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

February 15, 2022 updated by: ANRS, Emerging Infectious Diseases

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

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

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Lomé, Togo
        • Recruiting
        • ONG, Espoir Vie Togo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male who have sex with men living with HIV or not

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence at inclusion of anal lesions
Time Frame: at Day 0
According to HIV status among MSM in Lomé, Togo
at Day 0

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: At Day 0, at 12 month and 24 month
According to HIV status
At Day 0, at 12 month and 24 month
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
Time Frame: At Day 0, at 12 month and 24 month
According to HIV status
At Day 0, at 12 month and 24 month
Determination of different Chlamydia trachomatis strains
Time Frame: At Day 0
At Day 0
Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatis
Time Frame: At Day 0
According to HIV status
At Day 0
Incidence of HIV
Time Frame: at 12 month and 24 month
at 12 month and 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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