NCT06286527

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

January 18, 2024

Last Update Submit

May 23, 2024

Conditions

Keywords

PrEP (HIV pre-exposure prophylaxis)quality of lifesexual life

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

adult PrEP users

Other: anonymous self-administered online questionnaire

Interventions

proposition to participate through billboards with a QR code leading to the questionnaire.

adult PrEP users

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

current PrEP users in sexual health centers or other PrEP facilities

You may qualify if:

  • current PrEP use
  • adult

You may not qualify if:

  • unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olivier EPAULARD

Grenoble, Is, 38043, France

RECRUITING

Central Study Contacts

Olivier Epaulard, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 29, 2024

Study Start

February 15, 2024

Primary Completion

September 6, 2024

Study Completion

September 6, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations