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. 2018 Jun 7;8(6):e021170.
doi: 10.1136/bmjopen-2017-021170.

POP-Brazil study protocol: a nationwide cross-sectional evaluation of the prevalence and genotype distribution of human papillomavirus (HPV) in Brazil

Eliana Marcia Wendland  1   2 , Juliana Caierão  1 , Carla Domingues  3 , Ana Goretti Kalume Maranhão  3 , Flávia Moreno Alves de Souza  4 , Luciano Serpa Hammes  1 , Maicon Falavigna  1   5 , Juliana Balbinot Hilgert  6 , Fernando Neves Hugo  6 , Marina Bessel  1 , Luisa Lina Villa  7 , Adele Schwartz Benzaken  4
Affiliations

POP-Brazil study protocol: a nationwide cross-sectional evaluation of the prevalence and genotype distribution of human papillomavirus (HPV) in Brazil

Eliana Marcia Wendland et al. BMJ Open. .

Abstract

Introduction: Human papillomavirus (HPV) is associated with the development of genital warts and different types of cancer, including virtually all cervical cancers and a considerable number of penile, anal and oropharyngeal cancers. Data regarding the prevalence of HPV infection in Brazil are limited and fragmented. We aim to determine HPV prevalence in sexually active women and men aged 16-25 years and to investigate regional differences in virus prevalence and types.

Methods and analysis: This is a nationwide, multicentric, cross-sectional, prospective study that will include participants aged 16-25 years from all Brazilian capital cities. Recruitment will occur in primary health units by trained health professionals who will be responsible for collecting biological samples and interviewing the volunteers. After signing informed consent, all participants will answer a questionnaire that will collect sociodemographic and behavioural data. All samples will be processed in a certified central laboratory, and strict quality control will be performed by many different procedures, including double data entry, training and certification of primary care health professionals responsible for data collection, simulation of interviews, and auditing and monitoring of visits. The sample size will be standardised based on the population distribution of each capital using SAS and R statistical software.

Ethics and dissemination: The project was approved by the research ethics committee of the main institution and the corresponding ethics committees of the recruitment sites. This will be the first Brazilian nationwide study to determine overall HPV prevalence and to examine regional differences and social, demographic and behavioural factors related to HPV infection. Critical analysis of the study results will contribute to epidemiological knowledge and will set a baseline for future evaluation of the impact of the National HPV Vaccination Program.

Keywords: Brazil; anogenital; hpv infection; nationwide study; prevalence.

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Conflict of interest statement

Competing interests: ASB, FMAdS, CD and AGKM work for the Ministry of Health of Brazil. LLV is a consultant for Merck for the HPV quadrivalent vaccine and for Qiagen, BD and Roche for HPV DNA tests.

Figures

Figure 1
Figure 1
Workflow of the study. (1) Data are collected in public health units from all 27 Brazilian capitals; (2) data entry into the web-based system is performed by primary care professionals and is monitored by the main research team in Porto Alegre (Hospital Moinhos de Vento); (3) paper forms are sent to Porto Alegre along with biological samples which are processed for DNA extraction Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) and (4) extracted DNA is sent to Universidade de São Paulo (USP) for HPV detection and typing. Finally, the results are included in the web-based system and are made available for the primary care professionals and participants using a code number and password. HPV, human papillomavirus.
Figure 2
Figure 2
Description of the study’s major quality-control steps during each phase of the study.
See this image and copyright information in PMC

References

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