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NCT04095065 · ClinicalTrials.gov registry record · NA

Engineering an Online STI Prevention Program: RCT

A NA study of Sexually Transmitted Diseases and Alcohol Consumption, sponsored by Penn State University.

Completed
Registry status
NA
Development phase
3,098
Enrollment target
4
Study locations

NCT04095065 is a NA study of Sexually Transmitted Diseases and Alcohol Consumption that has completed, run by Penn State University. The registered enrollment target is 3,098 participants, above the 1,162-participant average among 35 other Sexually Transmitted Diseases trials with a reported enrollment target (167% higher). The trial reports 4 study locations across 4 states.

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The verdict

NCT04095065, a NA study of Sexually Transmitted Diseases and Alcohol Consumption, has completed, sponsored by Penn State University.

COMPLETED
Registry status
NA
Development phase
3,098 participants
Enrollment target
4
Study locations

Study 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 behavio

Interventions

  • BEHAVIORAL itMatters
  • BEHAVIORAL itMatters and itMatters Sexual Violence Prevention
  • BEHAVIORAL itMatters Well-being and itMatters Sexual Violence Prevention
  • BEHAVIORAL itMatters Well-being

Study Locations (4)

California

  • Fresno State University - Fresno

North Carolina

  • University of North Carolina - Greensboro - Greensboro

North Dakota

  • North Dakota State University - Fargo

Tennessee

  • Middle Tennessee State University - Murfreesboro

Trial Details

FieldValue
Enrollment Target 3,098 participants
Start Date 2019-07-15
Est. Completion 2019-12-31
Phase NA

Sponsor

Penn State University

219 total trials

What the Registry Record Tells You About NCT04095065

The ClinicalTrials.gov registry entry for NCT04095065 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3,098 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,162-participant average among 35 other Sexually Transmitted Diseases trials with a reported enrollment target (167% higher). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sexually Transmitted Diseases appearing as the primary indexed condition, and to 4 interventions - of which itMatters is the first listed.

NCT04095065 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, North Carolina, North Dakota.

Frequently Asked Questions

What is clinical trial NCT04095065 about?

NCT04095065 is a clinical study titled "Engineering an Online STI Prevention Program: RCT". 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...

What is the current status of trial NCT04095065?

This trial is currently completed. It is a NA study. The enrollment target is 3,098 participants. The study started on 2019-07-15. Estimated completion is 2019-12-31.

What conditions does trial NCT04095065 study?

This clinical trial studies the following conditions: Sexually Transmitted Diseases, Alcohol Consumption.

What interventions are being tested in trial NCT04095065?

The interventions under investigation include: itMatters (BEHAVIORAL), itMatters and itMatters Sexual Violence Prevention (BEHAVIORAL), itMatters Well-being and itMatters Sexual Violence Prevention (BEHAVIORAL), itMatters Well-being (BEHAVIORAL).

Who is sponsoring clinical trial NCT04095065?

This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04095065 being conducted?

This trial has 4 study locations across California, North Carolina, North Dakota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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