title: Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.
abstract: BACKGROUND
  Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods.
  
  
  METHODS
  A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV.
  
  
  BACKGROUND
  This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals and meetings.
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Alexandre
authors: A
authors: Grangeiro
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Márcia Thereza
authors: MT
authors: Couto
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Maria Fernanda
authors: MF
authors: Peres
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Olinda
authors: O
authors: Luiz
authors: Programa de Pós-Graduação em Saúde Coletiva, Universidade Católica de Santos, São Paulo, Brazil.
authors: Eliana Miura
authors: EM
authors: Zucchi
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Euclides Ayres
authors: EA
authors: de Castilho
authors: Centro de Referência e Treinamento em DST/Aids, Secretaria de Estado da Saúde de São Paulo, São Paulo, Brazil.
authors: Denize Lotufo
authors: DL
authors: Estevam
authors: Centro de Referência e Treinamento em DST/Aids, Secretaria de Estado da Saúde de São Paulo, São Paulo, Brazil.
authors: Rosa
authors: R
authors: Alencar
authors: Centro de Referência e Treinamento em DST/Aids, Secretaria de Estado da Saúde de São Paulo, São Paulo, Brazil.
authors: Karina
authors: K
authors: Wolffenbüttel
authors: Instituto de Saúde, Secretaria de Estado da Saúde de São Paulo, São Paulo, Brazil.
authors: Maria Mercedes
authors: MM
authors: Escuder
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil Departamento de Saúde Coletiva, Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, Brazil.
authors: Gabriela
authors: G
authors: Calazans
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil Escola FIOCRUZ de Governo, Diretoria Regional de Brasília, Fundação Oswaldo Cruz, Brasília, Brazil.
authors: Dulce
authors: D
authors: Ferraz
authors: Hospital São José, Secretaria de Estado da Saúde do Ceará, Fortaleza, Ceará, Brazil.
authors: Érico
authors: É
authors: Arruda
authors: Serviço de Atendimento Especializado de Doenças Sexualmente Transmissíveis e Aids da Vila dos Comerciários, Secretaria Municipal de Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Maria da Gloria
authors: Mda G
authors: Corrêa
authors: Centro de Referência em Especialidades Central, Secretaria Municipal de Saúde de Ribeirão Preto, São Paulo, Ribeirão Preto, Brazil.
authors: Fabiana Rezende
authors: FR
authors: Amaral
authors: Centro de Orientação e Aconselhamento, Secretaria Municipal de Saúde de Curitiba, Curitiba, Paraná, Brazil.
authors: Juliane Cardoso Villela
authors: JC
authors: Santos
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Vivian Salles
authors: VS
authors: Alvarez
authors: Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors: Tiago
authors: T
authors: Kietzmann
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control; D000293:Adolescent; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001938:Brazil; D005500:Follow-Up Studies; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D056990:Post-Exposure Prophylaxis; D065129:Pre-Exposure Prophylaxis; D012725:Sexual Behavior
chemical_list: D019380:Anti-HIV Agents
keywords: Brazil; HIV; Post-Exposure Prophylaxis; Pre-Exposure Prophylaxis; combination HIV prevention; prevention and control