Predicting STIs in people using HIV prevention medication in Spain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop and validate a predictive model for acquiring sexually transmitted infections (STIs) among individuals using pre-exposure prophylaxis (PrEP) for HIV in Spain. It involves an ambispective cohort design across 23 hospitals, where all PrEP users will be monitored quarterly following national protocols. At each visit, various STIs will be diagnosed using different sample types, and the primary outcome will be whether an STI is developed. The study will include individuals who have initiated PrEP and meet specific eligibility criteria.

Why it matters

Who can join: the full rules

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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Where it's running

• Hospital Universitario de Torrecárdenas
  Almería, Spain Recruiting
• Hospital Universitario Puerto Real
  Cadiz, Spain Recruiting
• Hospital Universitario Santa Lucía
  Cartagena, Spain Recruiting
• hospital Universitario reina Sofía
  Córdoba, Spain Recruiting
• Hospital Virgen de la Luz
  Cuenca, Spain Recruiting
• Hospital Universitario de Elche
  Elche, Spain Recruiting

Study contacts

• Principal investigator: Anaïs Corma-Gómez, MD, PhD — Hospital Clínico Universitario de Valencia
• Study coordinator: Anaïs Corma-Gómez
• Email: anais.corgo@gmail.com
• Phone: +34676170692

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.