Clinical trial NCT03995862: Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region
Official title: Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Exposure Prophylaxis
HIV Seronegativity
Drug Combination
Keywords: tenofovir disoproxil fumarate and emtricitabine combination
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Wardship patient
* Patient under curatorship
* Patient unable to give his non-opposition to the use of his health data

Primary outcomes:
measure: Questionnaire
timeFrame: one day
Secondary outcomes:
measure: Incidence of HIV infections in PrEP patients and their management
timeFrame: up to 3 years
measure: Use of post-exposure treatment
timeFrame: up to 3 years
measure: Adherence to PrEP
timeFrame: one month
measure: Tolerance of PrEP
timeFrame: up to 3 years
measure: Impact of PrEP on the evolution of risky sexual behavior
timeFrame: 4 weeks
measure: Sexually Transmitted Infections
timeFrame: up to 3 years
measure: Impact of PrEP in HIV and hepatitis screening
timeFrame: one day
Other outcomes:
Locations:
city: Belley
country: France
facility: CH de Belley
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Contamine-sur-Arve
country: France
facility: CH Alpes Léman
city: La Tronche
country: France
facility: CHU Grenoble
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Sallanches
country: France
facility: CH de Sallanches
Study officials:
affiliation: CH Annecy Genevois
name: Cecile Janssen, MD
role: PRINCIPAL_INVESTIGATOR
References: