Clinical trial NCT04095065: Engineering an Online STI Prevention Program: RCT
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 (MOST)
College students
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Greensboro
First posted: 2019-09-19
Enrollment: 3098
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire
timeFrame: Condom use will be assessed 60 days post-intervention.
measure: Penetrative sex at most recent hookup collected via online questionnaire
timeFrame: This measure will be assessed 60 days post-intervention
measure: Attitudes about sexual violence
timeFrame: This measure will be assessed 60 days post-intervention.
Secondary outcomes:
measure: Injunctive norms about the intersection of alcohol and sex
timeFrame: This measure will be assessed 60 days post-intervention.
measure: Descriptive norms about the intersection of alcohol and sex
timeFrame: This measure will be assessed 60 days post-intervention.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Fresno State University
state: California
city: Greensboro
country: United States
facility: University of North Carolina - Greensboro
state: North Carolina
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
Study officials:
affiliation: Penn State University
name: Linda M Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanner AE, Guastaferro KM, Rulison KL, Wyrick DL, Milroy JJ, Bhandari S, Thorpe S, Ware S, Miller AM, Collins LM. A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence. Ann Behav Med. 2021 Nov 18;55(12):1184-1187. doi: 10.1093/abm/kaab003.