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CompletedNCT03975517PREPUpdated Dec 19, 2022

Sexual Risks in Prep Users

An observational study in HIV Infection, Prep Prescription and Vaccinations, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • HIV Infection
  • Prep Prescription
  • Vaccinations
  • Sexually Transmitted Diseases

Keywords

  • Prep
  • Sexual behavior
  • HIV
  • Syphilis
  • Chlamydia infection
  • Hepatitis
  • Gonococcus
03

In context

Sexually Transmitted Diseases

424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.

This study's enrollment of 200 is below the median of 513 across 74 observational studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion criteria:

  • HIV-infected patients
  • refusal of study participation
  • not on Prep
  • not fluent in French language
  • safeguarding justice
  • on guardianship or trusteeship
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • BehavioralPrEP

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

06

What researchers measure

Primary outcomes

  1. Analysis of sexual behavior in Prep users

    Sexual behavior will be evaluated with a questionnaire

    Time frame: 6 months

Secondary outcomes

  1. Description of the medical profile of the Strasbourgeoise active file

    Describe the active line of people using Prep and followed in the center

    Time frame: 6 months

07

Study locations

1 site
  • Les Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03975517
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jun 5, 2019
Start date
Jun 4, 2019
Primary completion
Jun 4, 2019
Completion
Mar 5, 2020
Last update
Dec 19, 2022

Study contacts

David REY
principal investigator · Hôpitaux Universitaires de Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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