Implementation of PrEP to HIV in Brazilian Transgender Women

Summary

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.

Timeline

Start

2017-07-10

Primary completion

2019-07

Completion

2020-07

Publications

• Cattani VB, Jalil EM, Eksterman L, Torres T, Wagner Cardoso S, Castro CRV, Monteiro L, Wilson E, Bushman L, Anderson P, Veloso VG, Grinsztejn B, Estrela R; PrEParadas study team. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions. Clin Pharmacokinet. 2023 Jul;62(7):1031-1041. doi: 10.1007/s40262-023-01248-0. Epub 2023 Jun 1.
• Jalil EM, Torres TS, Luz PM, Monteiro L, Moreira RI, de Castro CRV, Leite IDC, Cunha M, de Cassia Elias Estrela R, Ramos M, Hoagland B, Wagner Cardoso S, Anderson P, Veloso VG, Wilson E, Grinsztejn B; PrEParadas Study Team. Low PrEP adherence despite high retention among transgender women in Brazil: the PrEParadas study. J Int AIDS Soc. 2022 Mar;25(3):e25896. doi: 10.1002/jia2.25896.

Drugs

Indications

No indication recorded.