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Engineering an Online STI Prevention Program: RCT
NCT04095065 · View on ClinicalTrials.gov ↗
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 3,098 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04095065
The ClinicalTrials.gov registry entry for NCT04095065 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,098 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 233 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04095065 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, North Carolina, North Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04095065?
This trial is sponsored by Penn State University, which has 233 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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