Sexual Risks in Prep Users

NCT03975517 | Completed

• 1 other identifier: 7300
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Prep Prescription; Vaccinations; Sexually Transmitted Diseases

Keywords

Prep; Sexual behavior; HIV; Syphilis; Chlamydia infection; Hepatitis; Gonococcus

Outcome Measures

Primary Outcomes (1)

• Analysis of sexual behavior in Prep users

  Sexual behavior will be evaluated with a questionnaire

  6 months

Secondary Outcomes (1)

• Description of the medical profile of the Strasbourgeoise active file

  6 months

Interventions

PrEP BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Sexual Behavior; Syphilis; Chlamydia Infections; Hepatitis

Condition Hierarchy (Ancestors)

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

Study Officials

• David REY

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: June 5, 2019
• Study Start: June 4, 2019
• Primary Completion: June 4, 2019
• Study Completion: March 5, 2020
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

FR (1)