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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 May 2021
• Main ID: NCT02626286
• Date of registration: 20/11/2015
• Prospective Registration: No
• Primary sponsor: ANRS, Emerging Infectious Diseases
• Public title: Feasibility and Interest of a HIV Quarterly Preventive Global Care in Men Who Have Sex With Men in Sub-Saharan Africa CohMSM
• Scientific 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)
• Date of first enrolment: June 2015
• Target sample size: 885
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02626286
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Burkina Faso, Burundi, Côte D'Ivoire, Mali, Togo

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Other: HIV quarterly global care

Primary Outcome(s)

Antiretroviral therapy maintenance probability in HIV-positive MSM [Time Frame: 3 years]

Number of co-infections with several viral variants [Time Frame: 3 years]

Number of male sex partners [Time Frame: 3 years]

Number of transmitted and acquired resistance mutations [Time Frame: 3 years]

Number of HIV subtypes / circulating recombinant forms [Time Frame: 3 years]

Antiretroviral therapy initiation probability in HIV-positive MSM [Time Frame: 3 years]

Percentage of HIV-positive MSM with CD4=reference (or CD4<100/mm3) [Time Frame: 3 years]

Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status [Time Frame: 3 years]

Incidence of sexually transmitted infections [Time Frame: 3 years]

Number of unprotected anal sex [Time Frame: 3 years]

Percentage of HIV-positive MSM with viral load>1000 copies/mL [Time Frame: 3 years]

Percentage of antiretroviral therapy observance in HIV-positive MSM [Time Frame: 3 years]

Percentage of HIV-positive MSM died under antiretroviral therapy [Time Frame: 3 years]

Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4) [Time Frame: 3 years]

Percentage of performed tests/scheduled tests [Time Frame: 3 years]

Number of people followed after 3 years compared to the number of persons included (retention in the program) [Time Frame: 3 years]

Percentage of performed visits/scheduled visits [Time Frame: 3 years]

Secondary ID(s)

ANRS 12324 CohMSM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Programme PAC-CI, Abidjan, Côte d'Ivoire

ARCAD-SIDA MALI

Association African Solidarité

Coalition Internationale Sida

IRD Unité SESSTIM (IRD, Inserm, Université Aix-Marseille)

Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso

Espace Confiance, Côte d'Ivoire

Espoir Vie-Togo - ONG

Expertise France

Université Montpellier