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Clinical Trials/NCT06600087
NCT06600087
Completed
Not Applicable

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

University Hospital, Bordeaux6 sites in 1 country248 target enrollmentStarted: November 4, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University Hospital, Bordeaux
Enrollment
248
Locations
6
Primary Endpoint
Prevalence of Sexually Transmitted Infections (STIs) within the last three months

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Outcomes

Primary Outcomes

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

Time Frame: At baseline (Day 0)

Secondary Outcomes

  • 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))

Investigators

Sponsor
University Hospital, Bordeaux
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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