Pre-Exposure ProphylaxisPrEP2ANCT03995862
Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region
An observational study of Pre-Exposure Prophylaxis and HIV Seronegativity, run by Centre Hospitalier Annecy Genevois at 6 sites in France.
Trial summary
Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Exposure Prophylaxis, HIV Seronegativity, Drug Combination
- What is being tested?
- Questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 242 participants
- Where
- 6 sitesFrance
- Study dates
- 29 May 2019to 6 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients in care, at high risk of HIV infection, according to the criteria defined by the French Ministery Of Health for the use of FTC / TDF in PreP (men who have sex with men, transgender, heterosexual women migrants or not, sex workers (sexual intercourse in exchange for money, drugs, housing, food), intravenous drug users) HIV-negative, exposed by their sexual practices to a high risk of HIV infection.
Who may be able to join
- Patient having initiated or wishing to initiate PrEP according to the recommendations of the French High Authority of Health in the centers involved in the collection of data
- Patient informed of the study and having indicated his non opposition for the collection of his health data
Who cannot join
- Wardship patient
- Patient under curatorship
- Patient unable to give his non-opposition to the use of his health data
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH de Belley
Belley
CH Métropole Savoie
Chambéry, 73000
CH Alpes Léman
Contamine-sur-Arve
CHU Grenoble
La Tronche, 38000
Centre Hospitalier Annecy Genevois
Metz-Tessy, 74374
CH de Sallanches
Sallanches
About this study
Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does not decrease.
New HIV prevention strategies are therefore clearly needed. Since 2009, several studies have shown that tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), an antiretroviral therapy combining two nucleoside reverse transcriptase inhibitors used for the treatment of patients seropositive for HIV, has preventive activity on HIV transmission. These results enabled the TDF/FTC to obtain in France an extension of the marketing authorization in March 2017 for preexposure prophylaxis (PrEP) of HIV transmission among patients at high risk of contamination.
Read more
Since the approval, many studies around the world investigate the use of PrEP in routine practice, highlighting its effectiveness in real life. These studies describe the population of patients who benefit from PrEP in order to adapt their multidisciplinary care but also track the transmission of other sexually transmitted infections to prevent their emergence, given the observed decline in condom use. However, these studies are limited to big cities while PrEP is accessible in all territories.
The Rhône-Alpes region is one of the three French regions that has been the most involved in the implementation of PrEP, one year after the FTC/TDF approval in France. Given the geographical position of the investigators, both in province and close to Switzerland, where the FTC/TDF is not authorized for PrEP, and the non-university nature of five of the six involved hospitals, the investigators would like to determine the profile of patients consulting in this region to benefit from PrEP. This analysis will also determine if the population at risk of the "Alpine Arc" region is similar to that observed in the other cohorts in order to adapt patient care.
- Being tested
- Questionnaire
- Keywords
- tenofovir disoproxil fumarate and emtricitabine combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A questionnaire should be completed by the patient the day of inclusion. Health data will be collected in patients medical file from inclusion to the date of the end of study (i.e. no follow-up for the last patient included and a maximum of three years of follow-up for the first patient included).
| Study group | Role | What they receive |
|---|---|---|
| Patients in care, at high risk of HIV infection | Patients in care, at high risk of HIV infection, according to the criteria defined by the French Ministry Of Health for the use of FTC / TDF in PreP (men who have sex with men, transgender, heterosexual women migrants or not, sex workers (sexual intercourse in exchange for money, drugs, housing, food), intravenous drug users) HIV-negative, exposed by their sexual practices to a high risk of HIV infection. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Characterisation of people asking for HIV prophylaxis (either implementation or follow-up) : age, gender, past medical history and risk-taking of patients consulting for PrEP
Measured: one day
Secondary outcomes (7)
Incidence of HIV infections in PrEP patients and their management
Incidence of HIV infection in different key populations starting PrEP and according to PrEP use pattern (continuous or on demand) Frequency of HIV resistance to antiretrovirals (especially FTC and tenofovir - mutations at positions 184, 65, and 70 on the reverse transcriptase gene) Evaluation of the date of contamination (primary infection)
Measured: up to 3 years
Use of post-exposure treatment
Frequency of use of post-exposure treatment, reasons, tolerance and effectiveness
Measured: up to 3 years
Adherence to PrEP
Number of tablet consumption in the last month before the visit to the hospital as reported by the patients during the visit according to PrEP use pattern (continuous or on demand)
Measured: one month
Tolerance of PrEP
Number of Clinical and Biological Adverse Events Considered Related to PrEP and Serious (CTCAE v5.0, grade 3 and 4), or Those Leading to Discontinuation of PrEP
Measured: up to 3 years
Impact of PrEP on the evolution of risky sexual behavior
Number of sexual partners in the 4 weeks prior to visits Analysis of the last sex before the visit (type of sexual intercourse, use of the condom and / or PrEP)
Measured: 4 weeks
Sexually Transmitted Infections
Number of Sexually Transmitted Infections (syphilis, chlamydia, gonococci, hepatitis C) acquired under PrEP and evolution during follow-up
Measured: up to 3 years
Impact of PrEP in HIV and hepatitis screening
Number of patients for HIV and/or Hepatitis positive at first consultation
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start29 May 2019
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure ProphylaxisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile Janssen, MD, Principal investigator, CH Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995862
- Sponsor's protocol ID
- 18-39-PrEP2A
- Other IDs
- 2018-A02993-52
- Acronym
- PrEP2A
- Status last verified
- Feb 2024
- First submitted
- 14 Jun 2019
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region
- ClinicalTrials.gov ID
- NCT03995862
- Acronym / sponsor ID
- PrEP2A / 18-39-PrEP2A
- Keywords
- tenofovir disoproxil fumarate and emtricitabine combination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 24 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.
Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does not decrease.
New HIV prevention strategies are therefore clearly needed. Since 2009, several studies have shown that tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), an antiretroviral therapy combining two nucleoside reverse transcriptase inhibitors used for the treatment of patients seropositive for HIV, has preventive activity on HIV transmission. These results enabled the TDF/FTC to obtain in France an extension of the marketing authorization in March 2017 for preexposure prophylaxis (PrEP) of HIV transmission among patients at high risk of contamination.
Since the approval, many studies around the world investigate the use of PrEP in routine practice, highlighting its effectiveness in real life. These studies describe the population of patients who benefit from PrEP in order to adapt their multidisciplinary care but also track the transmission of other sexually transmitted infections to prevent their emergence, given the observed decline in condom use. However, these studies are limited to big cities while PrEP is accessible in all territories.
The Rhône-Alpes region is one of the three French regions that has been the most involved in the implementation of PrEP, one year after the FTC/TDF approval in France. Given the geographical position of the investigators, both in province and close to Switzerland, where the FTC/TDF is not authorized for PrEP, and the non-university nature of five of the six involved hospitals, the investigators would like to determine the profile of patients consulting in this region to benefit from PrEP. This analysis will also determine if the population at risk of the "Alpine Arc" region is similar to that observed in the other cohorts in order to adapt patient care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in care, at high risk of HIV infection | – | Other: QuestionnairePatients in care, at high risk of HIV infection, according to the criteria defined by the French Ministry Of Health for the use of FTC / TDF in PreP (men who have sex with men, transgender, heterosexual women migrants or not, sex workers (sexual intercourse in exchange for money, drugs, housing, food), intravenous drug users) HIV-negative, exposed by their sexual practices to a high risk of HIV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in care, at high risk of HIV infection, according to the criteria defined by the French Ministery Of Health for the use of FTC / TDF in PreP (men who have sex with men, transgender, heterosexual women migrants or not, sex workers (sexual intercourse in exchange for money, drugs, housing, food), intravenous drug users) HIV-negative, exposed by their sexual practices to a high risk of HIV infection.
Key inclusion criteria (2 listed)
- Patient having initiated or wishing to initiate PrEP according to the recommendations of the French High Authority of Health in the centers involved in the collection of data
- Patient informed of the study and having indicated his non opposition for the collection of his health data
Key exclusion criteria (3 listed)
- Wardship patient
- Patient under curatorship
- Patient unable to give his non-opposition to the use of his health data
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 |
|---|---|---|
| QuestionnaireA questionnaire should be completed by the patient the day of inclusion. Health data will be collected in patients medical file from inclusion to the date of the end of study (i.e. no follow-up for the last patient included and a maximum of three years of follow-up for the first patient included). | Other | Patients in care, at high risk of HIV infection |
Primary outcome
Questionnaire
Time frame: one day
Characterisation of people asking for HIV prophylaxis (either implementation or follow-up) : age, gender, past medical history and risk-taking of patients consulting for PrEP
7 secondary outcomes
Incidence of HIV infections in PrEP patients and their management
Time frame: up to 3 years
Use of post-exposure treatment
Time frame: up to 3 years
Adherence to PrEP
Time frame: one month
Tolerance of PrEP
Time frame: up to 3 years
Impact of PrEP on the evolution of risky sexual behavior
Time frame: 4 weeks
Sexually Transmitted Infections
Time frame: up to 3 years
Impact of PrEP in HIV and hepatitis screening
Time frame: one day
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 7 Feb 2024.
- 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.
Cecile Janssen, MD principal investigator
CH Annecy Genevois
6 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 Prophylaxis and HIV Seronegativity, run by Centre Hospitalier Annecy Genevois at 6 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 2 inclusion and 3 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Questionnaire (time frame: one day). 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 7 Feb 2024.