PREMIS: Preventive Misconception in HIV Prevention Trials

描述（由申请人提供）：艾滋病预防试验的一些参与者在参加试验后从事更危险的行为，这种现象称为“行为去抑制”。“这种行为可能会损害研究参与者的健康和预防试验的科学价值。通过风险咨询和教育减少这些行为的努力并不总是成功的。“PREMIS：HIV预防试验中的预防性误解”是为了了解风险行为如何与参与者对预防试验和正在测试的研究性干预措施的错误信念有关。在以前的工作中，我们已经提到这些错误的信念为“预防性误解”，并建议他们可能会产生的方式知情同意过程发生。更好地了解预防性误解和风险行为之间的关系，可以为修改预防性试验中的同意程序以减少风险行为增加的负面影响提供信息。为了达到我们的目标，我们将追求3个具体目标：（1）完善预防误解的概念模型。(2)制定和评估预防误解的措施。(3)探讨新开发的预防性误解措施的得分是否与参加艾滋病预防试验的参与者的危险行为相关。我们将从HIV预防试验网络进行的试验中总共收集280名美国参与者的数据。在研究完成后，我们将定义和测量预防性错误观念，并提供第一个明确的数据之间的关系，预防性错误观念和风险行为。 公共卫生相关性：艾滋病毒预防试验提出了重要的伦理问题。拟议的研究可能有助于研究人员和机构审查委员会设计和测试知情同意过程的修改，以尽量减少危及预防研究伦理地位的信念和行为。这些干预措施可能有助于降低预防试验参与者的艾滋病毒传播风险，并增加这些试验的科学价值。

DESCRIPTION (provided by applicant): Some participants in HIV prevention trials engage in more risky behaviors after they enroll in a trial, a phenomenon known as "behavioral disinhibition." Such behaviors can compromise the health of the research participant and the scientific value of the prevention trial. Efforts to reduce these behaviors through risk counseling and education are not always successful. The objective of "PREMIS: Preventive Misconception in HIV Prevention Trials" is to understand how risk behavior may be related to participants' false beliefs about the prevention trial and the investigational intervention being tested. In previous work, we have referred to these false beliefs as the "preventive misconception" and have suggested that they could arise from the way the informed consent process takes place. A better understanding of the relationship between the preventive misconception and risk behavior could inform efforts to modify the consent process in prevention trials to reduce the negative effects of increased risk behavior. To achieve our objective, we will pursue 3 specific aims: (1) To refine a conceptual model of preventive misconception. (2) To develop and evaluate a measure of preventive misconception. (3) To explore whether scores on the newly developed measure of preventive misconception are associated with risk behavior among participants enrolled in HIV prevention trials. We will collect data from a total of 280 US participants in trials conducted by the HIV Prevention Trials Network. At the completion of the study, we will have defined and measured the preventive misconception and provided the first clear data on the relationship between the preventive misconception and risk behavior. PUBLIC HEALTH RELEVANCE: HIV prevention trials raise important ethical questions. The proposed research may help investigators and institutional review boards to design and test modifications to the informed consent process to minimize beliefs and behaviors that jeopardize the ethical status of prevention research. Such interventions may help to reduce the risk of HIV transmission for participants in prevention trials and increase the scientific value of these trials.