Impact of Immediate Versus South African Recommendations Guided ART

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01509508
Study type	Interventional
Source	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact
Status	Completed
Phase	N/A
Start date	March 2012
Completion date	June 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms