Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region

NCT03995862 | Completed

• 2 other identifiers: 18-39-PrEP2A2018-A02993-52
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 6

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.

Conditions

Pre-Exposure Prophylaxis; HIV Seronegativity; Drug Combination

Keywords

tenofovir disoproxil fumarate and emtricitabine combination

Outcome Measures

Primary Outcomes (1)

• 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

  one day

Secondary Outcomes (7)

• Incidence of HIV infections in PrEP patients and their management

  up to 3 years

• Use of post-exposure treatment

  up to 3 years

• Adherence to PrEP

  one month

• Tolerance of PrEP

  up to 3 years

• Impact of PrEP on the evolution of risky sexual behavior

  4 weeks

Study Arms (1)

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.

Other: Questionnaire

Interventions

Questionnaire 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).

Patients in care, at high risk of HIV infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (6)

CH de Belley

Belley, France

Location

CH Métropole Savoie

Chambéry, 73000, France

Location

CH Alpes Léman

Contamine-sur-Arve, France

Location

CHU Grenoble

La Tronche, 38000, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

Location

CH de Sallanches

Sallanches, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cecile Janssen, MD

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 24, 2019
• Study Start: May 29, 2019
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (6)