Clinical CompetenceCC-TrainedNCT06844097
Intervention for Medical Student to Promote Cervical Cancer Screening Among Latinx Transmasculine Individuals
A study testing Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module and Disaster Preparedness Course in people with Clinical Competence and Medical Education, run by Ponce Medical School Foundation, Inc..
Trial summary
The team aims to test the effectiveness of an intervention to increase gender-affirming cervical cancer prevention behaviors targeted at medical students studying in Puerto Rico and Florida. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Clinical Competence, Medical Education, Cervical Cancer Screening
- What is being tested?
- Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module and Disaster Preparedness Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2025to 31 Aug 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical student currently in third year of medical school training
Who cannot join
- Do not speak English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Testing the Effectiveness of an Intervention to Foster Cervical Cancer Screening Promotion for Latinx Trans Men Among Medical Students
The team aims to test the effectiveness of an intervention to increase gender-affirming cervical cancer prevention behaviors targeted at medical students studying in Puerto Rico and Florida. The team expects that after exposure to the intervention, relative to the control group, participants in the experimental condition will manifest more favorable changes in knowledge, attitudes, and behaviors of adequate care towards Latinx transmasculine and non-binary people.
Read the detailed description
Transmen (TM) and non-binary individuals (NB; individuals assigned female sex at birth who identify as a man, male, or another diverse non-binary gender identity on the masculine spectrum) are at higher risk of screening-detectable cancers. Latinx TM-NB (LTM-NB) are at a higher risk for cervical cancer (CC) as they intersect two health disparity populations with high risk for this type of cancer (gender identity and ethnic minorities). Despite CC being highly preventable, LTM-NB individuals have been found to have lower rates of CC screening than cisgender female patients (persons who are not transgender). Unfortunately, findings from the team's previous funded studies with LTM-NB individuals in Puerto Rico (PR) and Florida evidence that providers lack knowledge regarding LTM-NB individual's healthcare needs, have negative stigmatizing attitudes, and manifest discriminatory behaviors in clinical interactions with LTM-NB individuals; which greatly limits their ability for engaging in recommended education and prevention guidelines of care for CC screening and prevention. In light of this, the research team (community stakeholders from PR and Mainland US, researchers, and providers) has developed a brief online intervention to improve medical students' competencies for cervical cancer education and screening promotion among LTM-NB individuals.
The proposed study aims to: 1) Test the effectiveness of the intervention in increasing medical students' knowledge, attitudes, and skills for providing healthcare to LTM-NB. , 2) Determine the acceptability, appropriateness, and feasibility of implementing the interventions in real-world medical educational settings.
While the team has preliminary data regarding the efficacy of the intervention, this pilot is proposing a rigorous study design: Aim 1 will measure the magnitude of effect of the intervention, and Aim 2 measures the implementation. This study will address cervical cancer disparities among LTM-NB individuals. The impact of this study will reveal new effective interventions and implementation strategies. The translational implications of this work will result in providing medical schools with a cross-cultural tool to train students on cervical cancer prevention for LTM-NB individuals.
- Being tested
- Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module, Disaster Preparedness Course
- Keywords
- Latinx transmaculine, Latinx Non-Binary, Medical Students, SGM Cancer Research, Efficacy Study, Cervical Cancer Prevention Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Cancer Trans Inclusive Education (CC-TRAINED) ModuleBehavioural
An online course designed to increase cervical cancer prevention clinical skills among medical students when working with Latinx transmasculine populations.
Disaster Preparedness CourseBehavioural
An online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module | Experimental | Participants assigned to the experimental condition will receive the CC-TRAINED intervention. Receives: Behavioral: Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module |
| Disaster Preparedness Course | Other | Participants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness Receives: Behavioral: Disaster Preparedness Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change cervical cancer preventive behaviors, as determined by the Cervical Cancer Preventive Behaviors Inventory
The CCPBI includes 46 non-verbal and verbal behaviors that can be manifested during the SPS interactions with LTM. The team expects that following intervention exposure, relative to control group participants, intervention participants will manifest a higher mean number of CC preventive behaviors on the CCPBI outcome.
Measured: Baseline, immediately after the intervention
Change in LTMNB knowledge, as determined by Transmasculine knowledge index
This measure assesses health professionals' knowledge of TM-specific health issues. Intervention participants, relative to controls, will have a higher mean knowledge (literacy) level regarding LTM issues.
Measured: Baseline, immediately after the intervention
Change negative attitudes towards LTMNB, as determined by the transgender stigma scale
This scale measures stigma related to transgender identity among healthcare providers. Intervention participants, relative to controls, will have a lower mean level of stigmatizing attitudes toward LTM
Measured: Baseline, immediately after the intervention
Change negative and increase positive emotions related to LTMNB, as determined by the Emotional Reactions Scale
This scale measures emotional reactions to LTMNB. Intervention participants, relative to control participants, will have an increase in the mean of positive emotions, and a reduction in the mean level of negative emotions.
Measured: Baseline, immediately after the intervention
Change cultural humility, as determined by the cross-cultural scale
This adaptation of the Cross-Cultural Care Scale55 measures cultural humility preparedness and skills towards multiple identities. Intervention participants, relative to control participants, will have an increase in the mean of cultural humility.
Measured: Baseline, immediately after the intervention
Secondary outcomes (1)
Sex as a biological variable
Following NIH guidance regarding investigating differential effects of sex and gender, we will repeat all analyses twice, stratified by a) sex at birth and b) current gender identification, respectively.
Measured: Baseline, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start7 Apr 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical CompetenceStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alixida Ramos Pibernus, PhD, Principal investigator, Ponce Health Sciences UniversityMatthew B Schabath, PhD, Principal investigator, H. Lee Moffit Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844097
- Sponsor's protocol ID
- 2308159535R001
- Other IDs
- 2U54CA163071-11
- Acronym
- CC-Trained
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of an Intervention to Foster Cervical Cancer Screening Promotion for Latinx Trans Men Among Medical Students
- ClinicalTrials.gov ID
- NCT06844097
- Acronym / sponsor ID
- CC-Trained / 2308159535R001
- Keywords
- Latinx transmaculine, Latinx Non-Binary, Medical Students, SGM Cancer Research, Efficacy Study, Cervical Cancer Prevention Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ponce Medical School Foundation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), H. Lee Moffitt Cancer Center and Research Institute
- Study start
- 7 Apr 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
The team aims to test the effectiveness of an intervention to increase gender-affirming cervical cancer prevention behaviors targeted at medical students studying in Puerto Rico and Florida. The team expects that after exposure to the intervention, relative to the control group, participants in the experimental condition will manifest more favorable changes in knowledge, attitudes, and behaviors of adequate care towards Latinx transmasculine and non-binary people.
Detailed description
Transmen (TM) and non-binary individuals (NB; individuals assigned female sex at birth who identify as a man, male, or another diverse non-binary gender identity on the masculine spectrum) are at higher risk of screening-detectable cancers. Latinx TM-NB (LTM-NB) are at a higher risk for cervical cancer (CC) as they intersect two health disparity populations with high risk for this type of cancer (gender identity and ethnic minorities). Despite CC being highly preventable, LTM-NB individuals have been found to have lower rates of CC screening than cisgender female patients (persons who are not transgender). Unfortunately, findings from the team's previous funded studies with LTM-NB individuals in Puerto Rico (PR) and Florida evidence that providers lack knowledge regarding LTM-NB individual's healthcare needs, have negative stigmatizing attitudes, and manifest discriminatory behaviors in clinical interactions with LTM-NB individuals; which greatly limits their ability for engaging in recommended education and prevention guidelines of care for CC screening and prevention. In light of this, the research team (community stakeholders from PR and Mainland US, researchers, and providers) has developed a brief online intervention to improve medical students' competencies for cervical cancer education and screening promotion among LTM-NB individuals.
The proposed study aims to: 1) Test the effectiveness of the intervention in increasing medical students' knowledge, attitudes, and skills for providing healthcare to LTM-NB. , 2) Determine the acceptability, appropriateness, and feasibility of implementing the interventions in real-world medical educational settings.
While the team has preliminary data regarding the efficacy of the intervention, this pilot is proposing a rigorous study design: Aim 1 will measure the magnitude of effect of the intervention, and Aim 2 measures the implementation. This study will address cervical cancer disparities among LTM-NB individuals. The impact of this study will reveal new effective interventions and implementation strategies. The translational implications of this work will result in providing medical schools with a cross-cultural tool to train students on cervical cancer prevention for LTM-NB individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module | Experimental | Behavioral: Cervical Cancer Trans Inclusive Education (CC-TRAINED) ModuleParticipants assigned to the experimental condition will receive the CC-TRAINED intervention. |
| Disaster Preparedness Course | Other | Behavioral: Disaster Preparedness CourseParticipants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student currently in third year of medical school training
Key exclusion criteria (1 listed)
- Do not speak English
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 |
|---|---|---|
| Cervical Cancer Trans Inclusive Education (CC-TRAINED) ModuleAn online course designed to increase cervical cancer prevention clinical skills among medical students when working with Latinx transmasculine populations. | Behavioural | Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module |
| Disaster Preparedness CourseAn online course designed to improve professionals' skills and competencies for engaging in disaster preparedness. | Behavioural | Disaster Preparedness Course |
Primary outcome
Change cervical cancer preventive behaviors, as determined by the Cervical Cancer Preventive Behaviors Inventory
Time frame: Baseline, immediately after the intervention
The CCPBI includes 46 non-verbal and verbal behaviors that can be manifested during the SPS interactions with LTM. The team expects that following intervention exposure, relative to control group participants, intervention participants will manifest a higher mean number of CC preventive behaviors on the CCPBI outcome.
Change in LTMNB knowledge, as determined by Transmasculine knowledge index
Time frame: Baseline, immediately after the intervention
This measure assesses health professionals' knowledge of TM-specific health issues. Intervention participants, relative to controls, will have a higher mean knowledge (literacy) level regarding LTM issues.
Change negative attitudes towards LTMNB, as determined by the transgender stigma scale
Time frame: Baseline, immediately after the intervention
This scale measures stigma related to transgender identity among healthcare providers. Intervention participants, relative to controls, will have a lower mean level of stigmatizing attitudes toward LTM
Change negative and increase positive emotions related to LTMNB, as determined by the Emotional Reactions Scale
Time frame: Baseline, immediately after the intervention
This scale measures emotional reactions to LTMNB. Intervention participants, relative to control participants, will have an increase in the mean of positive emotions, and a reduction in the mean level of negative emotions.
Change cultural humility, as determined by the cross-cultural scale
Time frame: Baseline, immediately after the intervention
This adaptation of the Cross-Cultural Care Scale55 measures cultural humility preparedness and skills towards multiple identities. Intervention participants, relative to control participants, will have an increase in the mean of cultural humility.
1 secondary outcome
Sex as a biological variable
Time frame: Baseline, immediately after the intervention
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 4 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Alixida Ramos Pibernus, PhD principal investigator
Ponce Health Sciences University
Matthew B Schabath, PhD principal investigator
H. Lee Moffit Cancer Center and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module and Disaster Preparedness Course in people with Clinical Competence and Medical Education, run by Ponce Medical School Foundation, Inc..
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Alixida Ramos-Pibernus, PhD (787-840-2575, aliramos@psm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change cervical cancer preventive behaviors, as determined by the Cervical Cancer Preventive Behaviors Inventory (time frame: Baseline, immediately after the intervention). The study lists 5 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 4 Mar 2025.