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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04154358
• Other study ID #: 1410051-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Human Papilloma Virus
• Papilloma
• Transgenderism
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV testing
will perform HPV testing with self-collected specimen

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	The Equality Clinic of Augusta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence of barriers to care	Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.	1 year
Secondary	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.	1 year
Secondary	rate of HPV vaccination	Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.	1 year