NCT04864951

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

April 25, 2021

Last Update Submit

March 13, 2023

Conditions

Papillomavirus InfectionTranssexualism

Outcome Measures

Primary Outcomes (1)

  • HPV prevalence in transpeople

    HPV prevalence in transpeople

    one year

Study Arms (1)

Transpeople

OTHER

1x urine sampling for HPV analysis 1x survey

Diagnostic Test: Colli-Pee urine collection deviceOther: Survey

Interventions

Colli-Pee urine collection deviceDIAGNOSTIC_TEST

first-void urine is collected using Colli-Pee and subsequently analyzed using Anyplex™ II HPV HR Detection from Seegene.

Transpeople
SurveyOTHER

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

Transpeople

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsall study participants classify themselves as transmen, transwomen, genderqueer, non-binary or other gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Insufficient knowledge of German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

Location

Institute of Microbiology and Immunology Faculty of Medicine

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

  • Reisner SL, Deutsch MB, Peitzmeier SM, White Hughto JM, Cavanaugh TP, Pardee DJ, McLean SA, Panther LA, Gelman M, Mimiaga MJ, Potter JE. Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients. PLoS One. 2018 Mar 14;13(3):e0190172. doi: 10.1371/journal.pone.0190172. eCollection 2018.

    PMID: 29538411BACKGROUND

  • Pils S, Mlakar J, Poljak M, Domjanic GG, Kaufmann U, Springer S, Salat A, Langthaler E, Joura EA. HPV screening in the urine of transpeople - A prevalence study. EClinicalMedicine. 2022 Oct 12;54:101702. doi: 10.1016/j.eclinm.2022.101702. eCollection 2022 Dec.

    PMID: 36263396DERIVED

MeSH Terms

Conditions

Papillomavirus InfectionsTranssexualism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexualitySexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Elmar Joura, MD

    Medical University of Vienna, Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 29, 2021

Study Start

May 2, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)AU(1)