HPV Prevalence in Transpersons - a Prospective Study

Transsexualism Clinical Trial

Official title:

HPV Prevalence in Transpersons - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864951
• Other study ID #: 1186/2021
• Status: Completed
• Phase: N/A
• Start date: May 2, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Transpeople

• Age over 18 years

• Sufficient knowledge of German

Exclusion Criteria:

• Age under 18 years

• Insufficient knowledge of German

Related Conditions & MeSH terms

• Papillomavirus Infection
• Papillomavirus Infections
• Transsexualism

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Slovenia	Institute of Microbiology and Immunology Faculty of Medicine	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Sophie Pils

Countries where clinical trial is conducted

Austria,  Slovenia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV prevalence in transpeople	HPV prevalence in transpeople	one year