Engineering an Online STI Prevention Program

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Sexual Behavior; Alcohol Consumption
• Intervention / Treatment: Behavioral: Knowledge alone; Behavioral: Self-efficacy alone; Behavioral: Perceived benefits alone; Behavioral: Perceived benefits and self-efficacy; Behavioral: Injunctive norms; Behavioral: Injunctive norms and self-efficacy; Behavioral: Injunctive norms and perceived benefits; Behavioral: Injunctive norms, perceived benefits, and self-efficacy; Behavioral: Descriptive norms alone; Behavioral: Descriptive norms and self-efficacy; Behavioral: Descriptive norms and perceived benefits; Behavioral: Descriptive norms,perceived benefits,self-efficacy; Behavioral: Descriptive and injunctive norms; Behavioral: Descriptive norms, injunctive norms,self-efficacy; Behavioral: Descriptive and injunctive norms, benefits; Behavioral: Descriptive and injunctive norms, benefits,efficacy; Behavioral: Expectancies alone; Behavioral: Expectancies and self-efficacy; Behavioral: Expectancies and Perceived Benefits; Behavioral: Expectancies, perceived benefits, self-efficacy; Behavioral: Expectancies and injunctive norms; Behavioral: Expectancies, injunctive norms, and self-efficacy; Behavioral: Expectancies, injunctive norms, benefits; Behavioral: Expectancies, injunctive norms, benefits, efficacy; Behavioral: Expectancies and descriptive norms; Behavioral: Expectancies, descriptive norms, and self-efficacy; Behavioral: Expectancies, descriptive norms, and benefits; Behavioral: Expectancies,descriptive norms, benefits, efficacy; Behavioral: Expectancies, descriptive and injunctive norms; Behavioral: Expectancies, descr& injun norms, efficacy; Behavioral: Expectancies, desc & injun norms, benefits; Behavioral: Expectancies,desc & injun norms,benefits,efficacy

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 first (of two) screening experiments.

• Study Type: Interventional
• Enrollment (Actual): 3997
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93740
      • Fresno State University
  • Illinois
    • Carbondale, Illinois, United States, 62901
      • Southern Illinois University
  • North Carolina
    • Greensboro, North Carolina, United States, 27411
      • North Carolina A&T State University
  • North Dakota
    • Fargo, North Dakota, United States, 58108-6050
      • North Dakota State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

32

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Knowledge alone; Participants will have access to the knowledge module for a period up to 3 weeks.	Behavioral: Knowledge alone; Increase knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
Experimental: Self-efficacy alone; Participants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks.	Behavioral: Self-efficacy alone; Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Perceived benefits alone; Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks.	Behavioral: Perceived benefits alone; Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Benefits and self-efficacy; Participants will have access to the knowledge module plus the perceived benefits and self-efficacy modules for a period up to 3 weeks.	Behavioral: Perceived benefits and self-efficacy; Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Injunctive norms alone; Participants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks.	Behavioral: Injunctive norms; Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Injunctive norms and 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.	Behavioral: Injunctive norms and self-efficacy; Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Injunctive norms and perceived benefits; Participants will have access to the knowledge module plus the injunctive norms and perceived benefits modules for a period up to 3 weeks.	Behavioral: Injunctive norms and perceived benefits; Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Injunctive norms, perceived 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.	Behavioral: Injunctive norms, perceived benefits, and self-efficacy; Correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Descriptive norms alone; Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks.	Behavioral: Descriptive norms alone; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
Experimental: 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.	Behavioral: Descriptive norms and self-efficacy; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Descriptive norms and perceived benefits; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Descriptive norms,perceived benefits,self-efficacy; Participants will have access to the knowledge module plus the descriptive norms module for a period up to 3 weeks.	Behavioral: Descriptive norms,perceived benefits,self-efficacy; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Descriptive and injunctive norms; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Descriptive norms, injunctive norms,self-efficacy; 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.	Behavioral: Descriptive norms, injunctive norms,self-efficacy; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Descriptive and injunctive norms, 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.	Behavioral: Descriptive and injunctive norms, benefits; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Descriptive and 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.	Behavioral: Descriptive and injunctive norms, benefits,efficacy; Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies alone; Participants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks.	Behavioral: Expectancies alone; Decrease the expectation that alcohol is needed to have good sexual encounter.
Experimental: 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.	Behavioral: Expectancies and self-efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Expectancies and Perceived Benefits; Decrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Expectancies, perceived 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.	Behavioral: Expectancies, perceived benefits, self-efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Expectancies and injunctive norms; Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Expectancies, injunctive norms, and 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.	Behavioral: Expectancies, injunctive norms, and self-efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Expectancies, injunctive norms, benefits; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: 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.	Behavioral: Expectancies, injunctive norms, benefits, efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Expectancies and descriptive norms; Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
Experimental: Expectancies, descriptive norms, and 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.	Behavioral: Expectancies, descriptive norms, and self-efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies, descriptive norms, and 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.	Behavioral: Expectancies, descriptive norms, and benefits; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: 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.	Behavioral: Expectancies,descriptive norms, benefits, efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: 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.	Behavioral: Expectancies, descriptive and injunctive norms; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
Experimental: Expectancies, descr& injun 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.	Behavioral: Expectancies, descr& injun norms, efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
Experimental: Expectancies, desc & injun 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.	Behavioral: Expectancies, desc & injun norms, benefits; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
Experimental: Expectancies,desc & injun norms,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.	Behavioral: Expectancies,desc & injun norms,benefits,efficacy; Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.	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.	This measure will be assessed immediately following the 3-week intervention
Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.	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.	This measure will be assessed immediately following the 3-week intervention
Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.	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.	This measure will be assessed immediately following the 3-week intervention
Perceived benefits about using protective behavioral strategies collected via an online questionnaire.	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.	This measure will be assessed immediately following the 3-week intervention
Self-efficacy to use protective behavioral strategies collected via an online questionnaire.	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.	This measure will be assessed immediately following the 3-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge drinking behavior collected via an online questionnaire	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.	This measure will be assessed 1 month following the completion of the intervention
Unprotected sex behavior at most recent sex collected via an online questionnaire	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.	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 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.	This measure will be assessed 1 month following the completion of the intervention

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: University of North Carolina, Greensboro

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: college students; multiphase optimization strategy
• Additional Relevant MeSH Terms: Pathologic Processes; Drinking Behavior; Infections; Communicable Diseases; Disease Attributes; Alcohol Drinking; Sexually Transmitted Diseases
• Other Study ID Numbers: R01AA022931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No