Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence (TasP)
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.
Sponsor: ANRS, Emerging Infectious Diseases
A observational or N/A phase clinical study on HIV Infection, this trial is completed. The trial is conducted by ANRS, Emerging Infectious Diseases and has accumulated 8 data snapshots since 2012. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)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
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
Status Flow
Change History
8 versions recorded-
Apr 16, 2026 — Present [daily]
Completed
Phase: NA → None
-
Sep 2024 — Apr 2026 [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Oct 2021 — Jul 2024 [monthly]
Completed NA
-
Jan 2021 — Oct 2021 [monthly]
Completed NA
▶ Show 3 earlier versions
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Jul 2018 — Jan 2021 [monthly]
Completed NA
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Jun 2018 — Jul 2018 [monthly]
Completed NA
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Jan 2017 — Jun 2018 [monthly]
Completed NA
First recorded
Mar 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- ANRS, Emerging Infectious Diseases
- Africa Centre For Health and Population Studies
- University of KwaZulu
For direct contact, visit the study record on ClinicalTrials.gov .