Sexual Risks in Prep Users

Completed

• Conditions: Sexually Transmitted Diseases; HIV Infection; Prep Prescription; Vaccinations

• Registration Number: NCT03975517
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.

Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-06-03
• Study Start: 2019-06-04
• Primary Completion: 2019-06-04
• Study First Posted: 2019-06-05
• Study Completion: 2020-03-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• non HIV-infected subjects
• men aged 18 years or older
• having non protected sexual relationship
• taking Prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand
• affiliated to social security

Exclusion criteria:

• HIV-infected patients
• refusal of study participation
• not on Prep
• not fluent in French language
• safeguarding justice
• on guardianship or trusteeship

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of sexual behavior in Prep users	6 months	Sexual behavior will be evaluated with a questionnaire

Secondary Outcome Measures

Name	Time	Method
Description of the medical profile of the Strasbourgeoise active file	6 months	Describe the active line of people using Prep and followed in the center

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France