{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T01:31:58Z","timestamp":1775698318455,"version":"3.50.1"},"reference-count":24,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T00:00:00Z","timestamp":1697328000000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Ministry of Health of the Government of Catalonia"},{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI21\/01589"],"award-info":[{"award-number":["PI21\/01589"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,9,27]]},"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      The objectives of the study are: to design and implement a pilot intervention to offer self-sampling kits to detect HIV,\n                      <jats:italic>Chlamydia trachomatis<\/jats:italic>\n                      (CT),\n                      <jats:italic>Neisseria gonorrhoeae<\/jats:italic>\n                      (NG) and\n                      <jats:italic>Treponema pallidum<\/jats:italic>\n                      (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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/testate.org\/\">https:\/\/testate.org\/<\/jats:ext-link>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05752643\">NCT05752643<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-073459","type":"journal-article","created":{"date-parts":[[2023,10,16]],"date-time":"2023-10-16T13:10:26Z","timestamp":1697461826000},"page":"e073459","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["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"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05752643","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05752643","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5259-2242","authenticated-orcid":false,"given":"Cristina","family":"Agust\u00ed","sequence":"first","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain"},{"name":"Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3372-6134","authenticated-orcid":false,"given":"H\u00e9ctor","family":"Mart\u00ednez Riveros","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain"},{"name":"PhD in Methodology of Biomedical Research and Public Health, Department of Paediatrics, Obstetrics and Gynecology and Preventive Medicine, Univ Autonoma de Barcelona, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Garc\u00eda-P\u00e9rez","sequence":"additional","affiliation":[{"name":"Vall d'Hebron-Drassanes STI and HIV Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicente","family":"Descalzo","sequence":"additional","affiliation":[{"name":"Vall d'Hebron-Drassanes STI and HIV Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gema","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital. Department of Genetics and Microbiology, Univ Autonoma de Barcelona, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aida","family":"Ram\u00edrez-Marinero","sequence":"additional","affiliation":[{"name":"Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital. Department of Genetics and Microbiology, Univ Autonoma de Barcelona, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Victoria","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain"},{"name":"Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital. Department of Genetics and Microbiology, Univ Autonoma de Barcelona, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yesika","family":"D\u00edaz","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcos","family":"Montoro-Fernandez","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pol","family":"Romano-deGea","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvia G","family":"Araujo","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esteve","family":"Muntada","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordi","family":"Casabona","sequence":"additional","affiliation":[{"name":"Centre of Epidemiological Studies on Sexually Transmitted Infections and AIDS of Catalonia (CEEISCAT), The Ministry of Health, Government of Catalonia, Badalona, Spain"},{"name":"Spanish Consortium for Research on Epidemiology and Public Health (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain"},{"name":"Germans Trias i Pujol Research Institute (IGTP), Campus Can Ruti, Badalona, Spain"},{"name":"Department of Paediatrics, Obstetrics and Gynecology and Preventive Medicine, Univ Autonoma de Barcelona, Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,10,16]]},"reference":[{"key":"2025121407550423000_13.10.e073459.1","unstructured":"Centro Nacional de Epidemiolog\u00eda . Vigilancia Epidemiol\u00f3gica del VIH Y SIDA en Espa\u00f1a 2021 Sist INF Sobre Nuevos Diagn\u00f3sticos VIH Regist Nac Casos SIDA plan Nac Sobre El SIDA. 2022. Available: https:\/\/www.isciii.es\/QueHacemos\/Servicios\/VigilanciaSaludPublicaRENAVE\/EnfermedadesTransmisibles\/Documents\/VIH\/informesdevigilanciaVIHysidaanteriores\/InformeVIH_SIDA_2022_CCAA.pdfOV2017.pdf"},{"key":"2025121407550423000_13.10.e073459.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00056-2"},{"key":"2025121407550423000_13.10.e073459.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1011205"},{"key":"2025121407550423000_13.10.e073459.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1108524"},{"key":"2025121407550423000_13.10.e073459.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1110711"},{"key":"2025121407550423000_13.10.e073459.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)61127-7"},{"key":"2025121407550423000_13.10.e073459.7","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/S1473-3099(17)30540-6","article-title":"Cost-effectiveness of pre-exposure prophylaxis for HIV prevention in men who have sex with men in the UK: a Modelling study and health economic evaluation","volume":"18","author":"Cambiano","year":"2018","journal-title":"Lancet Infect Dis"},{"key":"2025121407550423000_13.10.e073459.8","unstructured":"PLAN NACIONAL SOBRE SIDA GRUPO DE EXPERTOS PrEP P EL . Documento de Consenso - Profilaxis Preexposici\u00f3n al VIH en Espa\u00f1a. 2018."},{"key":"2025121407550423000_13.10.e073459.9","unstructured":"Joint United Nations Programme on HIV\/AIDS . 90-90-90 An ambitious treatment target to help end the AIDS epidemic. Geneva, 2014."},{"key":"2025121407550423000_13.10.e073459.10","unstructured":"Grupo de Trabajo de PrEP . Plan Nacional Sobre El Sida. In: Ministerio de Sanidad. Manual de implementaci\u00f3n de un Programa de Profilaxis Preexposici\u00f3n al VIH en Espa\u00f1a. Madrid, 2020."},{"key":"2025121407550423000_13.10.e073459.11","doi-asserted-by":"crossref","DOI":"10.2807\/1560-7917.ES.2020.25.47.2001943","article-title":"Impact of the COVID-19 pandemic on testing services for HIV, viral hepatitis and sexually transmitted infections in the WHO European region","volume":"25","author":"Sim\u00f5es","year":"2020","journal-title":"Euro Surveill"},{"key":"2025121407550423000_13.10.e073459.12","unstructured":"European Centre for Disease Prevention and Control . Continuum of HIV care. Monitoring implementation of the Dublin Declaration on partnership to fight HIV\/AIDS in Europe and Central Asia: 2018 progress report. Stockholm, 2019."},{"key":"2025121407550423000_13.10.e073459.13","doi-asserted-by":"crossref","DOI":"10.1186\/s12889-016-3408-z","article-title":"A systematic review of randomised control trials of sexual health interventions delivered by mobile Technologies","volume":"16","author":"Burns","year":"2016","journal-title":"BMC Public Health"},{"key":"2025121407550423000_13.10.e073459.14","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-052841"},{"key":"2025121407550423000_13.10.e073459.15","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1097\/OLQ.0000000000000221","article-title":"Could home STI specimen collection with E-prescription be a cost-effective strategy for clinical trials and clinical care","volume":"42","author":"Blake","year":"2015","journal-title":"Sex Transm Dis"},{"key":"2025121407550423000_13.10.e073459.16","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002479","article-title":"Internet-accessed sexually transmitted infection (E-STI) testing and results service: A randomised, single-blind, controlled trial","volume":"14","author":"Wilson","year":"2017","journal-title":"PLoS Med"},{"key":"2025121407550423000_13.10.e073459.17","doi-asserted-by":"crossref","DOI":"10.2196\/jmir.4384","article-title":"Swab2Know: an HIV-testing strategy using oral fluid samples and online communication of test results for men who have sex with men in Belgium","volume":"17","author":"Platteau","year":"2015","journal-title":"J Med Internet Res"},{"key":"2025121407550423000_13.10.e073459.18","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2015-052090"},{"key":"2025121407550423000_13.10.e073459.19","doi-asserted-by":"crossref","DOI":"10.1186\/s12889-022-12705-z","article-title":"Outcomes of a community-led online-based HIV self-testing demonstration among Cisgender men who have sex with men and Transgender women in the Philippines during the COVID-19 pandemic: a retrospective cohort study","volume":"22","author":"Eustaquio","year":"2022","journal-title":"BMC Public Health"},{"key":"2025121407550423000_13.10.e073459.20","doi-asserted-by":"crossref","DOI":"10.1002\/jia2.25118","article-title":"What would you choose: online or Offline or mixed services? feasibility of online HIV counselling and testing among Thai men who have sex with men and Transgender women and factors associated with service uptake","volume":"21","author":"Phanuphak","year":"2018","journal-title":"J Int AIDS Soc"},{"key":"2025121407550423000_13.10.e073459.21","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1097\/QAI.0000000000002919","article-title":"A peer-led online community to increase HIV self-testing among African American and Latinx MSM: A randomized controlled trial","volume":"90","author":"Young","year":"2022","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2025121407550423000_13.10.e073459.22","unstructured":"Agusti C , Munoz R , Gonzalez V , et al . n.d. High acceptability and effectiveness of an online self-sampling intervention for HIV in gay, Bisexual and other men who have sex with men and Trans women in Spain. Available: http:\/\/programme.aids2020.org\/Abstract\/Abstract\/1565"},{"key":"2025121407550423000_13.10.e073459.23","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200203080-00012"},{"key":"2025121407550423000_13.10.e073459.24","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0246129","article-title":"Implementation of pre-exposure prophylaxis programme in Spain. feasibility of four different delivery models","volume":"16","author":"Iniesta","year":"2021","journal-title":"PLoS One"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-073459","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T15:55:28Z","timestamp":1765727728000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-073459"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10]]},"references-count":24,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2023,10,16]]},"published-print":{"date-parts":[[2023,10]]}},"alternative-id":["10.1136\/bmjopen-2023-073459"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-073459","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10]]}}}