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

April 10, 2026 updated by: ANRS, Emerging Infectious Diseases

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

885

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Centre Oasis, Association African Solidarité (AAS)
  • Côte d’Ivoire
      • Abidjan, Côte d’Ivoire
        • Clinique de Confiance, Espace Confiance
  • Mali
      • Bamako, Mali
        • Clinique des Halles, ARCAD-SIDA
  • Togo
      • Lomé, Togo
        • Espoir vie Togo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 5, 2021

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimated)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12324 CohMSM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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