Intervention for Medical Student to Promote Cervical Cancer Screening Among Latinx Transmasculine Individuals (CC-Trained)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medical Education; Cervical Cancer Screening; Clinical Competence
• Intervention / Treatment: Behavioral: Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module; Behavioral: Disaster Preparedness Course

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alixida Ramos-Pibernus, PhD; Phone Number: 787-840-2575; Email: aliramos@psm.edu
• Study Contact Backup: Name: Matthew B Schabath, PhD; Phone Number: 813-745-4150; Email: matthew.schabath@moffitt.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Medical student currently in third year of medical school training

Exclusion Criteria:

• Do not speak English

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module; Participants assigned to the experimental condition will receive the CC-TRAINED intervention.	Behavioral: Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module; An online course designed to increase cervical cancer prevention clinical skills among medical students when working with Latinx transmasculine populations.
Other: Disaster Preparedness Course; Participants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness	Behavioral: Disaster Preparedness Course; An online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	Baseline, immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately after the intervention

Collaborators and Investigators

• Sponsor: Ponce Medical School Foundation, Inc.
• Collaborators: National Cancer Institute (NCI); H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Alixida Ramos Pibernus, PhD, Ponce Health Sciences University; Principal Investigator: Matthew B Schabath, PhD, H. Lee Moffit Cancer center and research institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Medical Students; Efficacy Study; Latinx transmaculine; Latinx Non-Binary; SGM Cancer Research; Cervical Cancer Prevention Intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2308159535R001; 2U54CA163071-11 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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