HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

NCT05981807 | Unknown

• 1 other identifier: 2023-A00672-43
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Human Papillomavirus Infection; Human Immunodeficiency Virus Infection; Sexually Transmitted Diseases

Keywords

HPV; HIV; Transgender; Dysplasia; Neisseria gonorrhoeae; Chlamydia trachomatis; Syphilis; STI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Prevalence of HPV infections at the genital, anal and ENT level and according to HIV status

  12 months

• Prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status

  12 months

• Prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status

  12 months

• 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

  12 months

Study Arms (1)

Transgender population

Cohort of transgender people (man to woman and woman to man)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

MeSH Terms

Conditions

Papillomavirus Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Syphilis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial

Study Officials

• Jade GHOSN, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jade GHOSN, MD PhD

CONTACT

(+33) 1 40 25 78 03; jade.ghosn@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-08