Trial | NCT01509508  Report issue

Title

Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence
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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    efavirenz tenofovir ...

  • Study Participants

    28153
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 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
Study Started
Mar 31
2012
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Jul 21
2016
Estimate

Drug Immediate ARV treatment initiation with TDF/FTC/EFV

All HIV-infected adults will be offered ART regardless of their immunological and clinical staging. The first line regimen proposed will be Atripla (R), a fixed dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(FTC/TDF/EFV). The dosing will be 1 tablet OD.

Other South African recommendation guided ARV (TDF/FTC/EFV) initiation

HIV-infected adult participants will be eligible for ART as per the South African guidelines (August 2011) if: CD4 count ≤ 350 cells/mm3 irrespective of clinical symptoms WHO clinical stage 3 or 4 irrespective of CD4 count MDR or XDR TB The first line regimen proposed will be Atripla (R), a fixes dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(TDF/FTC/EFV). The dosing will be 1 tablet OD.

Immediate ARV treatment initiation Experimental

Initiation of ARV treatment regardless of participants's immunological and clinical staging

South African recommendation guided ARV initiation Other

HIV-infected individuals will be assessed clinically and immunologically and when eligible for treatment as per South African guidelines will be offered ART

Criteria 

Inclusion Criteria:

Aged 16 and more
Member of a household in the designated cluster within the Hlabisa sub-district of KwaZulu Natal in South Africa
Able and willing to give written informed consent for trial participation and/or HIV counselling and testing
No Results Posted