Engineering an Online STI Prevention Program: CSE2

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases; Alcohol Consumption
• Interventions: Behavioral: Expectancies, descriptive and injunctive norms; Behavioral: Descriptive norms alone; Behavioral: Benefits and self-efficacy; Behavioral: Injunctive norms and self-efficacy; Behavioral: Injunctive norms, benefits, self-efficacy; Behavioral: Self-efficacy alone; Behavioral: Injunctive norms alone; Behavioral: Descriptive norms, benefits, self-efficacy; Behavioral: Expectancies alone; Behavioral: Expectancies and self-efficacy; Behavioral: Expectancies, benefits, self-efficacy; Behavioral: Expectancies, injunctive norms, self-efficacy; Behavioral: Expectancies, descriptive & injunctive, benefits, efficacy; Behavioral: Knowledge Alone; Behavioral: Perceived benefits alone; Behavioral: Descriptive norms and self-efficacy; Behavioral: Descriptive and injunctive norms, self-efficacy; Behavioral: Descriptive & injunctive norms, benefits, efficacy; Behavioral: Expectancies, descriptive norms, & self-efficacy; Behavioral: Expectancies, descriptive & injunctive norms, efficacy; Behavioral: Injunctive norms and benefits; Behavioral: Expectancies and perceived benefits; Behavioral: Expectancies and descriptive norms; Behavioral: Expectancies, descriptive norms, benefits; Behavioral: Expectancies, descriptive & injunctive norms, benefits; Behavioral: Descriptive norms and perceived benefits; Behavioral: Descriptive and injunctive norms, and benefits; Behavioral: Descriptive norms and injunctive norms; Behavioral: Expectancies and injunctive norms; Behavioral: Expectancies, injunctive norms, and benefits; Behavioral: Expectancies, injunctive norms, benefits, efficacy; Behavioral: Expectancies, descriptive norms, benefits, efficacy

• Registration Number: NCT03408743
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study Start: 2017-09-18
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2946

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Expectancies, descriptive and injunctive norms	Expectancies, descriptive and injunctive norms	Participants will have access to the knowledge module plus the expectancies , descriptive norms, and injunctive norms modules for a period up to 3 weeks.
Descriptive norms alone	Descriptive norms alone	Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.
Benefits and self-efficacy	Benefits and self-efficacy	Participants will have access to the knowledge module plus perceived benefits and self-efficacy modules for a period up to 3 weeks.
Injunctive norms and self-efficacy	Injunctive norms and self-efficacy	Participants will have access to the knowledge module plus injunctive norms and self-efficacy modules for a period up to 3 weeks.
Injunctive norms, benefits, self-efficacy	Injunctive norms, benefits, self-efficacy	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.
Self-efficacy alone	Self-efficacy alone	Participants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks.
Injunctive norms alone	Injunctive norms alone	Participants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks.
Descriptive norms, benefits, self-efficacy	Descriptive norms, benefits, self-efficacy	Participants will have access to the knowledge module plus the descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
Expectancies alone	Expectancies alone	Participants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks.
Expectancies and self-efficacy	Expectancies and self-efficacy	Participants will have access to the knowledge module plus the expectancies and self-efficacy modules for a period up to 3 weeks.
Expectancies, benefits, self-efficacy	Expectancies, benefits, self-efficacy	Participants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks.
Expectancies, injunctive norms, self-efficacy	Expectancies, injunctive norms, self-efficacy	Participants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks.
Expectancies, descriptive & injunctive, benefits, efficacy	Expectancies, descriptive & injunctive, benefits, efficacy	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.
Knowledge alone	Knowledge Alone	Participants will have access to the knowledge module for a period up to 3 weeks.
Perceived benefits alone	Perceived benefits alone	Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks. \*Also referred to as 'benefits' in other arm descriptions\*\*
Descriptive norms and self-efficacy	Descriptive norms and self-efficacy	Participants will have access to the knowledge module plus the descriptive norms and self-efficacy modules for a period up to 3 weeks.
Descriptive and injunctive norms, self-efficacy	Descriptive and injunctive norms, self-efficacy	Participants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks.
Descriptive & injunctive norms, benefits, efficacy	Descriptive & injunctive norms, benefits, efficacy	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.
Expectancies, descriptive norms, self-efficacy	Expectancies, descriptive norms, & self-efficacy	Participants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks.
Expectancies, descriptive & injunctive norms, efficacy	Expectancies, descriptive & injunctive norms, efficacy	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.
Injunctive norms and benefits	Injunctive norms and benefits	Participants will have access to the knowledge module plus injunctive norms and perceived benefits modules for a period up to 3 weeks.
Expectancies and perceived benefits	Expectancies and perceived benefits	Participants will have access to the knowledge module plus the expectancies and perceived benefits modules for a period up to 3 weeks.
Expectancies and descriptive norms	Expectancies and descriptive norms	Participants will have access to the knowledge module plus the expectancies and descriptive norms modules for a period up to 3 weeks.
Expectancies, descriptive norms, benefits	Expectancies, descriptive norms, benefits	Participants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks.
Expectancies, descriptive & injunctive norms, benefits	Expectancies, descriptive & injunctive norms, benefits	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.
Descriptive norms and perceived benefits	Descriptive norms and perceived benefits	Participants will have access to the knowledge module plus the descriptive norms and perceived benefits modules for a period up to 3 weeks.
Descriptive and injunctive norms, and benefits	Descriptive and injunctive norms, and benefits	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.
Descriptive norms and injunctive norms	Descriptive norms and injunctive norms	Participants will have access to the knowledge module plus the descriptive norms and injunctive norms modules for a period up to 3 weeks.
Expectancies and injunctive norms	Expectancies and injunctive norms	Participants will have access to the knowledge module plus the expectancies and injunctive norms modules for a period up to 3 weeks.
Expectancies, injunctive norms, and benefits	Expectancies, injunctive norms, and benefits	Participants will have access to the knowledge module plus the expectancies, injunctive norms, and perceived benefits modules for a period up to 3 weeks.
Expectancies, injunctive norms, benefits, efficacy	Expectancies, injunctive norms, benefits, efficacy	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.
Expectancies, descriptive norms, benefits, efficacy	Expectancies, descriptive norms, benefits, efficacy	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.

Primary Outcome Measures

Name	Time	Method
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.	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.	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.	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.	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.	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 Outcome Measures

Name	Time	Method
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.	This item asks whether or not a condom was used for oral, anal or vaginal sex. This variable will be collapsed into a dichotomous variable with unprotected anal or vaginal sex versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
Binge drinking behavior collected via an online questionnaire.	This measure will be assessed 1 month following the completion of the intervention.	This item asks how many times in the past two weeks a male has 5 or more drinks in a 2-hour period (or females 4 or more drinks in a 2-hour period). This variable will be collapsed into 1 or more times versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.
Penetrative sex at most recent hookup collected via an online questionnaire.	This measure will be assessed 1 month following the completion of the intervention.	This item asks whether or not the most recent hookup included vaginal or anal sex. This variable will be collapsed into a dichotomous variable with penetrative sex versus other and reported as a prevalence of this behavior and used as a dichotomous outcome in regression analyses.

Trial Locations

Locations (4)

Texas A&M University; 🇺🇸 College Station, Texas, United States

Middle Tennessee State University; 🇺🇸 Murfreesboro, Tennessee, United States

North Dakota State University; 🇺🇸 Fargo, North Dakota, United States

Fresno State University; 🇺🇸 Fresno, California, United States