Pre-exposure HIV Prophylaxis (PrEP)SatisPrePNCT05269199
Sexual Health Impact of Using Pre-exposure HIV Prophylaxis
An observational study of Pre-exposure HIV Prophylaxis (PrEP), run by University Hospital, Clermont-Ferrand at 7 sites in France.
Trial summary
Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pre-exposure HIV Prophylaxis (PrEP)
- How many people
- 56 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Apr 2022to 12 Mar 2023
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men who have sex with men (MSM), using Pre-Exposure HIV Prohylaxis (PrEP)
Who may be able to join
- Adult patient, male having sex with men, not infected with HIV, and using HIV prophylaxis by pre-exposure treatment (PrEP) for at least 1 year, received in consultation for renewal of this prescription.
- Able to give his non-opposition to participate in the research.
- Affiliation to a social security scheme.
Who cannot join
- Patient under curatorship/guardianship or safeguard of justice
- Refusal to participate
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH Brioude
Brioude
CEGIDD Clermont Ferrand
Clermont-Ferrand
CHU Clermont-Ferrand
Clermont-Ferrand
CH Le Puy en Velay
Le Puy-en-Velay
CH Montluçon
Montluçon
CH Moulins
Moulins
CH Vichy
Vichy
About this study
Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).
Read the detailed description
This study is perform to study the sexual health satisfaction of men who have sex with men (MSM), since the use pre-exposure HIV prophylaxis (PrEP), compared to the time before PrEP.
- Conditions
- Pre-exposure HIV Prophylaxis (PrEP)
- Keywords
- PrEP, MSM
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual health satisfaction
To study the sexual health satisfaction of men who have sex with men (MSM), since the use of HIV prophylaxis by pre-exposure treatment (PrEP), compared to the time before PrEP.
Measured: 1 day during the scheduled consultation
Secondary outcomes (4)
Sentimental satisfaction
To study the sentimental satisfaction since the use of HIV prophylaxis by treatment before exposure (PrEP), compared to the time before PrEP.
Measured: 1 day during the scheduled consultation
Risky behaviours
To study risky behaviours without, then on PrEP since the use of HIV prophylaxis by treatment before exposure (PrEP), compared to the time before PrEP.
Measured: 1 day during the scheduled consultation
Specific care
Describe the use of specific care during PrEP.
Measured: 1 day during the scheduled consultation
Predictors of satisfaction
Define possible predictors of satisfaction with PrEP.
Measured: 1 day during the scheduled consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Apr 2022
- Primary completion12 Sep 2022
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-exposure HIV Prophylaxis (PrEP)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269199
- Sponsor's protocol ID
- RNI 2021 JACOMET
- Acronym
- SatisPreP
- Status last verified
- Oct 2021
- First submitted
- 25 Feb 2022
- Last updated
- 1 May 2023
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health Impact of Using Pre-exposure HIV Prophylaxis
- ClinicalTrials.gov ID
- NCT05269199
- Acronym / sponsor ID
- SatisPreP / RNI 2021 JACOMET
- Conditions
- Pre-exposure HIV Prophylaxis (PrEP)
- Keywords
- PrEP, MSM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 7 Mar 2022 (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.
Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).
Detailed description
This study is perform to study the sexual health satisfaction of men who have sex with men (MSM), since the use pre-exposure HIV prophylaxis (PrEP), compared to the time before PrEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men who have sex with men (MSM), using Pre-Exposure HIV Prohylaxis (PrEP)
Key inclusion criteria (3 listed)
- Adult patient, male having sex with men, not infected with HIV, and using HIV prophylaxis by pre-exposure treatment (PrEP) for at least 1 year, received in consultation for renewal of this prescription.
- Able to give his non-opposition to participate in the research.
- Affiliation to a social security scheme.
Key exclusion criteria (2 listed)
- Patient under curatorship/guardianship or safeguard of justice
- Refusal 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.
Primary outcome
Sexual health satisfaction
Time frame: 1 day during the scheduled consultation
To study the sexual health satisfaction of men who have sex with men (MSM), since the use of HIV prophylaxis by pre-exposure treatment (PrEP), compared to the time before PrEP.
4 secondary outcomes
Sentimental satisfaction
Time frame: 1 day during the scheduled consultation
Risky behaviours
Time frame: 1 day during the scheduled consultation
Specific care
Time frame: 1 day during the scheduled consultation
Predictors of satisfaction
Time frame: 1 day during the scheduled consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-exposure HIV Prophylaxis (PrEP), run by University Hospital, Clermont-Ferrand at 7 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual health satisfaction (time frame: 1 day during the scheduled consultation). 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 1 May 2023.