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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
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 effec...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4550731/ https://www.ncbi.nlm.nih.gov/pubmed/26307622 http://dx.doi.org/10.1136/bmjopen-2015-009021 |
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author | Grangeiro, Alexandre Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura de Castilho, Euclides Ayres Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago |
author_facet | Grangeiro, Alexandre Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura de Castilho, Euclides Ayres Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago |
author_sort | Grangeiro, Alexandre |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4550731 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-45507312015-08-31 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 Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura de Castilho, Euclides Ayres Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago BMJ Open HIV/AIDS 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. BMJ Publishing Group 2015-08-25 /pmc/articles/PMC4550731/ /pubmed/26307622 http://dx.doi.org/10.1136/bmjopen-2015-009021 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | HIV/AIDS Grangeiro, Alexandre Couto, Márcia Thereza Peres, Maria Fernanda Luiz, Olinda Zucchi, Eliana Miura de Castilho, Euclides Ayres Estevam, Denize Lotufo Alencar, Rosa Wolffenbüttel, Karina Escuder, Maria Mercedes Calazans, Gabriela Ferraz, Dulce Arruda, Érico Corrêa, Maria da Gloria Amaral, Fabiana Rezende Santos, Juliane Cardoso Villela Alvarez, Vivian Salles Kietzmann, Tiago 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 |
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_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_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 |
topic | HIV/AIDS |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4550731/ https://www.ncbi.nlm.nih.gov/pubmed/26307622 http://dx.doi.org/10.1136/bmjopen-2015-009021 |
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