Same-day initiation of oral pre-exposure prophylaxis among gay, bisexual, and other cisgender men who have sex with men and transgender women in Brazil, Mexico, and Peru (ImPrEP): a prospective, single-arm, open-label, multicentre implementation study

作者：Valdiléa G. Veloso, Carlos Cáceres, Brenda Hoagland, Ronaldo I. Moreira, Hamid Vega-Ramírez, Kelika A. Konda, Iuri Costa Leite, Sergio Bautista‐Arredondo, Marcus Lacerda, José Valdez Madruga, Alessandro Farias, Josué N Lima, Ronaldo Zonta, Lilian M. Lauria, Cesar Vidal Osco Tamayo, Hector Javier Salvatierra Flores, Yovanna Margot Cabrera Santa Cruz, Ricardo Martín Moreno Aguayo, Marcelo Cunha, Júlio Moreira, Alessandra Ramos Makkeda, Steven Díaz, Juan V. Guanira, Heleen Vermandere, Marcos Benedetti, Heather Ingold, Cristina Pimenta, Thiago S. Torres, Beatriz Grinsztejn, J. David Urbaez-Brito, Polyana Monteiro d’Albuquerque, Claudio Palombo, Paulo Ricardo de Alencastro, Raquel Keiko de Luca Ito, João L. Benedetti, Fabio V. Maria, Paula M. Luz, Lucilene Freitas, Kim Mattos Geraldo, Mônica Derrico, Sandro Nazer, Tania Kristic, Renato Girade, Renato Lima, Antônio R. Carvalho, Carla Rocha, Pedro Nuno Leite, Marcio Lessa, Marília Santini-Oliveira, Daniel R. B. Bezerra, Cleo de Oliveira Souza, Jacinto Corrêa, Marcelo Ribeiro‐Alves, Carolina Fischinger Moura de Souza, Camilla Portugal, Mônica dos Santos Valões, Gabriel Lima Mota, Joyce Alves Gomes, C Falcão, Fernanda Falcão Riberson, Luciano Melo, Talita Andrade Oliveira, Agnaldo Moreira Oliveira Júnior, Bruna de Paula Fonseca e Fonseca, Leonor Henriette de Lannoy, Ludymilla Anderson Santiago Carlos, João Paulo Cunha, Sonia Maria de Alencastro Coracini, Thiago Oliveira Rodrigues, Emília Regina Scharf Mettrau, Kelly Vieira Meira, Heder Tavares, Ana Paula Nunes Viveiros Valeiras, Taiane Miyake Alves de Carvalho Rocha, Alex Amorim, Patrícia Sabadini, Luiz Gustavo Córdoba, Caio Gusmão, Erika Faustino, Júlia Hansen, Agatha Mirian Cunha, Neuza Uchiyama Nishimura, Jaime Eduardo Flygare Razo Prereira Santos, Aline Barnabé Cano, W Dias, Magô Tonhon, Tania Regina Rezende, Alex Rodrigues Gomes, Eloá dos Santos Rodrigues, Maria das Dores Aires Carneiro, Alexandre Castilho, Mariana Carvalho, Dulce Díaz-Sosa, Centli Guillén-Díaz-Barriga, Lorena Hernández, Rebeca Robles, María Elena Medina‐Mora, Marcela González, Ivonne Huerta Icelo, Araczy Martinez Davalos, José Gomez Castro, Luis Obed Ocampo Valdez, Fernanda Ramírez Barajas, Verónica Ruiz González, Galileo Vargas Guadarrama, Israel Macías, J. Sánchez, Juan Pablo Osuna Noriega, H. Rodrigo Moheno M, Jorge M. Bernal Ramírez, Víctor Dante Galicia Juarez, Gerardo Iván Martínez Vizcaíno, Francisco Javier Arjona, G Calvo, Silver K. Vargas, Oliver Antonio Elorreaga Reyes, Ximena Gutierrez, Fernando Olivos, Damaris Caviedes, Daniella Adriazola, Eduardo Juárez, Gabriela Mariño, Jazmin Qquellon, Francesca Vasquez, Jean Pierre Jiron, Sonia C. Flores, Karen Campos · 发表于：The Lancet HIV · 年份：2022 · DOI：10.1016/s2352-3018(22)00331-9 · 被引用次数：83 · 研究领域：HIV/AIDS Research and Interventions、HIV/AIDS drug development and treatment、HIV-related health complications and treatments

BACKGROUND: Although gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender women have the highest HIV burden in Latin America, pre-exposure prophylaxis (PrEP) implementation is poor. We aimed to assess the feasibility of same-day oral PrEP delivery in Brazil, Mexico, and Peru. METHODS: Implementation PrEP (ImPrEP) was a prospective, single-arm, open-label, multicentre PrEP implementation study conducted in Brazil (14 sites), Mexico (four sites), and Peru (ten sites). MSM and transgender women were eligible to participate if they were aged 18 years or older, HIV-negative, and reported one or more prespecified criteria. Enrolled participants received same-day initiation of daily oral PrEP (tenofovir disoproxil fumarate [300 mg] coformulated with emtricitabine [200 mg]). Follow-up visits were scheduled at week 4 and quarterly thereafter. We used logistic regression models to identify factors associated with early loss to follow-up (not returning after enrolment), PrEP adherence (medication possession ratio ≥0·6), and long-term PrEP engagement (attending three or more visits within 52 weeks). This study is registered at the Brazilian Registry of Clinical Trials, U1111-1217-6021. FINDINGS: From Feb 6, 2018, to June 30, 2021, 9979 participants were screened and 9509 were enrolled (Brazil n=3928, Mexico n=3288, and Peru n=2293). 543 (5·7%) participants were transgender women, 8966 (94·3%) were cisgender men, and 2481 (26·1%) were aged 18-24 years. There ...