Clinical trial NCT06860945: Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Official title: Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexually Transmitted Infections (STIs)
HIV
PrEP
Keywords: STI
HIV
PrEP
modelling
machine learning
adherence
persistence
Lead sponsor: Hospital Universitario de Valme
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2025-03-06
Enrollment: 9000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals who meet the criteria for PrEP use in Spain, are over 16 years old, and have taken at least one pill.

Brief summary: 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.


Eligibility criteria: 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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Primary outcomes:
measure: STI predictive model
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: STI incidence
timeFrame: through study completion, an average of 5 years
measure: STI dynamics
timeFrame: through study completion, an average of 5 years
measure: asymptomatic STIs
timeFrame: through study completion, an average of 5 years
measure: behavioral changes
timeFrame: through study completion, an average of 5 years
measure: DOXYPEP
timeFrame: through study completion, an average of 5 years
measure: PrEP discontinuation
timeFrame: through study completion, an average of 5 years
measure: Predictor of PrEP discontinuation
timeFrame: through study completion, an average of 5 years
measure: PrEP adherence
timeFrame: through study completion, an average of 5 years
measure: Time to discontinuation
timeFrame: through study completion, an average of 5 years
measure: HIV incident infection
timeFrame: through study completion, an average of 5 years
measure: HIV incident infection
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Universitario de Torrecárdenas
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real
city: Cartagena
country: Spain
facility: Hospital Universitario Santa Lucía
city: Cuenca
country: Spain
facility: Hospital Virgen de la Luz
city: Córdoba
country: Spain
facility: hospital Universitario reina Sofía
city: Elche
country: Spain
facility: Hospital Universitario de Elche
city: Granada
country: Spain
facility: Hospital Clínico Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Jerez
country: Spain
facility: Hospital de Jerez de la Frontera
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Dr. Negrín
city: Madrid
country: Spain
facility: Centro Sanitario Sandoval
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Universitario Álvaro Cunqueiro
Study officials:
affiliation: Hospital Clínico Universitario de Valencia
name: Anaïs Corma-Gómez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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