Engineering an Online STI Prevention Program: CSE2

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Sexually Transmitted Diseases; Alcohol Consumption

Treatments: Behavioral: Descriptive norms alone; Behavioral: Descriptive norms and self-efficacy; Behavioral: Expectancies, injunctive norms, self-efficacy; Behavioral: Injunctive norms alone; Behavioral: Expectancies, descriptive norms, benefits, efficacy; Behavioral: Expectancies alone; Behavioral: Perceived benefits alone; Behavioral: Injunctive norms, benefits, self-efficacy; Behavioral: Descriptive norms and injunctive norms; Behavioral: Descriptive and injunctive norms, self-efficacy; Behavioral: Expectancies, descriptive & injunctive, benefits, efficacy; Behavioral: Expectancies, descriptive norms, benefits; Behavioral: Expectancies, injunctive norms, benefits, efficacy; Behavioral: Expectancies, injunctive norms, and benefits; Behavioral: Expectancies, descriptive & injunctive norms, efficacy; Behavioral: Expectancies, descriptive & injunctive norms, benefits; Behavioral: Descriptive norms and perceived benefits; Behavioral: Self-efficacy alone; Behavioral: Expectancies, descriptive and injunctive norms; Behavioral: Expectancies and descriptive norms; Behavioral: Expectancies, benefits, self-efficacy; Behavioral: Injunctive norms and benefits; Behavioral: Expectancies and perceived benefits; Behavioral: Expectancies and injunctive norms; Behavioral: Knowledge Alone; Behavioral: Descriptive and injunctive norms, and benefits; Behavioral: Descriptive norms, benefits, self-efficacy; Behavioral: Benefits and self-efficacy; Behavioral: Descriptive & injunctive norms, benefits, efficacy; Behavioral: Injunctive norms and self-efficacy; Behavioral: Expectancies, descriptive norms, & self-efficacy; Behavioral: Expectancies and self-efficacy

Study type: Interventional

Funder types: Other

Identifiers

NCT03408743

R01AA022931-2

R01AA022931

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 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.

Enrollment: 2,946 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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2,946 participants in 32 patient groups

Knowledge alone

Experimental group

Description:

Participants will have access to the knowledge module for a period up to 3 weeks.

Treatment:

Behavioral: Knowledge Alone

Self-efficacy alone

Experimental group

Description:

Participants will have access to the knowledge module plus the self-efficacy module for a period up to 3 weeks.

Treatment:

Behavioral: Self-efficacy alone

Perceived benefits alone

Experimental group

Description:

Participants will have access to the knowledge module plus the perceived benefits module for a period up to 3 weeks. \*Also referred to as 'benefits' in other arm descriptions\*\*

Treatment:

Behavioral: Perceived benefits alone

Benefits and self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus perceived benefits and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Benefits and self-efficacy

Injunctive norms alone

Experimental group

Description:

Participants will have access to the knowledge module plus the injunctive norms module for a period up to 3 weeks.

Treatment:

Behavioral: Injunctive norms alone

Injunctive norms and self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus injunctive norms and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Injunctive norms and self-efficacy

Injunctive norms and benefits

Experimental group

Description:

Participants will have access to the knowledge module plus injunctive norms and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Injunctive norms and benefits

Injunctive norms, benefits, self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Injunctive norms, benefits, self-efficacy

Descriptive norms alone

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive norms alone

Descriptive norms and self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive norms and self-efficacy

Descriptive norms and perceived benefits

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive norms and perceived benefits

Descriptive norms, benefits, self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive norms, benefits, self-efficacy

Descriptive norms and injunctive norms

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms and injunctive norms modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive norms and injunctive norms

Descriptive and injunctive norms, self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the injunctive norms and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive and injunctive norms, self-efficacy

Descriptive and injunctive norms, and benefits

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive and injunctive norms, and benefits

Descriptive & injunctive norms, benefits, efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Descriptive & injunctive norms, benefits, efficacy

Expectancies alone

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies module for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies alone

Expectancies and self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies and self-efficacy

Expectancies and perceived benefits

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies and perceived benefits

Expectancies, benefits, self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, benefits, self-efficacy

Expectancies and injunctive norms

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies and injunctive norms modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies and injunctive norms

Expectancies, injunctive norms, self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, injunctive norms, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, injunctive norms, self-efficacy

Expectancies, injunctive norms, and benefits

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, injunctive norms, and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, injunctive norms, and benefits

Expectancies, injunctive norms, benefits, efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, injunctive norms, benefits, efficacy

Expectancies and descriptive norms

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies and descriptive norms modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies and descriptive norms

Expectancies, descriptive norms, self-efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, descriptive norms, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive norms, & self-efficacy

Expectancies, descriptive norms, benefits

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, descriptive norms, and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive norms, benefits

Expectancies, descriptive norms, benefits, efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, descriptive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive norms, benefits, efficacy

Expectancies, descriptive and injunctive norms

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies , descriptive norms, and injunctive norms modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive and injunctive norms

Expectancies, descriptive & injunctive norms, efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies , descriptive norms, injunctive norms, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive & injunctive norms, efficacy

Expectancies, descriptive & injunctive norms, benefits

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, and perceived benefits modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive & injunctive norms, benefits

Expectancies, descriptive & injunctive, benefits, efficacy

Experimental group

Description:

Participants will have access to the knowledge module plus the expectancies, descriptive norms, injunctive norms, perceived benefits, and self-efficacy modules for a period up to 3 weeks.

Treatment:

Behavioral: Expectancies, descriptive & injunctive, benefits, efficacy