Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 8:03 PM
Study NCT ID:
NCT01509508
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2011-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
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:
True
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?: