Status:
RECRUITING
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Lead Sponsor:
Hospital Universitario de Valme
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Sexually Transmitted Infections (STIs)
HIV
Eligibility:
All Genders
16+ years
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 providin...
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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Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
9000 Patients enrolled
Trial Details
Trial ID
NCT06860945
Start Date
January 1 2025
End Date
January 1 2026
Last Update
March 6 2025
Active Locations (26)
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1
Hospital Universitario de Torrecárdenas
Almería, Spain
2
Hospital Universitario Puerto Real
Cadiz, Spain
3
Hospital Universitario Santa Lucía
Cartagena, Spain
4
hospital Universitario reina Sofía
Córdoba, Spain