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临床试验/NCT02897804
NCT02897804已完成不适用

Engineering an Online STI Prevention Program

Penn State University8 个研究点 分布在 1 个国家目标入组 3,997 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,997
试验地点
8
主要终点
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.

研究概览

简要总结

The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.

详细描述

As part of the MOST approach, the investigators will conduct a series of screening experiments to build an optimized intervention. The current study is the first (of two) screening experiments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Currently enrolled at an American college or University.
  • A first year student or first-year transfer student.
  • 18 years of age or older.
  • Have not gone through previous versions of itMatters before

排除标准

  • Not a first year student or transfer student
  • Younger than 18 years of age
  • Have gone through previous versions of itMatters

研究组 & 干预措施

Knowledge alone

Experimental

Participants will have access to the knowledge module for a period up to 3 weeks.

干预措施: Knowledge alone (Behavioral)

Self-efficacy alone

Experimental

Participants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks.

干预措施: Self-efficacy alone (Behavioral)

Perceived benefits alone

Experimental

Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks.

干预措施: Perceived benefits alone (Behavioral)

Benefits and self-efficacy

Experimental

Participants will have access to the knowledge module plus the perceived benefits and self-efficacy modules for a period up to 3 weeks.

干预措施: Perceived benefits and self-efficacy (Behavioral)

Injunctive norms alone

Experimental

Participants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks.

干预措施: Injunctive norms (Behavioral)

Injunctive norms and self-efficacy

Experimental

Participants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks.

干预措施: Injunctive norms and self-efficacy (Behavioral)

Injunctive norms and perceived benefits

Experimental

Participants will have access to the knowledge module plus the injunctive norms and perceived benefits modules for a period up to 3 weeks.

干预措施: Injunctive norms and perceived benefits (Behavioral)

Injunctive norms, perceived benefits,self-efficacy

Experimental

Participants will have access to the knowledge module plus the injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

干预措施: Injunctive norms, perceived benefits, and self-efficacy (Behavioral)

Descriptive norms alone

Experimental

Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks.

干预措施: Descriptive norms alone (Behavioral)

Descriptive norms and self-efficacy

Experimental

Participants will have access to the knowledge module plus the descriptive norms and self-efficacy modules for a period up to 3 weeks.

干预措施: Descriptive norms and self-efficacy (Behavioral)

Descriptive norms and perceived benefits

Experimental

Participants will have access to the knowledge module plus the descriptive norms and perceived benefits modules for a period up to 3 weeks.

干预措施: Descriptive norms and perceived benefits (Behavioral)

Descriptive norms,perceived benefits,self-efficacy

Experimental

Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks.

干预措施: Descriptive norms,perceived benefits,self-efficacy (Behavioral)

Descriptive norms and injunctive norms

Experimental

Participants will have access to the knowledge module plus the descriptive norms and injunctive norms modules for a period up to 3 weeks.

干预措施: Descriptive and injunctive norms (Behavioral)

Descriptive norms, injunctive norms,self-efficacy

Experimental

Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks.

干预措施: Descriptive norms, injunctive norms,self-efficacy (Behavioral)

Descriptive and injunctive norms, benefits

Experimental

Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.

干预措施: Descriptive and injunctive norms, benefits (Behavioral)

Descriptive and injunctive norms, benefits,efficacy

Experimental

Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

干预措施: Descriptive and injunctive norms, benefits,efficacy (Behavioral)

Expectancies alone

Experimental

Participants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks.

干预措施: Expectancies alone (Behavioral)

Expectancies and self-efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies and self-efficacy (Behavioral)

Expectancies and perceived benefits

Experimental

Participants will have access to the knowledge module plus the expectancies and perceived benefits modules for a period up to 3 weeks.

干预措施: Expectancies and Perceived Benefits (Behavioral)

Expectancies, perceived benefits, self-efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies, perceived benefits, self-efficacy (Behavioral)

Expectancies and injunctive norms

Experimental

Participants will have access to the knowledge module plus the expectancies and injunctive norms modules for a period up to 3 weeks.

干预措施: Expectancies and injunctive norms (Behavioral)

Expectancies, injunctive norms, and self-efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies, injunctive norms, and self-efficacy (Behavioral)

Expectancies, injunctive norms, and benefits

Experimental

Participants will have access to the knowledge module plus the expectancies, injunctive norms, and perceived benefits modules for a period up to 3 weeks.

干预措施: Expectancies, injunctive norms, benefits (Behavioral)

Expectancies, injunctive norms, benefits, efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies, injunctive norms, benefits, efficacy (Behavioral)

Expectancies and descriptive norms

Experimental

Participants will have access to the knowledge module plus the expectancies and descriptive norms modules for a period up to 3 weeks.

干预措施: Expectancies and descriptive norms (Behavioral)

Expectancies, descriptive norms, and self-efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies, descriptive norms, and self-efficacy (Behavioral)

Expectancies, descriptive norms, and benefits

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks.

干预措施: Expectancies, descriptive norms, and benefits (Behavioral)

Expectancies,descriptive norms, benefits, efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies,descriptive norms, benefits, efficacy (Behavioral)

Expectancies, descriptive and injunctive norms

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, and injunctive norms modules for a period up to 3 weeks.

干预措施: Expectancies, descriptive and injunctive norms (Behavioral)

Expectancies, descr& injun norms, efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies, descr& injun norms, efficacy (Behavioral)

Expectancies, desc & injun norms, benefits

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.

干预措施: Expectancies, desc & injun norms, benefits (Behavioral)

Expectancies,desc & injun norms,benefits,efficacy

Experimental

Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

干预措施: Expectancies,desc & injun norms,benefits,efficacy (Behavioral)

结局指标

主要结局

Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.

时间窗: This measure will be assessed immediately following the 3-week intervention

This scale consists of 6 items and will be created as a weighted scale score. Analyses will report the mean and standard deviation and expected mean values from a regression analysis. The scale will reflect the average perceived prevalence of the alcohol and sex behaviors.

Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.

时间窗: This measure will be assessed immediately following the 3-week intervention

This scale consists of 6 items and will be created as a weighted scale score. Analyses will report the mean and standard deviation and expected mean values from a regression analysis. The scale will reflect the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.

Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.

时间窗: This measure will be assessed immediately following the 3-week intervention

This scale consists of 10 items and will be created as a weighted scale score. Analyses will report the mean and standard deviation and expected mean values from a regression analysis. The scale will reflect the average number of drinks expected to experience the 10 different outcomes.

Perceived benefits about using protective behavioral strategies collected via an online questionnaire.

时间窗: This measure will be assessed immediately following the 3-week intervention

This scale consists of 11 items and will be created as a weighted scale score. Analyses will report the mean and standard deviation and expected mean values from a regression analysis. The scale will reflect the average likelihood of contracting an STI using the listed behaviors.

Self-efficacy to use protective behavioral strategies collected via an online questionnaire.

时间窗: This measure will be assessed immediately following the 3-week intervention

This scale consists of 9 items and will be created as a weighted scale score. Analyses will report the mean and standard deviation and expected mean values from a regression analysis. The scale will reflect the average level of confidence is using protective behavioral strategies to reduce the risk of contracting and STI, ranging from not at all confident to extremely confident.

次要结局

  • Unprotected sex behavior at most recent sex collected via an online questionnaire(This measure will be assessed 1 month following the completion of the intervention)
  • Binge drinking behavior collected via an online questionnaire(This measure will be assessed 1 month following the completion of the intervention)
  • Penetrative sex at most recent hookup collected via an online questionnaire(This measure will be assessed 1 month following the completion of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Collins

Director of The Methodology Center and Distinguished Professor

Penn State University

研究点 (8)

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