Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05981807 |
| Other study ID # |
2023-A00672-43 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
August 2023 |
| Source |
ANRS, Emerging Infectious Diseases |
| Contact |
Jade GHOSN, MD PhD |
| Phone |
(+33) 1 40 25 78 03 |
| Email |
jade.ghosn[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
