HPV Prevalence in Transpersons - a Prospective Study

March 13, 2023 updated by: Sophie Pils
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Microbiology and Immunology Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18 years
  • Insufficient knowledge of German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transpeople

1x urine sampling for HPV analysis

1x survey
Diagnostic test: Colli-Pee urine collection device
first-void urine is collected using Colli-Pee and subsequently analyzed using Anyplex™ II HPV HR Detection from Seegene.
Other: Survey
Subjects are asked to complete a survey that includes questions about sexual orientation, hormone therapy, gender reassignment surgery, number of sexual partners, HPV vaccination, and smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV prevalence in transpeople
Time Frame: one year
HPV prevalence in transpeople
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophie Pils

Investigators

  • Principal Investigator: Elmar Joura, MD, Medical University of Vienna, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

April 25, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1186/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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