Papillomavirus InfectionsDepIST-HNCT04910438
Prevalence and Longitudinal Follow-up of Anal Lesions, HPV Infection and Associated Sexually Transmitted Infections Among Men Who Have Sex With Men in Togo.
An observational study of Papillomavirus Infections and HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in Togo.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections, HIV Infections
- What is being tested?
- STIs screening and care
- How many people
- 200 participants
- Where
- 1 siteTogo
- Study dates
- 24 Jun 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male who have sex with men living with HIV or not
Who may be able to join
- 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
Who cannot join
- Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or sexually transmitted infections (CohMSM ANRS 12324-EF cohort of Lomé)
Trial locations and contacts
1 site in 1 country.
Arnold Sadio contact
Togo1 site, 1 recruiting
- Recruiting
ONG, Espoir Vie Togo
Lomé
Ephrem Mensah, MD, +228 90 01 64 11, ephremensah@hotmail.fr
About this study
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
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
Read the 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.
- Conditions
- Papillomavirus Infections, HIV Infections
- Being tested
- STIs screening and care
- Keywords
- HPV, HIV, MSM, Togo
- Medical subject headings
- Papillomavirus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIs screening and careOther
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence at inclusion of anal lesions
According to HIV status among MSM in Lomé, Togo
Measured: at Day 0
Secondary outcomes (8)
Prevalence of anal lesions at baseline
According to HIV status among MSM in Lomé, Togo
Measured: at Day 0
Incidence of anal lesions
According to HIV status among MSM in Lomé, Togo
Measured: at 12 month and 24 month
Describe the number of worsening events of anal cytological lesions
According to HIV status among MSM in Lomé, Togo
Measured: at 12 month and 24 month
Describe the proportion of recurrence of anal lesions
According to HIV status among MSM who received available treatment, in Lomé, Togo
Measured: at 12 month and 24 month
Prevalence of HPV infections
Measured: at Day 0
Incidence of HPV infection
Measured: at 12 month and 24 month
Describe the proportion of persistent HPV infections
Measured: at 12 month and 24 month
Describe the proportion of clearance of HPV infections
in the same individual, on anal and oral specimens, based on HIV status.
Measured: at 12 month and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start24 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- 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
- Responsible party
- Sponsor
- Investigators
- Charlotte Charpentier, Principal investigator, Hôpital Bichat Claude Bernard, Paris, FranceDidier Ekouevi, Principal investigator, Lomé University, Togo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910438
- Sponsor's protocol ID
- ANRS 12400 DepIST-H
- Acronym
- DepIST-H
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferre VM, Sadio AJ, Gbeasor-Komlanvi FA, Bucau M, Salou M, Bercot B, Bebear C, Abramowitz L, Zaidi M, Amenyah-Ehlan AP, Mensah E, Braille A, Couvelard A, Dagnra AC, Ghosn J, Descamps D, Charpentier C, Ekouevi DK. High prevalence of bacterial STI, anal HPV, cytological abnormalities and anal lesions among MSM in Togo, 2021: a baseline analysis of the ANRS I MIE 12,400/DepIST-H cohort. BMC Infect Dis. 2025 Sep 26;25(1):1156. doi: 10.1186/s12879-025-11338-y.
PubMed 41013315
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04910438
- Acronym / sponsor ID
- DepIST-H / ANRS 12400 DepIST-H
- Conditions
- Papillomavirus Infections, HIV Infections
- Keywords
- HPV, HIV, MSM, Togo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- 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
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male who have sex with men living with HIV or not
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in another biomedical and/or behavioural study on HIV, viral hepatitis or sexually transmitted infections (CohMSM ANRS 12324-EF cohort of Lomé)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Prevalence at inclusion of anal lesions
Time frame: at Day 0
According to HIV status among MSM in Lomé, Togo
8 secondary outcomes
Prevalence of anal lesions at baseline
Time frame: at Day 0
Incidence of anal lesions
Time frame: at 12 month and 24 month
Describe the number of worsening events of anal cytological lesions
Time frame: at 12 month and 24 month
Describe the proportion of recurrence of anal lesions
Time frame: at 12 month and 24 month
Prevalence of HPV infections
Time frame: at Day 0
Incidence of HPV infection
Time frame: at 12 month and 24 month
Describe the proportion of persistent HPV infections
Time frame: at 12 month and 24 month
Describe the proportion of clearance of HPV infections
Time frame: at 12 month and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Derived from this study: PubMed 41013315Ferre VM, Sadio AJ, Gbeasor-Komlanvi FA, Bucau M, Salou M, Bercot B, Bebear C, Abramowitz L, Zaidi M, Amenyah-Ehlan AP, Mensah E, Braille A, Couvelard A, Dagnra AC, Ghosn J, Descamps D, Charpentier C, Ekouevi DK. High prevalence of bacterial STI, anal HPV, cytological abnormalities and anal lesions among MSM in Togo, 2021: a baseline analysis of the ANRS I MIE 12,400/DepIST-H cohort. BMC Infect Dis. 2025 Sep 26;25(1):1156. doi: 10.1186/s12879-025-11338-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold Sadio contact
Charlotte Charpentier principal investigator
Hôpital Bichat Claude Bernard, Paris, France
Didier Ekouevi principal investigator
Lomé University, Togo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infections and HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in Togo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Togo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Koumavi Ekouevi (+228 99 68 67 35, didier.ekouevi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence at inclusion of anal lesions (time frame: at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.