Clinical trial NCT06844097: Intervention for Medical Student to Promote Cervical Cancer Screening Among Latinx Transmasculine Individuals
Official title: Testing the Effectiveness of an Intervention to Foster Cervical Cancer Screening Promotion for Latinx Trans Men Among Medical Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical Competence
Medical Education
Cervical Cancer Screening
Keywords: Latinx transmaculine
Latinx Non-Binary
Medical Students
SGM Cancer Research
Efficacy Study
Cervical Cancer Prevention Intervention
Lead sponsor: Ponce Medical School Foundation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2025-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Medical student currently in third year of medical school training

Exclusion Criteria:

* Do not speak English

Primary outcomes:
measure: Change cervical cancer preventive behaviors, as determined by the Cervical Cancer Preventive Behaviors Inventory
timeFrame: Baseline, immediately after the intervention
measure: Change in LTMNB knowledge, as determined by Transmasculine knowledge index
timeFrame: Baseline, immediately after the intervention
measure: Change negative attitudes towards LTMNB, as determined by the transgender stigma scale
timeFrame: Baseline, immediately after the intervention
measure: Change negative and increase positive emotions related to LTMNB, as determined by the Emotional Reactions Scale
timeFrame: Baseline, immediately after the intervention
measure: Change cultural humility, as determined by the cross-cultural scale
timeFrame: Baseline, immediately after the intervention
Secondary outcomes:
measure: Sex as a biological variable
timeFrame: Baseline, immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Ponce Health Sciences University
name: Alixida Ramos Pibernus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Lee Moffit Cancer Center and Research Institute
name: Matthew B Schabath, PhD
role: PRINCIPAL_INVESTIGATOR
References: