NCT02626286

Brief 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. 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: 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) counselling adapted for MSM, and v) the provision of condoms and lubricants.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
885

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

5.6 years

First QC Date

November 20, 2015

Last Update Submit

April 10, 2026

Conditions

HIV Infection

Keywords

HIVMen who have sex with men

Outcome Measures

Primary Outcomes (17)

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

    3 years

  • Percentage of performed visits/scheduled visits

    3 years

  • Percentage of performed tests/scheduled tests

    3 years

  • Incidence of sexually transmitted infections

    3 years

  • Number of unprotected anal sex

    3 years

  • Antiretroviral therapy initiation probability in HIV-positive MSM

    3 years

  • Antiretroviral therapy maintenance probability in HIV-positive MSM

    3 years

  • Percentage of antiretroviral therapy observance in HIV-positive MSM

    3 years

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

    3 years

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

    3 years

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

    3 years

  • Percentage of HIV-positive MSM died under antiretroviral therapy

    3 years

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

    3 years

  • Number of HIV subtypes / circulating recombinant forms

    3 years

  • Number of co-infections with several viral variants

    3 years

  • Number of transmitted and acquired resistance mutations

    3 years

  • Number of male sex partners

    3 years

Study Arms (1)

HIV quarterly global care

OTHER

HIV 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.

Other: HIV quarterly global care

Interventions

HIV quarterly global careOTHER
HIV quarterly global care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Oasis, Association African Solidarité (AAS)

Ouagadougou, Burkina Faso

Location

Clinique de Confiance, Espace Confiance

Abidjan, Côte d’Ivoire

Location

Clinique des Halles, ARCAD-SIDA

Bamako, Mali

Location

Espoir vie Togo

Lomé, Togo

Location

Related Publications (11)

  • 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.

    PMID: 37973698BACKGROUND

  • 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.

    PMID: 33753460BACKGROUND

  • 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.

    PMID: 33606001BACKGROUND

  • 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.

    PMID: 33306548BACKGROUND

  • 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.

    PMID: 31399923BACKGROUND

  • 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.

    PMID: 31371449BACKGROUND

  • 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.

    PMID: 31281855BACKGROUND

  • 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.

    PMID: 30829534BACKGROUND

  • 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.

    PMID: 30055043BACKGROUND

  • 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.

    PMID: 34022820RESULT

  • 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.

    PMID: 34352834DERIVED

MeSH Terms

Conditions

HIV InfectionsHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

December 10, 2015

Study Start

June 1, 2015

Primary Completion

January 5, 2021

Study Completion

January 5, 2021

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

TO(1)BU(1)MA(1)CÔ(1)