Reducing Alcohol Involved Sexual Violence in Higher Education

NCT05185440 | Recruiting

• 2 other identifiers: STUDY20090065R01AA023260
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Violence; Drinking Heavy

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  within 7 days after clinic visit

Secondary Outcomes (6)

• Self-efficacy to enact harm reduction strategies

  4 months and 12 months

• Use of harm reduction strategies

  4 months and 12 months

• Self-efficacy to use confidential SV-related services

  4 months and 12 months

• Use of SV-related services

  4 months and 12 months

• SV victimization (exploratory)

  4 months and 12 months

Study Arms (4)

GIFTSS Training Only

ACTIVE COMPARATOR

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

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

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

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

Behavioral: GIFTSS Training; Behavioral: Learning Collaborative; Behavioral: Provider Scripts

Interventions

GIFTSS Training 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 Only; GIFTSS Training and Learning Collaborative; GIFTSS Training and Provider Scripts; GIFTSS Training, Learning Collaborative, and Provider Scripts

Learning Collaborative 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 Learning Collaborative; GIFTSS Training, Learning Collaborative, and Provider Scripts

Provider Scripts BEHAVIORAL

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

GIFTSS Training and Provider Scripts; GIFTSS Training, Learning Collaborative, and Provider Scripts

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of Pittsburgh: lead
• Johns Hopkins University: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Central Study Contacts

Elizabeth Walker

CONTACT

412-692-8504; elw108@pitt.edu

Elizabeth Miller

CONTACT

412-692-8504; elizabeth.miller@chp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adolescent and Young Adult Medicine

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: June 12, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after end of study

Locations

US (1)