Condition: PrEP · PrEP Adherence Monitoring · HIV · Sponsor: Fondazione ICONA
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 management and move toward the goal of zero new HIV infections in Italy. Primary Objective * To assess the incidence of new HIV infections among PrEP users in Italy. Secondary Objectives * Incidence of other sexually transmitted infections (STIs); * Tolerability of PrEP; * Psychological and behavioral aspects related to PrEP use; * Adherence and persistence in care; * Use of therapies and prophylaxis for STIs during PrEP use. Study Design and Coordination This is a prospective observational study, promoted by Fondazione ICONA in collaboration with clinical centers and community-based organizations. …
This description comes directly from the study's public registry record.
Thomas Masoero Mr., Master of Science · +39 3481134565 · thomas.masoero@icona.org
Always discuss trial participation with your own doctor first.
| Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive | Chieti, Abruzzo, Italy | Not Yet Recruiting |
| Ospedale Civile Santo Spirito - U.O. Malattie Infettive | Pescara, Abruzzo, Italy | Not Yet Recruiting |
| AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive | Bari, Apulia, Italy | Not Yet Recruiting |
| A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive | Foggia, Apulia, Italy | Not Yet Recruiting |
| Ospdale San Carlo | Potenza, Basilicate, Italy | Not Yet Recruiting |
| Università della Campania Luigi Vanvitelli - Malattie Infettive | Caserta, Campania, Italy | Not Yet Recruiting |
| A.O.U. Federico II - U.O.C. di Malattie Infettive | Naples, Campania, Italy | Not Yet Recruiting |
| Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO - IV Divisione, U.O.C. di Immunodeficienze e Malattie Infettive di Genere | Naples, Campania, Italy | Not Yet Recruiting |
| Presidio Ospedaliero A.O.U. Vanvitelli - U.O. di Malattie Infettive | Naples, Campania, Italy | Not Yet Recruiting |
| A.O.U. Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna - U.O. di Malattie Infettive | Bologna, Emilia-Romagna, Italy | Not Yet Recruiting |
| BLQ Check Point | Bologna, Emilia-Romagna, Italy | Recruiting |
| A.O.U. di Ferrara - Arcispedale Sant'Anna - U.S. Gestione Ambulatorio HIV/AIDS U.O. Malattie Infettive | Ferrara, Emilia-Romagna, Italy | Not Yet Recruiting |
+ 41 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07186244