Centering Gender Affirming Resources in Higher Education

Not Applicable

Recruiting

• Conditions: Drinking Heavy; Sexual Violence

• Registration Number: NCT06390332
• Lead Sponsor: University of Pittsburgh

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).

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-28
• Study First Posted: 2024-04-30
• Study Start: 2024-12-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Provider perception of intervention appropriateness	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
Provider perception of intervention acceptability	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
Provider perception of intervention usability	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
Provider perception of intervention feasibility	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

Secondary Outcome Measures

Name	Time	Method
Trans-Inclusivity in professional settings	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
Knowledge and attitudes about TGD individuals.	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
Attitudes concerning transphobia	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
Social desirability	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
Human value of transgender people	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
Use of TGD-inclusive practices	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
Self-Efficacy to use trans and gender affirming practices	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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States