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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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HIV Infection

Intervention / Treatment
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* Other: HIV quarterly global care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV quarterly global care<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 visits |  | 3 years | 
| Percentage of performed tests/scheduled tests |  | 3 years | 
| Incidence of sexually transmitted infections |  | 3 years | 
| Number of unprotected anal sex |  | 3 years | 
| Antiretroviral therapy initiation probability in HIV-positive MSM |  | 3 years | 
| Antiretroviral therapy maintenance probability in HIV-positive MSM |  | 3 years | 
| Percentage of antiretroviral therapy observance in HIV-positive MSM |  | 3 years | 
| Percentage of HIV-positive MSM with viral load>1000 copies/mL |  | 3 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 therapy |  | 3 years | 
| Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status |  | 3 years | 
| Number of HIV subtypes / circulating recombinant forms |  | 3 years | 
| Number of co-infections with several viral variants |  | 3 years | 
| Number of transmitted and acquired resistance mutations |  | 3 years | 
| Number of male sex partners |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Men who have sex with men