HIV Pre-exposure Prophylaxis UsePREP-QUAL-VSNCT06286527
Quality of Sexual Life of PrEP Users
An observational study of HIV Pre-exposure Prophylaxis Use and Adult, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Pre-exposure Prophylaxis Use, Adult
- What is being tested?
- anonymous self-administered online questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2024to 6 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: current PrEP users in sexual health centers or other PrEP facilities
Who may be able to join
- current PrEP use
- adult
Who cannot join
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Olivier EPAULARD
Grenoble, Is, 38043
Olivier EPAULARD, MD, PhD, +33476765291, oepaulard@chu-grenoble.fr
About this study
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.
Read the 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.
- Conditions
- HIV Pre-exposure Prophylaxis Use, Adult
- Being tested
- anonymous self-administered online questionnaire
- Keywords
- PrEP (HIV pre-exposure prophylaxis), quality of life, sexual life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anonymous self-administered online questionnaireOther
proposition to participate through billboards with a QR code leading to the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| adult PrEP users | Not described Receives: Other: anonymous self-administered online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Feb 2024
- Primary completion6 Sep 2024 (estimated)
- Study completion6 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Pre-exposure Prophylaxis UseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286527
- Sponsor's protocol ID
- EssaiClinique_PREP-QUAL-VS
- Acronym
- PREP-QUAL-VS
- Status last verified
- May 2024
- First submitted
- 18 Jan 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Sexual Life of PrEP Users
- ClinicalTrials.gov ID
- NCT06286527
- Acronym / sponsor ID
- PREP-QUAL-VS / EssaiClinique_PREP-QUAL-VS
- Conditions
- HIV Pre-exposure Prophylaxis Use, Adult
- Keywords
- PrEP (HIV pre-exposure prophylaxis), quality of life, sexual life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 6 Sep 2024 (estimated)
- Study completion
- 6 Sep 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult PrEP users | – | Other: anonymous self-administered online questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- current PrEP users in sexual health centers or other PrEP facilities
Key inclusion criteria (2 listed)
- current PrEP use
- adult
Key exclusion criteria (1 listed)
- unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anonymous self-administered online questionnaireproposition to participate through billboards with a QR code leading to the questionnaire. | Other | adult PrEP users |
Primary outcome
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Pre-exposure Prophylaxis Use and Adult, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Epaulard, MD, PhD (+33476765291, oepaulard@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of sexual life as assessed by a set of questions (time frame: inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.