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Sexual Risks in Prep Users (PREP)

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ClinicalTrials.gov Identifier: NCT03975517
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
HIV Infection Prep Prescription Vaccinations Sexually Transmitted Diseases Behavioral: PrEP

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)
Actual Study Start Date : June 4, 2019
Actual Primary Completion Date : June 4, 2019
Estimated Study Completion Date : June 2021

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


Primary Outcome Measures :
  1. Analysis of sexual behavior in Prep users [ Time Frame: 6 months ]
    Sexual behavior will be evaluated with a questionnaire


Secondary Outcome Measures :
  1. Description of the medical profile of the Strasbourgeoise active file [ Time Frame: 6 months ]
    Describe the active line of people using Prep and followed in the center



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Non HIV-infected subjects, who have a high risk to be infected by HIV, mostly because of non protected sexual intercourse.

Most of them are MSM (men who have sex with men). And who started Prep (emtricitable/tenofovir disoproxil fumarate), or will initiate Prep

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975517


Contacts
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Contact: David REY +33 3.69.55.13.51 David.rey@chru-strasbourg.fr

Locations
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France
Les Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: David REY    +33 3.69.55.13.51    David.rey@chru-strasbourg.fr   
Principal Investigator: David REY         
Sub-Investigator: Marie-Laure BATARD         
Sub-Investigator: Christine CHENEAU         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: David REY Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03975517     History of Changes
Other Study ID Numbers: 7300
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:
Prep
Sexual behavior
HIV
Syphilis
Chlamydia infection
Hepatitis
Gonococcus

Additional relevant MeSH terms:
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HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female