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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

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02626286
Acronym
CohMSM
Enrollment
885
Registered
2015-12-10
Start date
2015-06-01
Completion date
2021-01-05
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV, Men who have sex with men

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.

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.

Interventions

OTHERHIV quarterly global care

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Number of people followed after 3 years compared to the number of persons included (retention in the program)3 years
Percentage of performed visits/scheduled visits3 years
Percentage of performed tests/scheduled tests3 years
Incidence of sexually transmitted infections3 years
Number of unprotected anal sex3 years
Antiretroviral therapy initiation probability in HIV-positive MSM3 years
Antiretroviral therapy maintenance probability in HIV-positive MSM3 years
Percentage of antiretroviral therapy observance in HIV-positive MSM3 years
Percentage of HIV-positive MSM with viral load>1000 copies/mL3 years
Percentage of HIV-positive MSM with CD4≤reference (or CD4<100/mm3)3 years
Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4)3 years
Percentage of HIV-positive MSM died under antiretroviral therapy3 years
Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status3 years
Number of HIV subtypes / circulating recombinant forms3 years
Number of co-infections with several viral variants3 years
Number of transmitted and acquired resistance mutations3 years
Number of male sex partners3 years

Countries

Burkina Faso, Côte d’Ivoire, Mali, Togo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026