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Clinical Trials/NCT03408743
NCT03408743
Completed
Not Applicable

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

Penn State University4 sites in 1 country2,946 target enrollmentSeptember 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Consumption
Sponsor
Penn State University
Enrollment
2946
Locations
4
Primary Endpoint
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2017
End Date
December 31, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Linda Collins

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

Penn State University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (4)

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