NCT06844097

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Apr 2025Aug 2026

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

February 19, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

Latinx transmaculineLatinx Non-BinaryMedical StudentsSGM Cancer ResearchEfficacy StudyCervical Cancer Prevention Intervention

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Sex as a biological variable

    Baseline, immediately after the intervention

Study Arms (2)

Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module

EXPERIMENTAL

Participants assigned to the experimental condition will receive the CC-TRAINED intervention.

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

Behavioral: Disaster Preparedness Course

Interventions

An online course designed to increase cervical cancer prevention clinical skills among medical students when working with Latinx transmasculine populations.

Cervical Cancer Trans Inclusive Education (CC-TRAINED) Module

An online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.

Disaster Preparedness Course

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student currently in third year of medical school training

You may not qualify if:

  • Do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Alixida Ramos Pibernus, PhD

    Ponce Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Matthew B Schabath, PhD

    H. Lee Moffit Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alixida Ramos-Pibernus, PhD

CONTACT

Matthew B Schabath, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

April 7, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share