Phase:Open Label
Principal Investigator(s):Beatriz Grinsztejn
Objective:A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and transgender women . The demonstration project aims to include 400 participants over 12 months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.     **Preliminary results presented in July 2015 show high uptake of PrEP, with higher uptake among those at increased risk and with an existing awareness of PrEP.**
Prevention Option(s):PrEP
Study Design:Open label
Arms and Assigned Interventions
DescriptionFixed dose combination of emtricitabine (FTC) / tenofovir (TDF) (200/300 mg) once daily orally
Mode of DeliveryTablet
Official Code: NCT01989611
Trial Sponsors: Centro de Referência e Treinamento DST AIDS, Oswaldo Cruz Foundation, University of Sao Paulo
Start Date
End Date
October 1, 2014
January 31, 2016
Age range: 18 Years ↔ any
Population:Gay and Bisexual Men Who Have Sex with Men