Prevention of HIV in "Île-de-France"

NCT03113123 | Unknown DMC

• 2 other identifiers: ANRS PREVENIR2016-A01577-44
• Study Type: interventional
• Target: 3,257
• Locations: 1 country
• Sites: 22

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.

Conditions

HIV Infections

Keywords

Adherence; Prevention; Tenofovir; Emtricitabine; Antiretroviral; Prophylaxis; Men who have sex with men

Outcome Measures

Primary Outcomes (1)

• Reduction of new HIV diagnosis

  Number of new HIV infections

  three years

Secondary Outcomes (16)

• Number of recent infections

  three years

• Prevalence of HIV-infection at the screening visit (undiagnosed epidemic)

  two years

• Incidence of HIV infection

  three years

• Retention in the study

  two years

• Counselling

  three years

Study Arms (1)

PrEP with Truvada®

OTHER

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®

Interventions

PrEP with Truvada® DRUG

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.

Also known as: Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)

PrEP with Truvada®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (22)

Hôpital Avicenne

Bobigny, 93000, France

COMPLETED

Hôpital Jean Verdier

Bondy, 93143, France

COMPLETED

Hôpital Ambroise-Paré

Boulogne, 92104, France

COMPLETED

Hôpital Antoine Béclère

Clamart, 92141, France

COMPLETED

Hôpital Louis Mourier

Colombes, 92700, France

COMPLETED

Hôpital Henry Mondor

Créteil, 94010, France

COMPLETED

Hôpital Raymond Poincaré

Garches, 92380, France

COMPLETED

Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94275, France

COMPLETED

Centre Hospitalier Marc Jacquet

Melun, 77011, France

COMPLETED

Hôpital Cochin

Paris, 75006, France

COMPLETED

Hôpital Hôtel Dieu

Paris, 75181, France

COMPLETED

Hôpital Saint-Louis

Paris, 75475, France

RECRUITING

Hôpital Saint-Antoine

Paris, 75571, France

COMPLETED

Hôpital Pitié-Salpétrière

Paris, 75641, France

COMPLETED

Hôpital Pitié-Salpétrière

Paris, 75651, France

COMPLETED

Hôpital Necker-Enfants Malades

Paris, 75743, France

COMPLETED

Hôpital Bichat-Claude-Bernard

Paris, 75876, France

COMPLETED

Hôpital Européen Georges Pompidou

Paris, 75908, France

COMPLETED

Hôpital Tenon

Paris, 75970, France

RECRUITING

CHI Poissy Saint Germain en Laye

Saint-Germain-en-Laye, 78105, France

COMPLETED

Hôpital Foch

Suresnes, 92151, France

COMPLETED

Hôpital André Mignot

Versailles, 78157, France

COMPLETED

Related Publications (2)

• Protiere C, Sagaon-Teyssier L, Donadille C, Sow A, Gaubert G, Girard G, Mora M, Assoumou L, Beniguel L, Michels D, Ghosn J, Costagliola D, Rojas Castro D, Molina JM, Spire B; ANRS PREVENIR Study-Group. Perception of PrEP-related stigma in PrEP users: Results from the ANRS-PREVENIR cohort. HIV Med. 2023 Aug;24(8):938-945. doi: 10.1111/hiv.13491. Epub 2023 Apr 12.

  PMID: 37046178 DERIVED

• Molina JM, Ghosn J, Assoumou L, Delaugerre C, Algarte-Genin M, Pialoux G, Katlama C, Slama L, Liegeon G, Beniguel L, Ohayon M, Mouhim H, Goldwirt L, Spire B, Loze B, Surgers L, Pavie J, Lourenco J, Ben-Mechlia M, Le Mestre S, Rojas-Castro D, Costagliola D; ANRS PREVENIR Study Group. Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Lancet HIV. 2022 Aug;9(8):e554-e562. doi: 10.1016/S2352-3018(22)00133-3. Epub 2022 Jun 27.

  PMID: 35772417 DERIVED

Related Links

• sponsor of the study

MeSH Terms

Conditions

HIV Infections; Homosexuality

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jean-Michel MOLINA, Pr

  Hôpital Saint Louis, Paris, FRANCE

  PRINCIPAL INVESTIGATOR

• Jade GHOSN, MD

  Hôpital Hôtel-Dieu, Paris, FRANCE

  STUDY CHAIR

Central Study Contacts

Jean-Michel MOLINA, Pr

CONTACT

0142499066; jean-michel.molina@aphp.fr

Jade GHOSN, MD

CONTACT

0142348836; jade.ghosn@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: May 3, 2017
• Primary Completion: May 2, 2024
• Study Completion: October 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (22)