Clinical trial NCT04910438: Prevalence and Longitudinal Follow-up of Anal Lesions, HPV Infection and Associated Sexually Transmitted Infections Among Men Who Have Sex With Men in Togo.
Official 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 Lomé, Togo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Papillomavirus Infections
HIV Infections
Keywords: HPV
HIV
MSM
Togo
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Université de Lomé, Département de Santé Publique, Lomé, Togo
name: Bichat Hospital
name: Espoir Vie-Togo - ONG
name: Centre Africain de Recherche en Epidémiologie et en Santé Publique, Lomé, Togo
name: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
name: Laboratoire de Biologie Moléculaire et d'Immunologie, Lomé, Togo
name: Saint-Louis Hospital, Paris, France
name: University Hospital, Bordeaux
First posted: 2021-06-02
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male who have sex with men living with HIV or not

Brief 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 Lomé, Togo

Detailed 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 Lomé, 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 Lomé, 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 Lomé (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, Chi² 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.

Eligibility criteria: 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 Lomé
* 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 Lomé)

Primary outcomes:
measure: Prevalence at inclusion of anal lesions
timeFrame: at Day 0
Secondary outcomes:
measure: Prevalence of anal lesions at baseline
timeFrame: at Day 0
measure: Incidence of anal lesions
timeFrame: at 12 month and 24 month
measure: Describe the number of worsening events of anal cytological lesions
timeFrame: at 12 month and 24 month
measure: Describe the proportion of recurrence of anal lesions
timeFrame: at 12 month and 24 month
measure: Prevalence of HPV infections
timeFrame: at Day 0
measure: Incidence of HPV infection
timeFrame: at 12 month and 24 month
measure: Describe the proportion of persistent HPV infections
timeFrame: at 12 month and 24 month
measure: Describe the proportion of clearance of HPV infections
timeFrame: at 12 month and 24 month
Other outcomes:
measure: Prevalence of others STIs : N. gonorrhoeae, C. trachomatis, M. genitalium, T. vaginalis, Herpès Simplex Virus type 2 (HSV-2), syphilis, hepatitis B and hepatitis C
timeFrame: At Day 0, at 12 month and 24 month
measure: Incidence of others STIs : Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, Trichomonas vaginalis and Herpès Simplex Virus type 2 (HSV-2), syphilis, hepatitis B and hepatitis C
timeFrame: At Day 0, at 12 month and 24 month
measure: Determination of different Chlamydia trachomatis strains
timeFrame: At Day 0
measure: Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatis
timeFrame: At Day 0
measure: Incidence of HIV
timeFrame: at 12 month and 24 month
Locations:
city: Lomé
country: Togo
facility: ONG, Espoir Vie Togo
Study officials:
affiliation: Hôpital Bichat Claude Bernard, Paris, France
name: Charlotte Charpentier
role: PRINCIPAL_INVESTIGATOR
affiliation: Lomé University, Togo
name: Didier Ekouevi
role: PRINCIPAL_INVESTIGATOR
References: