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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06600087

Acronym

SAFER-PrEP

Enrollment

248

Registered

2024-09-19

Start date

2024-11-04

Completion date

2025-06-03

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Diseases

Keywords

Pre-Exposure Prophylaxis, HIV Prevention, Sexually Transmitted Infections, Long-term Effects, Behavioral Trends

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.

Interventions

BEHAVIORALQuestionnaire

Standardized self-administered questionnaire specifically designed for this study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026