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

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: HIV Infection

Treatments: Other: South African recommendation guided ARV (TDF/FTC/EFV) initiation; Drug: Immediate ARV treatment initiation with TDF/FTC/EFV

Study type: Interventional

Funder types: Other

Identifiers

NCT01509508

ANRS 12249 TasP

Details and patient eligibility

About

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.

Full 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

Enrollment: 28,153 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28,153 participants in 2 patient groups

Immediate ARV treatment initiation

Experimental group

Description:

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

Treatment:

Drug: Immediate ARV treatment initiation with TDF/FTC/EFV

South African recommendation guided ARV initiation

Other group

Description:

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

Treatment:

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