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

Sponsor
Augusta University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04154358
Collaborator
The Equality Clinic of Augusta (Other)
100
Enrollment
1
Arm
8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HPV testing
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. incidence of barriers to care [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 [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 [1 year]

    Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Augusta University
  • The Equality Clinic of Augusta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Augusta University
ClinicalTrials.gov Identifier:
NCT04154358
Other Study ID Numbers:
  • 1410051-2
First Posted:
Nov 6, 2019
Last Update Posted:
Mar 23, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Uterine Cervical Neoplasms
Papilloma

Study Results

No Results Posted as of Mar 23, 2020