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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
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

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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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


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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.



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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

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
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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