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

September 4, 2025 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Cegidd de Bordeaux
      • Bordeaux, France
        • CHU de Bordeaux - Service de médecine interne et maladies infectieuses
      • Bordeaux, France
        • Maison de la Santé de l'Hôpital Saint-André - Médecine Générale
      • Fargues-Saint-Hilaire, France
        • Cabinet de médecine générale
      • Le Teich, France
        • Cabinet de médecine générale
      • Libourne, France
        • Cegidd de Libourne
      • Mérignac, France
        • Cabinet de médecine générale
      • Périgueux, France
        • Cegidd de Perigueux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Participants on Pre-Exposure Prophylaxis (PrEP) for HIV

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PrEP less than a year
Behavioral: Questionnaire
Standardized self-administered questionnaire specifically designed for this study.
PrEP for over a year
Behavioral: Questionnaire
Standardized self-administered questionnaire specifically designed for this study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-Philippe JOSEPH, Prof, jean-philippe.joseph@u-bordeaux.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Actual)

June 3, 2025

Study Completion (Actual)

June 3, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2024/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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