Prevention ICONA Dedicated Ensemble
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione ICONA
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: PrIDE Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
Perioperative/PeriproceduralSecondary outcomes
1
Tolerability of PrEP expressed as the number of adverse events per person-years of follow-up after study enrollment
Time frame
Perioperative/Periprocedural2
Assess behavioral-related factors influencing PrEP use and persistence in care through questionnaires
Values monitored through ePROs questionnaire completed by participants at each visit.
Time frame
Perioperative/Periprocedural3
Assess adherence-related factors influencing PrEP use and persistence in care through questionnaire
Time frame
Perioperative/PeriproceduralSponsors and contacts
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Source ClinicalTrials.gov