Evidence map›Paper›PMID 23880306›Full record

Trial reportTrials2013

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.

Collins C Iwuji, Joanna Orne-Gliemann, Frank Tanser, Sylvie Boyer, Richard J Lessells, France Lert, John Imrie, Till Bärnighausen, Claire Rekacewicz, Brigitte Bazin and 3 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01509508 (A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP), which is not on this map. Cited by 77 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 2 pooled it
10.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01509508 nacompletednot on this map

A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa.

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2012 to 2016Enrolled28,153ConditionsHIV InfectionArmsImmediate ARV treatment initiation with TDF/FTC/EFV, South African recommendation guided ARV (TDF/FTC/EFV) initiation
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 2 syntheses or guidelines pooled it, 116 citations in OpenAlex.

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17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 4 countries.

Collins C IwujiAfrica Centre for Health and Population Studies, University of KwaZulu-Natal, Somkhele, KwaZulu-Natal, South Africa. ciwuji@africacentre.ac.za
Joanna Orne-Gliemann
Frank Tanser
Sylvie Boyer
Richard J Lessells
France Lert
John Imrie
Till Bärnighausen
Claire Rekacewicz
Brigitte Bazin
Marie-Louise Newell
François Dabis
ANRS 12249 TasP Study Group
Inserm · FRAgence Nationale de Recherches sur le Sida et les Hépatites Virales · FRHarvard University · USAfrica Health Research Institute · ZALondon School of Hygiene & Tropical Medicine · GBUniversity of KwaZulu-Natal · ZA

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Novel Methods to Inform HIV/TB Clinical Trial DevelopmentR01AI093269 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI REDDY, KRISHNA P · 2011 to 2024
$6.8M
Understanding causal pathways of HIV acquisition and transmission: a multi-level,R01HD058482 · NICHD · UNIVERSITY OF KWAZULU-NATAL · PI BARNIGHAUSEN, TILL, TANSER, FRANK COURTENEY · 2008 to 2012
$1.2M
NIAID NIH HHS UM1 AI068636NICHD NIH HHS R01 HD058482Wellcome Trust 090999Wellcome Trust 097410
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes. METHODS/

designA cluster-randomised trial in 34 (2 × 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 × 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/μL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters. DISCUSSION: We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability.

trial registrationClinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.

Indexed as

Guideline AdherencePractice Guidelines as TopicResearch DesignWorld Health OrganizationAdolescentAdultAnti-Retroviral AgentsCD4 Lymphocyte CountClinical ProtocolsCost-Benefit AnalysisDrug Administration ScheduleDrug CostsDrug Resistance, ViralFeasibility StudiesHealth Knowledge, Attitudes, PracticeHIV InfectionsAnti-Retroviral Agents

Identifiers

PMID23880306
PMCPMC3750830
OpenAlexW2109064013

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.