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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Page 1 of 7 (26 locations)

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