This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa. An interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo. All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.
This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa. The specific objectives are to assess the acceptability of PrEP, the adherence to PrEP and to quarterly HIV testing, the safety of daily and on-demand use of TDF/FTC, the impact of PrEP on the other prevention strategies, the incidence of sexually transmitted infections (STIs) on PrEP, the "real life" effectiveness of PrEP use and treatment-related resistance, and the cost and cost-effectiveness of PrEP. This interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo. All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants. These activities will be performed by community-based organisations which are pioneer in the fight against HIV, especially in MSM. The study will have a total duration of 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
649
All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (TDF 300 mg + FTC 200 mg), daily or on-demand, according the participant's choice, immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.
Centre Oasis, Association African Solidarité
Ouagadougou, Burkina Faso
Clinique de Confiance, Espace Confiance
Abidjan, Côte d’Ivoire
Clinique des Halles, ARCAD-SIDA
Bamako, Mali
Centre Lucia, Espoir Vie Togo
Lomé, Togo
Percentage of MSM under PrEP among eligible HIV-seronegative participants
To assess the acceptability of PrEP
Time frame: 3 years
Percentage of MSM using daily and/ord on-demand PrEP
To assess the acceptability of PrEP
Time frame: 3 years
Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)
To assess the acceptability of PrEP
Time frame: 3 years
Percentage of adherence reported by MSM
To assess the adherence to PrEP
Time frame: 3 years
Counting of TDF/FTC tablets
To assess the adherence to PrEP
Time frame: 3 years
Plasma concentrations of TDF and FTC
To assess the adherence to PrEP
Time frame: 3 years
Percentage of HIV tests performed
To assess the adherence to quarterly HIV testing
Time frame: 3 years
Clinical and biological adverse events related to TDF and FTC
To assess the safety of daily and on-demand use of TDF/FTC
Time frame: 3 years
Frequency of condomless anal intercourse
To assess the evolution of the other prevention strategies on PrEP
Time frame: 3 years
Frequency of sexual intercourse associated with alcohol and/or drug use
To assess the evolution of the other prevention strategies on PrEP
Time frame: 3 years
Incidence rate of STIs
To assess the incidence of STIs on PrEP
Time frame: 3 years
Incidence rate of HIV infection
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
Time frame: 3 years
Percentage of TDF/FTC resistance among MSM newly infected by HIV
To assess the "real life" effectiveness of PrEP use and the emergence of treatment-related resistance
Time frame: 3 years
Total cost of the intervention over the study period and in the long term
To assess the cost and cost-effectiveness of PrEP
Time frame: 3 years
Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term
To assess the cost and cost-effectiveness of PrEP
Time frame: 3 years
Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries
To assess the cost and cost-effectiveness of PrEP
Time frame: 3 years
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