HPV Prevalence in Transpersons - a Prospective Study

NCT ID: NCT04864951

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-02

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Papillomavirus Infection Transsexualism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Transpeople

1x urine sampling for HPV analysis

1x survey

Group Type OTHER

Colli-Pee urine collection device

Intervention Type DIAGNOSTIC_TEST

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

Survey

Intervention Type OTHER

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

Interventions

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Colli-Pee urine collection device

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age under 18 years
* Insufficient knowledge of German
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sophie Pils

OTHER

Sponsor Role lead

Responsible Party

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Sophie Pils

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elmar Joura, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Obstetrics and Gynecology

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Institute of Microbiology and Immunology Faculty of Medicine

Ljubljana, , Slovenia

Site Status

Countries

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Austria Slovenia

References

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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.

Reference Type BACKGROUND
PMID: 29538411 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36263396 (View on PubMed)

Other Identifiers

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1186/2021

Identifier Type: -

Identifier Source: org_study_id

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