[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582256":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":23,"locations":29,"responsibleParty":395,"collaborators":398,"id":402,"slug":403,"hasResults":404,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":9,"eligibilityCriteria":407,"healthyVolunteers":408,"sex":409,"minAge":410,"maxAge":10,"enrollmentInfo":411,"targetDuration":414,"studyType":415,"phases":10,"briefSummary":416,"conditions":417,"keywords":421,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},{"fullName":5,"class":6},"Hospital Universitario de Valme","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"STI_PrEPare",null,"All individuals with documented initiation of daily oral PrEP, who have collected the medication at least once and have taken at least one pill, will be included in the study.\n\nThe approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Disponible en http:\u002F\u002F.gesida-seimc.org\u002Fcategory\u002Fguias-clinicas\u002Fotras-guias-vigentes\u002F), are as follows:\n\n* People without HIV infection at the time of cohort inclusion\n* Age ≥ 16 yr who meet the following criteria:\n\n  * MSM and transgender women with at least two of the following criteria during the last year: \\> 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI\n  * Sex worker women who report non-habitual use of condoms.\n  * Cisgender males\u002Ffemales, who report condomless and present at least two of the same criteria as MSM and transgender.",[13],"Other: No Intervention: Observational Cohort",[15],{"type":6,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"No Intervention: Observational Cohort",[9],[19],{"name":20,"affiliation":21,"role":22},"Anaïs Corma-Gómez, MD, PhD","Hospital Clínico Universitario de Valencia","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Anaïs 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Nieves",{"type":37,"coordinates":141},[128,129],{"lat":129,"lon":128},[144,147],{"name":10,"role":26,"phone":145,"phoneExt":10,"email":146},"+34627010441","chidalgo72@gmail.com",{"name":148,"role":22,"phone":10,"phoneExt":10,"email":10},"Carmen Hidalgo",{"facility":150,"status":32,"city":151,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hospital Universitario Juan Ramón Jiménez","Huelva",{"type":37,"coordinates":153},[154,155],-6.94004,37.26638,{"lat":155,"lon":154},[158,162],{"name":159,"role":26,"phone":160,"phoneExt":10,"email":161},"Miguel Raffo, MD","+34670018065","xhalveyxx@hotmail.com",{"name":163,"role":22,"phone":10,"phoneExt":10,"email":10},"Miguel Raffo",{"facility":165,"status":32,"city":166,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Complejo Hospitalario de 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Universitario de Bellvitge","L'Hospitalet de Llobregat",{"type":37,"coordinates":198},[199,200],2.10028,41.35967,{"lat":200,"lon":199},[203,207],{"name":204,"role":26,"phone":205,"phoneExt":10,"email":206},"Jaime Vega, MD","+3493 260 75 00","jvega@bellvitgehospital.cat",{"name":208,"role":22,"phone":10,"phoneExt":10,"email":10},"Jaime Vega",{"facility":210,"status":32,"city":211,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Hospital Universitario Dr. Negrín","Las Palmas de Gran Canaria",{"type":37,"coordinates":213},[214,215],-15.41573,28.10178,{"lat":215,"lon":214},[218,222],{"name":219,"role":26,"phone":220,"phoneExt":10,"email":221},"Karim Mohammed, MD","+34928 45 00 00","karimmohamedramirez@gmail.com",{"name":223,"role":22,"phone":10,"phoneExt":10,"email":10},"Karim Mohammed",{"facility":225,"status":32,"city":226,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Centro Sanitario Sandoval","Madrid",{"type":37,"coordinates":228},[229,230],-3.70256,40.4165,{"lat":230,"lon":229},[233,237],{"name":234,"role":26,"phone":235,"phoneExt":10,"email":236},"Eva Orviz, MD","+34699205999","evaorviz@gmail.com",{"name":238,"role":22,"phone":10,"phoneExt":10,"email":10},"Eva Orviz",{"facility":240,"status":32,"city":226,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":241,"geoPoint":243,"contacts":244},"Hospital Fundación Jiménez Díaz",{"type":37,"coordinates":242},[229,230],{"lat":230,"lon":229},[245,249],{"name":246,"role":26,"phone":247,"phoneExt":10,"email":248},"Alfonso Cabello","+346511539707","ACabello@fjd.es",{"name":246,"role":22,"phone":10,"phoneExt":10,"email":10},{"facility":251,"status":32,"city":226,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":252,"geoPoint":254,"contacts":255},"Hospital Universitario Infanta Leonor",{"type":37,"coordinates":253},[229,230],{"lat":230,"lon":229},[256,260],{"name":257,"role":26,"phone":258,"phoneExt":10,"email":259},"Jorge Valencia, MD, PhD","+34661671082","jorge_vlr@yahoo.es",{"name":261,"role":22,"phone":10,"phoneExt":10,"email":10},"Jorge Valencia",{"facility":263,"status":32,"city":226,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":264,"geoPoint":266,"contacts":267},"Hospital Universitario La Princesa",{"type":37,"coordinates":265},[229,230],{"lat":230,"lon":229},[268,272],{"name":269,"role":26,"phone":270,"phoneExt":10,"email":271},"Lucio García-Fraile, MD","+34656943726","lucio.garciafraile@gmail.com",{"name":269,"role":22,"phone":10,"phoneExt":10,"email":10},{"facility":274,"status":32,"city":275,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Hospital Regional Universitario de 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Arrixaca","Murcia",{"type":37,"coordinates":304},[305,306],-1.13004,37.98704,{"lat":306,"lon":305},[309,313],{"name":310,"role":26,"phone":311,"phoneExt":10,"email":312},"Antonia Castillo, MD","+34650010933","amcastillonavarro@gmail.com",{"name":314,"role":22,"phone":10,"phoneExt":10,"email":10},"Antonia Castillo",{"facility":316,"status":32,"city":317,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Hospital Universitario Marqués de Valdecilla","Santander",{"type":37,"coordinates":319},[320,321],-3.80493,43.46589,{"lat":321,"lon":320},[324,328],{"name":325,"role":26,"phone":326,"phoneExt":10,"email":327},"Francisco Arnaiz","+34942 20 25 20","francisco.arnaizlasrevillas@scsalud.es",{"name":325,"role":22,"phone":10,"phoneExt":10,"email":10},{"facility":330,"status":32,"city":331,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Hospital Universitario Virgen de la Macarena","Seville",{"type":37,"coordinates":333},[334,335],-5.97317,37.38283,{"lat":335,"lon":334},[338,342],{"name":339,"role":26,"phone":340,"phoneExt":10,"email":341},"Jesús Sojo","+34600375968","jesodo@hotmail.com",{"name":343,"role":22,"phone":10,"phoneExt":10,"email":10},"Jesús Sojo, MD",{"facility":345,"status":32,"city":331,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":346,"geoPoint":348,"contacts":349},"Hospital Universitario Virgen de Valme",{"type":37,"coordinates":347},[334,335],{"lat":335,"lon":334},[350,354],{"name":351,"role":26,"phone":352,"phoneExt":10,"email":353},"Juan Macías, MD, PhD","+34955015757","jmacias7@us.es",{"name":351,"role":22,"phone":10,"phoneExt":10,"email":10},{"facility":356,"status":32,"city":331,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":357,"geoPoint":359,"contacts":360},"Hospital Universitario Virgen del Rocío",{"type":37,"coordinates":358},[334,335],{"lat":335,"lon":334},[361,365],{"name":362,"role":26,"phone":363,"phoneExt":10,"email":364},"Cesar Sotomayor, MD","+34658329709","caesarsotomayor@yahoo.com",{"name":366,"role":22,"phone":10,"phoneExt":10,"email":10},"Cesar Sotomayor",{"facility":368,"status":32,"city":369,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"Hospital Universitario de Valladolid","Valladolid",{"type":37,"coordinates":371},[372,373],-4.72353,41.65541,{"lat":373,"lon":372},[376,380],{"name":377,"role":26,"phone":378,"phoneExt":10,"email":379},"Pablo Tellería","+34983 420 000","pablotelleria92@gmail.com",{"name":377,"role":22,"phone":10,"phoneExt":10,"email":10},{"facility":382,"status":32,"city":383,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"Hospital Universitario Álvaro Cunqueiro","Vigo",{"type":37,"coordinates":385},[386,387],-8.72264,42.23282,{"lat":387,"lon":386},[390,394],{"name":391,"role":26,"phone":392,"phoneExt":10,"email":393},"Luis E Morano, MD, PhD","+34654028646","luis.morano.amado@gmail.com",{"name":391,"role":22,"phone":10,"phoneExt":10,"email":10},{"type":22,"investigatorFullName":396,"investigatorTitle":397,"investigatorAffiliation":21,"oldNameTitle":10,"oldOrganization":10},"Anais Corma-Gomez","Medical Doctor, PhD",[399],{"name":400,"class":401},"Instituto de Salud Carlos III","OTHER_GOV","100582256","development-of-a-predictive-model-for-sexually-transmitted-infections-in-individuals-using-pre-exposure-prophylaxis-for-hiv-in-spain-100582256",false,"NCT06860945","Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain","Inclusion Criteria:\n\n* All individuals with documented initiation of oral PrEP (daily or event-driven regimens), who have collected the medication at least once and have taken at least one pill, will be included in the study.\n\nThe approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Available at http:\u002F\u002F.gesida-seimc.org\u002Fcategory\u002Fguias-clinicas\u002Fotras-guias-vigentes\u002F), are as follows:\n\n* People without HIV infection at the time of cohort inclusion\n* Age ≥ 16 yr who meet the following criteria:\n* MSM and transgender women with at least two of the following criteria during the last year: \\> 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI\n* Sex worker women who report non-habitual use of condoms.\n* Cisgender males\u002Ffemales, who report condomless and present at least two of the same criteria as MSM and transgender.\n* PWID with unsafe injection practices\n\nExclusion Criteria: none\n\n\\-",true,"ALL","16 Years",{"count":412,"type":413},9000,"ESTIMATED","5 Years","OBSERVATIONAL","Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.\n\nMethods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical\u002Fvaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes\u002FNo). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.",[418,419,420],"Sexually Transmitted Infections (STIs)","HIV","PrEP",[422,419,420,423,424,425,426],"STI","modelling","machine learning","adherence","persistence","2025-02-28",{"date":429,"type":430},"2025-03-06","ACTUAL",{"date":432,"type":430},"2025-01-01",{"date":434,"type":413},"2026-01-01",{"name":5,"class":6},26]