跳至主要内容
临床试验/NCT01317784
NCT01317784已完成不适用

Behavioral Science Aspects of Rapid Test Acceptance

California State University, Long Beach2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,200
试验地点
2
主要终点
Test choice profile

研究概览

简要总结

The relevance of this research to public health is to make it possible to test for hepatitis C and syphilis at point of care so that people will receive their results immediately instead of requiring people to wait for at least a week to get their test results. This research will make rapid tests for HIV available that can detect HIV infection earlier and are more accurate than current tests available in the United States.

详细描述

This application addresses "Studies to improve access and utilization of HIV counseling and testing" for "HIV/AIDS and AIDS-related co-infections" such as "hepatitis C virus (HCV), other sexually transmitted infections (STIs)" that are part of PA-07-307 Drug Abuse Aspects of HIV/AIDS. The only rapid tests that are approved for use in the US currently are for HIV infection. Tests for other conditions such as hepatitis C (HCV) and syphilis are in use in other countries. In response to an Opportunity that the CDC published in the Federal Register, there are now candidate rapid test kits for HCV and syphilis available for experimental use in the US. Different combinations of rapid and standard tests will be offered to participants in a four-arm trial to assess which tests are accepted by the participants. Only a minority of clients at CBRS who have been offered the rapid test for HIV have accepted it. Those who chose rapid HIV tests were more likely to be male, educated, gay, young and White. They were less likely to be Black, or injection drug users. The proposed study has the potential to have a significant impact upon screening for HIV, syphilis, and HCV. Rapid tests have the potential to increase the receipt of test results, particularly among groups that are less likely to return for their results using traditional testing. The candidate tests are designed for Point of Care (either oral fluid and/or whole blood), and thus will require real-time testing, so the trial will be able to evaluate both the accuracy of the tests in settings of intended use and their acceptability to potential clients in real-world situations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • Over 17 years old
  • Mentally stable
  • Able to understand English or Spanish
  • At least one good vein for phlebotomy
  • Member of Behavioral Risk Group

排除标准

  • 未提供

结局指标

主要结局

Test choice profile

时间窗: one day (day one of study)

Which tests do participants choose to receive when bundled in different combinations?

次要结局

  • Return for standard test results(one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis G. Fisher

Professor and Director

California State University, Long Beach

研究点 (2)

Loading locations...

相似试验