CDC HIV Testing Guidelines: Unresolved Ethical Concerns
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
- 是
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)
