HIV InfectionPREPNCT03975517
Sexual Risks in Prep Users
An observational study of HIV Infection and Prep Prescription, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infection, Prep Prescription, Vaccinations
- What is being tested?
- PrEP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2019to 5 Mar 2020
- 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: Non HIV-infected subjects, who have a high risk to be infected by HIV, mostly because of non protected sexual intercourse. Most of them are MSM (men who have sex with men). And who started Prep (emtricitable/tenofovir disoproxil fumarate), or will initiate Prep
Who may be able to join
- non HIV-infected subjects
- men aged 18 years or older
- having non protected sexual relationship
- taking Prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand
- affiliated to social security
Who cannot join
- HIV-infected patients
- refusal of study participation
- not on Prep
- not fluent in French language
- safeguarding justice
- on guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.
Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.
- Being tested
- PrEP
- Keywords
- Prep, Sexual behavior, HIV, Syphilis, Chlamydia infection, Hepatitis, Gonococcus
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Syphilis, Chlamydia Infections, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPBehavioural
Define the behavioral characteristics of the active file of patients using PrEP in Strasbourg in 2019.
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of sexual behavior in Prep users
Sexual behavior will be evaluated with a questionnaire
Measured: 6 months
Secondary outcomes (1)
Description of the medical profile of the Strasbourgeoise active file
Describe the active line of people using Prep and followed in the center
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start4 Jun 2019
- Primary completion4 Jun 2019
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David REY, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975517
- Sponsor's protocol ID
- 7300
- Acronym
- PREP
- Status last verified
- Dec 2022
- First submitted
- 18 Mar 2019
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)
- ClinicalTrials.gov ID
- NCT03975517
- Acronym / sponsor ID
- PREP / 7300
- Keywords
- Prep, Sexual behavior, HIV, Syphilis, Chlamydia infection, Hepatitis, Gonococcus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 5 Jun 2019 (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.
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.
Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.
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
- Non HIV-infected subjects, who have a high risk to be infected by HIV, mostly because of non protected sexual intercourse. Most of them are MSM (men who have sex with men). And who started Prep (emtricitable/tenofovir disoproxil fumarate), or will initiate Prep
Key inclusion criteria (5 listed)
- non HIV-infected subjects
- men aged 18 years or older
- having non protected sexual relationship
- taking Prep (emtricitable/tenofovir disoproxil fumarate) either every day, or on-demand
- affiliated to social security
Key exclusion criteria (6 listed)
- HIV-infected patients
- refusal of study participation
- not on Prep
- not fluent in French language
- safeguarding justice
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 |
|---|---|---|
| PrEPDefine the behavioral characteristics of the active file of patients using PrEP in Strasbourg in 2019. | Behavioural | – |
Primary outcome
Analysis of sexual behavior in Prep users
Time frame: 6 months
Sexual behavior will be evaluated with a questionnaire
1 secondary outcome
Description of the medical profile of the Strasbourgeoise active file
Time frame: 6 months
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 19 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
David REY principal investigator
Hôpitaux Universitaires de Strasbourg
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 Infection and Prep Prescription, run by University Hospital, Strasbourg, France 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 5 inclusion and 6 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 19 Dec 2022. 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?
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?
Analysis of sexual behavior in Prep users (time frame: 6 months). 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 19 Dec 2022.