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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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).
- Conditions
- Sexual Violence, Drinking Heavy
- 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 group | Role | What they receive |
|---|---|---|
| GIFTSS Training Only | Active comparator | Training for college health center clinicians and staff in implementation of GIFTSS Training Receives: Behavioral: GIFTSS Training |
| GIFTSS Training and Learning Collaborative | Experimental | Training 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 Scripts | Experimental | Training 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 Scripts | Experimental | Training 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.
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
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)
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
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
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
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
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
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.
- First posted11 Jan 2022
- Study start12 Jun 2023
- Primary completion1 Jul 2026
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Traci Kazmerski, University of Pittsburgh
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Alcohol Involved Sexual Violence in Higher Education
- ClinicalTrials.gov ID
- NCT05185440
- Acronym / sponsor ID
- RAISE / STUDY20090065
- Conditions
- Sexual Violence, Drinking Heavy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Jan 2022 (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.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GIFTSS Training Only | Active comparator | Behavioral: GIFTSS TrainingTraining for college health center clinicians and staff in implementation of GIFTSS Training |
| GIFTSS Training and Learning Collaborative | Experimental | Behavioral: GIFTSS Training, Behavioral: Learning CollaborativeTraining for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative to support implementation |
| GIFTSS Training and Provider Scripts | Experimental | Behavioral: GIFTSS Training, Behavioral: Provider ScriptsTraining for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts to support implementation |
| GIFTSS Training, Learning Collaborative, and Provider Scripts | Experimental | Behavioral: GIFTSS Training, Behavioral: Learning Collaborative, Behavioral: Provider ScriptsTraining for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative as well as provider scripts to support implementation |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- under the age of 18
- not enrolled as an undergraduate at a participating campus
- not seeking care at college health or counseling center
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 |
|---|---|---|
| GIFTSS Trainingtraining 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) | Behavioural | GIFTSS Training Only, GIFTSS Training and Learning Collaborative, GIFTSS Training and Provider Scripts, GIFTSS Training, Learning Collaborative, and Provider Scripts |
| Learning Collaborativelearning collaborative (anticipated meeting monthly) with college health center staff and clinicians to address common barriers to implementation of GIFTSS intervention, reinforce GIFTSS training | Behavioural | GIFTSS Training and Learning Collaborative, GIFTSS Training, Learning Collaborative, and Provider Scripts |
| Provider Scriptsscripts and prompts for college health center staff and clinicians to encourage implementation of GIFTSS intervention | Behavioural | GIFTSS Training and Provider Scripts, GIFTSS Training, Learning Collaborative, and Provider Scripts |
Primary outcome
Provider discussion
Time frame: within 7 days after clinic visit
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)
Receipt of educational resource card
Time frame: within 7 days after clinic visit
Participant self-report of receipt of the GIFTSS safety card during the visit (assessed in exit survey after visit)
6 secondary outcomes
Self-efficacy to enact harm reduction strategies
Time frame: 4 months and 12 months
Use of harm reduction strategies
Time frame: 4 months and 12 months
Self-efficacy to use confidential SV-related services
Time frame: 4 months and 12 months
Use of SV-related services
Time frame: 4 months and 12 months
SV victimization (exploratory)
Time frame: 4 months and 12 months
Alcohol use patterns (exploratory)
Time frame: 4 months and 12 months
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes. data sharing plan and archiving of de-identified data as required by NIH
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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.
1 site in 1 country: see every site and its status.
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.