HIV InfectionsSAFER-PrEPNCT06600087
Exploring Long-term Risks and STI Prevalence in Pre-Exposure Prophylaxis Users in Gironde, France
An observational study of HIV Infections and Sexually Transmitted Diseases, run by University Hospital, Bordeaux at 8 sites in France.
Trial summary
SAFER-PrEP investigates the long-term impact of Pre-Exposure Prophylaxis (PrEP) on risky sexual behaviors and Sexually Transmitted Infection (STI) prevalence among users in Aquitaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 248 participants
- Where
- 8 sitesFrance
- Study dates
- 4 Nov 2024to 3 Jun 2025
- 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: Participants on Pre-Exposure Prophylaxis (PrEP) for HIV
Who may be able to join
- Aged over 18 years old;
- Participants using PrEP for at least 6 months ;
- French-speaking, without comprehension disorders ;
- being affiliated to health insurance ;
- Willing to participate and to sign informed consent.
Who cannot join
- Individuals with known HIV positivity;
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Cegidd de Bordeaux
Bordeaux
CHU de Bordeaux - Service de médecine interne et maladies infectieuses
Bordeaux
Maison de la Santé de l'Hôpital Saint-André - Médecine Générale
Bordeaux
Cabinet de Medecine Generale
Fargues-Saint-Hilaire
Cabinet de Medecine Generale
Le Teich
Cegidd de Libourne
Libourne
Cabinet de Medecine Generale
Mérignac
Cegidd de Perigueux
Périgueux
About this study
Official title: Long-term Evolution of Risky Sexual Behaviors and Prevalence of Sexually Transmitted Infections Among Pre-Exposure Prophylaxis Users: A Retrospective Observational Study in Gironde, France
SAFER-PrEP investigates the long-term impact of Pre-Exposure Prophylaxis (PrEP) on risky sexual behaviors and Sexually Transmitted Infection (STI) prevalence among users in Aquitaine. The study aims to compare STI rates over the last three months between individuals on PrEP for over a year and those on PrEP for less than a year. This retrospective observational research offers insights into the evolving dynamics of sexual health practices, informing future PrEP prescriptions and enhancing preventive strategies.
Read the detailed description
Scientific Rationale: The SAFER-PrEP study stems from the imperative to comprehend the intricate interplay between Pre-Exposure Prophylaxis (PrEP) utilization and sexual health dynamics. Amidst the increasing adoption of PrEP for HIV prevention, concerns arise regarding potential behavioral shifts and heightened risks for Sexually Transmitted Infections (STIs). The comprehensive investigation into these phenomena seeks to provide nuanced insights into the long-term implications of PrEP, contributing valuable data to public health initiatives and refining prevention strategies in the face of evolving sexual health landscapes.
Procedure: Participants, comprising individuals on PrEP for over a year and those for less than a year, will be engaged through a observational approach. Data will be collected via self-administered questionnaires during routine consultations for PrEP renewal in various medical settings, including hospitals and private practices. This comprehensive strategy enables a nuanced exploration of sexual behaviors and STI prevalence.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Questionnaire
- Keywords
- Pre-Exposure Prophylaxis, HIV Prevention, Sexually Transmitted Infections, Long-term Effects, Behavioral Trends
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Standardized self-administered questionnaire specifically designed for this study.
| Study group | Role | What they receive |
|---|---|---|
| PrEP less than a year | Not described Receives: Behavioral: Questionnaire | |
| PrEP for over a year | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sexually Transmitted Infections (STIs) within the last three months
Measured: At baseline (Day 0)
Secondary outcomes (4)
Prevalence of risky sexual behaviors in the last three months.
Measured: At baseline (Day 0)
Description of the population of PrEP users in Aquitaine.
Measured: At baseline (Day 0)
Behavioral trends in PrEP users based on self-administered questionnaires.
Measured: At baseline (Day 0)
Comparison of STI prevalence between PrEP users for over a year and those for less than a year.
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Nov 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe JOSEPH, Prof, Principal investigator, jean-philippe.joseph@u-bordeaux.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600087
- Sponsor's protocol ID
- CHUBX 2024/03
- Acronym
- SAFER-PrEP
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evolution of Risky Sexual Behaviors and Prevalence of Sexually Transmitted Infections Among Pre-Exposure Prophylaxis Users: A Retrospective Observational Study in Gironde, France
- ClinicalTrials.gov ID
- NCT06600087
- Acronym / sponsor ID
- SAFER-PrEP / CHUBX 2024/03
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Pre-Exposure Prophylaxis, HIV Prevention, Sexually Transmitted Infections, Long-term Effects, Behavioral Trends
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 19 Sep 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.
SAFER-PrEP investigates the long-term impact of Pre-Exposure Prophylaxis (PrEP) on risky sexual behaviors and Sexually Transmitted Infection (STI) prevalence among users in Aquitaine. The study aims to compare STI rates over the last three months between individuals on PrEP for over a year and those on PrEP for less than a year. This retrospective observational research offers insights into the evolving dynamics of sexual health practices, informing future PrEP prescriptions and enhancing preventive strategies.
Detailed description
Scientific Rationale: The SAFER-PrEP study stems from the imperative to comprehend the intricate interplay between Pre-Exposure Prophylaxis (PrEP) utilization and sexual health dynamics. Amidst the increasing adoption of PrEP for HIV prevention, concerns arise regarding potential behavioral shifts and heightened risks for Sexually Transmitted Infections (STIs). The comprehensive investigation into these phenomena seeks to provide nuanced insights into the long-term implications of PrEP, contributing valuable data to public health initiatives and refining prevention strategies in the face of evolving sexual health landscapes.
Procedure: Participants, comprising individuals on PrEP for over a year and those for less than a year, will be engaged through a observational approach. Data will be collected via self-administered questionnaires during routine consultations for PrEP renewal in various medical settings, including hospitals and private practices. This comprehensive strategy enables a nuanced exploration of sexual behaviors and STI prevalence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP less than a year | – | Behavioral: Questionnaire |
| PrEP for over a year | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants on Pre-Exposure Prophylaxis (PrEP) for HIV
Key inclusion criteria (5 listed)
- Aged over 18 years old;
- Participants using PrEP for at least 6 months ;
- French-speaking, without comprehension disorders ;
- being affiliated to health insurance ;
- Willing to participate and to sign informed consent.
Key exclusion criteria (1 listed)
- Individuals with known HIV positivity;
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 |
|---|---|---|
| QuestionnaireStandardized self-administered questionnaire specifically designed for this study. | Behavioural | PrEP for over a year, PrEP less than a year |
Primary outcome
Prevalence of Sexually Transmitted Infections (STIs) within the last three months
Time frame: At baseline (Day 0)
4 secondary outcomes
Prevalence of risky sexual behaviors in the last three months.
Time frame: At baseline (Day 0)
Description of the population of PrEP users in Aquitaine.
Time frame: At baseline (Day 0)
Behavioral trends in PrEP users based on self-administered questionnaires.
Time frame: At baseline (Day 0)
Comparison of STI prevalence between PrEP users for over a year and those for less than a year.
Time frame: At baseline (Day 0)
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 5 Sep 2025.
- 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.
Jean-Philippe JOSEPH, Prof principal investigator
jean-philippe.joseph@u-bordeaux.fr
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexually Transmitted Diseases, run by University Hospital, Bordeaux at 8 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 5 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: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Prevalence of Sexually Transmitted Infections (STIs) within the last three months (time frame: At baseline (Day 0)). 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 5 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.