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Study identifier: NCT06860945 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Sexually Transmitted Infections (STIs) · HIV · PrEP  ·  Sponsor: Hospital Universitario de Valme

PhaseN/A
Planned participants9000
Who can joinAll sexes, 16 Years to no upper limit
Healthy volunteersYes

About this study

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 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.

This description comes directly from the study's public registry record.

Talk to the study team

Anaïs Corma-Gómez  ·  +34676170692  ·  anais.corgo@gmail.com

Always discuss trial participation with your own doctor first.

Locations (26)

Hospital Universitario de TorrecárdenasAlmería, SpainRecruiting
Hospital Universitario Puerto RealCadiz, SpainRecruiting
Hospital Universitario Santa LucíaCartagena, SpainRecruiting
hospital Universitario reina SofíaCórdoba, SpainRecruiting
Hospital Virgen de la LuzCuenca, SpainRecruiting
Hospital Universitario de ElcheElche, SpainRecruiting
Hospital Clínico Universitario San CecilioGranada, SpainRecruiting
Hospital Universitario Virgen de las NievesGranada, SpainRecruiting
Hospital Universitario Juan Ramón JiménezHuelva, SpainRecruiting
Complejo Hospitalario de JaénJaén, SpainRecruiting
Hospital de Jerez de la FronteraJerez de la Frontera, SpainRecruiting
Hospital Universitario de BellvitgeL'Hospitalet de Llobregat, SpainRecruiting

+ 14 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06860945