Builds a model to predict sexually transmitted infections in people using HIV prevention pills
Studies people taking HIV pre-exposure prophylaxis in Spain to predict sexually transmitted infections.
Plain-language title generated from the registry record
Registry title: Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Key facts
- Where
- Almería, Cadiz, Cartagena, Córdoba, Cuenca, Elche, Granada, Huelva, Jaén, Jerez de la Frontera, L'Hospitalet de Llobregat, Las Palmas de Gran Canaria, Madrid, Málaga, Murcia, Santander, Seville, Valladolid, and Vigo, SpainSee the 26 sites
Where in Spain
- Hospital Universitario de TorrecardenasAlmería, SpainTaking people
- Hospital Universitario Puerto RealCadiz, SpainTaking people
- Hospital Universitario Santa LucíaCartagena, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital Virgen de la LuzCuenca, SpainTaking people
- Hospital Universitario de ElcheElche, SpainTaking people
- Hospital Clinico Universitario San CecilioGranada, SpainTaking people
- Hospital Universitario Virgen de las NievesGranada, SpainTaking people
- Hospital Universitario Juan Ramon JimenezHuelva, SpainTaking people
- Complejo Hospitalario de JaenJaén, SpainTaking people
- Hospital de Jerez de la FronteraJerez de la Frontera, SpainTaking people
- Hospital Universitario de BellvitgeL'Hospitalet de Llobregat, SpainTaking people
- Hospital Universitario Dr. NegrínLas Palmas de Gran Canaria, SpainTaking people
- Centro Sanitario SandovalMadrid, SpainTaking people
- Hospital Fundación Jimenez DiazMadrid, SpainTaking people
- Hospital Universitario Infanta LeonorMadrid, SpainTaking people
- Hospital Universitario la PrincesaMadrid, SpainTaking people
- Hospital Regional Universitario de MalagaMálaga, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- Hospital Universitario Virgen de la ArrixacaMurcia, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- Hospital Universitario Virgen de la MacarenaSeville, SpainTaking people
- Hospital Universitario Virgen de ValmeSeville, SpainTaking people
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
- Hospital Universitario de ValladolidValladolid, SpainTaking people
- Hospital Universitario Alvaro CunqueiroVigo, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario de Valme
- Trial code
- NCT06860945
- Record updated
- 6 March 2025
- Original description
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.Read full original descriptionShow less
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
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.
Inclusion: 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: -.