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
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2015 |
| Outros Autores: | , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/43567 |
Resumo: | Ministério da Saúde e Conselho Nacional de Desenvolvimento Científico e Tecnológico |
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Grangeiro, AlexandreCouto, Márcia TherezaPeres, Maria FernandaLuiz, OlindaZucchi, Eliana MiuraCastilho, Euclides Ayres deEstevam, Denize LotufoAlencar, RosaWolffenbüttel, KarinaEscuder, Maria MercedesCalazans, GabrielaFerraz, Dulce Aurélia de SouzaArruda, ÉricoCorrêa, Maria da GloriaAmaral, Fabiana RezendeSantos, Juliane Cardoso VillelaAlvarez, Vivian SallesKietzmann, Tiago2020-09-23T14:23:36Z2020-09-23T14:23:36Z2015GRANGEIRO, Alexandre et al. 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. BMJ Open, [s.l], v. 5, e009021, 2015.2044-6055https://www.arca.fiocruz.br/handle/icict/4356710.1136/bmjopen-2015-009021Ministério da Saúde e Conselho Nacional de Desenvolvimento Científico e TecnológicoUniversidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Universidade Católica de Santos. Programa de Pós-Graduação em Saúde Coletiva. Santos, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Governo do Estado de São Paulo. Secretaria de Estado da Saúde de São Paulo. Centro de Referência e Treinamento em DST/Aids. São Paulo, SP, Brasil.Governo do Estado de São Paulo. Secretaria de Estado da Saúde de São Paulo. Centro de Referência e Treinamento em DST/Aids. São Paulo, SP, Brasil.Governo do Estado de São Paulo. Secretaria de Estado da Saúde de São Paulo. Centro de Referência e Treinamento em DST/Aids. São Paulo, SP, Brasil.Governo do Estado de São Paulo. Secretaria de Estado da Saúde de São Paulo. Instituto de Saúde. São Paulo, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil / Irmandade da Santa Casa de Misericórdia de São Paulo. Faculdade de Ciências Médicas. Departamento de Saúde Coletiva. São Paulo, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil / Fundação Oswaldo Cruz. Diretoria Regional de Brasília. Escola Fiocruz de Governo. Brasília, SP, Brasil.Governo do Estado do Ceará. Secretaria de Estado da Saúde do Ceará. Hospital São José. Fortaleza, CE, Brasil.Governo Municipal de Porto Alegre. Secretaria Municipal de Saúde de Porto Alegre. Serviço de Atendimento Especializado de Doenças Sexualmente Transmissíveis e Aids da Vila dos Comerciários. Porto Alegre, RS, Brasil.Governo Municipal de Ribeiro Preto. Secretaria Municipal de Saúde de Ribeirão Preto. Centro de Referência em Especialidades Central. Ribeirão Preto, SP, Brasil.Governo Municipal de Curitiba. Secretaria Municipal de Saúde de Curitiba. Centro de Orientação e Aconselhamento. Curitiba, PR, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.Introduction 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 and analysis 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. Ethics and dissemination 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.engBMJ Publishing GroupAcquired Immunodeficiency SyndromeAnti-HIV AgentsFollow-Up StudiesHIV InfectionsPatient Acceptance of Health CarePatient Education as TopicPost-Exposure ProphylaxisPre-Exposure ProphylaxisSexual BehaviorAcquired Immunodeficiency SyndromeHIVCommunicable disease controlPre-exposure prophylaxisSíndrome de Imunodeficiência AdquiridaFármacos Anti-HIVSeguimentosInfecções por HIVAceitação pelo Paciente de Cuidados de SaúdeEducação de Pacientes como AssuntoProfilaxia Pós-ExposiçãoProfilaxia Pré-ExposiçãoComportamento SexualPre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! 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| dc.title.pt_BR.fl_str_mv |
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 |
| 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 |
| spellingShingle |
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 Grangeiro, Alexandre Acquired Immunodeficiency Syndrome Anti-HIV Agents Follow-Up Studies HIV Infections Patient Acceptance of Health Care Patient Education as Topic Post-Exposure Prophylaxis Pre-Exposure Prophylaxis Sexual Behavior Acquired Immunodeficiency Syndrome HIV Communicable disease control Pre-exposure prophylaxis Síndrome de Imunodeficiência Adquirida Fármacos Anti-HIV Seguimentos Infecções por HIV Aceitação pelo Paciente de Cuidados de Saúde Educação de Pacientes como Assunto Profilaxia Pós-Exposição Profilaxia Pré-Exposição Comportamento Sexual |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| author |
Grangeiro, Alexandre |
| author_facet |
Grangeiro, Alexandre Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura Castilho, Euclides Ayres de Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Aurélia de Souza Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago |
| author_role |
author |
| author2 |
Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura Castilho, Euclides Ayres de Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Aurélia de Souza Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago |
| author2_role |
author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Grangeiro, Alexandre Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura Castilho, Euclides Ayres de Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Aurélia de Souza Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago |
| dc.subject.mesh.pt_BR.fl_str_mv |
Acquired Immunodeficiency Syndrome Anti-HIV Agents Follow-Up Studies HIV Infections Patient Acceptance of Health Care Patient Education as Topic Post-Exposure Prophylaxis Pre-Exposure Prophylaxis Sexual Behavior |
| topic |
Acquired Immunodeficiency Syndrome Anti-HIV Agents Follow-Up Studies HIV Infections Patient Acceptance of Health Care Patient Education as Topic Post-Exposure Prophylaxis Pre-Exposure Prophylaxis Sexual Behavior Acquired Immunodeficiency Syndrome HIV Communicable disease control Pre-exposure prophylaxis Síndrome de Imunodeficiência Adquirida Fármacos Anti-HIV Seguimentos Infecções por HIV Aceitação pelo Paciente de Cuidados de Saúde Educação de Pacientes como Assunto Profilaxia Pós-Exposição Profilaxia Pré-Exposição Comportamento Sexual |
| dc.subject.en.pt_BR.fl_str_mv |
Acquired Immunodeficiency Syndrome HIV Communicable disease control Pre-exposure prophylaxis |
| dc.subject.decs.pt_BR.fl_str_mv |
Síndrome de Imunodeficiência Adquirida Fármacos Anti-HIV Seguimentos Infecções por HIV Aceitação pelo Paciente de Cuidados de Saúde Educação de Pacientes como Assunto Profilaxia Pós-Exposição Profilaxia Pré-Exposição Comportamento Sexual |
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Ministério da Saúde e Conselho Nacional de Desenvolvimento Científico e Tecnológico |
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2015 |
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2015 |
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2020-09-23T14:23:36Z |
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2020-09-23T14:23:36Z |
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GRANGEIRO, Alexandre et al. 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. BMJ Open, [s.l], v. 5, e009021, 2015. |
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https://www.arca.fiocruz.br/handle/icict/43567 |
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2044-6055 |
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10.1136/bmjopen-2015-009021 |
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GRANGEIRO, Alexandre et al. 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. BMJ Open, [s.l], v. 5, e009021, 2015. 2044-6055 10.1136/bmjopen-2015-009021 |
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BMJ Publishing Group |
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BMJ Publishing Group |
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