Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men
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|ClinicalTrials.gov 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):
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 :
- 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 :
- 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.
- 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.
- rate of HPV vaccination [ Time Frame: 1 year ]Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.
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