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HIV InfectionCohMSMNCT02626286

Feasibility and Interest of a HIV Quarterly Preventive Global Care in Men Who Have Sex With Men in Sub-Saharan Africa

A study testing HIV quarterly global care in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population. 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
HIV Infection
What is being tested?
HIV quarterly global care
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
885 participants
Where
4 sitesin 4 countries
Study dates
Jun 2015to 5 Jan 2021
Phase
Interventional
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

Who may be able to join

  • Man over 18 years
  • Reporting at least one anal sex (passive or active) with another man within the last three months
  • Able to reach the local site of the study
  • Agreeing to participate in the study and signing the informed consent form

Who cannot join

  • History of antiretroviral therapy (except for pre- or post-exposure prophylaxis)
  • Participation in another biomedical or behavioral research on HIV or sexually transmitted infections
  • Impairment of the person making his participation in the study, or information understanding, difficult or impossible
  • Predictable protocol violation (geographical distance or other reasons)

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Burkina Faso1 site

  • Centre Oasis, Association African Solidarité (AAS)

    Ouagadougou

Other trials in Burkina Faso

Côte d’Ivoire1 site

  • Clinique de Confiance, Espace Confiance

    Abidjan

Other trials in Côte d’Ivoire

Mali1 site

  • Clinique des Halles, ARCAD-SIDA

    Bamako

Other trials in Mali

Togo1 site

  • Espoir vie Togo

    Lomé

About this study

Official title: Prevention of HIV Infection in Men Who Have Sex With Men in Sub-Saharan Africa: Feasibility and Interest of a Quarterly Preventive Global Care (CohMSM)

The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population. This interventional, open label, multicenter, multidisciplinary cohort study will be conducted in Burkina Faso, Ivory Coast, Mali and Togo.

All participants will receive a HIV quarterly preventive global care including:

  1. data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) counselling adapted for MSM, and v) the provision of condoms and lubricants.
Read the detailed description

The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population.

Regarding HIV-negative MSM, the specific objectives are to assess:

  1. the acceptability of the preventive global care including quarterly monitoring and HIV screening as well as the associated medical, behavioral and social factors, and
  2. changes in sexual behavior among MSM during the project as well as the associated medical, behavioral and social factors.

Regarding HIV-positive MSM, the specific objectives are to assess:

  1. the acceptability of the preventive global care including antiretroviral therapy initiation whatever the CD4 T cell count and the clinical stage, as well as the associated medical, behavioral and social factors,
  2. adherence and response to antiretroviral therapy as well as the associated medical, behavioral and social factors,
  3. changes in sexual behavior among MSM during the project as well as the associated medical, behavioral and social factors,
  4. risk of HIV transmission as well as the associated medical, behavioral and social factors, and
  5. describe the virologic characteristics (subtypes / circulating recombinant forms, co-infection with multiple variants and transmitted and acquired resistance profiles).

Regarding healthcare professionals, the specific objective is to evaluate the perception of the preventive global care.

This interventional, open label, multicenter, multidisciplinary cohort study will be conducted in Burkina Faso, Ivory Coast, Mali and Togo.

All participants will receive a HIV quarterly preventive global care including:

  1. data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) counselling adapted for MSM, and v) the provision of condoms and lubricants.

In addition, vaccination against hepatitis B virus and annual tests for syphilis will be offered. HIV-negative MSM will also be offered an HIV screening test at each quarterly visit. HIV-positive MSM will be offered immediate support of HIV infection including antiretroviral therapy. A total of 700 MSM over 18 years (500 HIV-negative and 200 HIV-positive) reporting at least one anal sex (passive or active) with another man within the last three months will be recruited and followed for 24 to 36 months. MSM lost to follow-up, transferred, died or having seroconverted for HIV during follow-up will be replaced in their respective group (seronegative or seropositive) by other MSM. The study will last 3 years.

Conditions
HIV Infection
Being tested
HIV quarterly global care
Keywords
HIV, Men who have sex with men
Medical subject headings
HIV Infections, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV quarterly global careOther

Study groups in NCT02626286
Study groupRoleWhat they receive
HIV quarterly global careOtherHIV quarterly global care including i) data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) prevention counselling adapted for MSM, v) the provision of condoms and lubricants, and vi) HIV screening test at each quarterly visit for HIV-negative MSM or immediate support of HIV infection including antiretroviral therapy for HIV-positive MSM.
Receives: Other: HIV quarterly global care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of people followed after 3 years compared to the number of persons included (retention in the program)

    Measured: 3 years

  2. Percentage of performed visits/scheduled visits

    Measured: 3 years

  3. Percentage of performed tests/scheduled tests

    Measured: 3 years

  4. Incidence of sexually transmitted infections

    Measured: 3 years

  5. Number of unprotected anal sex

    Measured: 3 years

  6. Antiretroviral therapy initiation probability in HIV-positive MSM

    Measured: 3 years

  7. Antiretroviral therapy maintenance probability in HIV-positive MSM

    Measured: 3 years

  8. Percentage of antiretroviral therapy observance in HIV-positive MSM

    Measured: 3 years

  9. Percentage of HIV-positive MSM with viral load>1000 copies/mL

    Measured: 3 years

  10. Percentage of HIV-positive MSM with CD4≤reference (or CD4<100/mm3)

    Measured: 3 years

  11. Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4)

    Measured: 3 years

  12. Percentage of HIV-positive MSM died under antiretroviral therapy

    Measured: 3 years

  13. Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status

    Measured: 3 years

  14. Number of HIV subtypes / circulating recombinant forms

    Measured: 3 years

  15. Number of co-infections with several viral variants

    Measured: 3 years

  16. Number of transmitted and acquired resistance mutations

    Measured: 3 years

  17. Number of male sex partners

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion5 Jan 2021
  4. Study completion5 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
885 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02626286
Sponsor's protocol ID
ANRS 12324 CohMSM
Acronym
CohMSM
Status last verified
Apr 2026
First submitted
20 Nov 2015
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No

Publications

  • Fiorentino M, Coulibaly B, Couderc C, Keita BD, Anoma C, Dah E, Mensah E, Aka TN, Toure JR, Camara D, Kokouba AR, Maradan G, Mora M, Bourrelly M, Riegel L, Rojas-Castro D, Spire B, Laurent C, Sagaon-Teyssier L; CohMSM Study Group. Men Who Have Sex with Both Men and Women in West Africa: Factors Associated with a High Behavioral Risk of Acquiring HIV from Male Partners and Transmission to Women (CohMSM ANRS 12324-Expertise France). Arch Sex Behav. 2024 Feb;53(2):757-769. doi: 10.1007/s10508-023-02715-2. Epub 2023 Nov 16.

    PubMed 37973698

  • Yaya I, Diallo F, Kouame MJ, Agboyibor MK, Traore I, Coulibaly A, Maiga K, Mora M, Palvadeau P, Dah ETT, Mensah E, Anoma C, Dembele Keita B, Spire B, Laurent C; CohMSM Study Group. Decrease in incidence of sexually transmitted infections symptoms in men who have sex with men enrolled in a quarterly HIV prevention and care programme in West Africa (CohMSM ANRS 12324-Expertise France). Sex Transm Infect. 2022 Mar;98(2):85-94. doi: 10.1136/sextrans-2020-054755. Epub 2021 Mar 22.

    PubMed 33753460

  • Yaya I, Boyer V, Ehlan PA, Coulibaly A, Agboyibor MK, Traore I, Kouame MJ, Maiga AK, Kotchi OR, Nyasenu YT, Maradan G, Rojas-Castro D, Diallo F, Anoma C, Dah TTE, Mensah E, Dembele Keita B, Spire B, Dagnra CA, Laurent C; CohMSM Study Group. Heterogeneity in the Prevalence of High-Risk Human Papillomavirus Infection in Human Immunodeficiency Virus-Negative and Human Immunodeficiency Virus-Positive Men Who Have Sex With Men in West Africa. Clin Infect Dis. 2021 Dec 16;73(12):2184-2192. doi: 10.1093/cid/ciab157.

    PubMed 33606001

  • Fiorentino M, Eubanks A, Coulaud PJ, Couderc C, Keita BD, Anoma C, Dah E, Mensah E, Maradan G, Bourrelly M, Riegel L, Rojas-Castro D, Yaya I, Spire B, Laurent C, Sagaon-Teyssier L; CohMSM Study Group. Homonegativity, sexual violence and condom use with women in men who have sex with men and women in West Africa. AIDS. 2021 Mar 15;35(4):681-687. doi: 10.1097/QAD.0000000000002782.

    PubMed 33306548

  • Coulaud PJ, Sagaon-Teyssier L, Mimi M, M'madi Mrenda B, Maradan G, Mora M, Bourrelly M, Keita BD, Keita AA, Anoma C, Babo Yoro SA, Dah TTE, Coulibaly C, Mensah E, Agbomadji S, Bernier A, Couderc C, Laurent C, Spire B; CohMSM Study Group. Combined Sexual Behavioral Profiles in HIV-Seronegative Men Who have Sex with Men in West Africa (CohMSM ANRS 12324-Expertise France). Arch Sex Behav. 2020 Jan;49(1):331-345. doi: 10.1007/s10508-019-01513-z. Epub 2019 Aug 9.

    PubMed 31399923

  • Coulaud PJ, Sagaon-Teyssier L, Mimi M, Maradan G, Mora M, Bourrelly M, Dembele Keita B, Keita AA, Anoma C, Yoro SB, Dah ETT, Coulibaly C, Mensah E, Agbomadji S, Palvadeau P, Bernier A, Rojas Castro D, Couderc C, Laurent C, Spire B; CohMSM Study Group. Changes in risky sexual behaviours among West African MSM enrolled in a quarterly HIV testing and counselling prevention programme (CohMSM ANRS 12324 - Expertise France). Sex Transm Infect. 2020 Mar;96(2):115-120. doi: 10.1136/sextrans-2018-053892. Epub 2019 Aug 1.

    PubMed 31371449

  • Dah TTE, Couderc C, Coulibaly A, Kouame MJ, Agboyibor MK, Traore I, Maradan G, Rojas Castro D, Mensah E, Anoma C, Dembele Keita B, Spire B, Laurent C; CohMSM Study Group. Hepatitis B Virus Prevalence and Vaccination in Men Who Have Sex With Men in West Africa (CohMSM ANRS 12324-Expertise France). Open Forum Infect Dis. 2019 May 23;6(7):ofz249. doi: 10.1093/ofid/ofz249. eCollection 2019 Jul.

    PubMed 31281855

  • Coulaud PJ, Preau M, Maradan G, Mora M, Traore F, Oga M, Thio E, Ekon L, Dembele Keita B, Anoma C, Ter Tiero Dah E, Mensah E, Bernier A, Couderc C, Laurent C, Spire B; CohMSM Study Group. Taking empowerment into account: the response of community-based organisations to the HIV care needs of men who have sex with men in West Africa (CohMSM ANRS 12324 - Expertise France). AIDS Care. 2019 Nov;31(11):1403-1411. doi: 10.1080/09540121.2019.1587358. Epub 2019 Mar 4.

    PubMed 30829534

  • Coulaud PJ, Sagaon-Teyssier L, M'madi Mrenda B, Maradan G, Mora M, Bourrelly M, Dembele Keita B, Keita AA, Anoma C, Babo Yoro SA, Dah TTE, Coulibaly C, Mensah E, Agbomadji S, Bernier A, Couderc C, Laurent C, Spire B; CohMSM Study Group. Interest in HIV pre-exposure prophylaxis in men who have sex with men in West Africa (CohMSM ANRS 12324 - Expertise France). Trop Med Int Health. 2018 Oct;23(10):1084-1091. doi: 10.1111/tmi.13129. Epub 2018 Aug 29.

    PubMed 30055043

  • Dah TTE, Yaya I, Sagaon-Teyssier L, Coulibaly A, Kouame MJ, Agboyibor MK, Maiga K, Traore I, Mora M, Palvadeau P, Rojas-Castro D, Diallo F, Mensah E, Anoma C, Keita BD, Spire B, Laurent C; CohMSM Study Group. Adherence to quarterly HIV prevention services and its impact on HIV incidence in men who have sex with men in West Africa (CohMSM ANRS 12324 - Expertise France). BMC Public Health. 2021 May 22;21(1):972. doi: 10.1186/s12889-021-10994-4.

    PubMed 34022820

  • Dah TTE, Yaya I, Mensah E, Coulibaly A, Kouame JM, Traore I, Mora M, Palvadeau P, Anoma C, Keita BD, Spire B, Laurent C; CohMSM Study Group. Rapid antiretroviral therapy initiation and its effect on treatment response in MSM in West Africa. AIDS. 2021 Nov 1;35(13):2201-2210. doi: 10.1097/QAD.0000000000003046.

    PubMed 34352834

Questions about this trial

What is this clinical trial studying?

A study testing HIV quarterly global care in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 4 countries.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Burkina Faso, Côte d’Ivoire, Mali, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of people followed after 3 years compared to the number of persons included (retention in the program) (time frame: 3 years). The study lists 17 primary outcomes in all. 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 NCT02626286, which also lists 11 linked publications.

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 15 Apr 2026.

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