HIV, Prevention Clinical Trial
Official title:
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women
Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining
the informed consent and confirmation of eligibility within 45 days after the screening
visit.
Once included, participants will be examined in a follow-up visit performed four weeks later
and evaluated for evidence of seroconversion to HIV, medication compliance and clinical
toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively
(quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on
medication compliance and risk reduction.
The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the
PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring
of renal function and dispensing of the drug Truvada [emtricitabine 1 tablet (FTC) /
tenofovir (TDF) (200/300 mg) once a day orally for 12 months].
Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will
be encouraged to return for a follow-up visit after discontinuation of medication for
monitoring of the status and evaluation of HIV as the resolution of side effects.
n/a