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Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region (PrEP2A)

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ClinicalTrials.gov Identifier: NCT03995862
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Annecy Genevois

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.


Condition or disease Intervention/treatment
Pre-Exposure Prophylaxis HIV Seronegativity Drug Combination Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 19, 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of HIV infections in PrEP patients and their management [ Time Frame: up to 3 years ]
    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)

  2. Use of post-exposure treatment [ Time Frame: up to 3 years ]
    Frequency of use of post-exposure treatment, reasons, tolerance and effectiveness

  3. Adherence to PrEP [ Time Frame: one month ]
    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)

  4. Tolerance of PrEP [ Time Frame: up to 3 years ]
    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

  5. Impact of PrEP on the evolution of risky sexual behavior [ Time Frame: 4 weeks ]
    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)

  6. Sexually Transmitted Infections [ Time Frame: up to 3 years ]
    Number of Sexually Transmitted Infections (syphilis, chlamydia, gonococci, hepatitis C) acquired under PrEP and evolution during follow-up

  7. Impact of PrEP in HIV and hepatitis screening [ Time Frame: one day ]
    Number of patients for HIV and/or Hepatitis positive at first consultation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995862


Contacts
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Contact: Emilie Piet, MD +33450496654 epiet@ch-annecygenevois.fr
Contact: Marion Noret +33456497240 mnoret@ch-annecygenevois.fr

Locations
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France
CH de Belley Recruiting
Belley, France
Contact: Dorothée Boissaud, MD         
CH Métropole Savoie Recruiting
Chambéry, France, 73000
Contact: Pierre Bouttaz, MD         
CH Alpes Léman Recruiting
Contamine-sur-Arve, France
Contact: Dominique Huguet, MD         
CHU Grenoble Recruiting
La Tronche, France, 38000
Contact: Olivier Epaulard, MD PHD         
Centre Hospitalier Annecy Genevois Recruiting
Metz-Tessy, France, 74374
Contact: Cecile Janssen, MD         
CH de Sallanches Recruiting
Sallanches, France
Contact: Alice Couturier, MD         
Sponsors and Collaborators
Centre Hospitalier Annecy Genevois
Investigators
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Principal Investigator: Cecile Janssen, MD Centre Hospitalier Annecy Genevois
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Responsible Party: Centre Hospitalier Annecy Genevois
ClinicalTrials.gov Identifier: NCT03995862    
Other Study ID Numbers: 18-39-PrEP2A
2018-A02993-52 ( Other Identifier: ANSM )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Annecy Genevois:
tenofovir disoproxil fumarate and emtricitabine combination