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Completed

NCT Number: NCT06600087

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Questionnaire

Behavioral

Standardized self-administered questionnaire specifically designed for this study.

Primary outcomes

  1. Prevalence of Sexually Transmitted Infections (STIs) within the last three months

    Time frame: At baseline (Day 0)

Secondary outcomes

  1. Prevalence of risky sexual behaviors in the last three months.

    Time frame: At baseline (Day 0)

  2. Description of the population of PrEP users in Aquitaine.

    Time frame: At baseline (Day 0)

  3. Behavioral trends in PrEP users based on self-administered questionnaires.

    Time frame: At baseline (Day 0)

  4. Comparison of STI prevalence between PrEP users for over a year and those for less than a year.

    Time frame: At baseline (Day 0)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: SAFER-PrEP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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