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Taking people in ItalyNo phase

Following HIV-negative adults in Italy who take PrEP to prevent HIV

Follows HIV-negative adults in Italy taking PrEP, a daily medicine to prevent HIV.

Plain-language title generated from the registry record
Registry title: Prevention ICONA Dedicated Ensemble

Key facts

Where
Ancona, Bari, Bergamo, Bologna, Bolzano, Brescia, Cagliari, Caserta, Catania, Chieti, Cremona, Enna, Ferrara, Florence, Foggia, Genoa, Latina, Lecco, Marsala, Messina, Milan, Modena, Naples, Padova, Palermo, Pescara, Pistoia, Potenza, Reggio Emilia, Rome, Sassari, Siena, Syracuse, Trento, Turin, Udine, Vicenza, and Viterbo, ItalySee the 53 sites

Where in Italy

  • A.O.U. Ospedali Riuniti Umberto I - Salesi - Lancisi- Università Politecnica delle Marche Servizio Regionale di Immunologia Clinica e Tipizzazione TessutaleAncona, ItalyNot yet recruiting
  • AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie InfettiveBari, ItalyNot yet recruiting
  • ASST Papa Giovanni XXIII , Struttura Complessa Malattie InfettiveBergamo, ItalyTaking people
  • A.O.U. Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna - U.O. di Malattie InfettiveBologna, ItalyNot yet recruiting
  • BLQ Check PointBologna, ItalyTaking people
  • Azienda Sanitaria dell'Alto Adige - Malattie InfettiveBolzano, ItalyNot yet recruiting
  • Azienda Ospedaliera Spedali Civili di Brescia - I Divisione di Malattie InfettiveBrescia, ItalyNot yet recruiting
  • Policlinico Universitario Duilio Casula, AOU di Cagliari - Medicina Interna e Malattie del FegatoCagliari, ItalyNot yet recruiting
  • Università della Campania Luigi Vanvitelli - Malattie InfettiveCaserta, ItalyNot yet recruiting
  • ARNAS Garibaldi - P.O. Nesima - U.O.C. di Malattie InfettiveCatania, ItalyNot yet recruiting
  • Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie InfettiveChieti, ItalyNot yet recruiting
  • Istituti Ospitalieri di Cremona - U.O. Malattie InfettiveCremona, ItalyNot yet recruiting
  • PO "Umberto I" ASPEnna, ItalyTaking people
  • A.O.U. di Ferrara - Arcispedale Sant'Anna - U.S. Gestione Ambulatorio HIV/AIDS U.O. Malattie InfettiveFerrara, ItalyNot yet recruiting
  • AOUC Azienda Ospedaliero-Universitaria Careggi - S.O.D. di Malattie Infettive e TropicaliFlorence, ItalyNot yet recruiting
  • Ospedale Santa Maria Annunziata - Azienda Sanitaria di Firenze - U.O. di Malattie InfettiveFlorence, ItalyNot yet recruiting
  • A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie InfettiveFoggia, ItalyNot yet recruiting
  • Università di Genova e Ospedale Policlinico San Martino - Clinica di Malattie InfettiveGenoa, ItalyNot yet recruiting
  • Università Sapienza Polo Pontino - U.O. di Malattie InfettiveLatina, ItalyNot yet recruiting
  • ASST di Lecco - Ospedale Alessandro Manzoni - S.C. di Malattie InfettiveLecco, ItalyTaking people
  • Ospedale Paolo Borsellino - Unità Operativa Complessa Malattie Infettive - ASPMarsala, ItalyNot yet recruiting
  • A.O.U. Policlinico "G. Martino" - U.O.C. di Malattie InfettiveMessina, ItalyNot yet recruiting
  • Associazione Milano Check PointMilan, ItalyTaking people
  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Dipartimento Malattie InfettiveMilan, ItalyTaking people
  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Malattie InfettiveMilan, ItalyTaking people
  • ASST Santi Paolo e Carlo - U.O.C. di Malattie Infettive e Tropicali, Presidio San PaoloMilan, ItalyTaking people
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Divisione di Malattie InfettiveMilan, ItalyNot yet recruiting
  • Ospedale San Raffaele, Università Vita-Salute - Clinica Malattie InfettiveMilan, ItalyTaking people
  • Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e TropicaliModena, ItalyTaking people
  • A.O.U. Federico II - U.O.C. di Malattie InfettiveNaples, ItalyNot yet recruiting
  • Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO - IV Divisione, U.O.C. di Immunodeficienze e Malattie Infettive di GenereNaples, ItalyNot yet recruiting
  • Presidio Ospedaliero A.O.U. Vanvitelli - U.O. di Malattie InfettiveNaples, ItalyNot yet recruiting
  • Azienda Ospedaliera di Padova - U.O.C. Malattie InfettivePadova, ItalyTaking people
  • A.O.U. Policlinico "P. Giaccone" - U.O.C. Malattie Infettive e Centro Regionale di Riferimento AIDSPalermo, ItalyNot yet recruiting
  • ARNAS Civico di Cristina Benfratelli - Unità Operativa Malattie infettivePalermo, ItalyNot yet recruiting
  • Ospedale Civile Santo Spirito - U.O. Malattie InfettivePescara, ItalyNot yet recruiting
  • Presidio Ospedaliero di Pistoia - U.O. Malattie Infettive IIPistoia, ItalyNot yet recruiting
  • Ospdale San CarloPotenza, ItalyNot yet recruiting
  • Azienda Ospedaliera Arcispedale Santa Maria Nuova - U.O. Malattie InfettiveReggio Emilia, ItalyNot yet recruiting
  • Circolo Mario MieliRome, ItalyTaking people
  • INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze ViraliRome, ItalyTaking people
  • Roma Check PointRome, ItalyTaking people
  • Università Cattolica del Sacro Cuore - Istituto di Clinica delle Malattie InfettiveRome, ItalyNot yet recruiting
  • Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e TropicaliRome, ItalyTaking people
  • Università degli Studi di Roma, Policlinico "Tor Vergata" - Divisione di Malattie InfettiveRome, ItalyNot yet recruiting
  • Azienda Ospedaliero Universitaria di Sassari, Malattie Infettive Dipartimento di Medicina Clinica e SperimentaleSassari, ItalyTaking people
  • A.O.U. Senese, Policlinico S. Maria alle Scotte - U.O.C. di Malattie InfettiveSiena, ItalyNot yet recruiting
  • Azienda Sanitaria Provinciale 8 - Presidio Umberto I - U.O. di Malattie InfettiveSyracuse, ItalyNot yet recruiting
  • Ospedale Santa Chiara di Trento - Unità Operativa di Malattie InfettiveTrento, ItalyNot yet recruiting
  • Ospedale Amedeo di Savoia, Università degli Studi di Torino - Clinica di Malattie InfettiveTurin, ItalyTaking people
  • Azienda Ospedaliera Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia - Clinica Malattie InfettiveUdine, ItalyNot yet recruiting
  • Azienda ULSS 8 Berica - Divisione Malattie InfettiveVicenza, ItalyTaking people
  • Ospedale Bel Colle Viterbo - U.O.C. Medicina protetta - Malattie infettiveViterbo, ItalyNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Fondazione ICONA
Trial code
NCT07186244
Record updated
22 September 2025
Original description
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.Read full original descriptionShow less

Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)

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. The coordinating enrolling center is INMI "L. Spallanzani" IRCCS in Rome.

Participating Centers:

* 49 university and hospital-based centers across Italy; * 4 non-clinical checkpoints offering PrEP screening, prescription, and follow-up.

Study Population Adults (≥18 years) who are HIV-negative, sexually active, and considered eligible for PrEP per national or international guidelines, including both new and current PrEP users.

Inclusion Criteria

* Age ≥18 years; * Negative HIV test at enrollment; * Willingness to initiate or continue PrEP; * Informed consent provided. Exclusion Criteria * HIV infection or strong suspicion of infection; * Contraindications to PrEP medications; Known allergy to PrEP components; Refusal to comply with study procedures.

Inclusion: 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: Individuals with contraindications to the use of medications included in the PrEP regimen (as per the product information); Individuals with HIV infection or with strong clinical/epidemiological suspicion of HIV infection; 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.

ClinicalTrials.gov NCT07186244