Predicting Sexually Transmitted Infections in People Using HIV Pre-Exposure Prophylaxis PrEP in Spain
Led by Hospital Universitario de Valme · Updated on 2025-03-06
9000
Participants Needed
26
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
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 Spains 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
Brief Title
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Research Team
A
Anaïs Corma-Gómez
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Documented start of oral PrEP (daily or event-driven) with at least one pill taken
No HIV infection at the time of joining the study
MSM and transgender women with at least two of the following in the past year: more than 10 sexual partners, condomless anal sex, chemsex, post-exposure prophylaxis (PEP), or at least one STI
Sex worker women reporting non-regular condom use
Cisgender males or females reporting condomless sex and at least two of the same criteria as MSM and transgender women
People who inject drugs (PWID) with unsafe injection practices
You will not qualify if you...
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
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
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Can we screen less frequently for STI among PrEP users? Assessing the effect of biannual STI screening on timing of diagnosis and transmission risk in the AMPrEP Study.
Vita W Jongen, Hanne M L Zimmermann, Marit Goedhart...
Cost-effectiveness of two screening strategies for Chlamydia trachomatis and Neisseria gonorrhoeae as part of the PrEP programme in the Netherlands: a modelling study.
Francine van Wifferen, Elske Hoornenborg, Maarten F Schim van der Loeff...
Comparison of Trends in Rates of Sexually Transmitted Infections Before vs After Initiation of HIV Preexposure Prophylaxis Among Men Who Have Sex With Men.
Sexual behaviour and incidence of HIV and sexually transmitted infections among men who have sex with men using daily and event-driven pre-exposure prophylaxis in AMPrEP: 2 year results from a demonstration study.
Elske Hoornenborg, Liza Coyer, Roel C A Achterbergh...
Effects of Pre-exposure Prophylaxis for the Prevention of Human Immunodeficiency Virus Infection on Sexual Risk Behavior in Men Who Have Sex With Men: A Systematic Review and Meta-analysis.
Michael W Traeger, Sophia E Schroeder, Edwina J Wright...