HPV Prevalence in Transpersons - a Prospective Study

Not Applicable

Completed

• Conditions: Transsexualism; Papillomavirus Infection
• Interventions: Diagnostic Test: Colli-Pee urine collection device; Other: Survey

• Registration Number: NCT04864951
• Lead Sponsor: Sophie Pils

Brief Summary

In this study, Human Papilloma Virus (HPV) prevalence will be determined once in the urine of 200 trans people. In addition, subjects will be asked to complete a questionnaire about their sexual orientation, which is adapted from the largest published study.

Detailed Description

All transpeople who visit the outpatient clinic are asked to participate in the study. After being informed and signing the Informed Consent Form, the subjects are asked to give first-void urine and fill out the survey. The urine samples are sent pseudonymously to the University of Ljubljana for analysis. The subjects will be informed about their results within 3 weeks.If the result is positive, the subjects will be offered voluntary further care in our HPV outpatient clinic. However, this will take place outside the study. The data collected there can be used for further analyses.

Study Timeline

• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-25
• Study First Posted: 2021-04-29
• Study Start: 2021-05-02
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• Transpeople
• Age over 18 years
• Sufficient knowledge of German

Exclusion Criteria

• Age under 18 years
• Insufficient knowledge of German

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transpeople	Colli-Pee urine collection device	1x urine sampling for HPV analysis 1x survey
Transpeople	Survey	1x urine sampling for HPV analysis 1x survey

Primary Outcome Measures

Name	Time	Method
HPV prevalence in transpeople	one year	HPV prevalence in transpeople

Trial Locations

Locations (2)

Institute of Microbiology and Immunology Faculty of Medicine; 🇸🇮 Ljubljana, Slovenia

Medical University of Vienna; 🇦🇹 Vienna, Austria