Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-29

Study Completion Date

2022-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre-Exposure Prophylaxis HIV Seronegativity Drug Combination

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaire

Intervention Type OTHER

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).

Interventions

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Questionnaire

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).

Intervention Type OTHER

Eligibility Criteria

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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