Sexual Risks in Prep Users

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.

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Key information

Conditions

HIV Infection Bacterial Infections Bacterial Infections and Mycoses Behavior Blood-Borne Infections Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Digestive System Diseases Disease Attributes Genital Diseases Gram-Negative Bacterial Infections HIV Infections Hepatitis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prep Prescription RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases Vaccinations Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrEP

Behavioral

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

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

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: PREP

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Jun 5, 2019
Registry last updated: Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed