Feasibility and Interest of a HIV Quarterly Preventive Global Care in Men Who Have Sex With Men in Sub-Saharan Africa
- Conditions
- HIV Infection
- Interventions
- Other: HIV quarterly global care
- Registration Number
- NCT02626286
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 885
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIV quarterly global care 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.
- Primary Outcome Measures
Name Time Method Percentage of performed tests/scheduled tests 3 years Number of people followed after 3 years compared to the number of persons included (retention in the program) 3 years Incidence of sexually transmitted infections 3 years Antiretroviral therapy initiation probability in HIV-positive MSM 3 years Antiretroviral therapy maintenance probability in HIV-positive MSM 3 years Percentage of HIV-positive MSM died under antiretroviral therapy 3 years Number of unprotected anal sex 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 performed visits/scheduled visits 3 years Number of transmitted and acquired resistance mutations 3 years Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4) 3 years Number of HIV subtypes / circulating recombinant forms 3 years Number of co-infections with several viral variants 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 male sex partners 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Clinique des Halles, ARCAD-SIDA
🇲🇱Bamako, Mali
Espoir vie Togo
🇹🇬Lome, Togo
Centre Oasis, Association African Solidarité (AAS)
🇧🇫Ouagadougou, Burkina Faso
Clinique de Confiance, Espace Confiance
🇨🇮Abidjan, Côte D'Ivoire