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

Primary Purpose

Transgenderism, Cervical Cancer, Human Papilloma Virus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HPV testing
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Transgenderism

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HPV Testing

    Arm Description

    Will perform HPV testing with self-collected specimen

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    incidence of barriers to care
    Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.
    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.
    rate of HPV vaccination
    Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.

    Full Information

    First Posted
    November 4, 2019
    Last Updated
    March 20, 2020
    Sponsor
    Augusta University
    Collaborators
    The Equality Clinic of Augusta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04154358
    Brief Title
    Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men
    Official Title
    Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Augusta University
    Collaborators
    The Equality Clinic of Augusta

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transgenderism, Cervical Cancer, Human Papilloma Virus

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HPV Testing
    Arm Type
    Experimental
    Arm Description
    Will perform HPV testing with self-collected specimen
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    HPV testing
    Intervention Description
    will perform HPV testing with self-collected specimen
    Primary Outcome Measure Information:
    Title
    Rate of cervical cancer screening
    Description
    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
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    incidence of barriers to care
    Description
    Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.
    Time Frame
    1 year
    Title
    incidence of high risk sexual practices
    Description
    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.
    Time Frame
    1 year
    Title
    rate of HPV vaccination
    Description
    Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Must be transgender masculine identifying with uterus and cervix.
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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