HPV Prevalence in Transpersons - a Prospective Study
Primary Purpose
Papillomavirus Infection, Transsexualism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Colli-Pee urine collection device
Survey
Sponsored by
About this trial
This is an interventional screening trial for Papillomavirus Infection
Eligibility Criteria
Inclusion Criteria:
- Transpeople
- Age over 18 years
- Sufficient knowledge of German
Exclusion Criteria:
- Age under 18 years
- Insufficient knowledge of German
Sites / Locations
- Medical University of Vienna
- Institute of Microbiology and Immunology Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Transpeople
Arm Description
1x urine sampling for HPV analysis 1x survey
Outcomes
Primary Outcome Measures
HPV prevalence in transpeople
HPV prevalence in transpeople
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04864951
Brief Title
HPV Prevalence in Transpersons - a Prospective Study
Official Title
HPV Prevalence in Transpersons - a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sophie Pils
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infection, Transsexualism
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transpeople
Arm Type
Other
Arm Description
1x urine sampling for HPV analysis
1x survey
Intervention Type
Diagnostic Test
Intervention Name(s)
Colli-Pee urine collection device
Intervention Description
first-void urine is collected using Colli-Pee and subsequently analyzed using Anyplex™ II HPV HR Detection from Seegene.
Intervention Type
Other
Intervention Name(s)
Survey
Intervention Description
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
Primary Outcome Measure Information:
Title
HPV prevalence in transpeople
Description
HPV prevalence in transpeople
Time Frame
one year
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
all study participants classify themselves as transmen, transwomen, genderqueer, non-binary or other gender identity
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Transpeople
Age over 18 years
Sufficient knowledge of German
Exclusion Criteria:
Age under 18 years
Insufficient knowledge of German
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elmar Joura, MD
Organizational Affiliation
Medical University of Vienna, Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Institute of Microbiology and Immunology Faculty of Medicine
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29538411
Citation
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.
Results Reference
background
PubMed Identifier
36263396
Citation
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.
Results Reference
derived
Learn more about this trial
HPV Prevalence in Transpersons - a Prospective Study
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