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

NCT04154358 | Unknown

• 1 other identifier: 1410051-2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transgenderism; Cervical Cancer; Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

• incidence of barriers to care

  1 year

• incidence of high risk sexual practices

  1 year

• rate of HPV vaccination

  1 year

Study Arms (1)

HPV Testing

EXPERIMENTAL

Will perform HPV testing with self-collected specimen

Diagnostic Test: HPV testing

Interventions

HPV testing DIAGNOSTIC_TEST

will perform HPV testing with self-collected specimen

HPV Testing

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Must be transgender masculine identifying with uterus and cervix.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• impaired decision making capacity
• Absence of cervix
• Non-English speaking

Sponsors & Collaborators

• Augusta University: lead
• The Equality Clinic of Augusta: collaborator

MeSH Terms

Conditions

Transsexualism; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: May 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share