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Prevention ICONA Dedicated Ensemble

Recruitingn/aAges 18 Years - anyAllFondazione ICONA
NCT07186244 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the predominant route. Many individuals are still diagnosed late, and a portion of people living with HIV are unaware of their status. Pre-Exposure Prophylaxis (PrEP) has emerged as an effective biomedical strategy to prevent new infections, especially when integrated into comprehensive prevention efforts. Study Objectives The primary objective of this observational study is to establish a large prospective cohort of individuals using PrEP in Italy. The study aims to assess PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. These data will be instrumental in guiding future strategic interventions to optimize PrEP manageme

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \>18 years * Negative HIV Ab/Ag test (4th generation or higher) at the enrollment visit * Request and/or willingness to take PrEP, or already on PrEP * Ability to understand the study procedures and to sign informed consent Exclusion Criteria: * Individuals with HIV infection or with strong clinical/epidemiological suspicion of HIV infection * Individuals with contraindications to the use of medications included in the PrEP regimen (as per the product information) * Documented allergy to one or more pharmacological components of the proposed PrEP regimen * Lack of willingness to adhere to the required procedures and follow-up assessments
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What it tests

  • Not listed
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Where

53 sites
Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive
Chieti, Italy
Ospedale Civile Santo Spirito - U.O. Malattie Infettive
Pescara, Italy
AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive
Bari, Italy
A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive
Foggia, Italy
Ospdale San Carlo
Potenza, Italy
Università della Campania Luigi Vanvitelli - Malattie Infettive
Caserta, Italy
A.O.U. Federico II - U.O.C. di Malattie Infettive
Naples, Italy
Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO - IV Divisione, U.O.C. di Immunodeficienze e Malattie Infettive di Genere
Naples, Italy

…and 45 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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