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Feasibility and impact of online HIV/STI screening addressed to men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) in Spain (TESTATE PrEP): a study protocol for a non-blinded randomised controlled trial.
Agustí, Cristina; Martínez Riveros, Héctor; García-Pérez, Jorge; Descalzo, Vicente; Fernandez, Gema; Ramírez-Marinero, Aida; Gonzalez, Maria Victoria; Díaz, Yesika; Montoro-Fernandez, Marcos; Romano-deGea, Pol; Araujo, Silvia G; Muntada, Esteve; Casabona, Jordi.
Afiliação
  • Agustí C; Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain cagusti@iconcologia.net.
  • Martínez Riveros H; Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.
  • García-Pérez J; Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain.
  • Descalzo V; Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain.
  • Fernandez G; Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain.
  • Ramírez-Marinero A; PhD in Methodology of Biomedical Research and Public Health, Department of Paediatrics, Obstetrics and Gynecology and Preventive Medicine, Univ Autonoma de Barcelona, Badalona, Spain.
  • Gonzalez MV; Vall d'Hebron-Drassanes STI and HIV Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
  • Díaz Y; Vall d'Hebron-Drassanes STI and HIV Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
  • Montoro-Fernandez M; Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital. Department of Genetics and Microbiology, Univ Autonoma de Barcelona, Badalona, Spain.
  • Romano-deGea P; Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital. Department of Genetics and Microbiology, Univ Autonoma de Barcelona, Badalona, Spain.
  • Araujo SG; Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain.
  • Muntada E; Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.
  • Casabona J; Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital. Department of Genetics and Microbiology, Univ Autonoma de Barcelona, Badalona, Spain.
BMJ Open ; 13(10): e073459, 2023 10 16.
Article em En | MEDLINE | ID: mdl-37844988
INTRODUCTION: The objectives of the study are: to design and implement a pilot intervention to offer self-sampling kits to detect HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP) among gay, bisexual and other men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) as part of PrEP follow-up. To evaluate if the pilot intervention causes a reduction of the retention to PrEP follow-up among the target population. To analyse the capacity of the intervention to reduce the healthcare burden on the PrEP service. To evaluate the acceptability of the intervention among PrEP users and PrEP service healthcare workers and; to validate dried blood samples for treponemal and non-treponemal antibody detection using the Dual Path Platform syphilis screening and confirmatory assay compared with blood drawn by venous puncture. METHODS AND ANALYSIS: We will perform a non-blinded randomised controlled non-inferiority trial among PrEP users on follow-up. Participants on the control arm will follow the usual follow-up protocol with quarterly face-to-face visits where they will be tested for HIV and sexually transmitted infections (STIs). Participants in the experimental arm will alternate face-to-face meetings with online screening of HIV and STIs. The website https://testate.org/ will include a module for online follow-up visits of participants. Participants of the experimental arm will order self-sampling kits for HIV, CT, NG and TP through the website, will send the samples to the laboratory and check their results online. We will compare the retention to follow up and the healthcare burden in both arms. The acceptability of the intervention among participants and healthcare workers will be assessed. ETHICS AND DISSEMINATION: The project has been approved by the CEIC-HUGTIP (Reference: PI-22-051). Subjects will be included after giving their informed consent. Final conclusions and recommendations will be shared with stakeholders. Two publications in peer-reviewed journals are expected. TRIAL REGISTRATION NUMBER: NCT05752643.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Sexualmente Transmissíveis / Infecções por HIV / Pessoas Transgênero / Profilaxia Pré-Exposição / Minorias Sexuais e de Gênero Limite: Female / Humans / Male País/Região como assunto: Europa Idioma: En Revista: BMJ Open Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Sexualmente Transmissíveis / Infecções por HIV / Pessoas Transgênero / Profilaxia Pré-Exposição / Minorias Sexuais e de Gênero Limite: Female / Humans / Male País/Região como assunto: Europa Idioma: En Revista: BMJ Open Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Espanha