Prevention of HIV in "Île-de-France"

HIV Infections Clinical Trial

— ANRS-PREVENIR  

Official title:

Prevention of HIV in "Île-de-France"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03113123
• Other study ID #: ANRS PREVENIR
• Secondary ID: 2016-A01577-44
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: October 2024

Study information

• Verified date: June 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: Jean-Michel MOLINA, Pr
• Phone: 0142499066
• Email: jean-michel.molina[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3257
• Est. completion date: October 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Hôpital Jean Verdier	Bondy
France	Hôpital Ambroise-Paré	Boulogne
France	Hôpital Antoine Béclère	Clamart
France	Hôpital Louis Mourier	Colombes
France	Hôpital Henry Mondor	Creteil
France	Hôpital Raymond Poincaré	Garches
France	Hôpital de Bicêtre	Le Kremlin Bicêtre
France	Centre Hospitalier Marc Jacquet	Melun
France	Hôpital Bichat-Claude-Bernard	Paris
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Hôtel Dieu	Paris
France	Hôpital Necker-Enfants Malades	Paris
France	Hôpital Pitié-Salpétrière	Paris
France	Hôpital Pitié-Salpétrière	Paris
France	Hôpital Saint-Antoine	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Tenon	Paris
France	CHI Poissy Saint Germain en Laye	Saint Germain en Laye
France	Hôpital Foch	Suresnes
France	Hôpital André Mignot	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of new HIV diagnosis	Number of new HIV infections	three years
Secondary	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	three years
Secondary	Prevalence of HIV-infection at the screening visit (undiagnosed epidemic)	Number of HIV-infected persons at screening visit	two years
Secondary	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.)	three years
Secondary	Retention in the study	Retention in the study, reasons for consent withdrawal	two years
Secondary	Counselling	Impact of a less intense counselling than the one provided in the ANRS IPERGAY trial, on adherence and efficacy of PrEP	three years
Secondary	Type of counselling	Impact of counselling according to the type of counselling provided: communautary-based or educational	three years
Secondary	Post-exposure prophylaxis	Evaluate the participants' need for post-exposure prophylaxis during the course of the study	three years
Secondary	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	three years
Secondary	PrEP dosing schedule	Assessment of the PrEP dosing schedule used by MSM participants (daily or intermittent) throughout the course of the study	three years
Secondary	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	three years
Secondary	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	three years
Secondary	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	three years
Secondary	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)	three years
Secondary	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	three years
Secondary	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)	three years
Secondary	Cost-effectiveness	Cost-effectiveness of the comprehensive prevention strategy provided in this study	three years

External Links

•   sponsor of the study