Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborator
Expertise France
Université Montpellier
SESSTIM (UMR 912 INSERM / IRD / Université Aix-Marseille)
Coalition Internationale Sida, Pantin, France
ARCAD-SIDA, Bamako, Mali
Espace Confiance, Abidjan, Côte d'Ivoire
PACCI, Abidjan, Côte d'Ivoire
Association African Solidarité, Ouagadougou, Burkina Faso
Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso
ANSS, Bujumbura, Burundi
Faculté de médecine de Bujumbura, Burundi

Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT02626286

First received: November 20, 2015
Last updated: August 10, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infection

Other : HIV quarterly global care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • 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 ]
  • Percentage of performed tests/scheduled tests [ Time Frame: 3 years ]
  • Incidence of sexually transmitted infections [ Time Frame: 3 years ]
  • Number of unprotected anal sex [ Time Frame: 3 years ]
  • Antiretroviral therapy initiation probability in HIV-positive MSM [ Time Frame: 3 years ]
  • Antiretroviral therapy maintenance probability in HIV-positive MSM [ Time Frame: 3 years ]
  • Percentage of antiretroviral therapy observance in HIV-positive MSM [ Time Frame: 3 years ]
  • Percentage of HIV-positive MSM with viral load>1000 copies/mL [ 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 new or recurrent AIDS-defining events (clinical stage 4) [ Time Frame: 3 years ]
  • Percentage of HIV-positive MSM died under antiretroviral therapy [ 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 ]
  • Number of HIV subtypes / circulating recombinant forms [ Time Frame: 3 years ]
  • Number of co-infections with several viral variants [ Time Frame: 3 years ]
  • Number of transmitted and acquired resistance mutations [ Time Frame: 3 years ]
  • Number of male sex partners [ Time Frame: 3 years ]

Estimated Enrollment: 700
Study Start Date: June 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: HIV quarterly global care
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

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:
  • 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,
  • adherence and response to antiretroviral therapy as well as the associated medical, behavioral and social factors,
  • changes in sexual behavior among MSM during the project as well as the associated medical, behavioral and social factors,
  • risk of HIV transmission as well as the associated medical, behavioral and social factors, and
  • 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:
    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.
    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.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: Male  
    Accepts Healthy Volunteers: Yes  

    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)

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02626286

    Contacts

    Contact:   Christian Laurent, PhD +33 4 67 41 61 50 christian.laurent@ird.fr
    Contact:   Bintou Dembélé Keita, MD +223 20 23 72 59 bdembele@arcadsida.org

    Locations

    Burkina Faso
    Centre Oasis, Association African Solidarité (AAS) Recruiting
    Ouagadougou, Burkina Faso
    Contact: Nicolas Meda, Pr    +226 50 30 82 57    nicolas.meda@univ-ouaga.bf
    Côte D'Ivoire
    Clinique de Confiance, Espace Confiance Recruiting
    Abidjan, Côte D'Ivoire
    Contact: Camille Anoma, MD    +225 21 35 28 61    anomacamille@yahoo.fr
    Mali
    Clinique des Halles, ARCAD-SIDA Recruiting
    Bamako, Mali
    Contact: Bintou Dembélé Keita, MD    +223 20 23 72 59    bdemebele@arcadsida.org
    Togo
    Espoir vie Togo Recruiting
    Lome, Togo
    Contact: Ephram Mensah, Dr    ephremensah@hotmail.fr

    Sponsors and Collaborators

    French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
    Expertise France
    Université Montpellier
    SESSTIM (UMR 912 INSERM / IRD / Université Aix-Marseille)
    Coalition Internationale Sida, Pantin, France
    ARCAD-SIDA, Bamako, Mali
    Espace Confiance, Abidjan, Côte d'Ivoire
    PACCI, Abidjan, Côte d'Ivoire
    Association African Solidarité, Ouagadougou, Burkina Faso
    Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso
    ANSS, Bujumbura, Burundi
    Faculté de médecine de Bujumbura, Burundi
    More Information

    More Information


    Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)  
    ClinicalTrials.gov Identifier: NCT02626286   History of Changes  
    Other Study ID Numbers: ANRS 12324 CohMSM  
    Study First Received: November 20, 2015  
    Last Updated: August 10, 2016  

    Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

    HIV
    Men who have sex with men

    Additional relevant MeSH terms:
    Infection
    HIV Infections
    Acquired Immunodeficiency Syndrome

    ClinicalTrials.gov processed this data on December 14, 2017
    This information is provided by ClinicalTrials.gov.