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)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Didier Koumavi Ekouevi
- Telefonnummer: +228 99 68 67 35
- E-post: didier.ekouevi@gmail.com
Studera Kontakt Backup
- Namn: Arnold Sadio
- E-post: sadioarnold@gmail.com
Studieorter
-
-
-
Lomé, Togo
- Rekrytering
- ONG, Espoir Vie Togo
-
Kontakt:
- Ephrem Mensah, MD
- Telefonnummer: +228 90 01 64 11
- E-post: ephremensah@hotmail.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prevalence at inclusion of anal lesions
Tidsram: at Day 0
|
According to HIV status among MSM in Lomé, Togo
|
at Day 0
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prevalence of anal lesions at baseline
Tidsram: at Day 0
|
According to HIV status among MSM in Lomé, Togo
|
at Day 0
|
|
Incidence of anal lesions
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: at Day 0
|
at Day 0
|
|
|
Incidence of HPV infection
Tidsram: at 12 month and 24 month
|
at 12 month and 24 month
|
|
|
Describe the proportion of persistent HPV infections
Tidsram: at 12 month and 24 month
|
at 12 month and 24 month
|
|
|
Describe the proportion of clearance of HPV infections
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: At Day 0
|
At Day 0
|
|
|
Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatis
Tidsram: At Day 0
|
According to HIV status
|
At Day 0
|
|
Incidence of HIV
Tidsram: at 12 month and 24 month
|
at 12 month and 24 month
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Charlotte Charpentier, Hôpital Bichat Claude Bernard, Paris, France
- Huvudutredare: Didier Ekouevi, Lomé University, Togo
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ANRS 12400 DepIST-H
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på HIV-infektioner
-
Institut PasteurRekrytering
-
Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
-
Catholic University of the Sacred HeartAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
-
University of MalayaTeleflexRekryteringCLABSI - Central Line Associated Bloodstream InfectionMalaysia
-
Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
-
National Taiwan University Hospital Hsin-Chu BranchAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
National Taiwan University HospitalAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
Boston Children's HospitalSterileCare Inc.Anmälan via inbjudanCentral Line komplikation | Central Line-associated Bloodstream Infection (CLABSI)Förenta staterna
Kliniska prövningar på STIs screening and care
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RekryteringFörsta episod psykos (FEP) | Klinisk högrisk för psykos (CHR)Förenta staterna
-
Northwell HealthNational Institute on Aging (NIA)Aktiv, inte rekryterande
-
Northwell HealthNational Institute on Aging (NIA)Aktiv, inte rekryterandeDeliriumFörenta staterna
-
Karolinska InstitutetRekrytering
-
Abramson Cancer Center at Penn MedicineGilead SciencesRekryteringBröstcancer | Sociala bestämningsfaktorer för hälsa (SDOH)Förenta staterna
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)AvslutadSubstansmissbrukFörenta staterna
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRekryteringUppförandestörning | Autism-spektrumstörningSchweiz