Prevalence and Longitudinal Follow-up of Anal Lesions HPV Infection and Associated Sexually Transmitted Infections Among Men Who Have Sex With Men in Togo.

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    200
  • sponsor
    ANRS, Emerging Infectious Diseases
Updated on 4 August 2021
cancer
antiretroviral
hepatitis
AIDS
HIV Vaccine

Summary

The DepIST-H study, funded by the French AIDS and Hepatitis Research Agency (ANRS), is to estimate prevalence (the number of cases over a given period of time) and incidence (the number of new cases over a given period of time) of anal lesions (condylomas, dysplasia, cancers) by HIV status among MSM in Lom, Togo

Description

Title: Prevalence and longitudinal follow-up over 2 years of anal lesions, HPV infection and associated sexually transmitted infections among men who have sex with men (MSM) in Lom, Togo (ANRS12400 DepIST-H)

Main objective: To estimate the prevalence and incidence of anal lesions (condyloma, dysplasia and anal cancers) according to HIV status among MSM in Lom, Togo

Specific objectives :

To estimate the prevalence of HPV infection at baseline (M0) at anal and oropharyngeal sites To describe the persistence of HPV infection at Year 1 and 2 at the anal and oropharyngeal sites To describe the recurrence of anal lesions at Year 1 and 2 To estimate prevalence and incidence of associated STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex Virus type 2, Mycoplasma genitalium, Trichomonas vaginalis) HBV, HCV and syphilis

Methods :

This study is a prospective cohort with a 2-year follow-up of 200 MSM in Lom (100 HIV- and 100 HIV+). Three data collection systems are integrated into the cohort: (i) clinical data, (ii) socio-behavioural questionnaires, and (iii) biological data.

Sample size: 200 participants (100 HIV+ and 100 HIV-)

Interventions :

Screening for anal dysplasia, HPV infection, HIV infection and several STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, Trichomonas vaginalis, HSV-2 and HBV).

Offering comprehensive care including prevention strategies adapted to the various STIs mentioned above and their complications, particularly the progression to anal cancer for HPV infections in MSM.

Statistical analysis methods :

Use of mixed approaches. For quantitative indicators, descriptive analysis techniques, bivariate analysis (Student t test or Wilcoxon test for quantitative variables, Chi or Fisher test for categorical variables) and multivariate analysis (logistic regression).

To estimate the incidence if the STIs, Kaplan-Meier curves, Cox models analyses will be conducted.

As the cohort is open and non-randomized, preliminary analyses will be conducted during the collection.

Details
Condition HIV infection, Immunodeficiency, Papillomavirus Infections, Human Papillomavirus Infection, HPV Infection, HIV Infections, human immunodeficiency virus, hiv disease
Treatment STIs screening and care
Clinical Study IdentifierNCT04910438
SponsorANRS, Emerging Infectious Diseases
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Being a male aged 18 or over
Self-reporting as being a MSM
Wishing to be part of a regular clinical follow-up
Agreeing to participate in the study and signing the informed consent form
Live in Lom
Having had anal intercourse within the past six months prior to inclusion visit
Regardless of HIV status (infected or not)
Whether or not the participant has already taken antiretrovirals

Exclusion Criteria

Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or sexually transmitted infections (CohMSM ANRS 12324-EF cohort of Lom)
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