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

This study is currently recruiting participants.
Verified March 2012 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: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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)


Condition Intervention
HIV Infection
 Drug: Immediate ARV treatment initiation with TDF/FTC/EFV
Other: WHO recommendation guided ARV (TDF/FTC/EFV) initiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 5000
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate ARV treatment initiation
Initiation of ARV treatment regardless of participants's immunological and clinical staging
 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.
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
 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.

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 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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509508

Contacts
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

Locations
South Africa
Hlabisa Hospital Recruiting
Hlabisa, KwaZulu-Natal, South Africa, 3937
Contact: Kevi Naidu         knaidu@afriacentre.ac.za    
Contact: Jabu Mbulu         jmbulu@africacentre.ac.za    
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: ANRS 12249 TasP
Study First Received: December 20, 2011
Last Updated: March 15, 2012
Health Authority: South Africa: Department of Health

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
Prevention
Treatment
South Africa

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013