Actively Recruiting
Led by Hospital Universitario de Valme · Updated on 2025-03-06
9000
Participants Needed
26
Research Sites
26 weeks
Total Duration
H
Hospital Universitario de Valme
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
Researchers are developing and validating a predictive model to understand the risk of acquiring sexually transmitted infections (STIs) among individuals using HIV pre-exposure prophylaxis (PrEP) within Spain's national program. This observational study includes PrEP users followed according to national protocols at 23 hospitals. The study focuses on STIs such as syphilis, gonorrhea, chlamydia, herpes, hepatitis, HIV, and MPOX, with the primary outcome being whether participants develop an STI. Participants are individuals who have started daily oral PrEP, have taken at least one pill, and meet the approved criteria by Spanish guidelines. They will be monitored quarterly with tests including blood samples and swabs from various sites to diagnose STIs. The study uses data from these visits to build and validate predictive models and analyze factors linked to STI acquisition. Participants will be followed over an average of five years with regular clinical visits to monitor for STIs and collect behavioral and adherence data. Researchers will measure the occurrence and number of STIs, changes in behavior, PrEP adherence, and discontinuation rates. The study aims to improve understanding of STI dynamics among PrEP users while ensuring ongoing monitoring and data collection throughout the participation period.
CONDITIONS
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time to collect data on sexually transmitted infections, behavioral changes, and PrEP use.
Regular visits as part of routine care
Total: 26 locations
1
Hospital Universitario de Torrecárdenas
Almería, Spain
Actively Recruiting
2
Hospital Universitario Puerto Real
Cadiz, Spain
Actively Recruiting
3
Hospital Universitario Santa Lucía
Cartagena, Spain
Actively Recruiting
4
hospital Universitario reina Sofía
Córdoba, Spain
Actively Recruiting
5
Hospital Virgen de la Luz
Cuenca, Spain
Actively Recruiting
6
Hospital Universitario de Elche
Elche, Spain
Actively Recruiting
7
Hospital Clínico Universitario San Cecilio
Granada, Spain
Actively Recruiting
8
Hospital Universitario Virgen de las Nieves
Granada, Spain
Actively Recruiting
9
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain
Actively Recruiting
10
Complejo Hospitalario de Jaén
Jaén, Spain
Actively Recruiting
11
Hospital de Jerez de la Frontera
Jerez de la Frontera, Spain
Actively Recruiting
12
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain
Actively Recruiting
13
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Spain
Actively Recruiting
14
Centro Sanitario Sandoval
Madrid, Spain
Actively Recruiting
15
Hospital Fundación Jiménez Díaz
Madrid, Spain
Actively Recruiting
16
Hospital Universitario Infanta Leonor
Madrid, Spain
Actively Recruiting
17
Hospital Universitario La Princesa
Madrid, Spain
Actively Recruiting
18
Hospital Regional Universitario de Málaga
Málaga, Spain
Actively Recruiting
19
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
20
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
21
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Actively Recruiting
22
Hospital Universitario Virgen de la Macarena
Seville, Spain
Actively Recruiting
23
Hospital Universitario Virgen de Valme
Seville, Spain
Actively Recruiting
24
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
25
Hospital Universitario de Valladolid
Valladolid, Spain
Actively Recruiting
26
Hospital Universitario Álvaro Cunqueiro
Vigo, Spain
Actively Recruiting
A
Anaïs Corma-Gómez
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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