NCT06600087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 12, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

Pre-Exposure ProphylaxisHIV PreventionSexually Transmitted InfectionsLong-term EffectsBehavioral Trends

Outcome Measures

Primary Outcomes (1)

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

    At baseline (Day 0)

Secondary Outcomes (4)

  • 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)

Study Arms (2)

PrEP less than a year

Behavioral: Questionnaire

PrEP for over a year

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Standardized self-administered questionnaire specifically designed for this study.

PrEP for over a yearPrEP less than a year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants on Pre-Exposure Prophylaxis (PrEP) for HIV

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals with known HIV positivity;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cegidd de Bordeaux

Bordeaux, France

Location

CHU de Bordeaux - Service de médecine interne et maladies infectieuses

Bordeaux, France

Location

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

Bordeaux, France

Location

Cabinet de Medecine Generale

Fargues-Saint-Hilaire, France

Location

Cabinet de Medecine Generale

Le Teich, France

Location

Cegidd de Libourne

Libourne, France

Location

Cabinet de Medecine Generale

Mérignac, France

Location

Cegidd de Perigueux

Périgueux, France

Location

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Philippe JOSEPH, Prof

    jean-philippe.joseph@u-bordeaux.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

November 4, 2024

Primary Completion

June 3, 2025

Study Completion

June 3, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations