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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04154358
Enrollment
100
Registered
2019-11-06
Start date
2020-05-01
Completion date
2020-12-31
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transgenderism, Cervical Cancer, Human Papilloma Virus

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.

Interventions

DIAGNOSTIC_TESTHPV testing

will perform HPV testing with self-collected specimen

Sponsors

The Equality Clinic of Augusta
CollaboratorUNKNOWN
Augusta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of cervical cancer screening1 yearEvaluate 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

MeasureTime frameDescription
rate of HPV vaccination1 yearEvaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.
incidence of barriers to care1 yearDetermine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.
incidence of high risk sexual practices1 yearEvaluate 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026