Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region

Pre-Exposure Prophylaxis Clinical Trial

— PrEP2A  

Official title:

Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995862
• Other study ID #: 18-39-PrEP2A
• Secondary ID: 2018-A02993-52
• Status: Completed
• Start date: May 29, 2019
• Est. completion date: April 6, 2022

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Combination
• HIV Seronegativity
• Pre-Exposure Prophylaxis

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	CH de Belley	Belley
France	CH Métropole Savoie	Chambéry
France	CH Alpes Léman	Contamine-sur-Arve
France	CHU Grenoble	La Tronche
France	Centre Hospitalier Annecy Genevois	Metz-Tessy
France	CH de Sallanches	Sallanches

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	up to 3 years
Secondary	Use of post-exposure treatment	Frequency of use of post-exposure treatment, reasons, tolerance and effectiveness	up to 3 years
Secondary	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)	one month
Secondary	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	up to 3 years
Secondary	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)	4 weeks
Secondary	Sexually Transmitted Infections	Number of Sexually Transmitted Infections (syphilis, chlamydia, gonococci, hepatitis C) acquired under PrEP and evolution during follow-up	up to 3 years
Secondary	Impact of PrEP in HIV and hepatitis screening	Number of patients for HIV and/or Hepatitis positive at first consultation	one day