Engineering an Online STI Prevention Program: RCT

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Sexually Transmitted Diseases; Alcohol Consumption

Treatments: Behavioral: itMatters and itMatters Sexual Violence Prevention; Behavioral: itMatters Well-being; Behavioral: itMatters; Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT04095065

R01AA02931-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,098 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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3,098 participants in 4 patient groups

itMatters

Experimental group

Description:

Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks.

Treatment:

Behavioral: itMatters

itMatters and itMatters Sexual Violence Prevention

Experimental group

Description:

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.

Treatment:

Behavioral: itMatters and itMatters Sexual Violence Prevention

itMatters Well-being and itMatters Sexual Violence Prevention

Experimental group

Description:

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.

Treatment:

Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention

itMatters Well-being

Experimental group

Description:

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.

Treatment:

Behavioral: itMatters Well-being