Clinical trial NCT03408743: Engineering an Online STI Prevention Program: CSE2
Official title: The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Sexually Transmitted Diseases
Keywords: Multiphase optimization strategy
College students
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Greensboro
First posted: 2018-01-24
Enrollment: 2946
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Descriptive norms about the intersection of alcohol and sex collected via an online questionnaire.
timeFrame: This measure will be assessed immediately following the 3-week intervention.
measure: Injunctive norms about the intersection of alcohol and sex collected via an online questionnaire.
timeFrame: his measure will be assessed immediately following the 3-week intervention.
measure: Expectancies about the intersection of alcohol use and sex collected via an online questionnaire.
timeFrame: This measure will be assessed immediately following the 3-week intervention.
measure: Perceived benefits about using protective behavioral strategies collected via an online questionnaire.
timeFrame: This measure will be assessed immediately following the 3-week intervention.
measure: Self-efficacy to use protective behavioral strategies collected via an online questionnaire.
timeFrame: This measure will be assessed immediately following the 3-week intervention.
Secondary outcomes:
measure: Binge drinking behavior collected via an online questionnaire.
timeFrame: This measure will be assessed 1 month following the completion of the intervention.
measure: Unprotected sex behavior at most recent sex collected via an online questionnaire.
timeFrame: This measure will be assessed 1 month following the completion of the intervention.
measure: Penetrative sex at most recent hookup collected via an online questionnaire.
timeFrame: This measure will be assessed 1 month following the completion of the intervention.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Fresno State University
state: California
city: Fargo
country: United States
facility: North Dakota State University
state: North Dakota
city: Murfreesboro
country: United States
facility: Middle Tennessee State University
state: Tennessee
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
affiliation: Penn State University
name: Linda M Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References: