Status:
RECRUITING
Prevention ICONA Dedicated Ensemble
Lead Sponsor:
Fondazione ICONA
Conditions:
PrEP
PrEP Adherence Monitoring
Eligibility:
All Genders
18+ years
Brief 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 ...
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 coll...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
September 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT07186244
Start Date
September 9 2024
End Date
December 31 2033
Last Update
September 22 2025
Active Locations (53)
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1
Ospedale Clinicizzato SS. Annunziata - Scuola di Specializzazione di Malattie Infettive
Chieti, Abruzzo, Italy
2
Ospedale Civile Santo Spirito - U.O. Malattie Infettive
Pescara, Abruzzo, Italy
3
AOU Consorziale - Policlinico Giovanni XXIII - Struttura Complessa di Malattie Infettive
Bari, Apulia, Italy
4
A.O.U. Ospedali Riuniti di Foggia - U.O.C. di Malattie Infettive
Foggia, Apulia, Italy