Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT).
Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT).
复制标题
设计阶段匹配干预试验以增加双法避孕药具的使用（PROTECT 项目）。
DOI：
10.1016/j.cct.2007.01.012
复制
发表时间：
2007
影响因子：
2.2
通讯作者：
Rossi,JosephS
中科院分区：
文献类型：
--
作者：
Peipert,Jeffrey;Redding,ColleenA;Blume,Jeffrey;Allsworth,JeniferE;Iannuccillo,Karen;Lozowski,Faye;Mayer,Kenneth;Morokoff,PatriciaJ;Rossi,JosephS
本手稿描述了一项名为“增加双重方法使用的阶段匹配干预”或“PROTECT项目”的随机临床试验。项目BACT比较了在高危妇女中推广使用双重避孕方法的两种方法。干预组接受基于跨理论行为改变模型的定制个性化反馈，使用基于计算机的多媒体程序。对照组接受避孕的一般信息。本试验的主要结局是1）自我报告的使用双重避孕方法和2）意外妊娠或性传播疾病事件或复发的生物学结局。在这份报告中，我们描述了问题的意义和背景，研究的具体目的，研究组织，患者选择，随机化，结果变量，数据收集，用于随访和测试的程序，主要和次要结果，以及统计分析。我们还描述了参与者的特征和用于确保患者安全和试验监测的程序。
This manuscript describes the randomized clinical trial titled Stage-Matched Intervention to Increase Dual Method Use or Project PROTECT. Project PROTECT compared two approaches to promote the use of dual methods of contraception among high-risk women. The intervention arm received tailored individualized feedback based on the Transtheoretical Model of Behavior Change using a computer-based multimedia program. The control arm received general information on contraception. The primary outcomes of this trial were 1) self-reported use of dual methods of contraception and 2) the biological outcomes of an unintended pregnancy or an incident or recurrent sexually transmitted disease. In this report, we describe the significance and background of the problem, the specific aims of the study, study organization, patient selection, randomization, outcome variables, data collection, procedures used for follow-up and testing, primary and secondary outcomes, and statistical analyses. We also describe participant characteristics and procedures used to assure patient safety and trial monitoring.