Alcohol ConsumptionNCT07557745
uSafeUS+ App Pilot Testing
A study testing uSafeUS+ and uSafeUS in people with Alcohol Consumption and Sexual Assault, run by University of Florida at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Sexual Assault
- What is being tested?
- uSafeUS+ and uSafeUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between the ages of 18 and 25 years old;
- Currently enrolled as a residential undergraduate student at a participating university;
- Intend to reside on or near (in the same town) campus over the two-month study period
- Own a smartphone/mobile device;
- Have consumed at least one alcoholic beverage per week or engaged in dating or social behaviors where alcohol is present at least once a week over the past 30 days;
- Intend to drink or go out at the same frequency (at least weekly) over the two-month study period
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Hampshire
Durham, New Hampshire, 03824
University of Florida
Gainesville, Florida, 32611
About this study
Official title: Expanding the uSafeUS Mobile App to Reduce Alcohol-Involved Sexual Assault on College Campuses
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:
Read more
- Do students like the app (overall and specific features)?
- How frequently do students use the app within the 1-month exposure period?
- What barriers and facilitators impact app use?
- Is there evidence of increased use of protective behaviors on drinking days and over time?
- 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.
Read the detailed description
Over 75% of campus sexual assaults involve alcohol, yet existing campus alcohol and SA prevention efforts designed for universal delivery are often siloed and limited in their ability to provide students with in-the-moment assistance to reduce risk. Smartphone apps are an integral part of college student life and are increasingly used to engage students in real-time alcohol prevention; however, none have integrated alcohol and sexual assault prevention into a single cross-cutting tool. This study addresses this gap by expanding a promising campus sexual assault prevention and response app (uSafeUS®) to include evidence-based alcohol harm reduction tools and real-time messaging to support students' use of protective behavioral strategies (PBS) in the moments when they most need them. The uSafeUS app, currently in use on 24 US college campuses, utilizes sexual assault PBS (e.g., sharing current locations and an expected return home time with trusted peers) as the primary risk reduction mechanism for students to use in social contexts where alcohol is present, yet none of the existing features directly address alcohol consumption. This project will leverage the existing uSafeUS infrastructure and a proven user-centered development process to expand app features to include an interactive drink tracker and personalized feedback messaging to reduce alcohol consumption and increase PBS use (uSafeUS+).
Following app development, the investigators will conduct a 3-arm pilot randomized controlled trial (N = 90) using an intensive longitudinal design to test uSafeUS+, relative to active (uSafeUS) and assessment-only control groups. Long term, uSafeUS+ is expected to reduce drinking outcomes and SA risk at 3-month follow-up by increasing PBS use and decreasing the amount students drink on days when students use PBS app features. This study will establish the feasibility and acceptability of uSafeUS+ and our proposed event-level evaluation approach, which is innovative and necessary to examine both between-group differences in behavioral outcomes over time and within-person variability in app feature use, acceptability, and behavioral outcomes across app use days, relative to non-app use days.
Specifically, the investigators will examine: a) app evaluability and evaluation plan feasibility using enrollment, retention, compliance, and app use data; b) overall acceptability of the app and evaluation procedures, including event-level variability in app acceptability during a 1-month app exposure period; c) psychometric properties of evaluation instruments; and d) preliminary effect sizes of app impacts on drinking and PBS use at the event level (via weekend daily diaries; uSafeUS+ vs. uSafeUS), and SA risk outcomes over time (1- and 2-month follow up; uSafeUS+ vs. uSafeUS + assessment-only control).
Participants will complete a baseline survey, which will determine participant eligibility, randomly assign students to conditions, and assess prior drinking behaviors, protective behavior use, and sexual assault experiences. Students in the uSafeUS+ or uSafeUS groups will be trained in using their assigned app and the daily survey protocols, followed by a 1-month app exposure period with integrated weekend daily diary assessments of event-level app feature acceptability, use context (where they were, who they were with), and outcomes (e.g., daily drinking, protective behavior use). The investigators will also passively collect embedded metadata on daily app usage. All students, regardless of group assignment, will complete 1- and 2-month drinking and SA risk surveys.
- Conditions
- Alcohol Consumption, Sexual Assault
- Being tested
- uSafeUS+, uSafeUS
- Keywords
- Alcohol harm reduction, Sexual Assault Risk Reduction, Protective Behavioral Strategy Use, College students, MHealth
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uSafeUS+Behavioural
Also called uSafeUS
uSafeUS app
uSafeUSBehavioural
uSafeUS app
| Study group | Role | What they receive |
|---|---|---|
| uSafeUS+ | Experimental | uSafeUS app with alcohol content Receives: Behavioral: uSafeUS+ |
| uSafeUS | Active comparator | Current UsafeUS app (no alcohol content) Receives: Behavioral: uSafeUS |
| assessment only (control) | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
The proportion of eligible participants (based on screening completion) who formally enroll in the study and complete baseline procedures.
Measured: Baseline
Retention from enrollment to 1-month follow up.
Retention from enrollment to 1-month follow-up will be defined as the proportion of enrolled participants who complete the 1-month follow-up assessment.
Measured: 1-month follow-up
Retention from enrollment to 2-month follow up.
Retention from enrollment to 2-month follow-up will be defined as the proportion of enrolled participants who complete the 2-month follow-up assessment.
Measured: 2-month follow up
Daily Protocol Compliance
For all groups, the investigators will calculate the percentage of daily surveys that each participant completes.
Measured: 1-month (assessed via daily surveys)
App use protocol compliance
The investigators will record the percentage of participants in uSafeUS+® and uSafeUS® groups who use the app at least weekly (minimum compliance)
Measured: 1-month (assessed via daily surveys)
Overall App Usage
Number of days students use the app during the 1-month exposure period; this will be captured in the daily diaries for the uSafeUS+ and uSafeUS app groups.
Measured: 1-month (assessed via daily surveys)
Overall App Acceptability
Overall app feature acceptability will be assessed at the end of the exposure period using the System Usability Scale (SUS). At 1 month Follow-up, the investigators will assess acceptability via SUS total score.
Measured: 1-month Follow Up (immediately post-intervention exposure)
Event- Level App Feature Acceptability
Within the daily surveys, feature acceptability assessments are adapted from standard app usability measures, such as the System Usability Scale (SUS; Brooke, 1996; Lewis, 2018) to assess the extent to which students found the features was easy to use. The investigators will report the aggregate mean (SD) across the features and app use period.
Measured: 1-month (assessed via daily surveys)
Event- Level App Messaging Acceptability
Adapted from measures used in Dr. Suffoletto's text-based intervention work and Dr. Scaglione's tailored app-based intervention development, the investigators will assess whether the real-time and engagement message content felt personally relevant. Daily diary measures will adapt these items to ask specifically about any messages they received the day before. The investigators will report an aggregate mean (SD) across the app use period for the uSafeUS+ group.
Measured: 1-month (assessed via daily surveys)
Secondary outcomes (3)
Evaluation design acceptability
Proportion of participants reporting willingness to participate in a study like this again
Measured: 2-month follow up
Sustained App Usage
Proportion of uSafeUS+ and uSafeUS participants who endorse continued use of their assigned app in the month after the exposure period (report separately by condition).
Measured: 2-month follow-up
Sustained App Acceptability
Proportion of participants who indicate they would recommend the app to a friend one month after initial exposure.
Measured: 2-month Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start11 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of New Hampshire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557745
- Sponsor's protocol ID
- 202501604
- Other IDs
- R34AA031379
- Status last verified
- May 2026
- First submitted
- 24 Mar 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from the baseline, daily diary, and follow-up assessments will be shared per NIH requirements established through the negotiated data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the uSafeUS Mobile App to Reduce Alcohol-Involved Sexual Assault on College Campuses
- ClinicalTrials.gov ID
- NCT07557745
- Acronym / sponsor ID
- 202501604
- Conditions
- Alcohol Consumption, Sexual Assault
- Keywords
- Alcohol harm reduction, Sexual Assault Risk Reduction, Protective Behavioral Strategy Use, College students, MHealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of New Hampshire
- Study start
- 11 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do students like the app (overall and specific features)?
- How frequently do students use the app within the 1-month exposure period?
- What barriers and facilitators impact app use?
- Is there evidence of increased use of protective behaviors on drinking days and over time?
- 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.
Detailed description
Over 75% of campus sexual assaults involve alcohol, yet existing campus alcohol and SA prevention efforts designed for universal delivery are often siloed and limited in their ability to provide students with in-the-moment assistance to reduce risk. Smartphone apps are an integral part of college student life and are increasingly used to engage students in real-time alcohol prevention; however, none have integrated alcohol and sexual assault prevention into a single cross-cutting tool. This study addresses this gap by expanding a promising campus sexual assault prevention and response app (uSafeUS®) to include evidence-based alcohol harm reduction tools and real-time messaging to support students' use of protective behavioral strategies (PBS) in the moments when they most need them. The uSafeUS app, currently in use on 24 US college campuses, utilizes sexual assault PBS (e.g., sharing current locations and an expected return home time with trusted peers) as the primary risk reduction mechanism for students to use in social contexts where alcohol is present, yet none of the existing features directly address alcohol consumption. This project will leverage the existing uSafeUS infrastructure and a proven user-centered development process to expand app features to include an interactive drink tracker and personalized feedback messaging to reduce alcohol consumption and increase PBS use (uSafeUS+).
Following app development, the investigators will conduct a 3-arm pilot randomized controlled trial (N = 90) using an intensive longitudinal design to test uSafeUS+, relative to active (uSafeUS) and assessment-only control groups. Long term, uSafeUS+ is expected to reduce drinking outcomes and SA risk at 3-month follow-up by increasing PBS use and decreasing the amount students drink on days when students use PBS app features. This study will establish the feasibility and acceptability of uSafeUS+ and our proposed event-level evaluation approach, which is innovative and necessary to examine both between-group differences in behavioral outcomes over time and within-person variability in app feature use, acceptability, and behavioral outcomes across app use days, relative to non-app use days.
Specifically, the investigators will examine: a) app evaluability and evaluation plan feasibility using enrollment, retention, compliance, and app use data; b) overall acceptability of the app and evaluation procedures, including event-level variability in app acceptability during a 1-month app exposure period; c) psychometric properties of evaluation instruments; and d) preliminary effect sizes of app impacts on drinking and PBS use at the event level (via weekend daily diaries; uSafeUS+ vs. uSafeUS), and SA risk outcomes over time (1- and 2-month follow up; uSafeUS+ vs. uSafeUS + assessment-only control).
Participants will complete a baseline survey, which will determine participant eligibility, randomly assign students to conditions, and assess prior drinking behaviors, protective behavior use, and sexual assault experiences. Students in the uSafeUS+ or uSafeUS groups will be trained in using their assigned app and the daily survey protocols, followed by a 1-month app exposure period with integrated weekend daily diary assessments of event-level app feature acceptability, use context (where they were, who they were with), and outcomes (e.g., daily drinking, protective behavior use). The investigators will also passively collect embedded metadata on daily app usage. All students, regardless of group assignment, will complete 1- and 2-month drinking and SA risk surveys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uSafeUS+ | Experimental | Behavioral: uSafeUS+uSafeUS app with alcohol content |
| uSafeUS | Active comparator | Behavioral: uSafeUSCurrent UsafeUS app (no alcohol content) |
| assessment only (control) | No intervention | –Control |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be between the ages of 18 and 25 years old;
- Currently enrolled as a residential undergraduate student at a participating university;
- Intend to reside on or near (in the same town) campus over the two-month study period
- Own a smartphone/mobile device;
- Have consumed at least one alcoholic beverage per week or engaged in dating or social behaviors where alcohol is present at least once a week over the past 30 days;
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uSafeUS+Also: uSafeUSuSafeUS app | Behavioural | uSafeUS+ |
| uSafeUSuSafeUS app | Behavioural | uSafeUS |
Primary outcome
Enrollment Rate
Time frame: Baseline
The proportion of eligible participants (based on screening completion) who formally enroll in the study and complete baseline procedures.
Retention from enrollment to 1-month follow up.
Time frame: 1-month follow-up
Retention from enrollment to 1-month follow-up will be defined as the proportion of enrolled participants who complete the 1-month follow-up assessment.
Retention from enrollment to 2-month follow up.
Time frame: 2-month follow up
Retention from enrollment to 2-month follow-up will be defined as the proportion of enrolled participants who complete the 2-month follow-up assessment.
Daily Protocol Compliance
Time frame: 1-month (assessed via daily surveys)
For all groups, the investigators will calculate the percentage of daily surveys that each participant completes.
App use protocol compliance
Time frame: 1-month (assessed via daily surveys)
The investigators will record the percentage of participants in uSafeUS+® and uSafeUS® groups who use the app at least weekly (minimum compliance)
Overall App Usage
Time frame: 1-month (assessed via daily surveys)
Number of days students use the app during the 1-month exposure period; this will be captured in the daily diaries for the uSafeUS+ and uSafeUS app groups.
Overall App Acceptability
Time frame: 1-month Follow Up (immediately post-intervention exposure)
Overall app feature acceptability will be assessed at the end of the exposure period using the System Usability Scale (SUS). At 1 month Follow-up, the investigators will assess acceptability via SUS total score.
Event- Level App Feature Acceptability
Time frame: 1-month (assessed via daily surveys)
Within the daily surveys, feature acceptability assessments are adapted from standard app usability measures, such as the System Usability Scale (SUS; Brooke, 1996; Lewis, 2018) to assess the extent to which students found the features was easy to use. The investigators will report the aggregate mean (SD) across the features and app use period.
Event- Level App Messaging Acceptability
Time frame: 1-month (assessed via daily surveys)
Adapted from measures used in Dr. Suffoletto's text-based intervention work and Dr. Scaglione's tailored app-based intervention development, the investigators will assess whether the real-time and engagement message content felt personally relevant. Daily diary measures will adapt these items to ask specifically about any messages they received the day before. The investigators will report an aggregate mean (SD) across the app use period for the uSafeUS+ group.
3 secondary outcomes
Evaluation design acceptability
Time frame: 2-month follow up
Sustained App Usage
Time frame: 2-month follow-up
Sustained App Acceptability
Time frame: 2-month Follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified data from the baseline, daily diary, and follow-up assessments will be shared per NIH requirements established through the negotiated data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uSafeUS+ and uSafeUS in people with Alcohol Consumption and Sexual Assault, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.