HIV PreventionNCT03795376
Dat'Aids Prevention
An observational study of HIV Prevention, run by DatAids at 31 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- How many people
- 6,500 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 1 Jan 2019to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- Male and female over 18 years old,
- HIV negative
- Attending for :
- HIV screening
- Hepatitis screening
- STI screening / treatment
Show all 10Show fewer
- Blood, body fluid or sexual exposure
- Post-exposure prophylaxis
- Pre-exposure prophylaxis
- Signed consent
Who cannot join
- HIV-infection
- Refusal to participate
Trial locations and contacts
31 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Solène Secher contact
31 sites in 3 countries
France29 sites, 29 recruiting
- Recruiting
Hôpital Nord Franche Comté
Belfort
Vincent GENDRIN
Vincent GENDRIN
- Recruiting
CHU Besançon - Hôpital Jean Minjoz
Besançon
Catherine CHIROUZE
Catherine CHIROUZE
- Recruiting
CHRU Brest
Brest
Sylvain JAFFUEL
Sylvain JAFFUEL
- Recruiting
CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand
Christine JACOMET
Christine JACOMET
- Recruiting
CHD Vendée
La Roche-sur-Yon
Dominique MERRIEN
Dominique MERRIEN
- Recruiting
Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
Le Kremlin-Bicêtre
Antoine CHERET
Antoine CHERET
- Recruiting
CHU Limoges
Limoges
Claire GENET
Claire GENET
- Recruiting
Hôpital de la Croix-Rousse - Hospices Civils de Lyon
Lyon
Dulce ALFAIATE
Dulce ALFAIATE
- Recruiting
Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
Marseille
Sylvie BREGIGEON-RONOT
Sylvie BREGIGEON-RONOT
- Recruiting
IHU - Assistance Publique des Hôpitaux de Marseille
Marseille
Amélie MENARD
Amélie MENARD
- Recruiting
CHR Metz-Thionville
Metz
Céline ROBERT
Céline ROBERT
- Recruiting
Hôpital Gui de Chauliac
Montpellier
Alain MAKINSON
Alain MAKINSON
- Recruiting
CHU Nancy - Hôpital Brabois
Nancy
Benjamin LEFEVRE
Benjamin LEFEVRE
- Recruiting
CHU Nantes - Hôtel-Dieu
Nantes
Clotilde ALLAVENA
Clotilde ALLAVENA
- Recruiting
CHU Nice - Hôpital l'Archet
Nice
Pascal PUGLIESE
Pascal PUGLIESE
- Recruiting
CH Nîmes
Nîmes
Paul LOUBET
Paul LOUBET
- Recruiting
CHR Orléans
Orléans
Laurent HOCQUELOUX
Laurent HOCQUELOUX
- Recruiting
Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
Paris
Christine KATLAMA
Christine KATLAMA
- Recruiting
Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
Paris
Yazdan YAZDANPANAH
Yazdan YAZDANPANAH
- Recruiting
Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
Paris
Claudine DUVIVIER
Claudine DUVIVIER
- Recruiting
Centre Hospitalier de Cornouaille
Quimper
Nolwenn HALL
Nolwenn HALL
- Recruiting
CHU Reims - Hôpital Robert Debré
Reims
Firouze BANISADR
Firouze BANISADR
- Recruiting
CHU Rennes - Hôpital Pontchaillou
Rennes
Cédric ARVIEUX
Cédric ARVIEUX
- Recruiting
CHU Rouen
Rouen
Manuel ETIENNE
Manuel ETIENNE
- Recruiting
CHU St Etienne - Hôpital Nord
Saint-Etienne
Amandine GAGNEUX-BRUNON
Amandine GAGNEUX-BRUNON
- Recruiting
CHU Strasbourg - Hôpital Civil
Strasbourg
Axel URSENBACH
Axel URSENBACH
- Recruiting
CHU Toulouse - Hôpital Purpan
Toulouse
Pierre DELOBEL
Pierre DELOBEL
- Recruiting
CHU Tourcoing - Hôpital Guy Chatiliez
Tourcoing
Olivier ROBINEAU
Olivier ROBINEAU
- Recruiting
CH Bretagne-Atlantique
Vannes
Grégory CORVAISIER
Grégory CORVAISIER
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU de Guadeloupe
Pointe-à-Pitre
Isabelle LAMAURY
Isabelle LAMAURY
Martinique1 site, 1 recruiting
- Recruiting
CHU de Martinique
Fort-de-France
André CABIE
André CABIE
About this study
Official title: 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
- Conditions
- HIV Prevention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled for HIV prevention in the cohort
Demographics, risk factors clinical and biological characteristics, treatment of patients enrolled for HIV prevention in the cohort
Measured: From date of enrollment, through study completion, an average of 1 year
Secondary outcomes (7)
Proportion of persons enrolled for pre-exposure prophylaxis in the cohort
Demographics, risk factors clinical and biological characteristics, treatment of patients attending for pre-exposure prophylaxis in the cohort
Measured: From date of enrollment, through study completion, an average of 1 year
Proportion of persons enrolled for post-exposure prophylaxis in the cohort
Demographics, risk factors clinical and biological characteristics, treatment of patients attending for post-exposure prophylaxis in the cohort
Measured: From date of enrollment, through study completion, an average of 1 year
Proportion of persons enrolled for hepatitis screening in the cohort
Demographics, risk factors clinical and biological characteristics, treatment of patients attending for hepatitis screening in the cohort
Measured: 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
Adequation between prevention practices and guidelines
Measured: 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
Adequation between prevention practices and guidelines
Measured: From date of enrollment, through study completion, an average of 1 year
Incidence of STIs
Measured: From date of enrollment, through study completion, an average of 1 year
Incidence of hepatitis
Measured: From date of enrollment, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DatAids
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PUGLIESE, MD, Principal investigator, Centre Hospitalier Universitaire de NiceAndré CABIE, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795376
- Sponsor's protocol ID
- DAT_002
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2018
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention in France : "Dat'AIDS Prevention"
- ClinicalTrials.gov ID
- NCT03795376
- Acronym / sponsor ID
- DAT_002
- Conditions
- HIV Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- DatAidsUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Male and female over 18 years old,
- HIV negative
- Attending for :
- HIV screening
- Hepatitis screening
Key exclusion criteria (2 listed)
- HIV-infection
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
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
Proportion of persons enrolled for hepatitis screening in the cohort
Time frame: 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
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
Incidence of STIs
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Solène Secher contact
Pascal PUGLIESE, MD principal investigator
Centre Hospitalier Universitaire de Nice
André CABIE, MD-PhD principal investigator
Centre Hospitalier Universitaire de Martinique
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by DatAids at 31 sites in 3 countries.
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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Guadeloupe, Martinique. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal Pugliese, MD (0033492035802, pugliese.p@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled for HIV prevention in the cohort (time frame: From date of enrollment, through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.