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Italy launches massive PrEP study to slash new HIV infections

NCT ID NCT07186244

Prevention Sponsor: Fondazione ICONA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study will follow 5,000 HIV-negative adults in Italy who are taking PrEP, a daily pill that prevents HIV. Researchers want to see how well PrEP works in real life, how many people stick with it, and what barriers they face. The goal is to use this information to improve HIV prevention and move toward zero new infections in Italy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pre-Exposure Prophylaxis (PrEP) medications
What this could lead to
If successful, this study could improve how PrEP is used in Italy, helping to reduce new HIV infections and guide better prevention strategies.
What could go wrong
This is an observational study, not a test of a new drug. It may not lead to immediate changes in treatment or prevention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

posterior leukoencephalopathy syndrome sexually transmitted disease HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV HIV-1-infection PREP Prep adherence monitoring STI Sti prevention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    53 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Federico II - U.O.C. di Malattie Infettive

    NOT_YET_RECRUITING

    Naples, Campania, Italy

  • A.O.U. Ospedali Riuniti Umberto I - Salesi - Lancisi- Università Politecnica delle Marche Servizio Regionale di Immunologia Clinica e Tipizzazione Tessutale

    NOT_YET_RECRUITING

    Ancona, The Marches, Italy

  • A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive

    NOT_YET_RECRUITING

    Foggia, Apulia, Italy

  • A.O.U. Policlinico "G. Martino" - U.O.C. di Malattie Infettive

    NOT_YET_RECRUITING

    Messina, Sicily, Italy

  • A.O.U. Policlinico "P. Giaccone" - U.O.C. Malattie Infettive e Centro Regionale di Riferimento AIDS

    NOT_YET_RECRUITING

    Palermo, Sicily, Italy

  • A.O.U. Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna - U.O. di Malattie Infettive

    NOT_YET_RECRUITING

    Bologna, Emilia-Romagna, Italy

  • A.O.U. Senese, Policlinico S. Maria alle Scotte - U.O.C. di Malattie Infettive

    NOT_YET_RECRUITING

    Siena, Tuscany, Italy

  • A.O.U. di Ferrara - Arcispedale Sant'Anna - U.S. Gestione Ambulatorio HIV/AIDS U.O. Malattie Infettive

    NOT_YET_RECRUITING

    Ferrara, Emilia-Romagna, Italy

  • AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive

    NOT_YET_RECRUITING

    Bari, Apulia, Italy

  • AOUC Azienda Ospedaliero-Universitaria Careggi - S.O.D. di Malattie Infettive e Tropicali

    NOT_YET_RECRUITING

    Florence, Tuscany, Italy

  • ARNAS Civico di Cristina Benfratelli - Unità Operativa Malattie infettive

    NOT_YET_RECRUITING

    Palermo, Sicily, Italy

  • ARNAS Garibaldi - P.O. Nesima - U.O.C. di Malattie Infettive

    NOT_YET_RECRUITING

    Catania, Sicily, Italy

  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Dipartimento Malattie Infettive

    RECRUITING

    Milan, Lombardy, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Malattie Infettive

    RECRUITING

    Milan, Lombardy, Italy

  • ASST Papa Giovanni XXIII , Struttura Complessa Malattie Infettive

    RECRUITING

    Bergamo, Lombardy, Italy

  • ASST Santi Paolo e Carlo - U.O.C. di Malattie Infettive e Tropicali, Presidio San Paolo

    RECRUITING

    Milan, Lombardy, Italy

  • ASST di Lecco - Ospedale Alessandro Manzoni - S.C. di Malattie Infettive

    RECRUITING

    Lecco, Lombardy, Italy

  • Associazione Milano Check Point

    RECRUITING

    Milan, Lombardy, Italy

  • Azienda Ospedaliera Arcispedale Santa Maria Nuova - U.O. Malattie Infettive

    NOT_YET_RECRUITING

    Reggio Emilia, Emilia-Romagna, Italy

  • Azienda Ospedaliera Spedali Civili di Brescia - I Divisione di Malattie Infettive

    NOT_YET_RECRUITING

    Brescia, Lombardy, Italy

  • Azienda Ospedaliera Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia - Clinica Malattie Infettive

    NOT_YET_RECRUITING

    Udine, Friuli Venezia Giulia, Italy

  • Azienda Ospedaliera dei Colli - Monaldi Cotugno CTO - IV Divisione, U.O.C. di Immunodeficienze e Malattie Infettive di Genere

    NOT_YET_RECRUITING

    Naples, Campania, Italy

  • Azienda Ospedaliera di Padova - U.O.C. Malattie Infettive

    RECRUITING

    Padova, Veneto, Italy

  • Azienda Ospedaliero Universitaria di Sassari, Malattie Infettive Dipartimento di Medicina Clinica e Sperimentale

    RECRUITING

    Sassari, Sardinia, Italy

  • Azienda Sanitaria Provinciale 8 - Presidio Umberto I - U.O. di Malattie Infettive

    NOT_YET_RECRUITING

    Syracuse, Sicily, Italy

  • Azienda Sanitaria dell'Alto Adige - Malattie Infettive

    NOT_YET_RECRUITING

    Bolzano, Trentino-Alto Adige, Italy

  • Azienda ULSS 8 Berica - Divisione Malattie Infettive

    RECRUITING

    Vicenza, Veneto, Italy

  • BLQ Check Point

    RECRUITING

    Bologna, Emilia-Romagna, Italy

  • Circolo Mario Mieli

    RECRUITING

    Rome, Lazio, Italy

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Divisione di Malattie Infettive

    NOT_YET_RECRUITING

    Milan, Lombardy, Italy

  • INMI "L. Spallanzani" IRCCS - U.O.C. Immunodeficienze Virali

    RECRUITING

    Rome, Lazio, Italy

  • Istituti Ospitalieri di Cremona - U.O. Malattie Infettive

    NOT_YET_RECRUITING

    Cremona, Lombardy, Italy

  • Ospdale San Carlo

    NOT_YET_RECRUITING

    Potenza, Basilicate, Italy

  • Ospedale Amedeo di Savoia, Università degli Studi di Torino - Clinica di Malattie Infettive

    RECRUITING

    Turin, Piedmont, Italy

  • Ospedale Bel Colle Viterbo - U.O.C. Medicina protetta - Malattie infettive

    NOT_YET_RECRUITING

    Viterbo, Lazio, Italy

  • Ospedale Civile Santo Spirito - U.O. Malattie Infettive

    NOT_YET_RECRUITING

    Pescara, Abruzzo, Italy

  • Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive

    NOT_YET_RECRUITING

    Chieti, Abruzzo, Italy

  • Ospedale Paolo Borsellino - Unità Operativa Complessa Malattie Infettive - ASP

    NOT_YET_RECRUITING

    Marsala, Sicily, Italy

  • Ospedale San Raffaele, Università Vita-Salute - Clinica Malattie Infettive

    RECRUITING

    Milan, Lombardy, Italy

  • Ospedale Santa Chiara di Trento - Unità Operativa di Malattie Infettive

    NOT_YET_RECRUITING

    Trento, Trentino-Alto Adige, Italy

  • Ospedale Santa Maria Annunziata - Azienda Sanitaria di Firenze - U.O. di Malattie Infettive

    NOT_YET_RECRUITING

    Florence, Tuscany, Italy

  • PO "Umberto I" ASP

    RECRUITING

    Enna, Sicily, Italy

  • Policlinico Universitario Duilio Casula, AOU di Cagliari - Medicina Interna e Malattie del Fegato

    NOT_YET_RECRUITING

    Cagliari, Sardinia, Italy

  • Presidio Ospedaliero A.O.U. Vanvitelli - U.O. di Malattie Infettive

    NOT_YET_RECRUITING

    Naples, Campania, Italy

  • Presidio Ospedaliero di Pistoia - U.O. Malattie Infettive II

    NOT_YET_RECRUITING

    Pistoia, Tuscany, Italy

  • Roma Check Point

    RECRUITING

    Rome, Lazio, Italy

  • Università Cattolica del Sacro Cuore - Istituto di Clinica delle Malattie Infettive

    NOT_YET_RECRUITING

    Rome, Lazio, Italy

  • Università Sapienza Polo Pontino - U.O. di Malattie Infettive

    NOT_YET_RECRUITING

    Latina, Lazio, Italy

  • Università degli Studi "La Sapienza" - Dipartimento di Malattie Infettive e Tropicali

    RECRUITING

    Rome, Lazio, Italy

  • Università degli Studi di Modena e Reggio Emilia, Modena - Clinica di Malattie Infettive e Tropicali

    RECRUITING

    Modena, Emilia-Romagna, Italy

  • Università degli Studi di Roma, Policlinico "Tor Vergata" - Divisione di Malattie Infettive

    NOT_YET_RECRUITING

    Rome, Lazio, Italy

  • Università della Campania Luigi Vanvitelli - Malattie Infettive

    NOT_YET_RECRUITING

    Caserta, Campania, Italy

  • Università di Genova e Ospedale Policlinico San Martino - Clinica di Malattie Infettive

    NOT_YET_RECRUITING

    Genoa, Liguria, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.