Centering Gender Affirming Resources in Higher Education

NCT ID: NCT06390332

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-11
• Study Completion Date: 2027-05-31

Brief Summary

Centering gender Affirming Resources in higher Education (CARE) project is nested within the parent study "Reducing Alcohol Involved Sexual violence in higher Education" (RAISE; R01 AA023260; NCT05185440). CARE is a pilot cluster-randomized trial that centers trans and gender diverse (TGD) students who are at elevated risk for SV and hazardous drinking. CARE tests a novel college health and counseling center (CHC) training program designed to improve provider knowledge about TGD individuals, increase their self-efficacy and use of trans-inclusive practices. This includes an evaluation of the feasibility, acceptability, appropriateness, and usability of CARE's training intervention for college health and counseling center providers. This research will produce the first rigorously evaluated TGD-focused CHC provider training which has the potential to increase the accessibility of CHC's for TGD university students- ultimately lowering rates of alcohol use and SV among this disproportionately impacted population.

Detailed Description

"Centering gender Affirming Resources in higher Education (CARE)" expands upon RAISE's (R01 AA023260) cluster-randomized controlled trial across 28+ college campuses that is evaluating harm reduction interventions to reduce risk for sexual violence (SV) among undergraduate college students receiving care from college health and counseling centers (CHCs). A previous study by this research team found that students identifying as transgender or gender diverse (TGD) report particularly high lifetime prevalence of SV that is associated with greater odds of binge drinking compared to students not exposed to SV. Compounding these vulnerabilities, TGD students face high rates of discrimination on university campuses that drive heavy alcohol use and SV inequities, and lead to distrust of potential support resources like CHCs. CARE enhances RAISE's intervention by employing community-partnered methodologies to develop a training for CHC providers designed specifically to increase their competence in addressing TGD students' health needs with a focus on alcohol use and SV. The training involves a brief e-learning (asynchronous) intervention aimed at improving providers' knowledge and attitudes about TGD individuals, skills in delivering competent and affirming care, and knowledge of and self-efficacy to use TGD-inclusive practices. This trial will assess the feasibility, acceptability, appropriateness, and usability of CARE's training intervention in 15 randomized CHC sites from the parent study (Aim 1). The study will examine CHC provider knowledge and attitudes about TGD individuals, and their knowledge, self-efficacy, and use of TGD-inclusive practices with follow-up at 4-6 months (Aim 2).

Conditions

Sexual Violence; Drinking Heavy

Study Design

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

Study Groups

Giving Information for Trauma Support and Safety (GIFTSS) Training

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

Group Type: ACTIVE_COMPARATOR

Giving Information for Trauma Support and Safety (GIFTSS) Training

Intervention Type: BEHAVIORAL

Training for college health center staff and clinicians on GIFTSS intervention which is a universal education and brief counseling to address sexual violence prevention and intervention.

GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules

Training for college health center clinicians and staff in implementation of GIFTSS combined with CARE's trans learning modules to support implementation with gender diverse service users.

Group Type: EXPERIMENTAL

Giving Information for Trauma Support and Safety (GIFTSS) Training

Intervention Type: BEHAVIORAL

Training for college health center staff and clinicians on GIFTSS intervention which is a universal education and brief counseling to address sexual violence prevention and intervention.

Centering gender Affirming Resources in higher Education (CARE) Learning Modules

Intervention Type: BEHAVIORAL

Training for college health center clinicians and staff on trans and gender diverse (TGD) affirming clinical practices in addition to sexual violence and alcohol abuse prevention that is inclusive of TGD service users

Interventions

Giving Information for Trauma Support and Safety (GIFTSS) Training

Training for college health center staff and clinicians on GIFTSS intervention which is a universal education and brief counseling to address sexual violence prevention and intervention.

Intervention Type: BEHAVIORAL

Centering gender Affirming Resources in higher Education (CARE) Learning Modules

Training for college health center clinicians and staff on trans and gender diverse (TGD) affirming clinical practices in addition to sexual violence and alcohol abuse prevention that is inclusive of TGD service users

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Those who are seeing undergraduate students at health and counseling appointments as a provider.
• Providers may include counselors, clinicians, nurses, health educators, medical assistants, social workers, advocates, and administrators.

Exclusion Criteria

• A college health or counseling center provider that does not interface with students.
• A college health or counseling center provider not participating in the RAISE study.

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Opportunity Fund

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Miller

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Regina Futcher, MSW

Role: CONTACT

futcherr2@upmc.edu

757-272-3783

Rachel Gartner, PhD

Role: CONTACT

rachelgart@pitt.edu

412-624-7232

Facility Contacts

Elizabeth Miller, MD, PhD

Role: primary

Other Identifiers

R01AA023260-07W1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY22040105

Identifier Type: -

Identifier Source: org_study_id