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

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ClinicalTrials.gov Identifier: NCT02626286
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Expertise France
Université Montpellier
SESSTIM (IRD, Inserm, Université Aix-Marseille)
Coalition Internationale Sida
ARCAD-SIDA MALI
Espace Confiance, Côte d'Ivoire
PACCI, Abidjan, Côte d'Ivoire
Association African Solidarité
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)

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.


Condition or disease Intervention/treatment Phase
HIV Infection Other: HIV quarterly global care Not Applicable

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:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
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)
Actual Study Start Date : June 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of people followed after 3 years compared to the number of persons included (retention in the program) [ Time Frame: 3 years ]
  2. Percentage of performed visits/scheduled visits [ Time Frame: 3 years ]
  3. Percentage of performed tests/scheduled tests [ Time Frame: 3 years ]
  4. Incidence of sexually transmitted infections [ Time Frame: 3 years ]
  5. Number of unprotected anal sex [ Time Frame: 3 years ]
  6. Antiretroviral therapy initiation probability in HIV-positive MSM [ Time Frame: 3 years ]
  7. Antiretroviral therapy maintenance probability in HIV-positive MSM [ Time Frame: 3 years ]
  8. Percentage of antiretroviral therapy observance in HIV-positive MSM [ Time Frame: 3 years ]
  9. Percentage of HIV-positive MSM with viral load>1000 copies/mL [ Time Frame: 3 years ]
  10. Percentage of HIV-positive MSM with CD4≤reference (or CD4<100/mm3) [ Time Frame: 3 years ]
  11. Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4) [ Time Frame: 3 years ]
  12. Percentage of HIV-positive MSM died under antiretroviral therapy [ Time Frame: 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 [ Time Frame: 3 years ]
  14. Number of HIV subtypes / circulating recombinant forms [ Time Frame: 3 years ]
  15. Number of co-infections with several viral variants [ Time Frame: 3 years ]
  16. Number of transmitted and acquired resistance mutations [ Time Frame: 3 years ]
  17. Number of male sex partners [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626286


Contacts
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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
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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 (IRD, Inserm, Université Aix-Marseille)
Coalition Internationale Sida
ARCAD-SIDA MALI
Espace Confiance, Côte d'Ivoire
PACCI, Abidjan, Côte d'Ivoire
Association African Solidarité
Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso
ANSS, Bujumbura, Burundi
Faculté de médecine de Bujumbura, Burundi

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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
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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:
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HIV Infections
Acquired Immunodeficiency Syndrome
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes