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临床试验/NCT00564369
NCT00564369已完成不适用

CDC HIV Testing Guidelines: Unresolved Ethical Concerns

Rhode Island Hospital4 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年7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
1,000
试验地点
4
主要终点
Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations

研究概览

简要总结

Advocacy groups have voiced concerns about the ethics of some of tenets of the CDC's new HIV testing recommendations for the healthcare setting. Three concerns are paramount: (1) the opt-out approach to HIV testing can potentially be coercive and not truly voluntary; (2) by replacing informed consent with general consent for medical care, test participants might not know or be adequately informed of the benefits and consequences of testing; and (3) eliminating HIV prevention counseling from the HIV testing process presumes that test participants are aware of how to prevent an HIV infection, which might not be correct. This study involves conducting interviews of HIV advocates who are raising these concerns, surveying outpatient and emergency department clinical providers about their beliefs and opinions regarding the tenets of the new guidelines, and then conducting a multi-center, randomized, controlled trial in which the ethical concerns of opt-out vs. opt-in testing are directly compared. We will conduct a multi-center, randomized, controlled, trial whereby patients will be surveyed on their perspectives and perceptions regarding opt-out or opt-in rapid HIV testing. We will survey the participants regarding their perception of coercion, their understanding of the elements contained in the informed consent process, their HIV risk factors, and their knowledge of HIV prevention. We will evaluate whether or not the CDC-recommended approaches regarding opt-out testing, consent, and decoupling of prevention counseling are supported. If there are no differences regarding these ethical concerns between testing approaches, then the opt-out approach would be considered not to be inferior to the opt-in approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-64-year-old patients in the outpatient family practice and medical clinics and emergency departments of Memorial Hospital, Miriam Hospital, and Rhode Island Hospital who speak English or Spanish and are not HIV infected

排除标准

  • HIV infection
  • Inability to speak English or Spanish
  • A physical, psychiatric, or mental disability that prevents participation in the study
  • Involvement in an HIV vaccine study

结局指标

主要结局

Perceptions among patients and providers regarding the concerns about the 2006 CDC HIV testing recommendations

时间窗: Immediate

次要结局

  • Comparison/contrast of patient and provider perspectives on concerns raised about the 2006 CDC HIV testing recommendations(Immediate)

研究者

申办方类型
Other

研究点 (4)

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