Risk compensation and pre-exposure prophylaxis use to prevent HIV infection

描述（由申请人提供）：抗逆转录病毒药物特鲁瓦达（Truvada）最近被FDA批准作为暴露前预防（PrEP），以降低高风险未感染人群感染艾滋病毒的风险。PrEP作为一种预防策略的一个主要问题是风险补偿，PrEP使用者认为自己不会再被感染，从而增加了危险的性行为。尽管PrEP有效性试验的结果没有发现风险行为的变化，但目前尚不清楚特鲁瓦达获得FDA批准后，风险性行为的发生率将如何以及以何种方式发生变化。我们建议1)在一项资助的实施研究中，对开始PrEP的男男性行为者（MSM）进行为期12个月的性风险补偿研究，重点关注PrEP的依从性；2)招募一组未PrEP的高危男男性行为者作为对照组，将6个月的性风险行为与PrEP组进行比较。通过利用目前资助的PrEP示范队列和添加非PrEP对照组进行比较，本研究将以及时和具有成本效益的方式提供有关风险补偿的宝贵信息。结果将为医生和卫生保健管理人员提供证据，以指导有关PrEP使用的政策，适当的行为咨询策略，以及支持患者参与和卫生保健教育。

DESCRIPTION (provided by applicant): The antiretroviral medication Truvada was recently approved by the FDA as a pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among high risk uninfected individuals. A primary concern of PrEP as a prevention strategy is risk compensation, where PrEP users increase their risky sexual behaviors believing they can no longer be infected. Although the results from the PrEP efficacy trials did not find changes in risk behavior, it remains unclear how, and in what ways, rates of risky sex will change now that that Truvada is FDA approved. We propose to 1) examine sexual risk compensation over 12 months among men who have sex with men (MSM) who are initiating PrEP in a funded implementation study focused on PrEP adherence, and 2) enroll a control group of non-PrEP high risk MSM to compare sexual risk behaviors with the PrEP group over 6-months. By leveraging a currently funded PrEP demonstration cohort and adding a non-PrEP control group for comparison, this study will provide valuable information regarding risk compensation in a timely and cost-effective manner. Results will give physicians and health care administrators evidence to guide policies concerning PrEP usage, appropriate behavioral counseling strategies, and support for patient engagement and education for their health care.