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.

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.

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

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01509508