Exploring Long-term Risks and STI Prevalence in Pre-Exposure Prophylaxis Users in Gironde, France

Recruiting

• Conditions: HIV Infections; Sexually Transmitted Diseases
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT06600087
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Study Start: 2024-11-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PrEP less than a year	Questionnaire	-
PrEP for over a year	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Prevalence of Sexually Transmitted Infections (STIs) within the last three months	At baseline (Day 0)

Secondary Outcome Measures

Name	Time	Method
Prevalence of risky sexual behaviors in the last three months.	At baseline (Day 0)
Description of the population of PrEP users in Aquitaine.	At baseline (Day 0)
Behavioral trends in PrEP users based on self-administered questionnaires.	At baseline (Day 0)
Comparison of STI prevalence between PrEP users for over a year and those for less than a year.	At baseline (Day 0)

Trial Locations

Locations (6)

Cabinet de Medecine Generale; 🇫🇷 Mérignac, France

Cegidd de Libourne; 🇫🇷 Libourne, France

Cegidd de Perigueux; 🇫🇷 Périgueux, France

Maison de la Santé de l'Hôpital Saint-André - Médecine Générale; 🇫🇷 Bordeaux, France

Cegidd de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Bordeaux - Service de médecine interne et maladies infectieuses; 🇫🇷 Bordeaux, France