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

NCT ID: NCT06600087

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-06-03

Brief Summary

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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

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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.

Conditions

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HIV Infections Sexually Transmitted Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PrEP less than a year

Questionnaire

Intervention Type BEHAVIORAL

Standardized self-administered questionnaire specifically designed for this study.

PrEP for over a year

Questionnaire

Intervention Type BEHAVIORAL

Standardized self-administered questionnaire specifically designed for this study.

Interventions

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Questionnaire

Standardized self-administered questionnaire specifically designed for this study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe JOSEPH, Prof

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Cegidd de Bordeaux

Bordeaux, , France

Site Status

CHU de Bordeaux - Service de médecine interne et maladies infectieuses

Bordeaux, , France

Site Status

Maison de la Santé de l'Hôpital Saint-André - Médecine Générale

Bordeaux, , France

Site Status

Cabinet de Medecine Generale

Fargues-Saint-Hilaire, , France

Site Status

Cabinet de Medecine Generale

Le Teich, , France

Site Status

Cegidd de Libourne

Libourne, , France

Site Status

Cabinet de Medecine Generale

Mérignac, , France

Site Status

Cegidd de Perigueux

Périgueux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2024/03

Identifier Type: -

Identifier Source: org_study_id

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