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HPV Prevalence in Transpersons - a Prospective Study

Sponsor
Sophie Pils (Other)
Overall Status
Recruiting
CT.gov ID
NCT04864951
Collaborator
(none)
200
Enrollment
2
Locations
1
Arm
12
Anticipated Duration (Months)
100
Patients Per Site
8.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Colli-Pee urine collection device
  • Other: Survey
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
HPV Prevalence in Transpersons - a Prospective Study
Actual Study Start Date :
May 2, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. HPV prevalence in transpeople [one year]

    HPV prevalence in transpeople

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Transpeople

  • Age over 18 years

  • Sufficient knowledge of German

Exclusion Criteria:

  • Age under 18 years

  • Insufficient knowledge of German

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090
2 Institute of Microbiology and Immunology Faculty of Medicine Ljubljana Slovenia 1000

Sponsors and Collaborators

  • Sophie Pils

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sophie Pils, Clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04864951
Other Study ID Numbers:
  • 1186/2021
First Posted:
Apr 29, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Papillomavirus Infections

Study Results

No Results Posted as of Oct 5, 2021