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

NCT ID: NCT04910438

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-24

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Papillomavirus Infections HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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STIs screening and care

* 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Lomé, Département de Santé Publique, Lomé, Togo

UNKNOWN

Sponsor Role collaborator

Bichat Hospital

OTHER

Sponsor Role collaborator

Espoir Vie-Togo - ONG

OTHER

Sponsor Role collaborator

Centre Africain de Recherche en Epidémiologie et en Santé Publique, Lomé, Togo

UNKNOWN

Sponsor Role collaborator

Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

OTHER

Sponsor Role collaborator

Laboratoire de Biologie Moléculaire et d'Immunologie, Lomé, Togo

UNKNOWN

Sponsor Role collaborator

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Charpentier

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat Claude Bernard, Paris, France

Didier Ekouevi

Role: PRINCIPAL_INVESTIGATOR

Lomé University, Togo

Locations

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ONG, Espoir Vie Togo

Lomé, , Togo

Site Status RECRUITING

Countries

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Togo

Central Contacts

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Didier Koumavi Ekouevi

Role: CONTACT

+228 99 68 67 35

Arnold Sadio

Role: CONTACT

Facility Contacts

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Ephrem Mensah, MD

Role: primary

+228 90 01 64 11

References

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Ferre VM, Sadio AJ, Gbeasor-Komlanvi FA, Bucau M, Salou M, Bercot B, Bebear C, Abramowitz L, Zaidi M, Amenyah-Ehlan AP, Mensah E, Braille A, Couvelard A, Dagnra AC, Ghosn J, Descamps D, Charpentier C, Ekouevi DK. High prevalence of bacterial STI, anal HPV, cytological abnormalities and anal lesions among MSM in Togo, 2021: a baseline analysis of the ANRS I MIE 12,400/DepIST-H cohort. BMC Infect Dis. 2025 Sep 26;25(1):1156. doi: 10.1186/s12879-025-11338-y.

Reference Type DERIVED
PMID: 41013315 (View on PubMed)

Other Identifiers

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ANRS 12400 DepIST-H

Identifier Type: -

Identifier Source: org_study_id

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