HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population (PrevHPV-TG)

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ClinicalTrials.gov Identifier: NCT05981807

Recruitment Status : Not yet recruiting

First Posted : August 8, 2023

Last Update Posted : August 8, 2023

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Sponsor:

Information provided by (Responsible Party):

ANRS, Emerging Infectious Diseases

Study Description

Brief Summary:

The goal of this observational study is to estimate the prevalence of HPV infections anal and ENT level and according to HIV status in transgender (TG) population. The main question it aims to answer is:

What is the prevalence of HPV lesions in transgender population (TG);
What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital, anal and ENT level

Condition or disease
Human Papillomavirus Infection Human Immunodeficiency Virus Infection Sexually Transmitted Diseases

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Detailed Description:

Context:

The few publications with an individualized transgender (TG) population have been conducted in South America (Peru, Argentina) showing very high anal or ano-genital hrHPV prevalences of around 97% (dos Ramos Farias et al., 2011; Brown et al., 2016). Recently a study conducted in 22 TGs showed a high prevalence of anal dysplastic lesions with low grade lesions detected in 8 individuals and high grade in 3 individuals (Kobayashi et al., 2017). Thus, in the face of this high prevalence of 50% anal dysplasia, the TG population therefore appears to be at risk for developing anal dysplastic lesions and this needs to be explored in another TG population. Furthermore, to our knowledge, no study has evaluated the concomitant prevalence of hrHPV infection at the anogenital and ENT levels in the transgender population. The Infectious and Tropical Diseases Department of Bichat-Claude Bernard Hospital is particularly involved in the follow-up of transgender individuals with a large active file that participates in clinical research projects (Pommier et al., 2019; Bertin et al., 2019; Phung et al., 2018).

Objectives:

Principal objective The primary objective of this study is to determine the prevalence of HPV lesions in transgender population (TG).

Secondary objectives

Secondary objectives include:

Estimate the prevalence of HPV infections at the genital, anal and ENT level and according to HIV status;
To estimate the prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status;
To estimate the prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status;
Describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level;
To estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status;
To estimate the prevalence of bacterial Sexually Transmitted Infections (STIs): Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status.

Methodology This is a national, non-interventional, cross-sectional, monocentric study among TG people (man to woman, and woman to man)

Estimated enrolment 200 participants

Outcomes Primary outcome:

The prevalence of HPV infections among TG people. Prevalence is defined as the percentage of subjects with HPV infection among TG people included, regardless the site where infection was detected.

Secondary outcomes:

The prevalence of HPV infections in each anatomical site (genital, anal and ENT) and by HIV status.
The prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.
The prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.
The types of hrHPV and lrHPV in each anatomical site (genital, anal).
The prevalence of dysplastic lesions (low grade and high grade) by HIV status.
The prevalence of bacterial STIs: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.

Eligibility Inclusion criteria

Age ≥ 18 years
To belong to transgender population : i.e. people who doesn't identify to the gender assigned at birth
To be affiliated to a social security system or be beneficiary of the Aide Médicale d'Etat (AME)

Non-inclusion criteria

To have ever been vaccinated against HPV
Research participation refusal
People under guardianship or curatorship, or deprived of liberty by administrative or judiciary measure

Statistical methods Individuals' characteristics will be described for all included subjects. Continuous variables will be described using mean, standard deviation, median, interquartiles values, minimal and maximal values. Qualitative variables will be described using numbers and percentages by modality. Prevalences will be described by proportion and their confidence interval will be calculated under binomial law. All statistical tests will be performed using 5% as significance level. Prevalence of high risk HPV infection in each anatomical site and the concordance of HPV types by anatomical site will be determined using Fleiss Kappa test.

Study Design

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Study Type :	Observational
Estimated Enrollment :	200 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Prevalence of Genital, Anal and Oral HPV Infection and Sexually Transmitted Infections, and of Anal Dysplasia in the Transgender Population (PrevHPV-TG)
Estimated Study Start Date :	October 2023
Estimated Primary Completion Date :	October 2024
Estimated Study Completion Date :	October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV LGBTQIA+ Health Sexually Transmitted Diseases

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Transgender population Cohort of transgender people (man to woman and woman to man)

Outcome Measures

Primary Outcome Measures :

Prevalence of HPV infection in transgender population [ Time Frame: 12 months ]
The prevalence of HPV infections is defined as the percentage of subjects with HPV infection among transgender people included, regardless the site of infection.

Secondary Outcome Measures :

Prevalence of HPV infections at the genital, anal and ENT level and according to HIV status [ Time Frame: 12 months ]
We will estimate the prevalence of HPV infections in each anatomical site (genital, anal and ENT) and according to HIV status.
Prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status [ Time Frame: 12 months ]
We will estimate the prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.
Prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status [ Time Frame: 12 months ]
We will estimate the prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.
Types of hrHPV and lrHPV detected at the genital, anal and ENT level [ Time Frame: 12 months ]
We will describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level
Prevalence of dysplastic lesions (low grade and high grade) by HIV status [ Time Frame: 12 months ]
We will estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status.
Prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status [ Time Frame: 12 months ]
We will estimate the prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The study will include people who belong to the transgender population : i.e. people who do not identify to the gender assigned at birth (man to woman and woman to man).

Criteria

Inclusion criteria:

Age ≥ 18 years
To belong to transgender population : i.e. people who doesn't identify to the gender assigned at birth
To be affiliated to a social security system or be beneficiary of AME

Exclusion criteria:

To have ever been vaccinated against HPV
Research participation refusal
People under guardianship or curatorship, or deprived of liberty by administrative or judiciary measure

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981807

Contacts

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Contact: Jade GHOSN, MD PhD	(+33) 1 40 25 78 03	jade.ghosn@aphp.fr

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases

Investigators

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Principal Investigator:	Jade GHOSN, MD PhD	Assistance Publique - Hôpitaux de Paris

More Information

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Responsible Party:	ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier:	NCT05981807
Other Study ID Numbers:	2023-A00672-43
First Posted:	August 8, 2023 Key Record Dates
Last Update Posted:	August 8, 2023
Last Verified:	August 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by ANRS, Emerging Infectious Diseases:


HPV HIV Transgender Dysplasia	Neisseria gonorrhoeae Chlamydia trachomatis Syphilis STI

Additional relevant MeSH terms:

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Infections Communicable Diseases Acquired Immunodeficiency Syndrome HIV Infections Sexually Transmitted Diseases Papillomavirus Infections Disease Attributes Pathologic Processes Immunologic Deficiency Syndromes Immune System Diseases Virus Diseases	Blood-Borne Infections Sexually Transmitted Diseases, Viral Lentivirus Infections Retroviridae Infections RNA Virus Infections Slow Virus Diseases Genital Diseases Urogenital Diseases DNA Virus Infections Tumor Virus Infections

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