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Completed

NCT Number: NCT02626286

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

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.

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Key information

Conditions

HIV Infection Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oasis, Association African Solidarité (AAS), Ouagadougou, Burkina Faso

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About this study

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:

  • the acceptability of the preventive global care including quarterly monitoring and HIV screening as well as the associated medical, behavioral and social factors, and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HIV quarterly global care

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • ARCAD-SIDA MALI
  • Association African Solidarité
  • Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso
  • Coalition Internationale Sida
  • Espace Confiance, Côte d'Ivoire
  • Espoir Vie-Togo - ONG
  • Expertise France
  • IRD Unité SESSTIM (IRD, Inserm, Université Aix-Marseille)
  • Programme PAC-CI, Abidjan, Côte d'Ivoire
  • Université Montpellier

Registry information

Official study 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)

Acronym: CohMSM

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2015
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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