- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06286527
Quality of Sexual Life of PrEP Users (PREP-QUAL-VS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Olivier Epaulard, MD, PhD
- Phone Number: +33476765291
- Email: oepaulard@chu-grenoble.fr
Study Locations
-
-
Is
-
Grenoble, Is, France, 38043
- Recruiting
- Olivier EPAULARD
-
Contact:
- Olivier Epaulard, MD, PhD
- Phone Number: +33476765291
- Email: oepaulard@chu-grenoble.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- current PrEP use
- adult
Exclusion Criteria:
- unwilling to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adult PrEP users
|
proposition to participate through billboards with a QR code leading to the questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perceived influence of PrEP use on the quality of sexual life
Time Frame: inclusion
|
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
|
|
quality of sexual life as assessed by a set of questions
Time Frame: inclusion
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EssaiClinique_PREP-QUAL-VS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.