Dat'Aids Prevention

HIV Prevention Clinical Trial

Official title:

HIV Prevention in France : "Dat'AIDS Prevention"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795376
• Other study ID #: DAT_002
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2029

Study information

• Verified date: February 2024
• Source: DatAids
• Contact: Pascal Pugliese, MD
• Phone: 0033492035802
• Email: pugliese.p[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6500
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Locations

Country	Name	City	State
France	Hôpital Nord Franche Comté	Belfort
France	CHU Besançon - Hôpital Jean Minjoz	Besançon
France	CHRU Brest	Brest
France	CHU Clermont-Ferrand - Hôpital Gabriel-Montpied	Clermont-Ferrand
France	CHD Vendée	La Roche-sur-Yon
France	Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris	Le Kremlin-Bicêtre
France	Hôpital de la Croix-Rousse - Hospices Civils de Lyon	Lyon
France	Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille	Marseille
France	Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille	Marseille
France	CHR Metz-Thionville	Metz
France	Hôpital Gui de Chauliac	Montpellier
France	CHU Nancy - Hôpital Brabois	Nancy
France	CHU Nantes - Hôtel-Dieu	Nantes
France	CHU Nice - Hôpital l'Archet	Nice
France	CH Niort	Niort
France	Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris	Paris
France	Hôpital Bichat - Assistance Publique des Hôpitaux de Paris	Paris
France	Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris	Paris
France	Centre Hospitalier de Cornouaille	Quimper
France	CHU Reims - Hôpital Robert Debré	Reims
France	CHU Rennes - Hôpital Pontchaillou	Rennes
France	CHU Rouen	Rouen
France	CHU St Etienne - Hôpital Nord	Saint-Étienne
France	CHU Strasbourg - Hôpital Civil	Strasbourg
France	CHU Toulouse - Hôpital Purpan	Toulouse
France	CHU Tourcoing - Hôpital Guy Chatiliez	Tourcoing
France	CH Troyes	Troyes
France	CH Bretagne-Atlantique	Vannes
Guadeloupe	CHU de Guadeloupe	Pointe-à-Pitre
Martinique	CHU de Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
DatAids

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From date of enrollment, through study completion, an average of 1 year
Secondary	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	From date of enrollment, through study completion, an average of 1 year
Secondary	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	From date of enrollment, through study completion, an average of 1 year
Secondary	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	From date of enrollment, through study completion, an average of 1 year
Secondary	Proportion of persons enrolled for pre-exposure prophylaxis in the cohort according to national French guidelines	Adequation between prevention practices and guidelines	From date of enrollment, through study completion, an average of 1 year
Secondary	Proportion of persons enrolled for post-exposure prophylaxis in the cohort according to national French guidelines	Adequation between prevention practices and guidelines	From date of enrollment, through study completion, an average of 1 year
Secondary	Incidence of STIs		From date of enrollment, through study completion, an average of 1 year
Secondary	Incidence of hepatitis		From date of enrollment, through study completion, an average of 1 year