Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men

Study Overview
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Brief Summary
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Transgender men are individuals born genetically female that have a gender identity that is incongruent with their biological sex. For those who have begun or completed transition, they may present as males but still have a uterus and cervix. Thus far, no distinction has been made between routine cervical cancer screening guidelines in non-transgender women and those for transgender men, despite wide variations in sexual practices, including lifelong vaginal abstinence. The purpose of this study is to offer transgender men seen at clinic visits self-collected HPV testing to evaluate for improved cervical cancer screening rates, as well as a survey to further investigate sexual practices, rates of appropriate screening prior to being offered self-collection, and barriers to obtaining appropriate care.

Official Title
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Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men

Conditions
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Transgenderism, Cervical Cancer, Human Papilloma Virus

Intervention / Treatment
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* Diagnostic Test: HPV testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >21 for survey and age> 25 for HPV testing Transgender male or gender non-conforming identity Female sex at birth Consent to participate in the study Exclusion Criteria: impaired decision making capacity Absence of cervix Non-English speaking

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV Testing<br>Will perform HPV testing with self-collected specimen | Diagnostic Test: HPV testing<br>* will perform HPV testing with self-collected specimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cervical cancer screening | Evaluate whether implementation of HPV DNA self swabs will increase rates of cervical cancer screening among transgender men by percentage of trans men who obtain screening through the study | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of barriers to care | Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey. | 1 year | 
| incidence of high risk sexual practices | Evaluate for the presence of high risk behaviors to determine whether transgender men in our population are at higher or lower risk for HPV-related cervical dysplasia. Measured via survey. | 1 year | 
| rate of HPV vaccination | Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey. | 1 year |