Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04910438
Acronym
DepIST-H
Enrollment
200
Registered
2021-06-02
Start date
2021-06-24
Completion date
2024-12-31
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Papillomavirus Infections

Keywords

HPV, HIV, MSM, Togo

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.

Interventions

OTHERSTIs 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Prevalence at inclusion of anal lesionsat Day 0According to HIV status among MSM in Lomé, Togo

Secondary

MeasureTime frameDescription
Describe the number of worsening events of anal cytological lesionsat 12 month and 24 monthAccording to HIV status among MSM in Lomé, Togo
Describe the proportion of recurrence of anal lesionsat 12 month and 24 monthAccording to HIV status among MSM who received available treatment, in Lomé, Togo
Prevalence of HPV infectionsat Day 0
Incidence of HPV infectionat 12 month and 24 month
Describe the proportion of persistent HPV infectionsat 12 month and 24 month
Describe the proportion of clearance of HPV infectionsat 12 month and 24 monthin the same individual, on anal and oral specimens, based on HIV status.
Prevalence of anal lesions at baselineat Day 0According to HIV status among MSM in Lomé, Togo
Incidence of anal lesionsat 12 month and 24 monthAccording to HIV status among MSM in Lomé, Togo

Other

MeasureTime frameDescription
Determination of different Chlamydia trachomatis strainsAt Day 0
Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatisAt Day 0According to HIV status
Incidence of HIVat 12 month and 24 month
Prevalence of others STIs : N. gonorrhoeae, C. trachomatis, M. genitalium, T. vaginalis, Herpès Simplex Virus type 2 (HSV-2), syphilis, hepatitis B and hepatitis CAt Day 0, at 12 month and 24 monthAccording to HIV status
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 CAt Day 0, at 12 month and 24 monthAccording to HIV status

Countries

Togo

Contacts

Primary ContactDidier Koumavi Ekouevi
didier.ekouevi@gmail.com+228 99 68 67 35
Backup ContactArnold Sadio
sadioarnold@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026