STAGE MATCHED INTERVENTION TO INCREASE DUAL METHOD USE

预防性传播感染（STI），人类 免疫缺陷病毒（艾滋病毒）和意外怀孕可以实现 使用双重避孕方法。 这项建议是 旨在开发、实施和评估 创新，计算机辅助的基于舞台的个性化互动 个体化干预（Individualized Intervention） 模型相比，加强标准护理咨询使用双重 避孕方法。 这项随机临床试验的400高- 风险妇女将评估行为和生物学的主要结果。妇女 将每隔6个月随访24个月，随访 进行访谈，以确定报告的使用双重避孕方法的情况 （行为结果）。 12和24个月时的临床检查， 将评估生物学结局，包括 性传播感染和意外怀孕的偶发或复发病例。 二次 结果将包括中间结果变量，如变化 在变革阶段、变革过程、决策平衡和自我 功效 本研究的主要假设是：1.的 个体化干预将导致双重避孕增加 使用; 2.个体化干预将导致保护 预防新的性传播感染病例， 有机体，和意外怀孕;和3。个性化 干预将导致次要结局的最大变化 措施 主要结局之间的比较将根据 使用至事件时间（生存）曲线的意向治疗原则 Kaplan-Meier非参数估计和对数秩分析 统计数据。如果发现有效，则阶段匹配干预具有 在学校、诊所、办公室广泛传播的潜力， 社区中心，以防止性传播感染/艾滋病毒和意外怀孕。

Protection from both sexually transmitted infections (STIs), human immunodeficiency virus (HIV), and unintended pregnancy can be achieved with the use of dual methods of contraception. This proposal is designed to develop, implement, and evaluate the impact of an innovative, computer-assisted stage-based individualized interactive intervention (Individualized Intervention) based on the transtheoretical model compared to enhanced standard care counseling on the use of dual methods of contraception. This randomized clinical trial of 400 high- risk women will assess behavioral and biological primary outcomes. Women will be followed at 6 month intervals for 24 months with follow-up interviews to determine reported use of dual methods of contraception (behavioral outcome). Clinical examinations at 12 and 24 months and with new onset of symptoms will assess biological outcomes including incident or recurrent cases of STI and unintended pregnancy. Secondary outcomes will include intermediate outcomes variables such as changes in stage of change, processes of change, decisional balance, and self- efficacy. The primary hypotheses of this study are: 1. the Individualized Intervention will result in increased dual contraceptive use; 2. the Individualized Intervention will result in protection against new cases of STIs, reinfection with sexually transmitted organisms, and unplanned pregnancies; and 3. the Individualized Intervention will lead to the greatest changes in secondary outcome measures. Comparisons among the primary outcomes will be made according to the intention-to-treat principle using time to event (survival) curve analysis with the Kaplan-Meier nonparametric estimator and the log rank statistic. If found to be effective, the stage-matched intervention has potential for widespread dissemination in schools, clinics, offices, and community centers to prevent STIs/HIV and unintended pregnancy.