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Prevention of HIV in "Île-de-France" (ANRS-PREVENIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03113123
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:

Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and women, heterosexual men and women, sex workers, migrants) in combination with overall prevention services (communautary-based or educational counselling; addiction, social and psychological care; condoms and lubricating gel; clean injection equipment; sexually transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV infection as soon as possible after diagnosis using an antiretroviral combination recommended by the French Guidelines on HIV treatment).

The individual benefit being already demonstrated in clinical trials, the aim is to demonstrate the public health impact of the interventional HIV prevention strategy by reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV infections among MSM/transgender in the Ile-de-France area after a 3-year period.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: PrEP with Truvada® Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3057 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of HIV in "Île-de-France"
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : April 3, 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
PrEP with Truvada®

On demand PrEP (only for MSM - with the possibility of dosing schedule switching): 2 pills of Truvada within 24 to 2 hours prior first sexual intercourse, then 1 pill every 24 hours during the period of sexual activity with one pill after the last sexual intercourse, and one last pill 24 hours later

Continuous PrEP: 1 pill every 24 hours, at least 7 days before the first sexual intercourse. When PrEP is to be discontinued, 2 pills 24 hours apart after the last sexual intercourse then stop PrEP. If PrEP is to be resumed, 1 pill every 24 hours, started at least 7 days before the first sexual intercourse or 2 pills at least 2 hours before the first sexual intercourse and then 1 pill every 24 hours.

Drug: PrEP with Truvada®

Associated with:

  • STD screening/treatment for syphilis, gonorrhoea and chlamydiae
  • HIV screening/therapy
  • Questionnaire
  • Addiction, social or psychological follow-up care if needed
  • Peer interactive counselling (peer counselors/nurses/physicians experienced with therapeutic education) at the baseline visit and at every follow-up visit up to 6 months. After 6 months, counselling will be provided at the request of participants if they need it. Counselors will remain in contact with the participants between visit to answer any questions relative to PrEP, treatment and prevention, and to facilitate participants interactions with study sites.
Other Name: Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)




Primary Outcome Measures :
  1. Reduction of new HIV diagnosis [ Time Frame: three years ]
    Number of new HIV infections


Secondary Outcome Measures :
  1. Number of recent infections [ Time Frame: three years ]
    Impact of the study on the total number and on recent HIV infections in Île-de- France, and in each key subgroup

  2. Prevalence of HIV-infection at the screening visit (undiagnosed epidemic) [ Time Frame: two years ]
    Number of HIV-infected persons at screening visit

  3. Incidence of HIV infection [ Time Frame: three years ]
    Incidence of HIV infection in Paris and in the Île-de-France area according to back-calculation approach, and by key subgroups (MSM, transgenders, migrants, etc.)

  4. Retention in the study [ Time Frame: two years ]
    Retention in the study, reasons for consent withdrawal

  5. Counselling [ Time Frame: three years ]
    Impact of a less intense counselling than the one provided in the ANRS IPERGAY trial, on adherence and efficacy of PrEP

  6. Type of counselling [ Time Frame: three years ]
    Impact of counselling according to the type of counselling provided: communautary-based or educational

  7. Post-exposure prophylaxis [ Time Frame: three years ]
    Evaluate the participants' need for post-exposure prophylaxis during the course of the study

  8. Adherence to PrEP [ Time Frame: three years ]

    Evaluation of adherence by self-administered online questionnaires on last sexual intercourse

    • Questionnaire on the use of PrEP during the last month prioir to study visit
    • Dried blood spots to assess TVF-DP and/or FTC-TP in red cells

  9. PrEP dosing schedule [ Time Frame: three years ]
    Assessment of the PrEP dosing schedule used by MSM participants (daily or intermittent) throughout the course of the study

  10. Safety and tolerability [ Time Frame: three years ]
    Assessment of PrEP tolerability and safety particularly: incidence of drug-related adverse events, incidence of grade 3-4 adverse events, incidence of adverse events leading to PrEP discontinuation

  11. Incident HIV infections [ Time Frame: three years ]

    Comprehensive study of incident HIV infections in those on PrEP Incidence of HIV-infection on PrEP

    • Emergence of drug-associated resistance mutations (in particular FTC and tenofovir- mutations at positions 184, 65, and 70 in reverse transcriptase gene)
    • Adherence to PrEP at the closest visit before HIV seroconversion and at previous visits

  12. Participants Behavior [ Time Frame: three years ]

    Acceptability of PrEP (including those who will decline participation in the study) and during the course of the study.

    Impact of PrEP, within a comprehensive prevention offer, on sexual behavior of the participants throughout follow-up

    • Number of partners during the previous 2 months
    • Number of sexual intercourses during the previous 4 weeks
    • Use of condom at last sexual intercourse
    • Incidence of STIs

  13. Integration of PrEP in the daily routine of participants [ Time Frame: three years ]
    • Factors associated with the integration of PrEP in the daily routine of participants

      - Qualitative study to explore the motivations, difficulties, behavior and expectations of the participants, their knowledge and communication on their use of PrEP. We will focus on:

    • Change in the use of sexual networks (internet, sex clubs, backrooms, sauna)
    • Feeling of sexual well-being during sexual intercourse (less worried about getting HIV infection)
    • Condom use (withdrawal of condom use)

  14. Care Providers Behavior [ Time Frame: three years ]
    Evaluation of knowledge, beliefs, perception and practice of the physicians, nurse and peer counselors involved in delivery of PrEP in the study

  15. Social epidemiology [ Time Frame: three years ]
    • Evaluation of social and/or territorial inequalities and disparities through collection of relevant indicators
    • Socio-economic status
    • Social insertion: marital status etc.
    • Origin (according to Ined definition) : french, french born from immigrant parents, immigrants
    • Précar score
    • Socio-economical background (according to IRIS indicator)

  16. Cost-effectiveness [ Time Frame: three years ]
    Cost-effectiveness of the comprehensive prevention strategy provided in this study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Men/transgender men/women who have sex with men, heterosexual men and women, sex workers
  • Negative for HIV-1 and HIV-2 (with a fourth generation enzyme-linked immunosorbent assay (ELISA) assay)
  • Willing the geocoding of the postal address and to be contacted via telephone or email, on a regular basis
  • Willing to comply to visits schedule (every 3 months)
  • Health security program
  • Informed consent form signed
  • High risk of acquiring HIV infection:

    • For MSM and transgenders:

      • Anal sex with at least two different sexual partners and no consistent condom use over the last 6 months
      • And/or history of STD during the last 12 months (syphilis, gonorrhea , chlamydiae, HBV or HCV infection)
      • And/or history of non-occupational post-exposure prophylaxis (PEP) during the last 12 months
      • And/or using psycho-actives drugs during sexual intercourses (cocaine, gammahydroxybutyric acid (GHB), Methylenedioxymethamphetamine (MDMA), mephedrone)
      • And/or having an HIV-infected sexual partner with a detectable plasma viral load (> 50 copies (cp)/milliliter (ml))
    • For heterosexual:

      • Sexual intercourse with 1 partner originating from regions with high prevalence of HIV infection (> 1%) (South America, Sub-Saharan Africa, South-East Asia, Eastern Europe, French Guyana) and no consistent condom use
      • and/or sex workers
      • and/or having a sexual partner who is an intravenous drug users sharing injection material
      • and/or having an HIV-infected sexual partner with a detectable plasma viral load (> 50 cp/ml)

Exclusion Criteria:

  • Stable and exclusive relationship with an HIV-negative partner, or with an HIV-positive partner on antiretroviral therapy (ART) with a plasma viral load < 50 cp/ml
  • Positive HIV infection
  • Clinical signs of positive HIV infection
  • Consistent condom use during sexual intercourse
  • Expected trip abroad for 3 consecutive months
  • Creatinine clearance lower than 50ml/min
  • History of chronic renal disease, osteoporosis or osteopenia
  • Receiving an investigational drug
  • Receiving or will receive potentially nephrotoxic treatments
  • Gastro-intestinal condition that could limit drug absorption
  • Potentially non compliant participants
  • Breastfeeding
  • Hypersensitivity to TDF/FTC
  • Positive HBs antigen or isolated anti hepatitis B core (HBc) antibodies if not willing to take daily PrEP
  • Severe condition (lymphoma, other cancers, cardio-vascular disease, end-stage renal failure, uncontrolled diabetes)

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): NCT03113123


Locations
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France
Hôpital Avicenne
Bobigny, France, 93000
Hôpital Jean Verdier
Bondy, France, 93143
Hôpital Ambroise-Paré
Boulogne, France, 92104
Hôpital Antoine Béclère
Clamart, France, 92141
Hôpital Louis Mourier
Colombes, France, 92700
Hôpital Henry Mondor
Creteil, France, 94010
Hôpital Raymond Poincaré
Garches, France, 92380
Hôpital de Bicêtre
Le Kremlin Bicêtre, France, 94275
Centre Hospitalier Marc Jacquet
Melun, France, 77011
Hôpital Cochin
Paris, France, 75006
Hôpital Hôtel Dieu
Paris, France, 75181
Hôpital Saint-Louis
Paris, France, 75475
Hôpital Saint-Antoine
Paris, France, 75571
Hôpital Pitié-Salpétrière
Paris, France, 75641
Hôpital Pitié-Salpétrière
Paris, France, 75651
Hôpital Necker-Enfants Malades
Paris, France, 75743
Hôpital Bichat-Claude-Bernard
Paris, France, 75876
Hôpital Européen Georges Pompidou
Paris, France, 75908
Hôpital Tenon
Paris, France, 75970
CHI Poissy Saint Germain en Laye
Saint Germain en Laye, France, 78105
Hôpital Foch
Suresnes, France, 92151
Hôpital André Mignot
Versailles, France, 78157
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
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Principal Investigator: Jean-Michel MOLINA, Pr Hôpital Saint Louis, Paris, FRANCE
Study Chair: Jade GHOSN, MD Hôpital Hôtel-Dieu, Paris, FRANCE

Additional Information:
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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03113123     History of Changes
Other Study ID Numbers: ANRS PREVENIR
2016-A01577-44 ( Registry Identifier: French Drug Regulatory Authorities Clinical Trial System )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Adherence
Prevention
Tenofovir
Emtricitabine
Antiretroviral
Prophylaxis
Men who have sex with men

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents