Dat'Aids Prevention

February 26, 2024 updated by: DatAids

HIV Prevention in France : "Dat'AIDS Prevention"

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

6500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Belfort, France
        • Recruiting
        • Hôpital Nord Franche Comté
        • Contact:
          • Vincent GENDRIN
        • Principal Investigator:
          • Vincent GENDRIN
      • Besançon, France
        • Recruiting
        • CHU Besançon - Hôpital Jean Minjoz
        • Contact:
          • Catherine CHIROUZE
        • Principal Investigator:
          • Catherine CHIROUZE
      • Brest, France
        • Recruiting
        • CHRU Brest
        • Principal Investigator:
          • Sylvain JAFFUEL
        • Contact:
          • Sylvain JAFFUEL
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
        • Principal Investigator:
          • Christine JACOMET
        • Contact:
          • Christine JACOMET
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendée
        • Contact:
          • Dominique MERRIEN
        • Principal Investigator:
          • Dominique MERRIEN
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
        • Principal Investigator:
          • Antoine CHERET
        • Contact:
          • Antoine CHERET
      • Lyon, France
        • Recruiting
        • Hôpital de la Croix-Rousse - Hospices Civils de Lyon
        • Contact:
          • Laurent COTTE
        • Principal Investigator:
          • Laurent COTTE
      • Marseille, France
        • Recruiting
        • Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille
        • Contact:
          • Isabelle RAVAUX
        • Principal Investigator:
          • Isabelle RAVAUX
      • Marseille, France
        • Recruiting
        • Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
        • Contact:
          • Sylvie BREGIGEON-RONOT
        • Principal Investigator:
          • Sylvie BREGIGEON-RONOT
      • Metz, France
        • Recruiting
        • CHR Metz-Thionville
        • Contact:
          • Céline ROBERT
        • Principal Investigator:
          • Céline ROBERT
      • Montpellier, France
        • Recruiting
        • Hopital Gui de Chauliac
        • Contact:
          • Alain MAKINSON
        • Principal Investigator:
          • Alain MAKINSON
      • Nancy, France
        • Recruiting
        • CHU Nancy - Hôpital Brabois
        • Contact:
          • Benjamin LEFEVRE
        • Principal Investigator:
          • Benjamin LEFEVRE
      • Nantes, France
        • Recruiting
        • CHU Nantes - Hôtel-Dieu
        • Contact:
          • François RAFFI
        • Principal Investigator:
          • François RAFFI
      • Nice, France
        • Recruiting
        • CHU Nice - Hôpital l'Archet
        • Principal Investigator:
          • Pascal PUGLIESE
        • Contact:
          • Pascal PUGLIESE
      • Niort, France
        • Recruiting
        • CH Niort
        • Principal Investigator:
          • Simon SUNDER
        • Contact:
          • Simon SUNDER
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Christine KATLAMA
        • Principal Investigator:
          • Christine KATLAMA
      • Paris, France
        • Recruiting
        • Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Yazdan YAZDANPANAH
        • Principal Investigator:
          • Yazdan YAZDANPANAH
      • Paris, France
        • Recruiting
        • Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
        • Principal Investigator:
          • Claudine Duvivier
        • Contact:
          • Claudine DUVIVIER
      • Quimper, France
        • Recruiting
        • Centre Hospitalier de Cornouaille
        • Contact:
          • Nolwenn HALL
        • Principal Investigator:
          • Nolwenn HALL
      • Reims, France
        • Recruiting
        • CHU Reims - Hôpital Robert Debré
        • Contact:
          • Firouze BANISADR
        • Principal Investigator:
          • Firouze BANISADR
      • Rennes, France
        • Recruiting
        • CHU Rennes - Hôpital Pontchaillou
        • Principal Investigator:
          • Pierre TATTEVIN
        • Contact:
          • Pierre TATTEVIN
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Contact:
          • Manuel ETIENNE
        • Principal Investigator:
          • Manuel ETIENNE
      • Saint-Étienne, France
        • Recruiting
        • CHU St Etienne - Hôpital Nord
        • Contact:
          • Amandine GAGNEUX-BRUNON
        • Principal Investigator:
          • Amandine GAGNEUX-BRUNON
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg - Hôpital Civil
        • Principal Investigator:
          • David REY
        • Contact:
          • David REY
      • Toulouse, France
        • Recruiting
        • CHU Toulouse - Hôpital Purpan
        • Contact:
          • Pierre DELOBEL
        • Principal Investigator:
          • Pierre DELOBEL
      • Tourcoing, France
        • Recruiting
        • CHU Tourcoing - Hôpital Guy Chatiliez
        • Contact:
          • Olivier ROBINEAU
        • Principal Investigator:
          • Olivier ROBINEAU
      • Troyes, France
        • Recruiting
        • CH Troyes
        • Contact:
          • Simona PAVEL
        • Principal Investigator:
          • Simona PAVEL
      • Vannes, France
        • Recruiting
        • CH Bretagne-Atlantique
        • Contact:
          • Grégory CORVAISIER
        • Principal Investigator:
          • Grégory CORVAISIER
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe
        • Recruiting
        • CHU de Guadeloupe
        • Principal Investigator:
          • Isabelle LAMAURY
        • Contact:
          • Isabelle LAMAURY
  • Martinique
      • Fort-de-France, Martinique
        • Recruiting
        • CHU de Martinique
        • Contact:
          • André CABIE
        • Principal Investigator:
          • André CABIE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients enrolled for HIV prevention in the cohort
Time Frame: From date of enrollment, through study completion, an average of 1 year
Demographics, risk factors clinical and biological characteristics, treatment of patients enrolled for HIV prevention in the cohort
From date of enrollment, through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of persons enrolled for pre-exposure prophylaxis in the cohort
Time Frame: From date of enrollment, through study completion, an average of 1 year
Demographics, risk factors clinical and biological characteristics, treatment of patients attending for pre-exposure prophylaxis in the cohort
From date of enrollment, through study completion, an average of 1 year
Proportion of persons enrolled for post-exposure prophylaxis in the cohort
Time Frame: From date of enrollment, through study completion, an average of 1 year
Demographics, risk factors clinical and biological characteristics, treatment of patients attending for post-exposure prophylaxis in the cohort
From date of enrollment, through study completion, an average of 1 year
Proportion of persons enrolled for hepatitis screening in the cohort
Time Frame: From date of enrollment, through study completion, an average of 1 year
Demographics, risk factors clinical and biological characteristics, treatment of patients attending for hepatitis screening in the cohort
From date of enrollment, through study completion, an average of 1 year
Proportion of persons enrolled for pre-exposure prophylaxis in the cohort according to national French guidelines
Time Frame: From date of enrollment, through study completion, an average of 1 year
Adequation between prevention practices and guidelines
From date of enrollment, through study completion, an average of 1 year
Proportion of persons enrolled for post-exposure prophylaxis in the cohort according to national French guidelines
Time Frame: From date of enrollment, through study completion, an average of 1 year
Adequation between prevention practices and guidelines
From date of enrollment, through study completion, an average of 1 year
Incidence of STIs
Time Frame: From date of enrollment, through study completion, an average of 1 year
From date of enrollment, through study completion, an average of 1 year
Incidence of hepatitis
Time Frame: From date of enrollment, through study completion, an average of 1 year
From date of enrollment, through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DatAids

Investigators

  • Principal Investigator: Pascal PUGLIESE, MD, Centre Hospitalier Universitaire de Nice
  • Principal Investigator: André CABIE, MD-PhD, Centre Hospitalier Universitaire de Martinique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DAT_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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