Centering Gender Affirming Resources in Higher Education (CARE)

September 2, 2026 updated by: Traci Kazmerski, University of Pittsburgh

Inclusive Practices for Gender Minority College Students to Reduce Sexual Violence and Heavy Drinking

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
          • Elizabeth Miller, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Giving Information for Trauma Support and Safety (GIFTSS) Training
Training for college health center clinicians and staff in implementation of GIFTSS
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Provider perception of intervention feasibility
Time Frame: Immediately after CARE training completion
Domain: Provider-Perceived Feasibility Specific Measurement: Feasibility of Intervention Measure (FIM). Specific Metric: End value Method of Aggregation: Mean score, range 1-5 cutoff mean score > 4, higher score indicates greater feasibility
Immediately after CARE training completion
Provider perception of intervention acceptability
Time Frame: Immediately after CARE training completion
Domain: Provider-Perceived Acceptability Specific Measurement: Acceptability of Intervention Measure (AIM) Specific Metric: End value Method of Aggregation: Mean score, range 1-5, cutoff mean score > 4, higher score indicates greater acceptability
Immediately after CARE training completion
Provider perception of intervention appropriateness
Time Frame: Immediately after CARE training completion
Domain: Provider-Perceived Appropriateness Specific Measurement: Intervention Appropriateness Measure (IAM) Specific Metric: End value Method of Aggregation: Mean score, range 1-5 , cutoff mean score > 4, higher score indicates greater appropriateness
Immediately after CARE training completion
Provider perception of intervention usability
Time Frame: Immediately after CARE training completion
Domain: Provider-Perceived Usability Specific Measurement: System Usability Scale (SUS) Specific Metric: End value Method of Aggregation: Mean score, range 1-5 , cutoff mean score > 4, higher score indicates greater usability
Immediately after CARE training completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge and attitudes about TGD individuals.
Time Frame: Baseline- Before taking CARE training
Domain: Assessing provider knowledge, attitudes, and beliefs about transgender people Specific Measurement: Transgender Knowledge, Attitudes, and Beliefs (T-KAB) scale Specific Metric: End value Method of Aggregation: Mean score, range 1 to 4, 4 indicating favorable attitudes and beliefs towards transgender people
Baseline- Before taking CARE training
Knowledge and attitudes about TGD individuals.
Time Frame: At 6 months
Domain: Assessing provider knowledge, attitudes, and beliefs about transgender people Specific Measurement: Transgender Knowledge, Attitudes, and Beliefs (T-KAB) scale Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 4, 4 indicating favorable attitudes and beliefs towards transgender people
At 6 months
Attitudes concerning transphobia
Time Frame: Baseline- Before taking CARE training
Domain: Assessing provider's attitudes regarding transphobia Specific Measurement: Transphobia Scale Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating a lesser degree of transphobia
Baseline- Before taking CARE training
Attitudes concerning transphobia
Time Frame: At 6 months
Domain: Assessing provider's attitudes regarding transphobia Specific Measurement: Transphobia Scale Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating a lesser degree of transphobia
At 6 months
Human value of transgender people
Time Frame: Baseline- Before taking CARE training
Domain: Assessing how providers view the human value of transgender people Specific Measurement: Transgender Attitudes and Beliefs Scale (TABS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating trans and gender diverse people hold high human value
Baseline- Before taking CARE training
Human value of transgender people
Time Frame: At 6 months
Domain: Assessing how providers view the human value of transgender people Specific Measurement: Transgender Attitudes and Beliefs Scale (TABS) Specific Metric: Change from Baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating trans and gender diverse people hold high human value
At 6 months
Use of TGD-inclusive practices
Time Frame: Baseline- Before taking CARE training
Domain: Use of transgender and gender diverse-inclusive practices Specific Measurement: The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 7, 7 indicating high preparedness and knowledge to work with transgender patients
Baseline- Before taking CARE training
Use of TGD-inclusive practices
Time Frame: At 6 months
Domain: Use of transgender and gender diverse-inclusive practices Specific Measurement: The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS) Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 7, 7 indicating high preparedness and knowledge to work with transgender patients
At 6 months
Trans-Inclusivity in professional settings
Time Frame: Baseline- Before taking CARE training
Domain: Assessing how trans-inclusive providers are in their practice Specific Measurement: The Trans-Inclusive Provider Scale (TIPS) Specific Metric: End value Method of Aggregation: Mean score, range 1 to 5, 5 indicating high trans-inclusivity in care practices)
Baseline- Before taking CARE training
Trans-Inclusivity in professional settings
Time Frame: At 6 months
Domain: Assessing how trans-inclusive providers are in their practice Specific Measurement: The Trans-Inclusive Provider Scale (TIPS) Specific Metric: Change from Baseline Method of Aggregation: Mean score, range 1 to 5, 5 indicating high trans-inclusivity in care practices
At 6 months
Social desirability
Time Frame: Baseline- Before taking CARE training
Domain: Measure of social desirability Specific Measurement: Marlowe- Crowne Social Desirability Scale Specific Metric: End Value Method of Aggregation: True and false questions, summary score from 0 to 1
Baseline- Before taking CARE training
Social desirability
Time Frame: At 6 months
Domain: Measure of social desirability Specific Measurement: Marlowe- Crowne Social Desirability Scale Specific Metric: Change from Baseline Method of Aggregation: True and false questions, summary score from 0 to 1
At 6 months
Self-Efficacy to use trans and gender affirming practices
Time Frame: Baseline- Before taking CARE training
Domain: Self-efficacy to use trans and gender affirming practices Specific Measurement: Investigator Developed Specific Metric: End value Method of Aggregation: Mean score, range 1 to 5, 5 indicating greater self-efficacy to use trans-affirming practices
Baseline- Before taking CARE training
Self-Efficacy to use trans and gender affirming practices
Time Frame: At 6 months
Domain: Self-efficacy to use trans and gender affirming practices Specific Measurement: Investigator Developed Specific Metric: Change from baseline Method of Aggregation: Mean score, range 1 to 5, 5 indicating greater self-efficacy to use trans-affirming practices
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Opportunity Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Miller, PhD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY22040105
  • R01AA023260-07W1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

12 months after end of study

IPD Sharing Access Criteria

data uploaded to NDA

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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