Predicting STIs in people using HIV prevention medication in Spain
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
This study is trying to see if a new way to predict sexually transmitted infections can help people using HIV prevention medication in Spain stay healthier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9000 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario de Valme Academic / other |
| Locations | 26 sites (Almería and 25 other locations) |
| Trial ID | NCT06860945 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 and older who are using PrEP and meet specific risk criteria.
Not a fit: Patients who are not using PrEP or do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict and prevent STIs in individuals using PrEP, leading to better health outcomes.
How similar studies have performed: While predictive modeling in this context is relatively novel, similar studies in other regions have shown promise in improving STI prevention strategies.
Eligibility criteria
Show full inclusion / exclusion 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 \-
Where this trial is running
Almería and 25 other locations
- 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)
- Hospital Clínico Universitario San Cecilio — Granada, Spain (Recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Spain (Recruiting)
- Hospital Universitario Juan Ramón Jiménez — Huelva, Spain (Recruiting)
- Complejo Hospitalario de Jaén — Jaén, Spain (Recruiting)
- Hospital de Jerez de la Frontera — Jerez de la Frontera, Spain (Recruiting)
- Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Spain (Recruiting)
- Hospital Universitario Dr. Negrín — Las Palmas de Gran Canaria, Spain (Recruiting)
- Centro Sanitario Sandoval — Madrid, Spain (Recruiting)
- Hospital Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
- Hospital Universitario Infanta Leonor — Madrid, Spain (Recruiting)
- Hospital Universitario La Princesa — Madrid, Spain (Recruiting)
- Hospital Regional Universitario de Málaga — Málaga, Spain (Recruiting)
- Hospital Universitario Virgen de la Victoria — Málaga, Spain (Recruiting)
- Hospital Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Spain (Recruiting)
- Hospital Universitario Virgen de la Macarena — Seville, Spain (Recruiting)
- Hospital Universitario Virgen de Valme — Seville, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
- Hospital Universitario de Valladolid — Valladolid, Spain (Recruiting)
- Hospital Universitario Álvaro Cunqueiro — Vigo, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.