Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain (STI_PrEPare)

February 28, 2025 updated by: Anais Corma-Gomez, Hospital Universitario de Valme

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital Universitario de Torrecardenas
        • Contact:
        • Contact:
          • Bárbara Hernández
        • Principal Investigator:
          • Bárbara Hernández
      • Cadiz, Spain
        • Recruiting
        • Hospital Universitario Puerto Real
        • Contact:
        • Principal Investigator:
          • Alberto Romero, MD, PhD
      • Cartagena, Spain
        • Recruiting
        • Hospital Universitario Santa Lucía
        • Contact:
        • Principal Investigator:
          • Francisco J Vera, MD, PhD
      • Cuenca, Spain
        • Recruiting
        • Hospital Virgen de la Luz
        • Contact:
        • Principal Investigator:
          • Olga Belinchón
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
        • Principal Investigator:
          • Diana Corona-mata, MD, PhD
      • Elche, Spain
        • Recruiting
        • Hospital Universitario de Elche
        • Principal Investigator:
          • Javier García
        • Contact:
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
        • Principal Investigator:
          • Carmen Hidalgo
      • Granada, Spain
        • Recruiting
        • Hospital Clinico Universitario San Cecilio
        • Contact:
        • Principal Investigator:
          • Naya Faro
      • Hospitalet de Llobregat, Spain
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Principal Investigator:
          • Jaime Vega
      • Huelva, Spain
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
        • Contact:
        • Principal Investigator:
          • Miguel Raffo
      • Jaén, Spain
        • Recruiting
        • Complejo Hospitalario de Jaen
        • Contact:
        • Contact:
          • Carmen Herrero, MD
        • Principal Investigator:
          • Carmen Herrero
      • Jerez, Spain
        • Recruiting
        • Hospital De Jerez De La Frontera
        • Contact:
        • Principal Investigator:
          • Salvador López, MD, PhD
      • Las Palmas de Gran Canaria, Spain
        • Recruiting
        • Hospital Universitario Dr. Negrín
        • Contact:
        • Principal Investigator:
          • Karim Mohammed
      • Madrid, Spain
        • Recruiting
        • Hospital Fundación Jiménez Diaz
        • Contact:
        • Principal Investigator:
          • Alfonso Cabello
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
        • Principal Investigator:
          • Jorge Valencia
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Princesa
        • Contact:
        • Principal Investigator:
          • Lucio García-Fraile, MD
      • Madrid, Spain
        • Recruiting
        • Centro Sanitario Sandoval
        • Contact:
        • Principal Investigator:
          • Eva Orviz
      • Murcia, Spain
        • Recruiting
        • Hospital Universitario Virgen de La Arrixaca
        • Contact:
        • Principal Investigator:
          • Antonia Castillo
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Principal Investigator:
          • Cristina Gómez-Ayerbe, MD, PhD
      • Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Contact:
        • Principal Investigator:
          • Inés Pérez-Camacho
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
        • Principal Investigator:
          • Francisco Arnaiz
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Cesar Sotomayor
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen de Valme
        • Contact:
          • Juan Macías, MD, PhD
          • Phone Number: +34955015757
          • Email: jmacias7@us.es
        • Principal Investigator:
          • Juan Macías, MD, PhD
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
        • Principal Investigator:
          • Jesús Sojo, MD
      • Valladolid, Spain
        • Recruiting
        • Hospital Universitario de Valladolid
        • Contact:
        • Principal Investigator:
          • Pablo Tellería
      • Vigo, Spain
        • Recruiting
        • Hospital Universitario Alvaro Cunqueiro
        • Contact:
        • Principal Investigator:
          • Luis E Morano, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STI_PrEPare

All individuals with documented initiation of daily oral PrEP, 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. Disponible en 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.
Other: No Intervention: Observational Cohort
No Intervention: Observational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STI predictive model
Time Frame: through study completion, an average of 5 years
Predictive model for the acquisition of sexually transmitted infections in individuals using PrEP within the national provision program for this strategy
through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STI incidence
Time Frame: through study completion, an average of 5 years
Incidence of sexually transmitted infections (STIs) in the cohort globally and by type of infection.
through study completion, an average of 5 years
STI dynamics
Time Frame: through study completion, an average of 5 years
Evolution of STI diagnoses during follow-up among PrEP users included in the study, both globally and by specific pathogen
through study completion, an average of 5 years
asymptomatic STIs
Time Frame: through study completion, an average of 5 years
Proportion of asymptomatic STIs diagnosed within the screening program.
through study completion, an average of 5 years
behavioral changes
Time Frame: through study completion, an average of 5 years
Sexual risk behaviors of individuals in the cohort, before and after initiating PrEP
through study completion, an average of 5 years
DOXYPEP
Time Frame: through study completion, an average of 5 years
Proportion of Individuals who might benefit from the 'Doxy-PEP' strategy (doxycycline use as post-exposure prophylaxis for chlamydia and syphilis)
through study completion, an average of 5 years
PrEP discontinuation
Time Frame: through study completion, an average of 5 years
Prevalence of oral PrEP discontinuation within a nationwide PrEP users' cohort.
through study completion, an average of 5 years
Predictor of PrEP discontinuation
Time Frame: through study completion, an average of 5 years
Predictors of oral PrEP discontinuation within a nationwide PrEP users' cohort.
through study completion, an average of 5 years
PrEP adherence
Time Frame: through study completion, an average of 5 years
Self-reported oral PrEP adherence.
through study completion, an average of 5 years
Time to discontinuation
Time Frame: through study completion, an average of 5 years
Time elapsed between oral PrEP initiation and oral PrEP discontinuation.
through study completion, an average of 5 years
HIV incident infection
Time Frame: through study completion, an average of 5 years
Incidence of HIV seroconversions
through study completion, an average of 5 years
HIV incident infection
Time Frame: through study completion, an average of 5 years
Profiles of those who acquire HIV while taking oral PrEP.
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Valme

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Anaïs Corma-Gómez, MD, PhD, Hospital Clinico Universitario de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STI_PrEP24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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