Engineering an Online STI Prevention Program: CSE2

Sexually Transmitted Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408743
• Other study ID #: R01AA022931-2
• Secondary ID: R01AA022931
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2019
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2946
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Knowledge Alone
Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
• Self-efficacy alone
Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
• 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.
• 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.
• Injunctive norms alone
Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
• 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.
• Injunctive norms and 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.
• Injunctive norms, benefits, 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.
• Descriptive norms alone
Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
• 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.
• 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.
• Descriptive norms, 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.
• Descriptive norms 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.
• Descriptive and injunctive norms, self-efficacy
orrect 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.
• Descriptive and injunctive norms, and 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.
• Descriptive & 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.
• Expectancies alone
Decrease the expectation that alcohol is needed to have good sexual encounter.
• 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.
• 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.
• Expectancies, 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.
• 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.
• Expectancies, injunctive norms, 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.
• Expectancies, injunctive norms, and 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.
• 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.
• 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.
• Expectancies, descriptive norms, & 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.
• Expectancies, descriptive 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; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
• 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.
• 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.
• Expectancies, descriptive & injunctive 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.
• Expectancies, descriptive & injunctive 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.
• Expectancies, descriptive & injunctive, 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.

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas
United States	North Dakota State University	Fargo	North Dakota
United States	Fresno State University	Fresno	California
United States	Middle Tennessee State University	Murfreesboro	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.	his measure will be assessed immediately following the 3-week intervention.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.