Prevention of HIV in "Île-de-France"

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2022
• Main ID: NCT03113123
• Date of registration: 10/04/2017
• Prospective Registration: Yes
• Primary sponsor: ANRS, Emerging Infectious Diseases
• Public title: Prevention of HIV in "Île-de-France" ANRS-PREVENIR
• Scientific title: Prevention of HIV in "Île-de-France"
• Date of first enrolment: May 3, 2017
• Target sample size: 3257
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03113123
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Jean-Michel MOLINA, Pr
• Affiliation: Hôpital Saint Louis, Paris, FRANCE

• Name: Jean-Michel MOLINA, Pr

• Name: Jade GHOSN, MD
• Affiliation: Hôpital Hôtel-Dieu, Paris, FRANCE

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: PrEP with Truvada®

Primary Outcome(s)

Reduction of new HIV diagnosis [Time Frame: three years]

Secondary Outcome(s)

PrEP dosing schedule [Time Frame: three years]

Care Providers Behavior [Time Frame: three years]

Incidence of HIV infection [Time Frame: three years]

Participants Behavior [Time Frame: three years]

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

Cost-effectiveness [Time Frame: three years]

Type of counselling [Time Frame: three years]

Counselling [Time Frame: three years]

Integration of PrEP in the daily routine of participants [Time Frame: three years]

Number of recent infections [Time Frame: three years]

Social epidemiology [Time Frame: three years]

Adherence to PrEP [Time Frame: three years]

Incident HIV infections [Time Frame: three years]

Post-exposure prophylaxis [Time Frame: three years]

Retention in the study [Time Frame: two years]

Safety and tolerability [Time Frame: three years]

Secondary ID(s)

ANRS PREVENIR

2016-A01577-44

Source(s) of Monetary Support

Please refer to primary and secondary sponsors