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临床试验/NCT03408743
NCT03408743已完成不适用

The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program

Penn State University8 个研究点 分布在 1 个国家目标入组 2,946 人开始时间: 2017年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,946
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 second (of two) screening experiments. The first screening experiment corresponds to clinicaltrials.gov ID # NCT02897804.

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

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.

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.

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

时间窗: his 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.

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.

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.

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

Distinguished Professor, Department of Human Development and Family Studies Professor, Department of Statistics

Penn State University

研究点 (8)

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