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NCT03975517 Clinical Trial

Sexual Risks in Prep Users

HIV Infection Clinical Trial

— PREP  

Official title:
Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03975517
Other study ID # 7300
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 4, 2019
Est. completion date March 5, 2020

Study information
Verified date December 2022
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 5, 2020
Est. primary completion date June 4, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Les Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of sexual behavior in Prep users Sexual behavior will be evaluated with a questionnaire 6 months
Secondary Description of the medical profile of the Strasbourgeoise active file Describe the active line of people using Prep and followed in the center 6 months
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