Clinical trial NCT03795376: Dat'Aids Prevention
Official title: HIV Prevention in France : "Dat'AIDS Prevention"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Prevention
Lead sponsor: DatAids
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All persons attending for HIV prevention and seeking care at 23 centers using NADIS are included in the Dataids Prevention cohort after receiving oral information and giving written consent. NADIS is an electronic medical record (EMR) for HIV infection (and Hepatitis B virus (HBV), Hepatitis C virus (HCV), STI) and HIV prevention in French public hospitals.

The Dataids Prevention study recruits persons HIV- and above the age of 18 years.

Brief summary: DatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France including overseas, aiming to describe HIV prevention in every aspect including HIV screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure prophylaxis


Eligibility criteria: Inclusion Criteria:

* Male and female over 18 years old,
* HIV negative
* Attending for :
* HIV screening
* Hepatitis screening
* STI screening / treatment
* Blood, body fluid or sexual exposure
* Post-exposure prophylaxis
* Pre-exposure prophylaxis
* Signed consent

Exclusion Criteria:

* HIV-infection
* Refusal to participate

Primary outcomes:
measure: Number of patients enrolled for HIV prevention in the cohort
timeFrame: From date of enrollment, through study completion, an average of 1 year
Secondary outcomes:
measure: Proportion of persons enrolled for pre-exposure prophylaxis in the cohort
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Proportion of persons enrolled for post-exposure prophylaxis in the cohort
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Proportion of persons enrolled for hepatitis screening in the cohort
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Proportion of persons enrolled for pre-exposure prophylaxis in the cohort according to national French guidelines
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Proportion of persons enrolled for post-exposure prophylaxis in the cohort according to national French guidelines
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Incidence of STIs
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Incidence of hepatitis
timeFrame: From date of enrollment, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche Comté
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Brest
country: France
facility: CHRU Brest
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille
city: Marseille
country: France
facility: Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
city: Metz
country: France
facility: CHR Metz-Thionville
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU Nancy - Hôpital Brabois
city: Nantes
country: France
facility: CHU Nantes - Hôtel-Dieu
city: Nice
country: France
facility: CHU Nice - Hôpital l'Archet
city: Niort
country: France
facility: CH Niort
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Reims
country: France
facility: CHU Reims - Hôpital Robert Debré
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Étienne
country: France
facility: CHU St Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: CHU Strasbourg - Hôpital Civil
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Purpan
city: Tourcoing
country: France
facility: CHU Tourcoing - Hôpital Guy Chatiliez
city: Troyes
country: France
facility: CH Troyes
city: Vannes
country: France
facility: CH Bretagne-Atlantique
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU de Guadeloupe
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pascal PUGLIESE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Martinique
name: André CABIE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: