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

Not Applicable

• Conditions: Transgenderism; Cervical Cancer; Human Papilloma Virus
• Interventions: Diagnostic Test: HPV testing

• Registration Number: NCT04154358
• Lead Sponsor: Augusta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-23
• Study Start: 2020-05-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV Testing	HPV testing	Will perform HPV testing with self-collected specimen

Primary Outcome Measures

Name	Time	Method
Rate of cervical cancer screening	1 year	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

Secondary Outcome Measures

Name	Time	Method
incidence of barriers to care	1 year	Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.
incidence of high risk sexual practices	1 year	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.
rate of HPV vaccination	1 year	Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.