Sexual Risks in Prep Users

NCT ID: NCT03975517

Last Updated: 2022-12-19

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-04

Study Completion Date

2020-03-05

Brief Summary

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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

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Conditions

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HIV Infection Prep Prescription Vaccinations Sexually Transmitted Diseases

Keywords

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Prep Sexual behavior HIV Syphilis Chlamydia infection Hepatitis Gonococcus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PrEP

Define the behavioral characteristics of the active file of patients using PrEP in Strasbourg in 2019.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David REY

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7300

Identifier Type: -

Identifier Source: org_study_id