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Sexual ViolenceRAISENCT05185440

Reducing Alcohol Involved Sexual Violence in Higher Education

A study testing GIFTSS Training, Learning Collaborative and Provider Scripts in people with Sexual Violence and Drinking Heavy, run by University of Pittsburgh at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This cluster-randomized controlled trial across 28+ college campuses focuses on undergraduate college students at elevated risk for sexual violence and hazardous drinking (i.e., students with prior history of sexual violence, students who are sexual or gender minority, and students with disabilities). Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Sexual Violence, Drinking Heavy
What is being tested?
GIFTSS Training, Learning Collaborative and Provider Scripts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteUnited States
Study dates
12 Jun 2023to Jul 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 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • undergraduate student enrolled at participating college campus
  • age 18-24 years
  • seeking care at a participating campus college health or counseling center for any reason

Who cannot join

  • under the age of 18
  • not enrolled as an undergraduate at a participating campus
  • not seeking care at college health or counseling center

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

This cluster-randomized controlled trial across 28+ college campuses focuses on undergraduate college students at elevated risk for sexual violence and hazardous drinking (i.e., students with prior history of sexual violence, students who are sexual or gender minority, and students with disabilities). "Reducing Alcohol Involved Sexual violence in higher Education (RAISE)" is a longitudinal study that will test research-informed strategies to improve implementation of a prevention intervention in college health and counseling centers, integrate a safety decision aid (via computer or mobile device) to more directly target harm reduction among students particularly vulnerable to hazardous drinking and SV, and evaluate campus policies that increase accessibility and uptake of confidential services for students. This is the first study to situate a sexual violence prevention intervention in college health and counseling centers to address two significant public health concerns -- alcohol-involved sexual violence and hazardous drinking on college campuses.

Read the detailed description

This is a collaborative study across 28+ college campuses focused on tailored harm reduction interventions to reduce risk for sexual violence (SV) among undergraduate college students receiving care from college health and counseling centers (CHCs). "Reducing Alcohol Involved Sexual violence in higher Education (RAISE)" is a longitudinal study that builds on a previous cluster-randomized controlled trial on college campuses in Pennsylvania and West Virginia (R01 AA023260). The study aims to reach students at elevated risk for SV and hazardous drinking: students with history of SV, students who identify as sexual/gender minority, and students who have disabilities (65% of our previous sample). SV, particularly alcohol-involved SV, remains highly prevalent on college campuses. A previous study by this research team found that a large proportion of students seeking care in CHCs have experienced SV victimization (n=2291, 64% of women, 32% of men re-port lifetime SV) which is associated with binge drinking. Students identifying as sexual or gender minority or endorsing a disability (i.e., physical, emotional, sensory, neurologic, and learning impairments) report particularly high lifetime prevalence of SV that is associated with greater odds of binge drinking compared to students not exposed to SV. The previous RCT involved training CHC staff to deliver a brief educational intervention to re-duce SV risk, titled "Giving Information for Trauma Support and Safety" (GIFTSS), to all students seeking care. Implementation varied across CHCs. Among students who received GIFTSS as intended, the study found significant increases in self-efficacy to use harm reduction strategies and SV-related services. Students with history of SV had greater than four-fold increase in odds of disclosing this history to providers. The study identified provider-, clinic-and campus-level changes needed to improve intervention delivery. To more directly target use of harm reduction strategies among students at elevated risk for SV and hazardous drinking, this current study will also integrate a safety decision aid (myPlan app for use on smartphone or computer) which increases harm reduction behaviors among college women experiencing partner violence. The focus of this renewal is to 1) test strategies to improve implementation of GIFTSS, 2) offer support for students at elevated risk for SV and hazardous drinking with tailored harm reduction strategies delivered via the myPlan app after the clinic visit, and 3) strengthen campus policies to promote access to SV services and reduce hazardous drinking. A 2x2 cluster randomized controlled trial will compare two implementation strategies for GIFTSS in CHCs (provider scripts vs. learning collaborative) focusing on undergraduate students ages 18-24 (N= 2400 across 28 campuses) with follow-up at 4 months and 12 months (Aim 1). The trial will also assess effectiveness of myPlan in increasing uptake of tailored harm reduction strategies for those at elevated risk for SV and hazardous drinking (Aim 2). Finally, the study will examine alcohol and SV policy changes on each campus that may increase access to and uptake of confidential services among students at elevated risk for hazardous drinking and SV (Aim 3).

Being tested
GIFTSS Training, Learning Collaborative, Provider Scripts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIFTSS TrainingBehavioural

    training for college health center staff and clinicians on GIFTSS intervention (Giving Information for Trauma Support and Safety -- universal education and brief counseling to address sexual violence prevention and intervention)

  • Learning CollaborativeBehavioural

    learning collaborative (anticipated meeting monthly) with college health center staff and clinicians to address common barriers to implementation of GIFTSS intervention, reinforce GIFTSS training

  • Provider ScriptsBehavioural

    scripts and prompts for college health center staff and clinicians to encourage implementation of GIFTSS intervention

Study groups in NCT05185440
Study groupRoleWhat they receive
GIFTSS Training OnlyActive comparatorTraining for college health center clinicians and staff in implementation of GIFTSS Training
Receives: Behavioral: GIFTSS Training
GIFTSS Training and Learning CollaborativeExperimentalTraining for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative to support implementation
Receives: Behavioral: GIFTSS Training; Behavioral: Learning Collaborative
GIFTSS Training and Provider ScriptsExperimentalTraining for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts to support implementation
Receives: Behavioral: GIFTSS Training; Behavioral: Provider Scripts
GIFTSS Training, Learning Collaborative, and Provider ScriptsExperimentalTraining for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative as well as provider scripts to support implementation
Receives: Behavioral: GIFTSS Training; Behavioral: Learning Collaborative; Behavioral: Provider Scripts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Provider discussion

    Yes to any items about SV and alcohol-involved SV talking points covered by provider during college health center visit (assessed in exit survey after visit)

    Measured: within 7 days after clinic visit

  2. Receipt of educational resource card

    Participant self-report of receipt of the GIFTSS safety card during the visit (assessed in exit survey after visit)

    Measured: within 7 days after clinic visit

Secondary outcomes (6)
  1. Self-efficacy to enact harm reduction strategies

    self-efficacy to use SV and drinking-related harm reduction behaviors (mean score, range 1 to 5, 5 indicating greater self-efficacy)

    Measured: 4 months and 12 months

  2. Use of harm reduction strategies

    use of SV and drinking-related harm reduction behaviors (summary score; 0 to 10, 10 being maximum number of strategies assessed)

    Measured: 4 months and 12 months

  3. Self-efficacy to use confidential SV-related services

    self-efficacy to use confidential SV services (including college health center, off campus advocate) (mean score, range 1 to 5, 5 indicating greater self-efficacy)

    Measured: 4 months and 12 months

  4. Use of SV-related services

    use of SV-related services (including college health center, off campus advocate) in past 3 months and past year (summary score; 0 to 10, 10 being maximum number of services assessed)

    Measured: 4 months and 12 months

  5. SV victimization (exploratory)

    experience of SV victimization (including alcohol as context) in past 3 months and past year (summary score; 0 to 10, 10 being maximum number of types of violence exposure assessed)

    Measured: 4 months and 12 months

  6. Alcohol use patterns (exploratory)

    Patterns of alcohol use (frequency and quantity of alcohol use in past month); frequency of binge drinking in past month; problem alcohol use (risk for alcohol use disorder using AUDIT); drinking motivations

    Measured: 4 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start12 Jun 2023
  3. Primary completion1 Jul 2026
  4. Study completionJul 2027 (estimated)

Resources

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
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05185440
Sponsor's protocol ID
STUDY20090065
Other IDs
R01AA023260
Acronym
RAISE
Status last verified
Jun 2026
First submitted
22 Dec 2021
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: data sharing plan and archiving of de-identified data as required by NIH

Questions about this trial

What is this clinical trial studying?

A study testing GIFTSS Training, Learning Collaborative and Provider Scripts in people with Sexual Violence and Drinking Heavy, run by University of Pittsburgh at 1 site 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 3 inclusion and 3 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Provider discussion (time frame: within 7 days after clinic visit). The study lists 2 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 3 Sep 2026.

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