Ignite Creation Date:
2024-05-06 @ 10:03 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03145753
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2017-05-05
Brief Title:
Education vs Education Plus Intervention in HIVHCV Diagnosis DRIVE 03
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
Impact on New HIVHCV Infection Diagnoses and Costs of Two HIVHCV Testing Programs Education and Support Only Versus Education and Support Plus a Resourced External Program DRIVE 03
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRIVE
Brief Summary:
Objectives A targeted HIV testing strategy TTS through an HIV risk of exposure and indicator conditions REIC questionnaire resulted in same rate of new HIV infection diagnosis NHID coverage and even reduced costs compared with a universal non targeted Non TSS HIV testing strategy in a prior study DRIVE 01 To compare number of New HIVHCV Infection Diagnoses NHID HIVHCV and costs two HIVHCV testing programs in the Primary Health Care an educational and support only initiative to enhance HIV HCV testing EDSUP or EDSUP plus a resourced external program DRIVE 03
Methodology Prospective randomized 11 clustered crossover study in one Health Care Area of Madrid Spain comparing the implementation of two HIV testing programs EDSUP only vs EDSUP plus DRIVE 03 program in 4 Primary Care Centers PCCs People randomized to EDSUP plus DRIVE 03 program non HIV infected between 18-65 years attending to any of the 4 PCCs not previously included in the study will be offered to participate HIV testing program will be evaluated by measuring absolute number of new diagnosed infections NDI HIVHCV and costs Other outcomes considered will be people assigned and offered to participate number of HIV tests performed coverage HIV HCV testsassigned population ratio and rate of NDI HIVHCV per tests performed Six months prior to randomization main outcome variables will be recorded in the 4 PPCs Before randomization EDSUP will be equally implemented in the 4 PCCs After randomization first six months DRIVE 03 program will be implemented in 2 PCCs and in the other 2 observation of interest variables will be conducted After first 6 month study period PCCs will be crossover to the opposite arm of randomization DRIVE 03 program will offer rapid HIV tests and testing staff to conduct all study procedures For NDI HIVHCV molecular epidemiology delayed diagnosis retention in care HIVHCV treatment and controleradication will be also monitored
Methodology Prospective randomized 11 clustered crossover study in one Health Care Area of Madrid Spain comparing the implementation of two HIV testing programs EDSUP only vs EDSUP plus DRIVE 03 program in 4 Primary Care Centers PCCs People randomized to EDSUP plus DRIVE 03 program non HIV infected between 18-65 years attending to any of the 4 PCCs not previously included in the study will be offered to participate HIV testing program will be evaluated by measuring absolute number of new diagnosed infections NDI HIVHCV and costs Other outcomes considered will be people assigned and offered to participate number of HIV tests performed coverage HIV HCV testsassigned population ratio and rate of NDI HIVHCV per tests performed Six months prior to randomization main outcome variables will be recorded in the 4 PPCs Before randomization EDSUP will be equally implemented in the 4 PCCs After randomization first six months DRIVE 03 program will be implemented in 2 PCCs and in the other 2 observation of interest variables will be conducted After first 6 month study period PCCs will be crossover to the opposite arm of randomization DRIVE 03 program will offer rapid HIV tests and testing staff to conduct all study procedures For NDI HIVHCV molecular epidemiology delayed diagnosis retention in care HIVHCV treatment and controleradication will be also monitored
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None