uSafeUS+ App Pilot Testing

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 31, 2026 → Oct 31, 2026
See other at-risk trials from University of Florida

Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Primary completion pushed from Aug 31, 2026 to Oct 31, 2026
    • Study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 2 of 2 sites
  2. Recruitment opened
    • Site details revised at 2 of 2 sites
    v3
  3. Study sites: 1 to 2v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to test the feasibility and acceptability of an innovative mobile application (uSafeUS+) to reduce college student drinking and sexual assault (SA) risk in real time. Following an initial period of app development, this study will use a pilot 3-arm randomized controlled trial (N = 90; 30/arm) to examine the acceptability, feasibility, and initial evidence of efficacy of the novel, expanded uSafeUS+ app, relative to the existing SA-only focused uSafeUS app (already in use on 24 college campuses), and an assessment-only control condition. Specifically, the investigators aim to answer the following research questions: 1. Do students like the app (overall and specific features)? 2. How frequently do students use the app within the 1-month exposure period? 3. What barriers and facilitators impact app use? 4. Is there evidence of increased use of protective behaviors on drinking days and over time? 5. Is there evidence of decreased drinking (amount, frequency) or SA risk on drinking days and over time? Participants will complete: * A baseline assessment * A 1-month app exposure period with daily surveys about app use on the weekends * Follow-up surveys at 1- and 2-months post-intervention.
Trial Details
NCT Number NCT07557745
Lead Sponsor University of Florida
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of New Hampshire
Conditions
(from sponsor)		 Alcohol Consumption, Sexual Assault
Related terms Alcohol Drinking
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov