Reducing Alcohol Involved Sexual Violence in Higher Education

NCT ID: NCT05185440

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2026-08-31

Brief 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). "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).

Conditions

Sexual Violence; Drinking Heavy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GIFTSS Training Only

Training for college health center clinicians and staff in implementation of GIFTSS Training

Group Type: ACTIVE_COMPARATOR

GIFTSS Training

Intervention Type: BEHAVIORAL

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)

GIFTSS Training and Learning Collaborative

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative to support implementation

Group Type: EXPERIMENTAL

GIFTSS Training

Intervention Type: BEHAVIORAL

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 Collaborative

Intervention Type: BEHAVIORAL

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

GIFTSS Training and Provider Scripts

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts to support implementation

Group Type: EXPERIMENTAL

GIFTSS Training

Intervention Type: BEHAVIORAL

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)

Provider Scripts

Intervention Type: BEHAVIORAL

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

GIFTSS Training, Learning Collaborative, and Provider Scripts

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

Group Type: EXPERIMENTAL

GIFTSS Training

Intervention Type: BEHAVIORAL

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 Collaborative

Intervention Type: BEHAVIORAL

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 Scripts

Intervention Type: BEHAVIORAL

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

Interventions

GIFTSS Training

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)

Intervention Type: BEHAVIORAL

Learning Collaborative

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

Intervention Type: BEHAVIORAL

Provider Scripts

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Miller

Director, Adolescent and Young Adult Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Walker

Role: CONTACT

elw108@pitt.edu

412-692-8504

Elizabeth Miller

Role: CONTACT

elizabeth.miller@chp.edu

412-692-8504

Facility Contacts

Elizabeth Miller, MD, PhD

Role: primary

Other Identifiers

R01AA023260

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20090065

Identifier Type: -

Identifier Source: org_study_id