Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 17 for:    condyloma | Recruiting, Not yet recruiting, Available Studies

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04910438
Recruitment Status : Not yet recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Collaborators:
Université de Lomé, Département de Santé Publique, Lomé, Togo
Bichat Hospital
Espoir Vie-Togo - ONG
Centre Africain de Recherche en Epidémiologie et en Santé Publique, Lomé, Togo
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Laboratoire de Biologie Moléculaire et d'Immunologie, Lomé, Togo
Saint-Louis Hospital, Paris, France
University Hospital, Bordeaux
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

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

Condition or disease Intervention/treatment
Papillomavirus Infections HIV Infections Other: STIs screening and care

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Prevalence at inclusion of anal lesions [ Time Frame: at Day 0 ]
    According to HIV status among MSM in Lomé, Togo


Secondary Outcome Measures :
  1. Prevalence of anal lesions at baseline [ Time Frame: at Day 0 ]
    According to HIV status among MSM in Lomé, Togo

  2. Incidence of anal lesions [ Time Frame: at 12 month and 24 month ]
    According to HIV status among MSM in Lomé, Togo

  3. Describe the number of worsening events of anal cytological lesions [ Time Frame: at 12 month and 24 month ]
    According to HIV status among MSM in Lomé, Togo

  4. Describe the proportion of recurrence of anal lesions [ Time Frame: at 12 month and 24 month ]
    According to HIV status among MSM who received available treatment, in Lomé, Togo

  5. Prevalence of HPV infections [ Time Frame: at Day 0 ]
  6. Incidence of HPV infection [ Time Frame: at 12 month and 24 month ]
  7. Describe the proportion of persistent HPV infections [ Time Frame: at 12 month and 24 month ]
  8. Describe the proportion of clearance of HPV infections [ Time Frame: at 12 month and 24 month ]
    in the same individual, on anal and oral specimens, based on HIV status.


Other Outcome Measures:
  1. 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 [ Time Frame: At Day 0, at 12 month and 24 month ]
    According to HIV status

  2. 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 [ Time Frame: At Day 0, at 12 month and 24 month ]
    According to HIV status

  3. Determination of different Chlamydia trachomatis strains [ Time Frame: At Day 0 ]
  4. Determination of antibiotic resistance profiles for Neisseria gonorrhoeae, Mycoplasma genitalium and Chlamydia trachomatis [ Time Frame: At Day 0 ]
    According to HIV status

  5. Incidence of HIV [ Time Frame: at 12 month and 24 month ]

Biospecimen Retention:   Samples Without DNA
Urine, Blood Anal smear pharyngeal and oral specimens urethral specimens Swab of herpes vesicles


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male who have sex with men living with HIV or not
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04910438


Contacts
Layout table for location contacts
Contact: Didier Koumavi Ekouevi +228 99 68 67 35 didier.ekouevi@gmail.com
Contact: Arnold Sadio sadioarnold@gmail.com

Locations
Layout table for location information
Togo
ONG, Espoir Vie Togo
Lomé, Togo
Contact: Ephrem Mensah, MD    +228 90 01 64 11    ephremensah@hotmail.fr   
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Université de Lomé, Département de Santé Publique, Lomé, Togo
Bichat Hospital
Espoir Vie-Togo - ONG
Centre Africain de Recherche en Epidémiologie et en Santé Publique, Lomé, Togo
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Laboratoire de Biologie Moléculaire et d'Immunologie, Lomé, Togo
Saint-Louis Hospital, Paris, France
University Hospital, Bordeaux
Investigators
Layout table for investigator information
Principal Investigator: Charlotte Charpentier Hôpital Bichat Claude Bernard, Paris, France
Principal Investigator: Didier Ekouevi Lomé University, Togo
Layout table for additonal information
Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04910438    
Other Study ID Numbers: ANRS 12400 DepIST-H
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases:
HPV
HIV
MSM
Togo
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Sexually Transmitted Diseases
Papillomavirus Infections
Virus Diseases
DNA Virus Infections
Tumor Virus Infections