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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04910438
Other study ID # ANRS 12400 DepIST-H
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2021
Est. completion date December 2024

Study information

Verified date February 2022
Source ANRS, Emerging Infectious Diseases
Contact Didier Koumavi Ekouevi
Phone +228 99 68 67 35
Email didier.ekouevi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
Togo ONG, Espoir Vie Togo Lomé

Sponsors (9)

Lead Sponsor Collaborator
ANRS, Emerging Infectious Diseases Bichat Hospital, Centre Africain de Recherche en Epidémiologie et en Santé Publique, Lomé, Togo, Espoir Vie-Togo - ONG, Laboratoire de Biologie Moléculaire et d'Immunologie, Lomé, Togo, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Saint-Louis Hospital, Paris, France, Université de Lomé, Département de Santé Publique, Lomé, Togo, University Hospital, Bordeaux

Country where clinical trial is conducted

Togo, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 According to HIV status At Day 0, at 12 month and 24 month
Other 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 According to HIV status At Day 0, at 12 month and 24 month
Other Determination of different Chlamydia trachomatis strains At Day 0
Other Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatis According to HIV status At Day 0
Other Incidence of HIV at 12 month and 24 month
Primary Prevalence at inclusion of anal lesions According to HIV status among MSM in Lomé, Togo at Day 0
Secondary Prevalence of anal lesions at baseline According to HIV status among MSM in Lomé, Togo at Day 0
Secondary Incidence of anal lesions According to HIV status among MSM in Lomé, Togo at 12 month and 24 month
Secondary Describe the number of worsening events of anal cytological lesions According to HIV status among MSM in Lomé, Togo at 12 month and 24 month
Secondary Describe the proportion of recurrence of anal lesions According to HIV status among MSM who received available treatment, in Lomé, Togo at 12 month and 24 month
Secondary Prevalence of HPV infections at Day 0
Secondary Incidence of HPV infection at 12 month and 24 month
Secondary Describe the proportion of persistent HPV infections at 12 month and 24 month
Secondary Describe the proportion of clearance of HPV infections in the same individual, on anal and oral specimens, based on HIV status. at 12 month and 24 month
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