NCT04910438

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 24, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

January 22, 2020

Last Update Submit

February 15, 2022

Conditions

Keywords

HPVHIVMSMTogo

Outcome Measures

Primary Outcomes (1)

  • Prevalence at inclusion of anal lesions

    According to HIV status among MSM in Lomé, Togo

    at Day 0

Secondary Outcomes (8)

  • Prevalence of anal lesions at baseline

    at Day 0

  • Incidence of anal lesions

    at 12 month and 24 month

  • Describe the number of worsening events of anal cytological lesions

    at 12 month and 24 month

  • Describe the proportion of recurrence of anal lesions

    at 12 month and 24 month

  • Prevalence of HPV infections

    at Day 0

  • +3 more secondary outcomes

Other Outcomes (5)

  • 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

    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

    At Day 0, at 12 month and 24 month

  • Determination of different Chlamydia trachomatis strains

    At Day 0

  • +2 more other outcomes

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.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male who have sex with men living with HIV or not

You may qualify if:

  • 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
  • Regardless of HIV status (infected or not)
  • Whether or not the participant has already taken antiretrovirals

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ONG, Espoir Vie Togo

Lomé, Togo

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, Blood Anal smear pharyngeal and oral specimens urethral specimens Swab of herpes vesicles

MeSH Terms

Conditions

Papillomavirus InfectionsHIV Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Charlotte Charpentier

    Hôpital Bichat Claude Bernard, Paris, France

    PRINCIPAL INVESTIGATOR
  • Didier Ekouevi

    Lomé University, Togo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Didier Koumavi Ekouevi

CONTACT

Arnold Sadio

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

June 2, 2021

Study Start

June 24, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations