A randomized controlled trial to evaluate the efficacy, acceptability and safety of event-driven pre-exposure prophylaxis for HIV using TAF/FTC in men who have sex with men in Thailand and France

INTERVENTION: Product Name: Truvada 200 mg/245 mg film‐coated tablets,Product Code: PRD293463,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Emtricitabine 200mg, Tenofovir Disoproxil Fumarate 300mg,Product Name: Descovy 200 mg/25 mg film‐coated tablets,Product Code: PRD4052394,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Emtricitabine 200mg, Tenofovir Alafenamide 25mg CONDITION: HIV prevention Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective:To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate. Primary end point(s):Confirmed HIV infection at any time during follow‐up, defined as a positive HIV antibody immunoassay (4th generation) and the presence of HIV ribonucleic acid (RNA) in this sample and another sample drawn separately. Secondary Objective:?To assess the efficacy of the internal active control, event‐driven F/TDF, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.,?To compare the acceptability of the event‐driven F/TAF strategy with the event‐driven F/TDF strategy.,?To assess the safety of event‐driven F/TAF relative to event‐driven F/TDF, in particular renal safety.,?To evaluate the efficacy of event‐driven F/TAF relative to event‐driven F/TDF in averting HIV infections compared to the background HIV incidence rate SECONDARY OUTCOME: Secondary end point(s):confirmed HIV infection as defined above, acceptability of the regimen at 12 months, occurrence of Grade 3 or 4 adverse events, occurrence of serious adverse events, change from baseline in estimated glomerular filtration rate (eGFR) and change from baseline in weight, Ratio of the number of HIV infections averted by event‐driven F/TAF to that averted by event‐driven F/TDF relative to the background HIV incidence rate. INCLUSION CRITERIA: Male at birth age = 18 years old,Reporting having se Xwith men,Negative 4th generation HIV‐1 and HIV‐2 test,Reporting condomless anal se Xwith men not more often than two days during the previous month and able to plan their sexual activity,Risk of HIV acquisition based on self‐report of at least one of the following behaviors during the 6 months before enrollment: condomless anal se Xwith at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and/or rectal gonorrhea and/or syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non‐injectable recreational drugs (crack, cocaine, amphetamine and its derivates, methamphetamine, MDMA, c‐hydroxybutyric acid or c‐butyrolactone),Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months