Clinical trial NCT06600087: Exploring Long-term Risks and STI Prevalence in Pre-Exposure Prophylaxis Users in Gironde, France
Official title: Long-term Evolution of Risky Sexual Behaviors and Prevalence of Sexually Transmitted Infections Among Pre-Exposure Prophylaxis Users: A Retrospective Observational Study in Gironde, France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: Pre-Exposure Prophylaxis
HIV Prevention
Sexually Transmitted Infections
Long-term Effects
Behavioral Trends
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants on Pre-Exposure Prophylaxis (PrEP) for HIV

Brief summary: SAFER-PrEP investigates the long-term impact of Pre-Exposure Prophylaxis (PrEP) on risky sexual behaviors and Sexually Transmitted Infection (STI) prevalence among users in Aquitaine. The study aims to compare STI rates over the last three months between individuals on PrEP for over a year and those on PrEP for less than a year. This retrospective observational research offers insights into the evolving dynamics of sexual health practices, informing future PrEP prescriptions and enhancing preventive strategies.

Detailed description: Scientific Rationale: The SAFER-PrEP study stems from the imperative to comprehend the intricate interplay between Pre-Exposure Prophylaxis (PrEP) utilization and sexual health dynamics. Amidst the increasing adoption of PrEP for HIV prevention, concerns arise regarding potential behavioral shifts and heightened risks for Sexually Transmitted Infections (STIs). The comprehensive investigation into these phenomena seeks to provide nuanced insights into the long-term implications of PrEP, contributing valuable data to public health initiatives and refining prevention strategies in the face of evolving sexual health landscapes.

Procedure: Participants, comprising individuals on PrEP for over a year and those for less than a year, will be engaged through a observational approach. Data will be collected via self-administered questionnaires during routine consultations for PrEP renewal in various medical settings, including hospitals and private practices. This comprehensive strategy enables a nuanced exploration of sexual behaviors and STI prevalence.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 years old;
* Participants using PrEP for at least 6 months ;
* French-speaking, without comprehension disorders ;
* being affiliated to health insurance ;
* Willing to participate and to sign informed consent.

Exclusion Criteria:

* Individuals with known HIV positivity;

Primary outcomes:
measure: Prevalence of Sexually Transmitted Infections (STIs) within the last three months
timeFrame: At baseline (Day 0)
Secondary outcomes:
measure: Prevalence of risky sexual behaviors in the last three months.
timeFrame: At baseline (Day 0)
measure: Description of the population of PrEP users in Aquitaine.
timeFrame: At baseline (Day 0)
measure: Behavioral trends in PrEP users based on self-administered questionnaires.
timeFrame: At baseline (Day 0)
measure: Comparison of STI prevalence between PrEP users for over a year and those for less than a year.
timeFrame: At baseline (Day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Cegidd de Bordeaux
city: Bordeaux
country: France
facility: CHU de Bordeaux - Service de médecine interne et maladies infectieuses
city: Bordeaux
country: France
facility: Maison de la Santé de l'Hôpital Saint-André - Médecine Générale
city: Fargues-Saint-Hilaire
country: France
facility: Cabinet de Medecine Generale
city: Le Teich
country: France
facility: Cabinet de Medecine Generale
city: Libourne
country: France
facility: Cegidd de Libourne
city: Mérignac
country: France
facility: Cabinet de Medecine Generale
city: Périgueux
country: France
facility: Cegidd de Perigueux
Study officials:
affiliation: jean-philippe.joseph@u-bordeaux.fr
name: Jean-Philippe JOSEPH, Prof
role: PRINCIPAL_INVESTIGATOR
References: