Clinical trial NCT05981807: HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
Official title: Prevalence of Genital, Anal and Oral HPV Infection and Sexually Transmitted Infections, and of Anal Dysplasia in the Transgender Population (PrevHPV-TG)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Papillomavirus Infection
Human Immunodeficiency Virus Infection
Sexually Transmitted Diseases
Keywords: HPV
HIV
Transgender
Dysplasia
Neisseria gonorrhoeae
Chlamydia trachomatis
Syphilis
STI
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2023-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of HPV infection in transgender population
timeFrame: 12 months
Secondary outcomes:
measure: Prevalence of HPV infections at the genital, anal and ENT level and according to HIV status
timeFrame: 12 months
measure: Prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status
timeFrame: 12 months
measure: Prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status
timeFrame: 12 months
measure: Types of hrHPV and lrHPV detected at the genital, anal and ENT level
timeFrame: 12 months
measure: Prevalence of dysplastic lesions (low grade and high grade) by HIV status
timeFrame: 12 months
measure: Prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jade GHOSN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: