Actively Recruiting
Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)
Led by Fondazione ICONA · Updated on 2025-09-22
5000
Participants Needed
53
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of HIV pre-exposure prophylaxis (PrEP) in Italy to prevent new HIV infections. The study aims to understand how effective and tolerable PrEP is, how well people stick with it, and what barriers exist to its long-term use. It is an observational study coordinated by Fondazione ICONA, including about 5,000 HIV-negative adults who are either starting or continuing PrEP. Participants are followed in 49 hospital and university infectious disease clinics and 4 community-based checkpoints across Italy. They attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires via a mobile app. The study collects data on demographics, clinical status, behavior, and quality of life to monitor HIV seroconversion rates and other outcomes. During the study, participants will be monitored for new HIV infections, side effects related to PrEP, adherence to treatment, and behavioral factors affecting persistence in care. Data are securely collected and managed in an electronic case report form. The study will run for at least 10 years, with regular follow-up visits to ensure ongoing assessment of PrEP's real-world use and impact.
CONDITIONS
Brief 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
- Request or willingness to start or continue PrEP
- Ability to understand the study and provide informed consent
You will not qualify if you...
- HIV infection or strong suspicion of HIV infection
- Contraindications to medications used in the PrEP regimen
- Known allergy to any components of the PrEP medications
- Unwillingness to follow study procedures and assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years
Participants who undergo routine care for HIV pre-exposure prophylaxis (PrEP) are observed through routine clinical visits including HIV/STI testing, safety labs, and electronic questionnaires via a mobile app.
Visits every 3 to 5 months through routine clinical care
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
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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