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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04154358
Other study ID # 1410051-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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