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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Didier Koumavi Ekouevi
- Telefonnummer: +228 99 68 67 35
- E-Mail: didier.ekouevi@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Arnold Sadio
- E-Mail: sadioarnold@gmail.com
Studienorte
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Lomé, Gehen
- Rekrutierung
- ONG, Espoir Vie Togo
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Kontakt:
- Ephrem Mensah, MD
- Telefonnummer: +228 90 01 64 11
- E-Mail: ephremensah@hotmail.fr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Prevalence at inclusion of anal lesions
Zeitfenster: at Day 0
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According to HIV status among MSM in Lomé, Togo
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at Day 0
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Prevalence of anal lesions at baseline
Zeitfenster: at Day 0
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According to HIV status among MSM in Lomé, Togo
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at Day 0
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Incidence of anal lesions
Zeitfenster: at 12 month and 24 month
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According to HIV status among MSM in Lomé, Togo
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at 12 month and 24 month
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Describe the number of worsening events of anal cytological lesions
Zeitfenster: at 12 month and 24 month
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According to HIV status among MSM in Lomé, Togo
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at 12 month and 24 month
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Describe the proportion of recurrence of anal lesions
Zeitfenster: at 12 month and 24 month
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According to HIV status among MSM who received available treatment, in Lomé, Togo
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at 12 month and 24 month
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Prevalence of HPV infections
Zeitfenster: at Day 0
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at Day 0
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Incidence of HPV infection
Zeitfenster: at 12 month and 24 month
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at 12 month and 24 month
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Describe the proportion of persistent HPV infections
Zeitfenster: at 12 month and 24 month
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at 12 month and 24 month
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Describe the proportion of clearance of HPV infections
Zeitfenster: at 12 month and 24 month
|
in the same individual, on anal and oral specimens, based on HIV status.
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at 12 month and 24 month
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: At Day 0, at 12 month and 24 month
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According to HIV status
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At Day 0, at 12 month and 24 month
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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
Zeitfenster: At Day 0, at 12 month and 24 month
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According to HIV status
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At Day 0, at 12 month and 24 month
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Determination of different Chlamydia trachomatis strains
Zeitfenster: At Day 0
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At Day 0
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Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatis
Zeitfenster: At Day 0
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According to HIV status
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At Day 0
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Incidence of HIV
Zeitfenster: at 12 month and 24 month
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at 12 month and 24 month
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Charlotte Charpentier, Hôpital Bichat Claude Bernard, Paris, France
- Hauptermittler: Didier Ekouevi, Lomé University, Togo
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ANRS 12400 DepIST-H
Plan für individuelle Teilnehmerdaten (IPD)
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