Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Analysis of sexual behavior in Prep users
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Analysis of sexual behavior in Prep users
Time Frame: 6 months
Sexual behavior will be evaluated with a questionnaire
Secondary Outcomes
- Description of the medical profile of the Strasbourgeoise active file(6 months)