 days following enrollment for linkage to PrEP, whichever comes first. The duration of the 593 project will be for 3.5 years or until all subjects have been enrolled and successfully linked, or 60 days pass for linkage to care or 90 days for linkage to PrEP.

Sample Size: Up to 600 subjects will be tested and offered linkage across all CCTG sites: LA County-USC Medical Center, Harbor-UCLA/City of Long Beach Department of Health and Human Services, UCSD/San Diego Health and Human Services Agency.

Study Population: Eligible subjects will include any persons 18 years of age or older who have been tested for HIV at one of the CCTG testing sites (LA County + USC, Long Beach Department of Health and Human Services, and San Diego Health and Human Services Agency).

研究类型

介入性

注册 (预期的)

600

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

  • 美国
    • California
      • Long Beach、California、美国、90815
        • City of Long Beach Department of Health and Human Services
      • Los Angeles、California、美国、90033
        • University of Southern California
      • San Diego、California、美国、92103
        • University of California, San Diego

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 years or older
  • Has had an HIV test result form the CCTG Consortium testing site as either positive or negative
  • Ability to provide informed consent
  • English or Spanish Speaking

Exclusion Criteria:

  • Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
  • Acute medical illness that requires transfer to a non CCTG hospital

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：卫生服务研究
  • 分配：不适用
  • 介入模型：单组作业
  • 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：Linkage to PrEP or Care
Subjects screened for HIV at any CCTG consortium site will be offered Linkage to PrEP or Care, depending on HIV status. After results are received, HIV testers will obtain verbal consent from the subject to connect with the ALERT Specialist, or otherwise offer the subject the ALERT Specialist contact information. When contacted, the ALERT Specialist will coordinate with the subject the scheduling of the PrEP or Care visit, and remain in contact to ensure linkage.
行为的：Linkage to PrEP or Care
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.

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 subjects linked to Care or PrEP
大体时间：Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test
The primary outcome will measure the proportion of subjects linked a) to HIV care within 60 days of testing HIV-positive or b) to PrEP within 90 days of testing HIV-negative
Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test

次要结果测量

结果测量
措施说明
大体时间
Acceptance of the linkage program
大体时间：60 days from date of HIV screening test
Secondary outcomes will measure the acceptance of the linkage program, which is defined as those individuals who, after testing either positive or HIV antibody negative, will agree to be contacted by the ALERT specialist.
60 days from date of HIV screening test

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。

赞助

University of California, San Diego

合作者

University of California, Los Angeles
University of Southern California
California HIV/AIDS Research Program
City of Long Beach Department of Health and Human Services

调查人员

  • 学习椅：Kathleen Jacobson, MD、University of Southern California
  • 学习椅：Michael Menchine, MD, MPH、University of Southern California
  • 首席研究员：Jill Blumenthal, MD、UC San Diego AntiViral Research Center (AVRC)

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)

2013年7月26日

初级完成 (实际的)

2018年1月22日

研究完成 (实际的)

2021年2月9日

研究注册日期

首次提交

2013年9月9日

首先提交符合 QC 标准的

2013年9月9日

首次发布 (估计)

2013年9月13日

研究记录更新

最后更新发布 (实际的)

2021年5月12日

上次提交的符合 QC 标准的更新

2021年5月10日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CCTG 593

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.

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