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临床试验/NCT04095065
NCT04095065已完成不适用

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

Penn State University4 个研究点 分布在 1 个国家目标入组 3,098 人开始时间: 2019年7月15日最近更新:
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
3,098
试验地点
4
主要终点
Unprotected behavior at most recent vaginal or anal sex collected via 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 have conducted two optimization trials (NCT02897804 and NCT 03408743) to identify the optimized intervention. The current study is the randomized controlled trial of the optimized intervention.

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
是

入选标准

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

排除标准

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

研究组 & 干预措施

itMatters

Experimental

Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks.

干预措施: itMatters (Behavioral)

itMatters and itMatters Sexual Violence Prevention

Experimental

Participants will have access to content focused on general knowledge and injunctive and descriptive norms related to alcohol use and sex. Additionally, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks.

干预措施: itMatters and itMatters Sexual Violence Prevention (Behavioral)

itMatters Well-being and itMatters Sexual Violence Prevention

Experimental

Participants will have access to content focused on basic information related to sleep wellness and time management. In Addition, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks.

干预措施: itMatters Well-being and itMatters Sexual Violence Prevention (Behavioral)

itMatters Well-being

Experimental

Participants will have access to content focused on basic information related to sleep wellness and time management. This content will be available for a period up to 3 weeks.

干预措施: itMatters Well-being (Behavioral)

结局指标

主要结局

Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire

时间窗: Condom use will be assessed 60 days post-intervention.

Two items ask whether or not a condom was used for vaginal or anal sex, for those who indicated recently having vaginal or anal sex. The variables will be reported as prevalence of this behavior and likely used as a dichotomous variable (unprotected/protected) in regression analyses.

Penetrative sex at most recent hookup collected via online questionnaire

时间窗: This measure will be assessed 60 days post-intervention

This item asks whether or not the most recent hookup included vaginal or anal sex. This will be reported as prevalence of the behavior and likely used as a dichotomous variable in regression analyses.

Attitudes about sexual violence

时间窗: This measure will be assessed 60 days post-intervention.

Four items ask about perceptions of sexual violence, including language, consent, pressure, and inappropriate touching. The scale will reflect the average perceptions of sexual violence attitudes.

次要结局

  • Injunctive norms about the intersection of alcohol and sex(This measure will be assessed 60 days post-intervention.)
  • Descriptive norms about the intersection of alcohol and sex(This measure will be assessed 60 days post-intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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