Quality of Sexual Life of PrEP Users (PREP-QUAL-VS)

May 23, 2024 updated by: University Hospital, Grenoble

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

Recruiting

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

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Is
      • Grenoble, Is, France, 38043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

current PrEP users in sexual health centers or other PrEP facilities

Description

Inclusion Criteria:

  • current PrEP use
  • adult

Exclusion Criteria:

  • unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adult PrEP users
Other: anonymous self-administered online questionnaire
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

September 6, 2024

Study Completion (Estimated)

September 6, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EssaiClinique_PREP-QUAL-VS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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