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

Recruiting

• Conditions: Papillomavirus Infections; HIV Infections

• Registration Number: NCT04910438
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Study Start: 2021-06-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence at inclusion of anal lesions	at Day 0	According to HIV status among MSM in Lomé, Togo

Secondary Outcome Measures

Name	Time	Method
Incidence of HPV infection	at 12 month and 24 month
Describe the proportion of clearance of HPV infections	at 12 month and 24 month	in the same individual, on anal and oral specimens, based on HIV status.
Describe the number of worsening events of anal cytological lesions	at 12 month and 24 month	According to HIV status among MSM in Lomé, Togo
Prevalence of anal lesions at baseline	at Day 0	According to HIV status among MSM in Lomé, Togo
Incidence of anal lesions	at 12 month and 24 month	According to HIV status among MSM in Lomé, Togo
Prevalence of HPV infections	at Day 0
Describe the proportion of persistent HPV infections	at 12 month and 24 month
Describe the proportion of recurrence of anal lesions	at 12 month and 24 month	According to HIV status among MSM who received available treatment, in Lomé, Togo

Trial Locations

Locations (1)

ONG, Espoir Vie Togo; 🇹🇬 Lomé, Togo