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HIV InfectionsANRS-PREVENIRNCT03113123

Prevention of HIV in "Île-de-France"

A study testing PrEP with Truvada® in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 22 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
PrEP with Truvada®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,257 participants
Where
22 sitesFrance
Study dates
3 May 2017to Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
Show all 15Show fewer
  • 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)

Trial locations and contacts

22 sites in 1 country.

Jean-Michel MOLINA, Pr contact

0142499066

jean-michel.molina@aphp.fr

Jade GHOSN, MD contact

0142348836

jade.ghosn@aphp.fr

22 sites in 1 country

France22 sites, 2 recruiting

  • Hôpital Avicenne

    Bobigny, 93000

    Completed

  • Hôpital Jean Verdier

    Bondy, 93143

    Completed

  • Hôpital Ambroise-Paré

    Boulogne, 92104

    Completed

  • Hôpital Antoine Béclère

    Clamart, 92141

    Completed

  • Hôpital Louis Mourier

    Colombes, 92700

    Completed

  • Hôpital Henry Mondor

    Créteil, 94010

    Completed

  • Hôpital Raymond Poincaré

    Garches, 92380

    Completed

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275

    Completed

  • Centre Hospitalier Marc Jacquet

    Melun, 77011

    Completed

  • Hôpital Cochin

    Paris, 75006

    Completed

  • Hôpital Hôtel Dieu

    Paris, 75181

    Completed

  • Hôpital Saint-Louis

    Paris, 75475

    Jean-Michel Molina, MD

    Jean-Michel Molina, MD

    Recruiting

  • Hôpital Saint-Antoine

    Paris, 75571

    Completed

  • Hôpital Pitié-Salpétrière

    Paris, 75641

    Completed

  • Hôpital Pitié-Salpétrière

    Paris, 75651

    Completed

  • Hôpital Necker-Enfants Malades

    Paris, 75743

    Completed

  • Hôpital Bichat-Claude-Bernard

    Paris, 75876

    Completed

  • Hôpital Européen Georges Pompidou

    Paris, 75908

    Completed

  • Hôpital Tenon

    Paris, 75970

    Gilles Pialoux, MD

    Gilles Pialoux, MD

    Recruiting

  • CHI Poissy Saint Germain en Laye

    Saint-Germain-en-Laye, 78105

    Completed

  • Hôpital Foch

    Suresnes, 92151

    Completed

  • Hôpital André Mignot

    Versailles, 78157

    Completed

Other trials in France

About this study

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.

Read the detailed description

Assuming the PrEP efficacy of 80% and that 85% of included participants being MSM - the objective is to evidence a decrease of at least 15% of new diagnosis of HIV infections among MSM in Ile-de-France area. This objective is in the framework of a commitment of large cities against AIDS with the political support of the City of Paris for the "Paris sans SIDA" program and the commitment of the Île-de-France area.

Secondary Objectives:

  • Prevalence of HIV infection at the screening visit (undiagnosed epidemic)
  • Incidence of HIV infection according to back-calculation approach, and by key subgroups

Operational Objectives:

  • Evaluate the origin of the recruitment according to the risk groups and the outreach actions
  • Assess linkage to care for PrEP, retention in the study, reasons for consent withdrawal and satisfaction of the participants according to the screening site, the type of PrEP supply, the costs of global care, the key subgroups, the type of counselling, the time from STD testing to initiation of PrEP treatment in study sites
  • Impact of a less intense counselling than the one provided in the ANRS IPERGAY trial, on adherence and efficacy of PrEP by comparing the incidence observed in MSM enrolled in the current study to that evidenced in the ANRS IPERGAY trial, with a method similar to that used in the Partner demonstration project in Kenya and Uganda.
  • Impact of the communautary-based and educational counselling

Clinical Objectives:

  • Estimation, in individuals seeking for PrEP and thus getting tested for HIV infection, the prevalence of HIV infection in different key subgroups, which is a surrogate marker of the undiagnosed (or "hidden") epidemic
  • Evaluate who will become HIV-infected during the course of the study while on PrEP, the proportion of patients on combined antiretroviral treatment and the proposition of patients with a suppressed HIV viral load 12 months after HIV infection
  • Evaluate the participants' need for post-exposure prophylaxis during the course of the study
  • Adherence to PrEP (questionnaire and dried blood spots)
  • Assessment of the PrEP dosing schedule used by MSM participants (daily or intermittent) throughout the course of the study
  • Assessment of PrEP tolerability and safety
  • Comprehensive study of incident HIV infections in those on PrEP (incidence, emergence of drug-associated resistance mutations, adherence to PrEP at the closest visit before HIV seroconversion and at previous visits)

Participants Behavior:

  • Acceptability of PrEP (including those who will decline participation in the study) and during the course of the study, and retention in the study.
  • Impact of PrEP, within a comprehensive prevention offer, on sexual behavior of the participants throughout follow-up
  • 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
  • Reasons related to the choice of the prevention strategy used in terms of dosing schedule (continuous or on demand in MSM) and type of counselling and participation to focus groups.

Care Providers Behavior: Evaluation of knowledge, beliefs, perception and practice of the physicians, nurse and peer counselors involved in delivery of PrEP in the study

Social epidemiology: Evaluation of social and/or territorial inequalities and disparities

Cost-effectiveness of the comprehensive prevention strategy

Conditions
HIV Infections
Being tested
PrEP with Truvada®
Keywords
Adherence, Prevention, Tenofovir, Emtricitabine, Antiretroviral, Prophylaxis, Men who have sex with men
Medical subject headings
HIV Infections, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEP with Truvada®Drug

    Also called Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)

    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.
Study groups in NCT03113123
Study groupRoleWhat they receive
PrEP with Truvada®OtherOn 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.
Receives: Drug: PrEP with Truvada®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of new HIV diagnosis

    Number of new HIV infections

    Measured: three years

Secondary outcomes (16)

  1. Number of recent infections

    Impact of the study on the total number and on recent HIV infections in Île-de- France, and in each key subgroup

    Measured: three years

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

    Number of HIV-infected persons at screening visit

    Measured: two years

  3. Incidence of HIV infection

    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.)

    Measured: three years

  4. Retention in the study

    Retention in the study, reasons for consent withdrawal

    Measured: two years

  5. Counselling

    Impact of a less intense counselling than the one provided in the ANRS IPERGAY trial, on adherence and efficacy of PrEP

    Measured: three years

  6. Type of counselling

    Impact of counselling according to the type of counselling provided: communautary-based or educational

    Measured: three years

  7. Post-exposure prophylaxis

    Evaluate the participants' need for post-exposure prophylaxis during the course of the study

    Measured: three years

  8. Adherence to PrEP

    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

    Measured: three years

  9. PrEP dosing schedule

    Assessment of the PrEP dosing schedule used by MSM participants (daily or intermittent) throughout the course of the study

    Measured: three years

  10. Safety and tolerability

    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

    Measured: three years

  11. Incident HIV infections

    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

    Measured: three years

  12. Participants Behavior

    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

    Measured: three years

  13. Integration of PrEP in the daily routine of participants

    • 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)

    Measured: three years

  14. Care Providers Behavior

    Evaluation of knowledge, beliefs, perception and practice of the physicians, nurse and peer counselors involved in delivery of PrEP in the study

    Measured: three years

  15. Social epidemiology

    • 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)

    Measured: three years

  16. Cost-effectiveness

    Cost-effectiveness of the comprehensive prevention strategy provided in this study

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start3 May 2017
  3. Primary completion2 May 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,257 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03113123
Sponsor's protocol ID
ANRS PREVENIR
Other IDs
2016-A01577-44
Acronym
ANRS-PREVENIR
Status last verified
Jun 2022
First submitted
10 Apr 2017
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37046178

  • 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.

    PubMed 35772417

Questions about this trial

What is this clinical trial studying?

A study testing PrEP with Truvada® in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean-Michel MOLINA, Pr (0142499066, jean-michel.molina@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of new HIV diagnosis (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03113123, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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