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Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain

Recruitingn/aAges 16 Years - anyAllHospital Universitario de Valme
NCT06860945 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Methods: 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/vaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes/No). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereu

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. The 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://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows: * People without HIV infection at the time of cohort inclusion * Age ≥ 16 yr who meet the following criteria: * 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 * Sex worker women who report non-habitual use of condoms. * Cisgender males/females, who report condomless and present at least two of the same criteria as MSM and transgender. * PWID with unsafe injection practices Exclusion Criteria: none \-
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What it tests

  • No Intervention: Observational Cohort
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Where

26 sites
Hospital Universitario de Torrecárdenas
Almería, Spain
Hospital Universitario Puerto Real
Cadiz, Spain
Hospital Universitario Santa Lucía
Cartagena, Spain
hospital Universitario reina Sofía
Córdoba, Spain
Hospital Virgen de la Luz
Cuenca, Spain
Hospital Universitario de Elche
Elche, Spain
Hospital Clínico Universitario San Cecilio
Granada, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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