Engineering an Online STI Prevention Program: RCT

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: NCT04095065
• Other study ID #: R01AA02931-3
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3098
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• 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 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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Sexually Transmitted Diseases

Intervention

Behavioral:
• itMatters
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.
• itMatters and itMatters Sexual Violence Prevention
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.
• itMatters Well-being and itMatters Sexual Violence Prevention
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.
• itMatters Well-being
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.

Locations

Country	Name	City	State
United States	North Dakota State University	Fargo	North Dakota
United States	Fresno State University	Fresno	California
United States	University of North Carolina - Greensboro	Greensboro	North Carolina
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	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.
Primary	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
Primary	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	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.
Secondary	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.