Quality of Sexual Life of PrEP Users

Adult Clinical Trial

— PREP-QUAL-VS  

Official title:

Quality of Sexual Life of PrEP Users

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286527
• Other study ID #: EssaiClinique_PREP-QUAL-VS
• Status: Not yet recruiting
• Start date: March 6, 2024
• Est. completion date: September 6, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Grenoble
• Contact: Olivier Epaulard, MD, PhD
• Phone: +33476765291
• Email: oepaulard[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France. PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life.

Description:

PrEP aims to protect against HIV; more broadly, PrEP is a holistic process, addressing vaccination (hepatitis A, hepatitis B, human papillomavirus, MPox), sexually transmitted infection diagnosis, mental health, issues related to psychoactive substance use, etc. This process is likely to impact not only "classical" health areas, but also fields concerning more widely the quality of life. In particular, the investigators emit the hypothesis that PrEP is associated with an increase of the quality of sexual life. the investigators have therefore designed a study based on a self-administered anonymous questionnaire to explore how PrEP user evaluate their quality of sexual life and how they perceive the impact of PrEP on this topic. Adult PrEP users will be recruited through billboard in sexual health center or another PrEP facility in France. A QR (quick response) code will be displayed, giving access to the questionnaire. Participation to the study is limited to fill once the questionnaire.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 6, 2024
• Est. primary completion date: September 6, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• current PrEP use
• adult

Exclusion Criteria:

• unwilling to participate

Related Conditions & MeSH terms

• Adult

Intervention

Other:
• anonymous self-administered online questionnaire
proposition to participate through billboards with a QR code leading to the questionnaire.

Locations

Country	Name	City	State
France	Olivier EPAULARD	Grenoble	Is

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of sexual life as assessed by a set of questions	The study relies on a self-administered, online, anonymous questionnaire of 40 questions. Some of these questions will allow assessing the perceived quality of sexual life, by exploring if participants are satisfied with the number of their partners, the sexual intercourses they have, the orgasms they reach, the lack of anxiety during mating and sexual intercourse, the bond they create with their partner(s), the feeling of fulfilment they have regarding their sexual intercourses. THE ANSWERS TO THE DATA WILL NOT BE USED TO CREATE A NUMERICAL SCALE.	inclusion
Primary	perceived influence of PrEP use on the quality of sexual life	Some questions of the already mentioned self-administered, online, anonymous questionnaire will allow assessing the perceived link between PrEP and quality of sexual life. More precisely, Participants will be asked the extent to which they see a link between PrEP use and the perceived quality of their sexual life in different axes (physical, emotional).	inclusion