Actively Recruiting
Prevention ICONA Dedicated Ensemble
Led by Fondazione ICONA · Updated on 2025-09-22
5000
Participants Needed
53
Research Sites
485 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention ICONA Dedicated Ensemble
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Negative HIV antibody/antigen test (4th generation or higher) at enrollment
- Willingness to start or continue PrEP use
- Ability to understand study procedures and provide informed consent
You will not qualify if you...
- HIV infection or strong suspicion of HIV infection
- Contraindications to medications included in the PrEP regimen
- Known allergy to any components of the PrEP medications
- Unwillingness to comply with study procedures and follow-up assessments
AI-Screening
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Trial Site Locations
Total: 53 locations
1
Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive
Chieti, Abruzzo, Italy
Not Yet Recruiting
2
Ospedale Civile Santo Spirito - U.O. Malattie Infettive
Pescara, Abruzzo, Italy
Not Yet Recruiting
3
AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive
Bari, Apulia, Italy
Not Yet Recruiting
4
A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive
Foggia, Apulia, Italy
Not Yet Recruiting
5
Ospdale San Carlo
Potenza, Basilicate, Italy
Not Yet Recruiting
6
Università della Campania Luigi Vanvitelli - Malattie Infettive
Caserta, Campania, Italy
Not Yet Recruiting
7
A.O.U. Federico II - U.O.C. di Malattie Infettive
Naples, Campania, Italy
Not Yet Recruiting
8
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
9
Presidio Ospedaliero A.O.U. Vanvitelli - U.O. di Malattie Infettive
Naples, Campania, Italy
Not Yet Recruiting
10
A.O.U. Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna - U.O. di Malattie Infettive
Bologna, Emilia-Romagna, Italy
Not Yet Recruiting
11
BLQ Check Point
Bologna, Emilia-Romagna, Italy
Actively Recruiting
12
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
13
Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e Tropicali
Modena, Emilia-Romagna, Italy
Actively Recruiting
14
Azienda Ospedaliera Arcispedale Santa Maria Nuova - U.O. Malattie Infettive
Reggio Emilia, Emilia-Romagna, Italy
Not Yet Recruiting
15
Azienda Ospedaliera Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia - Clinica Malattie Infettive
Udine, Friuli Venezia Giulia, Italy
Not Yet Recruiting
16
Università Sapienza Polo Pontino - U.O. di Malattie Infettive
Latina, Lazio, Italy
Not Yet Recruiting
17
Circolo Mario Mieli
Rome, Lazio, Italy
Actively Recruiting
18
INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze Virali
Rome, Lazio, Italy
Actively Recruiting
19
Roma Check Point
Rome, Lazio, Italy
Actively Recruiting
20
Università Cattolica del Sacro Cuore - Istituto di Clinica delle Malattie Infettive
Rome, Lazio, Italy
Not Yet Recruiting
21
Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e Tropicali
Rome, Lazio, Italy
Actively Recruiting
22
Università degli Studi di Roma, Policlinico "Tor Vergata" - Divisione di Malattie Infettive
Rome, Lazio, Italy
Not Yet Recruiting
23
Ospedale Bel Colle Viterbo - U.O.C. Medicina protetta - Malattie infettive
Viterbo, Lazio, Italy
Not Yet Recruiting
24
Università di Genova e Ospedale Policlinico San Martino - Clinica di Malattie Infettive
Genoa, Liguria, Italy
Not Yet Recruiting
25
ASST Papa Giovanni XXIII , Struttura Complessa Malattie Infettive
Bergamo, Lombardy, Italy
Actively Recruiting
26
Azienda Ospedaliera Spedali Civili di Brescia - I Divisione di Malattie Infettive
Brescia, Lombardy, Italy
Not Yet Recruiting
27
Istituti Ospitalieri di Cremona - U.O. Malattie Infettive
Cremona, Lombardy, Italy
Not Yet Recruiting
28
ASST di Lecco - Ospedale Alessandro Manzoni - S.C. di Malattie Infettive
Lecco, Lombardy, Italy
Actively Recruiting
29
Associazione Milano Check Point
Milan, Lombardy, Italy
Actively Recruiting
30
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Dipartimento Malattie Infettive
Milan, Lombardy, Italy
Actively Recruiting
31
ASST Grande Ospedale Metropolitano Niguarda - S.C. Malattie Infettive
Milan, Lombardy, Italy
Actively Recruiting
32
ASST Santi Paolo e Carlo - U.O.C. di Malattie Infettive e Tropicali, Presidio San Paolo
Milan, Lombardy, Italy
Actively Recruiting
33
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Divisione di Malattie Infettive
Milan, Lombardy, Italy
Not Yet Recruiting
34
Ospedale San Raffaele, Università Vita-Salute - Clinica Malattie Infettive
Milan, Lombardy, Italy
Actively Recruiting
35
Ospedale Amedeo di Savoia, Università degli Studi di Torino - Clinica di Malattie Infettive
Turin, Piedmont, Italy
Actively Recruiting
36
Policlinico Universitario Duilio Casula, AOU di Cagliari - Medicina Interna e Malattie del Fegato
Cagliari, Sardinia, Italy
Not Yet Recruiting
37
Azienda Ospedaliero Universitaria di Sassari, Malattie Infettive Dipartimento di Medicina Clinica e Sperimentale
Sassari, Sardinia, Italy
Actively Recruiting
38
ARNAS Garibaldi - P.O. Nesima - U.O.C. di Malattie Infettive
Catania, Sicily, Italy
Not Yet Recruiting
39
PO "Umberto I" ASP
Enna, Sicily, Italy
Actively Recruiting
40
Ospedale Paolo Borsellino - Unità Operativa Complessa Malattie Infettive - ASP
Marsala, Sicily, Italy
Not Yet Recruiting
41
A.O.U. Policlinico "G. Martino" - U.O.C. di Malattie Infettive
Messina, Sicily, Italy
Not Yet Recruiting
42
A.O.U. Policlinico "P. Giaccone" - U.O.C. Malattie Infettive e Centro Regionale di Riferimento AIDS
Palermo, Sicily, Italy
Not Yet Recruiting
43
ARNAS Civico di Cristina Benfratelli - Unità Operativa Malattie infettive
Palermo, Sicily, Italy
Not Yet Recruiting
44
Azienda Sanitaria Provinciale 8 - Presidio Umberto I - U.O. di Malattie Infettive
Syracuse, Sicily, Italy
Not Yet Recruiting
45
A.O.U. Ospedali Riuniti Umberto I - Salesi - Lancisi- Università Politecnica delle Marche Servizio Regionale di Immunologia Clinica e Tipizzazione Tessutale
Ancona, The Marches, Italy
Not Yet Recruiting
46
Azienda Sanitaria dell'Alto Adige - Malattie Infettive
Bolzano, Trentino-Alto Adige, Italy
Not Yet Recruiting
47
Ospedale Santa Chiara di Trento - Unità Operativa di Malattie Infettive
Trento, Trentino-Alto Adige, Italy
Not Yet Recruiting
48
AOUC Azienda Ospedaliero-Universitaria Careggi - S.O.D. di Malattie Infettive e Tropicali
Florence, Tuscany, Italy
Not Yet Recruiting
49
Ospedale Santa Maria Annunziata - Azienda Sanitaria di Firenze - U.O. di Malattie Infettive
Florence, Tuscany, Italy
Not Yet Recruiting
50
Presidio Ospedaliero di Pistoia - U.O. Malattie Infettive II
Pistoia, Tuscany, Italy
Not Yet Recruiting
51
A.O.U. Senese, Policlinico S. Maria alle Scotte - U.O.C. di Malattie Infettive
Siena, Tuscany, Italy
Not Yet Recruiting
52
Azienda Ospedaliera di Padova - U.O.C. Malattie Infettive
Padova, Veneto, Italy
Actively Recruiting
53
Azienda ULSS 8 Berica - Divisione Malattie Infettive
Vicenza, Veneto, Italy
Actively Recruiting
Research Team
T
Thomas Masoero Mr., Master of Science
CONTACT
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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