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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04154358
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : March 23, 2020
The Equality Clinic of Augusta
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Transgenderism Cervical Cancer Human Papilloma Virus Diagnostic Test: HPV testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HPV Testing
Will perform HPV testing with self-collected specimen
Diagnostic Test: HPV testing
will perform HPV testing with self-collected specimen

Primary Outcome Measures :
  1. Rate of cervical cancer screening [ Time Frame: 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 :
  1. incidence of barriers to care [ Time Frame: 1 year ]
    Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.

  2. incidence of high risk sexual practices [ Time Frame: 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.

  3. rate of HPV vaccination [ Time Frame: 1 year ]
    Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be transgender masculine identifying with uterus and cervix.
Accepts 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
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Responsible Party: Augusta University Identifier: NCT04154358    
Other Study ID Numbers: 1410051-2
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type