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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sexually Transmitted Diseases; Human Papillomavirus Infection; Human Immunodeficiency Virus Infection

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:

1. Estimate the prevalence of HPV infections at the genital, anal and ENT level and according to HIV status;
2. To estimate the prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status;
3. To estimate the prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status;
4. Describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level;
5. To estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status;
6. 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:

1. The prevalence of HPV infections in each anatomical site (genital, anal and ENT) and by HIV status.
2. The prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.
3. The prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.
4. The types of hrHPV and lrHPV in each anatomical site (genital, anal).
5. The prevalence of dysplastic lesions (low grade and high grade) by HIV status.
6. 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jade GHOSN, MD PhD; Phone Number: (+33) 1 40 25 78 03; Email: jade.ghosn@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Principal Investigator: Jade GHOSN, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIV; STI; Syphilis; HPV; Dysplasia; Chlamydia trachomatis; Neisseria gonorrhoeae; Transgender
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Papillomavirus Infections
• Other Study ID Numbers: 2023-A00672-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No