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

使用风险补偿和暴露前预防来预防 HIV 感染

基本信息

批准号：
8730228
负责人：
Joel E Milam
金额：
$ 28.35万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-04 至 2017-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8730228
关键词：
Address Adherence Administrator Advisory Committees Anal Sex Anti-Retroviral Agents Antiviral Agents Behavior assessment Behavioral Control Groups Counseling Couples Education Effectiveness Enrollment Evaluation Financial compensation Funding HIV HIV Infections HIV Seropositivity Healthcare Human immunodeficiency virus test Incidence Individual Intervention Label Lead Medical Participant Patients Perception Pharmaceutical Preparations Physicians Placebos Policies Population Prevention strategy Preventive Prophylactic treatment Provider Public Health Recruitment Activity Regimen Reporting Research Risk Risk Behaviors Risk Reduction Sampling Schedule Sexual Partners Tenofovir Text Time United States Food and Drug Administration Unsafe Sex arm cohort comparison group condoms cost effective efficacy trial emtricitabine experience high risk high risk sexual behavior improved meetings men who have sex with men prevent programs public health relevance safer sex sex sex risk sexually active truvada

项目摘要

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.

描述（由申请人提供）：抗逆转录病毒药物 Truvada 最近被 FDA 批准作为暴露前预防 (PrEP)，以降低高危未感染者感染 HIV 的风险。 PrEP 作为预防策略的一个主要问题是风险补偿，即 PrEP 使用者相信自己不会再被感染，因此增加了危险的性行为。尽管 PrEP 功效试验的结果没有发现危险行为发生变化，但既然 Truvada 已获得 FDA 批准，目前仍不清楚危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) 在一项重点关注 PrEP 依从性的资助实施研究中，检查正在启动 PrEP 的男男性行为者 (MSM) 12 个月内的性风险补偿，以及 2) 招募非 PrEP 高风险 MSM 作为对照组比较 6 个月内与 PrEP 组的性危险行为。通过利用目前资助的 PrEP 示范队列并添加非 PrEP 对照组进行比较，本研究将及时且经济高效地提供有关风险补偿的宝贵信息。结果将为医生和医疗保健管理者提供证据，以指导有关 PrEP 使用、适当的行为咨询策略以及支持患者参与和医疗保健教育的政策。