Engineering an Online STI Prevention Program: RCT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alcohol Consumption, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: itMatters
* Behavioral: itMatters and itMatters Sexual Violence Prevention
* Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention
* Behavioral: itMatters Well-being


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Not a first year student or transfer student Younger than 18 years old Have gone through previous versions of itMatters

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: itMatters<br>Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks. | Behavioral: itMatters<br>* Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing & treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse & sexual risk taking.<br>|
| Experimental: itMatters and itMatters Sexual Violence Prevention<br>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. | Behavioral: itMatters and itMatters Sexual Violence Prevention<br>* Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing & treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse & sexual risk taking. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increased knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.<br>|
| Experimental: itMatters Well-being and itMatters Sexual Violence Prevention<br>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. | Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention<br>* Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increase knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.<br>|
| Experimental: itMatters Well-being<br>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. | Behavioral: itMatters Well-being<br>* Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire | 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. | Condom use will be assessed 60 days post-intervention. | 
| Penetrative sex at most recent hookup collected via online questionnaire | 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. | This measure will be assessed 60 days post-intervention | 
| Attitudes about sexual violence | 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. | This measure will be assessed 60 days post-intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injunctive norms about the intersection of alcohol and sex | This scale consists of 5 items reflecting the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve. | This measure will be assessed 60 days post-intervention. | 
| Descriptive norms about the intersection of alcohol and sex | This scale consists of 5 items reflecting the average perceived prevalence of the alcohol and sex behaviors. | This measure will be assessed 60 days post-intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiphase optimization strategy (MOST), College students