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）：FDA最近批准了抗逆转录病毒药物Truvada作为预防前预防（PREP），以降低高风险未感染的个体中HIV感染的风险。作为预防策略的PREP的主要关注点是风险补偿，其中PREP用户认为无法再感染自己的风险性行为行为。尽管预备效力试验的结果并未发现风险行为的变化，但尚不清楚如何以及以何种方式将危险性发生率会改变，因为Truvada已获得FDA批准。我们提议1）在与男性发生性关系的男性中，在12个月内检查性风险补偿（MSM），他们在一项以准备依从性为基础的实施研究中启动PREP，以及2）招募一个非PREP高风险MSM的对照组，以将性风险行为与6个月以上的PREP组与PREP组进行比较。通过利用当前资助的PrEP示范队列并添加非PREP对照组进行比较，本研究将及时及时地提供有关风险补偿的宝贵信息。结果将使医生和医疗保健管理人员的证据指导有关PREP使用，适当的行为咨询策略以及支持患者参与和教育医疗保健的政策。