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

HIV Infections Clinical Trial

— DepIST-H  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910438
• Other study ID #: ANRS 12400 DepIST-H
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Papillomavirus Infections
• Sexually Transmitted Diseases

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