Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.

Inclusion Criteria

• •Male at birth age ≥ 18 years old
• •Reporting having sex with men
• •Negative 4th generation HIV-1 and HIV-2 test
• •Reporting condomless anal sex with 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 sex with 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.
• •Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months
• •In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France)
• •Symptoms and/or clinical signs consistent with an acute HIV infection
• •Women and trans women
• •Taking feminizing hormone therapy
• •Positive HIV test result at screening or enrollment even if HIV infection is not confirmed
• •Positive hepatitis B surface antigen test
• •ALT or AST \> 4 ULN
• •Estimated glomerular filtration rate \< 60mL/min/1.73m²
• •History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma
• •Hypersensitivity to the study products F/TDF or F/TAF
• •Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials
• •Use of intravenous drugs within the last 12 months
• •Person under legal guardianship
• •Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement.
• •Ongoing Post-Exposure Prophylaxis (PEP) for HIV