PrEPPrIDENCT07186244
Prevention ICONA Dedicated Ensemble
An observational study of PrEP and PrEP Adherence Monitoring, run by Fondazione ICONA at 53 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PrEP, PrEP Adherence Monitoring, HIV
- How many people
- 5,000 participants
- Where
- 53 sitesItaly
- Study dates
- 9 Sep 2024to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective enrollment is planned for all individuals taking PrEP in Italy, with the aim of establishing a cohort under active follow-up. Eligible participants are adults (>18 years old), HIV-negative, and sexually active, who-according to approved national and international guidelines and/or standard clinical practice-are deemed suitable to receive a PrEP prescription or are already undergoing PrEP.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
53 sites in 1 country. Contact the study team or a site near you to ask about taking part.
53 sites in 1 country
Italy53 sites, 53 recruiting
- Not yet recruiting
A.O.U. Ospedali Riuniti Umberto I - Salesi - Lancisi- Università Politecnica delle Marche Servizio Regionale di Immunologia Clinica e Tipizzazione Tessutale
Ancona, The Marches
- Not yet recruiting
AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive
Bari, Apulia
- Recruiting
ASST Papa Giovanni XXIII , Struttura Complessa Malattie Infettive
Bergamo, Lombardy
- Not yet recruiting
A.O.U. Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna - U.O. di Malattie Infettive
Bologna, Emilia-Romagna
- Recruiting
BLQ Check Point
Bologna, Emilia-Romagna
- Not yet recruiting
Azienda Sanitaria dell'Alto Adige - Malattie Infettive
Bolzano, Trentino-Alto Adige
- Not yet recruiting
Azienda Ospedaliera Spedali Civili di Brescia - I Divisione di Malattie Infettive
Brescia, Lombardy
- Not yet recruiting
Policlinico Universitario Duilio Casula, AOU di Cagliari - Medicina Interna e Malattie del Fegato
Cagliari, Sardinia
- Not yet recruiting
Università della Campania Luigi Vanvitelli - Malattie Infettive
Caserta, Campania
- Not yet recruiting
ARNAS Garibaldi - P.O. Nesima - U.O.C. di Malattie Infettive
Catania, Sicily
- Not yet recruiting
Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive
Chieti, Abruzzo
- Not yet recruiting
Istituti Ospitalieri di Cremona - U.O. Malattie Infettive
Cremona, Lombardy
- Recruiting
PO "Umberto I" ASP
Enna, Sicily
- Not yet recruiting
A.O.U. di Ferrara - Arcispedale Sant'Anna - U.S. Gestione Ambulatorio HIV/AIDS U.O. Malattie Infettive
Ferrara, Emilia-Romagna
- Not yet recruiting
AOUC Azienda Ospedaliero-Universitaria Careggi - S.O.D. di Malattie Infettive e Tropicali
Florence, Tuscany
- Not yet recruiting
Ospedale Santa Maria Annunziata - Azienda Sanitaria di Firenze - U.O. di Malattie Infettive
Florence, Tuscany
- Not yet recruiting
A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive
Foggia, Apulia
- Not yet recruiting
Università di Genova e Ospedale Policlinico San Martino - Clinica di Malattie Infettive
Genoa, Liguria
- Not yet recruiting
Università Sapienza Polo Pontino - U.O. di Malattie Infettive
Latina, Lazio
- Recruiting
ASST di Lecco - Ospedale Alessandro Manzoni - S.C. di Malattie Infettive
Lecco, Lombardy
- Not yet recruiting
Ospedale Paolo Borsellino - Unità Operativa Complessa Malattie Infettive - ASP
Marsala, Sicily
- Not yet recruiting
A.O.U. Policlinico "G. Martino" - U.O.C. di Malattie Infettive
Messina, Sicily
- Recruiting
Associazione Milano Check Point
Milan, Lombardy
- Recruiting
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Dipartimento Malattie Infettive
Milan, Lombardy
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - S.C. Malattie Infettive
Milan, Lombardy
- Recruiting
ASST Santi Paolo e Carlo - U.O.C. di Malattie Infettive e Tropicali, Presidio San Paolo
Milan, Lombardy
- Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Divisione di Malattie Infettive
Milan, Lombardy
- Recruiting
Ospedale San Raffaele, Università Vita-Salute - Clinica Malattie Infettive
Milan, Lombardy
- Recruiting
Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e Tropicali
Modena, Emilia-Romagna
- Not yet recruiting
A.O.U. Federico II - U.O.C. di Malattie Infettive
Naples, Campania
- Not yet recruiting
Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO - IV Divisione, U.O.C. di Immunodeficienze e Malattie Infettive di Genere
Naples, Campania
- Not yet recruiting
Presidio Ospedaliero A.O.U. Vanvitelli - U.O. di Malattie Infettive
Naples, Campania
- Recruiting
Azienda Ospedaliera di Padova - U.O.C. Malattie Infettive
Padova, Veneto
- Not yet recruiting
A.O.U. Policlinico "P. Giaccone" - U.O.C. Malattie Infettive e Centro Regionale di Riferimento AIDS
Palermo, Sicily
- Not yet recruiting
ARNAS Civico di Cristina Benfratelli - Unità Operativa Malattie infettive
Palermo, Sicily
- Not yet recruiting
Ospedale Civile Santo Spirito - U.O. Malattie Infettive
Pescara, Abruzzo
- Not yet recruiting
Presidio Ospedaliero di Pistoia - U.O. Malattie Infettive II
Pistoia, Tuscany
- Not yet recruiting
Ospdale San Carlo
Potenza, Basilicate
- Not yet recruiting
Azienda Ospedaliera Arcispedale Santa Maria Nuova - U.O. Malattie Infettive
Reggio Emilia, Emilia-Romagna
- Recruiting
Circolo Mario Mieli
Rome, Lazio
- Recruiting
INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze Virali
Rome, Lazio
- Recruiting
Roma Check Point
Rome, Lazio
- Not yet recruiting
Università Cattolica del Sacro Cuore - Istituto di Clinica delle Malattie Infettive
Rome, Lazio
- Recruiting
Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e Tropicali
Rome, Lazio
- Not yet recruiting
Università degli Studi di Roma, Policlinico "Tor Vergata" - Divisione di Malattie Infettive
Rome, Lazio
- Recruiting
Azienda Ospedaliero Universitaria di Sassari, Malattie Infettive Dipartimento di Medicina Clinica e Sperimentale
Sassari, Sardinia
- Not yet recruiting
A.O.U. Senese, Policlinico S. Maria alle Scotte - U.O.C. di Malattie Infettive
Siena, Tuscany
- Not yet recruiting
Azienda Sanitaria Provinciale 8 - Presidio Umberto I - U.O. di Malattie Infettive
Syracuse, Sicily
- Not yet recruiting
Ospedale Santa Chiara di Trento - Unità Operativa di Malattie Infettive
Trento, Trentino-Alto Adige
- Recruiting
Ospedale Amedeo di Savoia, Università degli Studi di Torino - Clinica di Malattie Infettive
Turin, Piedmont
- Not yet recruiting
Azienda Ospedaliera Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia - Clinica Malattie Infettive
Udine, Friuli Venezia Giulia
- Recruiting
Azienda ULSS 8 Berica - Divisione Malattie Infettive
Vicenza, Veneto
- Not yet recruiting
Ospedale Bel Colle Viterbo - U.O.C. Medicina protetta - Malattie infettive
Viterbo, Lazio
About this study
Official title: 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.
Read more
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.
Read the detailed description
The PrIDE study is a national, multicenter, prospective observational cohort aimed at assessing the effectiveness and real-world implementation of HIV pre-exposure prophylaxis (PrEP) in Italy. It collects sociodemographic, clinical, laboratory, behavioral, and quality-of-life data from about 5,000 HIV-negative adults (≥18 years) initiating or already on PrEP, in accordance with Italian and international guidelines.
All 49 university and hospital infectious disease clinics and 4 community-based checkpoints across Italy can participate. Participants are followed every 3-5 months through routine clinical visits, including HIV/STI testing, safety labs, and electronic questionnaires via a dedicated mobile app.
The primary objective is to estimate the incidence of HIV seroconversion, while secondary aims include monitoring sexually transmitted infections, evaluating safety and tolerability, and analyzing adherence, persistence, and behavioral factors. Data are collected in a secure, encrypted eCRF managed by the ICONA Foundation.
The study is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome, will run for at least 10 years, and requires approval from the Ethics Committees of all participating centers.
- Conditions
- PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection, STI, STI Prevention
- Keywords
- PrEP, HIV, STI, STI Prevention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PrIDE Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV seroconversion in individuals taking PrEP, from the time of cohort enrollment.
HIV seroconversion is defined as a new HIV infection occurring in a participant during the observational follow-up period. Seroconversion will be determined by a reactive 4th-generation HIV antibody/antigen (Ab/Ag) test confirmed by detectable HIV-RNA using real-time PCR. The measure will be taken at routine clinical visits approximately every 3 months, or when clinically indicated, according to national guidelines. All cases of confirmed HIV infection will be reviewed and documented by the coordinating center.
Measured: Perioperative/Periprocedural
Secondary outcomes (3)
Tolerability of PrEP expressed as the number of adverse events per person-years of follow-up after study enrollment
Measured: Perioperative/Periprocedural
Assess behavioral-related factors influencing PrEP use and persistence in care through questionnaires
Values monitored through ePROs questionnaire completed by participants at each visit.
Measured: Perioperative/Periprocedural
Assess adherence-related factors influencing PrEP use and persistence in care through questionnaire
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start9 Sep 2024
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione ICONA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186244
- Sponsor's protocol ID
- 1539
- Acronym
- PrIDE
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)
- ClinicalTrials.gov ID
- NCT07186244
- Acronym / sponsor ID
- PrIDE / 1539
- Conditions
- PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection, STI, STI Prevention
- Keywords
- PrEP, HIV, STI, STI Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fondazione ICONAUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The PrIDE study is a national, multicenter, prospective observational cohort aimed at assessing the effectiveness and real-world implementation of HIV pre-exposure prophylaxis (PrEP) in Italy. It collects sociodemographic, clinical, laboratory, behavioral, and quality-of-life data from about 5,000 HIV-negative adults (≥18 years) initiating or already on PrEP, in accordance with Italian and international guidelines.
All 49 university and hospital infectious disease clinics and 4 community-based checkpoints across Italy can participate. Participants are followed every 3-5 months through routine clinical visits, including HIV/STI testing, safety labs, and electronic questionnaires via a dedicated mobile app.
The primary objective is to estimate the incidence of HIV seroconversion, while secondary aims include monitoring sexually transmitted infections, evaluating safety and tolerability, and analyzing adherence, persistence, and behavioral factors. Data are collected in a secure, encrypted eCRF managed by the ICONA Foundation.
The study is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome, will run for at least 10 years, and requires approval from the Ethics Committees of all participating centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrIDE Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective enrollment is planned for all individuals taking PrEP in Italy, with the aim of establishing a cohort under active follow-up. Eligible participants are adults (>18 years old), HIV-negative, and sexually active, who-according to approved national and international guidelines and/or standard clinical practice-are deemed suitable to receive a PrEP prescription or are already undergoing PrEP.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of HIV seroconversion in individuals taking PrEP, from the time of cohort enrollment.
Time frame: Perioperative/Periprocedural
HIV seroconversion is defined as a new HIV infection occurring in a participant during the observational follow-up period. Seroconversion will be determined by a reactive 4th-generation HIV antibody/antigen (Ab/Ag) test confirmed by detectable HIV-RNA using real-time PCR. The measure will be taken at routine clinical visits approximately every 3 months, or when clinically indicated, according to national guidelines. All cases of confirmed HIV infection will be reviewed and documented by the coordinating center.
3 secondary outcomes
Tolerability of PrEP expressed as the number of adverse events per person-years of follow-up after study enrollment
Time frame: Perioperative/Periprocedural
Assess behavioral-related factors influencing PrEP use and persistence in care through questionnaires
Time frame: Perioperative/Periprocedural
Assess adherence-related factors influencing PrEP use and persistence in care through questionnaire
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PrEP and PrEP Adherence Monitoring, run by Fondazione ICONA at 53 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Masoero Mr., Master of Science (+39 3481134565, thomas.masoero@icona.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HIV seroconversion in individuals taking PrEP, from the time of cohort enrollment. (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.