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

NCT01509508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28153

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

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.

Sponsors & Collaborators

  • Africa Centre For Health and Population Studies

    collaborator OTHER

  • University of KwaZulu

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • François Dabis, PhD · INSERM unit 897, ISPED, Université Bordeaux II, France

  • Marie-Louise Newell, PhD · University of Southamton, United Kingdom

  • Deenan Pillay, PhD · Africa Centre for Health and Population Studies, University of KwaZullu Natal, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509508 on ClinicalTrials.gov