Clinical trial NCT02626286: Feasibility and Interest of a HIV Quarterly Preventive Global Care in Men Who Have Sex With Men in Sub-Saharan Africa
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV
Men who have sex with men
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Expertise France
name: Université Montpellier
name: IRD Unité SESSTIM (IRD, Inserm, Université Aix-Marseille)
name: Coalition Internationale Sida
name: ARCAD-SIDA MALI
name: Espace Confiance, Côte d'Ivoire
name: Programme PAC-CI, Abidjan, Côte d'Ivoire
name: Association African Solidarité
name: Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso
name: Espoir Vie-Togo - ONG
First posted: 2015-12-10
Enrollment: 885
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Number of people followed after 3 years compared to the number of persons included (retention in the program)
timeFrame: 3 years
measure: Percentage of performed visits/scheduled visits
timeFrame: 3 years
measure: Percentage of performed tests/scheduled tests
timeFrame: 3 years
measure: Incidence of sexually transmitted infections
timeFrame: 3 years
measure: Number of unprotected anal sex
timeFrame: 3 years
measure: Antiretroviral therapy initiation probability in HIV-positive MSM
timeFrame: 3 years
measure: Antiretroviral therapy maintenance probability in HIV-positive MSM
timeFrame: 3 years
measure: Percentage of antiretroviral therapy observance in HIV-positive MSM
timeFrame: 3 years
measure: Percentage of HIV-positive MSM with viral load>1000 copies/mL
timeFrame: 3 years
measure: Percentage of HIV-positive MSM with CD4≤reference (or CD4<100/mm3)
timeFrame: 3 years
measure: Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4)
timeFrame: 3 years
measure: Percentage of HIV-positive MSM died under antiretroviral therapy
timeFrame: 3 years
measure: Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status
timeFrame: 3 years
measure: Number of HIV subtypes / circulating recombinant forms
timeFrame: 3 years
measure: Number of co-infections with several viral variants
timeFrame: 3 years
measure: Number of transmitted and acquired resistance mutations
timeFrame: 3 years
measure: Number of male sex partners
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre Oasis, Association African Solidarité (AAS)
city: Abidjan
country: Côte D'Ivoire
facility: Clinique de Confiance, Espace Confiance
city: Bamako
country: Mali
facility: Clinique des Halles, ARCAD-SIDA
city: Lome
country: Togo
facility: Espoir vie Togo
Study officials:
References:
citation: Dah TTE, Yaya I, Mensah E, Coulibaly A, Kouame JM, Traore I, Mora M, Palvadeau P, Anoma C, Keita BD, Spire B, Laurent C; CohMSM Study Group. Rapid antiretroviral therapy initiation and its effect on treatment response in MSM in West Africa. AIDS. 2021 Nov 1;35(13):2201-2210. doi: 10.1097/QAD.0000000000003046.
citation: Dah TTE, Yaya I, Sagaon-Teyssier L, Coulibaly A, Kouame MJ, Agboyibor MK, Maiga K, Traore I, Mora M, Palvadeau P, Rojas-Castro D, Diallo F, Mensah E, Anoma C, Keita BD, Spire B, Laurent C; CohMSM Study Group. Adherence to quarterly HIV prevention services and its impact on HIV incidence in men who have sex with men in West Africa (CohMSM ANRS 12324 - Expertise France). BMC Public Health. 2021 May 22;21(1):972. doi: 10.1186/s12889-021-10994-4.
citation: Yaya I, Diallo F, Kouame MJ, Agboyibor MK, Traore I, Coulibaly A, Maiga K, Mora M, Palvadeau P, Dah ETT, Mensah E, Anoma C, Dembele Keita B, Spire B, Laurent C; CohMSM Study Group. Decrease in incidence of sexually transmitted infections symptoms in men who have sex with men enrolled in a quarterly HIV prevention and care programme in West Africa (CohMSM ANRS 12324-Expertise France). Sex Transm Infect. 2022 Mar;98(2):85-94. doi: 10.1136/sextrans-2020-054755. Epub 2021 Mar 22.