Background Using the multiphase optimization strategy (MOST), we previously developed and optimized an online behavioral intervention, itMatters, aimed at reducing the risk of sexually transmitted infections (STI) among first-year college students by targeting the intersection of alcohol use and sexual behaviors. Purpose We had two goals: (a) to evaluate the optimized itMatters intervention and (b) to determine whether the candidate sexual violence prevention (SVP) component (included at the request of participating universities) had a detectable effect and therefore should be added to create a new version of itMatters. We also describe the hybrid evaluation-optimization trial we conducted to accomplish these two goals in a single experiment. Methods First year college students (N = 3,098) at four universities in the USA were individually randomized in a hybrid evaluation-optimization 2 × 2 factorial trial. Data were analyzed using regression models, with pre-test outcome variables included as covariates in the models. Analyses were conducted separately with (a) immediate post-test scores and (b) 60-day follow-up scores as outcome variables. Results Experimental results indicated a significant effect of itMatters on targeted proximal outcomes (norms) and on one distal behavioral outcome (binge drinking). There were no significant effects on other behavioral outcomes, including the intersection of alcohol and sexual behaviors. In addition, there were mixed results (positive short-term effect; no effect at 60-day follow-up) of the SVP component on targeted proximal outcomes (students’ self-efficacy to reduce/prevent sexual violence and perceived effectiveness of protective behavioral strategies). Conclusions The hybrid evaluation-optimization trial enabled us to evaluate the individual and combined effectiveness of the optimized itMatters intervention and the SVP component in a single experiment, conserving resources and providing greatly improved efficiency. Trial Registration NCT04095065.

中文翻译：

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一项混合评估-优化试验，用于评估针对大学生酒精和性交叉的干预措施，同时测试旨在预防性暴力的附加组件

背景 使用多阶段优化策略 (MOST)，我们之前开发和优化了在线行为干预措施 itMatters，旨在通过针对饮酒和性行为的交叉点来降低一年级大学生的性传播感染 (STI) 风险. 目的 我们有两个目标：(a) 评估优化的 itMatters 干预和 (b) 确定候选性暴力预防 (SVP) 组件（应参与大学的要求包括在内）是否具有可检测的效果，因此应添加到创建一个新版本的 itMatters。我们还描述了我们为在单个实验中实现这两个目标而进行的混合评估优化试验。方法 一年级大学生（N = 3，098）在美国的四所大学被单独随机分配到混合评估优化 2 × 2 因子试验中。使用回归模型分析数据，将预测试结果变量作为协变量包含在模型中。分别以 (a) 即刻后测分数和 (b) 60 天随访分数作为结果变量进行分析。结果 实验结果表明，itMatters 对目标近端结果（规范）和一种远端行为结果（酗酒）有显着影响。对其他行为结果没有显着影响，包括酒精和性行为的交叉。此外，结果好坏参半（积极的短期效应；SVP 组件在 60 天随访时对目标近端结果（学生减少/预防性暴力的自我效能和保护性行为策略的感知有效性）没有影响。结论 混合评估-优化试验使我们能够在单个实验中评估优化的 itMatters 干预和 SVP 组件的单独和组合有效性，节省资源并大大提高效率。试用注册 NCT04095065。