Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01509508
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2011-12-20
Brief Title:
Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence The ARNS 12249 TasP Treatment as Prevention Trial in Hlabisa Sub-district KwaZulu-Natal South Africa
Status:
COMPLETED
Status Verified Date:
2016-07
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:
TasP
Brief Summary:
This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level
The proposed strategy is a two steps process
Extensive HIV counselling and testing and comprehensive prevention programme among a target population
Immediate ART initiation after HIV diagnosis irrespective of CD4 count criteria
The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected
The proposed strategy is a two steps process
Extensive HIV counselling and testing and comprehensive prevention programme among a target population
Immediate ART initiation after HIV diagnosis irrespective of CD4 count criteria
The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected
Detailed Description:
The trial objective is to estimate the effect of ART initiated immediately after HIV diagnosis on the reduction in incidence of new HIV infections in the general population It will be conducted in two phases
First phase aiming to evaluate the feasibility and acceptability of extensive HIV testing and early ARV treatment initiation on a subset of the target population Hlabisa sub-district in KwaZulu Natal South Africa completion on February 2014
Second phase full implementation of the trial in the target population from May 2014
The proposed intervention has two components
Component 1 Test HIV counselling and testing and comprehensive prevention programme among the entire target population
Component 2 Treat ART treatment initiation for HIV infected individuals following two strategies
control group ART initiation when eligible for treatment as per WHO guidelines
intervention group immediate ART initiation regardless of immunological and clinical staging
First phase aiming to evaluate the feasibility and acceptability of extensive HIV testing and early ARV treatment initiation on a subset of the target population Hlabisa sub-district in KwaZulu Natal South Africa completion on February 2014
Second phase full implementation of the trial in the target population from May 2014
The proposed intervention has two components
Component 1 Test HIV counselling and testing and comprehensive prevention programme among the entire target population
Component 2 Treat ART treatment initiation for HIV infected individuals following two strategies
control group ART initiation when eligible for treatment as per WHO guidelines
intervention group immediate ART initiation regardless of immunological and clinical staging
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