一项序贯随机化HIV预防试验的设计与分析考量
Design and analysis considerations for a sequentially randomized HIV prevention trial.
作者信息
Benkeser David, Horvath Keith, Reback Cathy J, Rusow Joshua, Hudgens Michael
机构信息
Department of Biostatistics and Bioinformatics, Emory University.
Department of Psychology, University of California, San Diego.
出版信息
Stat Biosci. 2020 Dec;12(3):446-467. doi: 10.1007/s12561-020-09274-3. Epub 2020 Mar 25.
Abstract
TechStep is a randomized trial of a mobile health interventions targeted towards transgender adolescents. The interventions include a short message system, a mobile-optimized web application, and electronic counseling. The primary outcomes are self-reported sexual risk behaviors and uptake of HIV preventing medication. In order that we may evaluate the efficacy of several different combinations of interventions, the trial has a sequentially randomized design. We use a causal framework to formalize the estimands of the primary and key secondary analyses of the TechStep trial data. Targeted minimum loss-based estimators of these quantities are described and studied in simulation.
摘要
TechStep是一项针对跨性别青少年的移动健康干预随机试验。干预措施包括短信系统、移动优化网络应用程序和电子咨询。主要结果是自我报告的性风险行为和艾滋病毒预防药物的使用情况。为了评估几种不同干预组合的效果，该试验采用了序贯随机设计。我们使用因果框架来规范TechStep试验数据主要和关键次要分析的估计量。在模拟中描述并研究了这些量基于最小损失的靶向估计量。
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2
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AIDS Patient Care STDS. 2019 Mar;33(3):120-130. doi: 10.1089/apc.2018.0249.
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