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Dat'Aids Prevention

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ClinicalTrials.gov Identifier: NCT03795376
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
DatAids

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

Condition or disease
HIV Prevention

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Study Type : Observational
Estimated Enrollment : 6500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV Prevention in France : "Dat'AIDS Prevention"
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Incidence of STIs [ Time Frame: From date of enrollment, through study completion, an average of 1 year ]
  7. Incidence of hepatitis [ Time Frame: From date of enrollment, through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795376


Contacts
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Contact: Pascal Pugliese, MD 0033492035802 pugliese.p@chu-nice.fr
Contact: Solène Secher solene.secher@gmail.com

Sponsors and Collaborators
DatAids
Investigators
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Principal Investigator: Pascal PUGLIESE, MD Centre Hospitalier Universitaire de Nice
Principal Investigator: André CABIE, MD-PhD Centre Hospitalier Universitaire de Martinique

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Responsible Party: DatAids
ClinicalTrials.gov Identifier: NCT03795376     History of Changes
Other Study ID Numbers: DAT_002
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No