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

描述(申请人提供)：抗逆转录病毒药物特鲁瓦达最近被FDA批准为暴露前预防(PrEP)，以降低高危未感染个体感染艾滋病毒的风险。PrEP作为预防策略的一个主要问题是风险补偿，PrEP使用者增加了他们危险的性行为，相信他们不会再被感染。尽管PrEP疗效试验的结果没有发现危险行为的变化，但尚不清楚既然特鲁瓦达获得了FDA的批准，危险性行为的比率将如何以及以何种方式发生变化。我们建议1)在一项专注于PrEP依从性的资助实施研究中，检查启动PrEP的男男性行为(MSM)在12个月内的性风险补偿，以及2)招募非PrEP高危MSM的控制组，以比较6个月内PrEP组和PrEP组的性风险行为。通过利用目前获得资金的PrEP示范队列，并增加一个非PrEP控制组进行比较，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教育他们的卫生保健。

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.