Sexual ViolenceCARENCT06390332
Centering Gender Affirming Resources in Higher Education
A study testing Giving Information for Trauma Support and Safety (GIFTSS) Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules in people with Sexual Violence and Drinking Heavy, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence, Drinking Heavy
- What is being tested?
- Giving Information for Trauma Support and Safety (GIFTSS) Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Elizabeth Miller, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Giving Information for Trauma Support and Safety (GIFTSS) Training, Centering gender Affirming Resources in higher Education (CARE) Learning Modules
- Keywords
- Transgender, Gender Minorities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving Information for Trauma Support and Safety (GIFTSS) TrainingBehavioural
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 ModulesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Giving Information for Trauma Support and Safety (GIFTSS) Training | Active comparator | Training for college health center clinicians and staff in implementation of GIFTSS Receives: Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training |
| GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules | Experimental | 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. Receives: Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training; Behavioral: Centering gender Affirming Resources in higher Education (CARE) Learning Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider perception of intervention feasibility
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
Measured: Immediately after CARE training completion
Provider perception of intervention acceptability
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
Measured: Immediately after CARE training completion
Provider perception of intervention appropriateness
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
Measured: Immediately after CARE training completion
Provider perception of intervention usability
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
Measured: Immediately after CARE training completion
Secondary outcomes (14)
Knowledge and attitudes about TGD individuals.
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
Measured: Baseline- Before taking CARE training
Knowledge and attitudes about TGD individuals.
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
Measured: At 6 months
Attitudes concerning transphobia
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
Measured: Baseline- Before taking CARE training
Attitudes concerning transphobia
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
Measured: At 6 months
Human value of transgender people
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
Measured: Baseline- Before taking CARE training
Human value of transgender people
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
Measured: At 6 months
Use of TGD-inclusive practices
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
Measured: Baseline- Before taking CARE training
Use of TGD-inclusive practices
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
Measured: At 6 months
Trans-Inclusivity in professional settings
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)
Measured: Baseline- Before taking CARE training
Trans-Inclusivity in professional settings
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
Measured: At 6 months
Social desirability
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
Measured: Baseline- Before taking CARE training
Social desirability
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
Measured: At 6 months
Self-Efficacy to use trans and gender affirming practices
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
Measured: Baseline- Before taking CARE training
Self-Efficacy to use trans and gender affirming practices
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
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start11 Dec 2024
- Primary completion9 Oct 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Opportunity Fund
- Responsible party
- Principal investigator, Traci Kazmerski, University of Pittsburgh
- Investigators
- Elizabeth Miller, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390332
- Sponsor's protocol ID
- STUDY22040105
- Other IDs
- R01AA023260-07W1
- Acronym
- CARE
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusive Practices for Gender Minority College Students to Reduce Sexual Violence and Heavy Drinking
- ClinicalTrials.gov ID
- NCT06390332
- Acronym / sponsor ID
- CARE / STUDY22040105
- Conditions
- Sexual Violence, Drinking Heavy
- Keywords
- Transgender, Gender Minorities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Opportunity Fund
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giving Information for Trauma Support and Safety (GIFTSS) Training | Active comparator | Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) TrainingTraining for college health center clinicians and staff in implementation of GIFTSS |
| GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules | Experimental | Behavioral: Giving Information for Trauma Support and Safety (GIFTSS) Training, Behavioral: Centering gender Affirming Resources in higher Education (CARE) Learning ModulesTraining 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Giving Information for Trauma Support and Safety (GIFTSS) TrainingTraining 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. | Behavioural | GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules, Giving Information for Trauma Support and Safety (GIFTSS) Training |
| Centering gender Affirming Resources in higher Education (CARE) Learning ModulesTraining 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 | Behavioural | GIFTSS Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules |
Primary outcome
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
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
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
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
14 secondary outcomes
Knowledge and attitudes about TGD individuals.
Time frame: Baseline- Before taking CARE training
Knowledge and attitudes about TGD individuals.
Time frame: At 6 months
Attitudes concerning transphobia
Time frame: Baseline- Before taking CARE training
Attitudes concerning transphobia
Time frame: At 6 months
Human value of transgender people
Time frame: Baseline- Before taking CARE training
Human value of transgender people
Time frame: At 6 months
Use of TGD-inclusive practices
Time frame: Baseline- Before taking CARE training
Use of TGD-inclusive practices
Time frame: At 6 months
Trans-Inclusivity in professional settings
Time frame: Baseline- Before taking CARE training
Trans-Inclusivity in professional settings
Time frame: At 6 months
Social desirability
Time frame: Baseline- Before taking CARE training
Social desirability
Time frame: At 6 months
Self-Efficacy to use trans and gender affirming practices
Time frame: Baseline- Before taking CARE training
Self-Efficacy to use trans and gender affirming practices
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Miller, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giving Information for Trauma Support and Safety (GIFTSS) Training and Centering gender Affirming Resources in higher Education (CARE) Learning Modules in people with Sexual Violence and Drinking Heavy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regina Futcher, MSW (757-272-3783, futcherr2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider perception of intervention feasibility (time frame: Immediately after CARE training completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.