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High pre‐exposure prophylaxis uptake and early adherence among men who have sex with men and transgender women at risk for HIV Infection: the PrEP Brasil demonstration project
Authors:Brenda Hoagland  Ronaldo I. Moreira  Raquel B. De Boni  Esper G. Kallas  José Valdez Madruga  Ricardo Vasconcelos  Silvia Goulart  Thiago S. Torres  Luana M. S. Marins  Peter L. Anderson  Paula M Luz  Iuri da Costa Leite  Albert Y. Liu  Valdilea G. Veloso  Beatriz Grinsztejn  for the PrEP Brasil Study Team
Affiliation:1. FIOCRUZ, Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil;2. School of Medicine, Universidade de São Paulo, Brazil;3. School of Medicine, Universidade de São Paulo, São Paulo, Brazil;4. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, USA;5. San Francisco Department of Public Health, Bridge HIV, San Francisco, CA, USA;6. Contributed equally as last authors;7. Clinical Trial Number 01989611;8. Clinical Trial Number 01989611Corresponding author: Beatriz Grinsztejn, INI/FIOCRUZ, Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040‐360, Brazil. Tel: 55‐21‐3865‐9128. Email:
Abstract:Introduction : The efficacy of pre‐exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established. Little is known about the feasibility of PrEP implementation in middle‐income settings with concentrated epidemics among men who have sex with men (MSM) and transgender women (TGW). Methods : PrEP Brasil is a prospective, multicentre, open‐label demonstration project assessing PrEP delivery in the context of the Brazilian Public Health System. HIV‐uninfected MSM and TGW in 3 referral centres in Rio de Janeiro and São Paulo were evaluated for eligibility and offered 48 weeks of daily emtricitabine/tenofovir for PrEP. Concentrations of tenofovir diphosphate in dried blood spot samples (DBS) at week 4 after enrolment (early adherence) were measured. Predictors of drug levels were assessed using ordinal logistic regression models considering the DBS drug level as a 3 level variable (<350 fmol/punch, ≥350–699 fmol/punch and ≥700 fmol/punch). Results : 1,270 individuals were assessed for participation; n = 738 were potentially eligible and n = 450 were offered PrEP (PrEP uptake was 60.9%). Eligible but not enrolled individuals were younger, had lower HIV risk perception and had lower PrEP awareness. At week 4, 424 participants (of the 450 enrolled) had DBS TFV‐DP concentrations, 94.1% in the protective range (≥350 fmol/punch, consistent with ≥2 pills per week), and 78% were in the highly protective range (≥700 fmol/punch, ≥4 pills per week). Participants with ≥12 years of schooling had 1.9 times the odds (95%CI 1.10–3.29) of a higher versus lower drug level than participants with <12 years of schooling. Condomless receptive anal intercourse in the prior 3 months was also associated with higher drug levels (adjusted OR = 1.78; 95% CI 1.08–2.94). Conclusions : The high uptake and early adherence indicate that PrEP for high‐risk MSM and TGW can be successfully delivered in the context of the Brazilian Public Health System. Interventions to address disparities on PrEP awareness and HIV risk perception among the younger and less educated are urgently needed in order to maximize the impact of this prevention strategy on the reduction of HIV infection among MSM and TGW in Brazil.
Keywords:Pre‐exposure prophylaxis  HIV prevention  MSM  transgender women  PrEP uptake  PrEP adherence  DRUG Levels
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