Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528626
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-07-05
Brief Title:
Tools to Identify People at Risk or Already Infected With HIV and HCV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to Identify People at Risk or Already Infected With HIV and HCV
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATENEA
Brief Summary:
Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV
Detailed Description:
Objectives To reduce hidden and incident HIV and HCV infection through the implementation of a risk and indicator conditions self-questionnaire SQ-RIC for HIV and HCV infection in addition to rapid HIV and HCV serological tests RT in the Health Centers HC Methodology stepped-wedge cluster randomized trial in 8 CS of the community of Madrid to to know if the implementation of the 2 tools described above improve risk identification and subsequent screening for HIV and HCV infection In the standard of care branch SOC the health personnel will ask people a series of questions to identify the HIV risk exposition and also they will be provided pop-up computer alerts of HIV indicator conditions in the electronic medical record moreover HIV and HCV serological tests will be carried out in the reference laboratory while in the intervention branch in addition to the SOC a SQ-RIC of HIV and HCV will be made available to the HC population through a quick response QR code as well as HIV and HCV RT The variables that will be compared are the percentage of HIV and HCV tests performed of people referred to receive PrEP and of new HIV and HCV diagnoses or not linked to care that are made during the periods assigned to the EDC branch vs those in the intervention branch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None