Impact of Immediate Versus WHO Recommendations Guided ART Initiation on HIV Incidence - Feasibility Phase (TasP)

This study is currently recruiting participants.
Verified July 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Collaborators:
Africa Centre For Health and Population Studies, South Africa
University of KwaZulu-Natal, South Africa
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01509508
First received: December 20, 2011
Last updated: July 16, 2013
Last verified: July 2013

December 20, 2011
July 16, 2013
March 2012
December 2015   (final data collection date for primary outcome measure)
  • Uptake of initial and repeat HIV counselling and testing [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Percentage of the target population tested for HIV
  • Uptake of ARV treatment among HIV-infected individuals [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Percentage of HIV-infected patients followed-up in the trial clinics receiving ARV treatment when eligible
Same as current
Complete list of historical versions of study NCT01509508 on ClinicalTrials.gov Archive Site
  • Sexual partnerships [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Percentage of participants reporting a certain number of sexual partnerhsips in the last 12 months
  • Safe sex and condom use [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Percentage of participants using a male condom with their partner during the last sexual intercourse
  • Quality of life [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    • the EQ-5D scale among the whole sample
    • the Patient Reported Outcomes Quality Of Life specific to HIV (PROQOL-HIV) instrument and the HIV/AIDS stigma instrument for PLWHA (HASI-P) tool among HIV-infected participants
  • Health care use and health care expenditures [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Percentage of participants reporting health care visits (primary care centre, pharmacy, hospitalisation) in the past four weeks and cost incurred
  • Stigma at community level [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Percentage of participants agreeing that people in the community do not blame people for having HIV Percentage of participants agreeing that people in the community avoid people with HIV
  • Adherence to ART [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Measured three-monthly using a visual analogue scale, pill identification test and pill count
  • Retention [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Proportion of HIV-infected participants still under active follow-up in the trial at key timepoints
Same as current
Not Provided
Not Provided
 
Impact of Immediate Versus WHO Recommendations Guided ART Initiation on HIV Incidence - Feasibility Phase
A Cluster Randomised Trial Comparing the Impact of Immediate Versus WHO Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa.

This trial is the first phase of a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level.

This first phase will allow an evaluation of the feasibility and acceptability of the following proposed two steps strategy:

  • 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. A cluster randomised controlled trial with a total of 34 communities used as the units for randomisation is planed to enroll a population of 42 500 individuals among which 8 000 are expected to be HIV-Infected.

This pilote phase will be implemented on a selected number of clusters (4) representing around 5 000 individuals (1 000 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 over a period of 24 months. 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)
  • Second phase: implementation of the trial in the target population if the procedures and approach are shown to be feasible

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
  • 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: WHO recommendation guided ARV (TDF/FTC/EFV) initiation

    HIV-infected adult participants will be eligible for ART as per the 2010 WHO guideline, and in line with the August 2011 South African guidelines 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.
  • Experimental: Immediate ARV treatment initiation
    Initiation of ARV treatment regardless of participants's immunological and clinical staging
    Intervention: Drug: Immediate ARV treatment initiation with TDF/FTC/EFV
  • WHO recommendation guided ARV initiation
    HIV-infected individuals will be assessed clinically and immunologically and when eligible for treatment as per WHO guidelines will be offered ART
    Intervention: Other: WHO recommendation guided ARV (TDF/FTC/EFV) initiation
Iwuji CC, Orne-Gliemann J, Tanser F, Boyer S, Lessells RJ, Lert F, Imrie J, Bärnighausen T, Rekacewicz C, Bazin B, Newell ML, Dabis F; ANRS 12249 TasP Study Group. Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial. Trials. 2013 Jul 23;14:230. doi: 10.1186/1745-6215-14-230.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact: Collins Iwuji, MRCP, MSc, Dip HIVMed +27 35 550 7502 ciwuji@africacentre.ac.za
Contact: Joanna Orne-Gliemann, PhD +33 5 57 57 45 17 ornegliemann_joanna@yahoo.fr
South Africa
 
NCT01509508
ANRS 12249 TasP
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Africa Centre For Health and Population Studies, South Africa
  • University of KwaZulu-Natal, South Africa
Study Chair: François Dabis, PhD INSERM unit 897, ISPED, Université Bordeaux II, France
Study Chair: Marie-Louise Newell, PhD Africa Centre, University of KwaZulu Natal, Somkhele, South Africa
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP