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.
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Percentage of MSM under PrEP among eligible HIV-seronegative participants
Timeframe: 3 years
Percentage of MSM using daily and/ord on-demand PrEP
Timeframe: 3 years
Number of MSM followed after 3 years compared to the number of MSM included (retention in the program)
Timeframe: 3 years
Percentage of adherence reported by MSM
Timeframe: 3 years
Counting of TDF/FTC tablets
Timeframe: 3 years
Plasma concentrations of TDF and FTC
Timeframe: 3 years
Percentage of HIV tests performed
Timeframe: 3 years
Clinical and biological adverse events related to TDF and FTC
Timeframe: 3 years
Frequency of condomless anal intercourse
Timeframe: 3 years
Frequency of sexual intercourse associated with alcohol and/or drug use
Timeframe: 3 years
Incidence rate of STIs
Timeframe: 3 years
Incidence rate of HIV infection
Timeframe: 3 years
Percentage of TDF/FTC resistance among MSM newly infected by HIV
Timeframe: 3 years
Total cost of the intervention over the study period and in the long term
Timeframe: 3 years
Incremental cost-effectiveness ratio of the intervention (versus no intervention) over the study period and in the long term
Timeframe: 3 years
Conditions of TDF/FTC price and of effectiveness for the intervention to be cost-effective in the study countries
Timeframe: 3 years