Clinical trial NCT06390332: Centering Gender Affirming Resources in Higher Education
Official title: Inclusive Practices for Gender Minority College Students to Reduce Sexual Violence and Heavy Drinking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Violence
Drinking Heavy
Keywords: Transgender
Gender Minorities
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Provider perception of intervention feasibility
timeFrame: Immediately after CARE training completion
measure: Provider perception of intervention acceptability
timeFrame: Immediately after CARE training completion
measure: Provider perception of intervention appropriateness
timeFrame: Immediately after CARE training completion
measure: Provider perception of intervention usability
timeFrame: Immediately after CARE training completion
Secondary outcomes:
measure: Knowledge and attitudes about TGD individuals.
timeFrame: Baseline- Before taking CARE training
measure: Knowledge and attitudes about TGD individuals.
timeFrame: At 6 months
measure: Attitudes concerning transphobia
timeFrame: Baseline- Before taking CARE training
measure: Attitudes concerning transphobia
timeFrame: At 6 months
measure: Human value of transgender people
timeFrame: Baseline- Before taking CARE training
measure: Human value of transgender people
timeFrame: At 6 months
measure: Use of TGD-inclusive practices
timeFrame: Baseline- Before taking CARE training
measure: Use of TGD-inclusive practices
timeFrame: At 6 months
measure: Trans-Inclusivity in professional settings
timeFrame: Baseline- Before taking CARE training
measure: Trans-Inclusivity in professional settings
timeFrame: At 6 months
measure: Social desirability
timeFrame: Baseline- Before taking CARE training
measure: Social desirability
timeFrame: At 6 months
measure: Self-Efficacy to use trans and gender affirming practices
timeFrame: Baseline- Before taking CARE training
measure: Self-Efficacy to use trans and gender affirming practices
timeFrame: At 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Principal Investigator
name: Elizabeth Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: