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

NCT ID: NCT04154358

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Transgenderism Cervical Cancer Human Papilloma Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HPV Testing

Will perform HPV testing with self-collected specimen

Group Type EXPERIMENTAL

HPV testing

Intervention Type DIAGNOSTIC_TEST

will perform HPV testing with self-collected specimen

Interventions

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HPV testing

will perform HPV testing with self-collected specimen

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Equality Clinic of Augusta

UNKNOWN

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1410051-2

Identifier Type: -

Identifier Source: org_study_id

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